Ad Law Access : Washington D.C. Advertising Lawyer & Attorney : Kelley Drye & Warren Law Firm : New York, Chicago, Connecticut, New Jersey, Brussels

The Agriculture Marketing Service of the United States Department of Agriculture announced an agreement reached with Canada’s Food Inspection Agency that will provide U.S. organic dairy, beef, sheep, goat and bison producers with more streamlined access to the Canadian market. Canada now considers U.S. organic requirements for access to pasture and living conditions to be equivalent to Canada’s ruminant stocking rates (number of animals in a given area). The agreement is part of the implementation of an Equivalence Arrangement the two countries entered into in 2009.

U.S. producers who provide ruminant animals with 30 percent of their feed during the grazing season from organic pasture, put animals on pasture at least 120 days per year, and provide animals with adequate space and living conditions which accommodate the natural behavior of livestock are now considered as having met the ruminant stocking rate requirement for labeling product as organic in Canada. U.S. producers are still prohibited from using sodium nitrate in the production of ruminant-derived products labeled as organic in Canada.
 

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On January 25, 2012, the Food Nutrition Service of the U.S. Department of Agriculture (“USDA”) issued a final rule that substantially modifies the menu planning and nutrition requirements for the National School Lunch Program and the School Breakfast Program. The rule, which is intended to improve the dietary habits of school children in grades K-12 and address health concerns related to child obesity, closely aligns the lunch and breakfast meal programs with the most recent “Dietary Guidelines for Americans,” published jointly by the USDA and Department of Health and Human Services and updated every five years. The final rule applies only to foods included in lunch and breakfast meals that are served in the school cafeteria and does not impact foods contained in vending machines or other sources of food at school.

The final rule represents a substantial shift in the nutritional composition and quantity of a number of food items that make up school breakfast and lunch meals and will have far-reaching implications for companies that make or market food products for use in school breakfast or lunch programs. Companies should evaluate the legal and business implications of the rule soon, as many of the changes to the nutrition quality standards are effective at the start of the 2012-2013 school year.

See the Kelley Drye client advisory for more information, and please contact us if you have questions concerning the USDA proposal or other matters.

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The United States Court of Appeals for the Fourth Circuit recently affirmed a West Virginia federal district court's holding that a plaintiff's common law tort claim was preempted by the 1976 Medical Device Amendments ("MDA") to the Food, Drug, and Cosmetic Act ("FDCA"). Under the MDA, certain medical devices, known as Class III devices, are required to receive premarket approval from the Food and Drug Administration ("FDA").  The MDA also allows the FDA to condition a grant of premarket approval on a requirement that a device meet certain performance standards. The establishment of a performance standard is a formal process that requires publication in the Federal Register and providing interested parties with an opportunity to comment.  The MDA expressly preempts state medical device regulations that are “different from, or in addition to, any [federal] requirement."

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In a unanimous opinion published on January 23, 2012, the Supreme Court reversed the Ninth Circuit Court of Appeals and held that a California law prohibiting the sale, processing or holding of a nonambulatory animal was expressly preempted by the Federal Meat Inspection Act (FMIA).

The case, National Meat Association v. Harris, dealt with Section 599f of the California Penal Code, which was enacted in 2008 in response to an undercover video released by the Humane Society showing workers in California kicking and electroshocking sick and disabled cows in an attempt to move the cows. The law makes it a crime for any slaughterhouse to “buy, sell or receive a nonambulatory animal,” or to “process, butcher or sell meat or products of nonambulatory animals for human consumption,” or “hold a nonambulatory animal without taking immediate action to humanely euthanize the animal.”

The National Meat Association (NMA) sued to enjoin enforcement of the law as applied to swine slaughterhouses and argued that the FMIA’s broad express preemption provision prohibited California from enacting distinct requirements for the handling of nonambulatory pigs. The FMIA and implementing regulations enacted by the Department of Agriculture’s Food Safety and Inspection Service (FSIS) broadly regulate slaughterhouses to promote meat safety and humane treatment. With respect to the treatment of nonambulatory pigs, FSIS regulations permit slaughterhouses to hold and eventually sell nonambulatory animals, subject to a “post-mortem” examination.

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Today the United States Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) published two proposed regulations that will affect companies that produce and market organic food products. One proposed rule would clarify which vitamins and minerals are permitted for use in organic food and infant formula, while the other proposed rule would renew the status of a number of substances as allowed or prohibited for use in organic food products.

Specifically, the USDA's proposed rule regarding vitamins and minerals would prohibit the use of vitamins and minerals in products labeled as "organic" unless the vitamin or mineral has been classified as essential by the Food and Drug Administration (FDA) or is otherwise listed on the USDA's National List of Allowed and Prohibited Substances (National List) for organic products. The National List dictates which non-organic ingredients and processing aids may be used in the processing and handling of organic food products. The proposed rule for vitamins and minerals covers organic food products, as well as organic infant formula, and allows synthetic forms of vitamins and minerals to be used in these products so long as the vitamin or mineral is identified as essential by FDA regulations.

The USDA's second proposed rule would renew regulations regarding whether certain substances are permitted for use in organic food production. Under the Organic Foods Production Act of 1990, the National Organic Standards Board (NOSB), an independent board of organic industry stakeholders, must review a substance's status every five years to ensure that the National List reflects current conditions and information related to organic food. Based on the NOSB's recommendations, the USDA is renewing the listing for over 200 allowed or prohibited substances. The rule also would clarify or restrict the allowances for several substances currently permitted in organic products, such as chlorine materials, lignin sulfonate, sulfur dioxide, and yeast.

Comments regarding the USDA's proposed rule for vitamins and minerals are due by March 12, 2012, while comments regarding substances subject to the USDA's second proposed rule are due by February 13, 2012.
 

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A disturbing trend has emerged in false advertising litigation: plaintiffs are filing class action complaints that are virtually identical to or rely heavily on FTC complaints or FDA warning letters. Those complaints allege that certain advertising claims are false, deceptive, and/or misleading because the defendants do not possess “prior substantiation” for the claims, i.e., the advertisers do not have a reasonable basis for making the challenged claims in the first instance.

Recently, however, both federal and state courts have dismissed cases that do little more than echo FTC complaints or FDA warning letters, and have simply alleged that the defendants lacked substantiation for the challenged advertising claims, on grounds that those allegations fail to state a claim. More specifically, courts have explained that the allegations in those cases impermissibly attempt to shift the plaintiffs’ burden of proving falsity onto the defendants to show that the challenged claims, in fact, are substantiated.

A new article authored by Dana Rosenfeld and Dan Blynn that appears in the ABA’s Antitrust magazine, “The ‘Prior Substantiation’ Doctrine: An Important Check On the Piggyback Class Action,” discusses the “prior substantiation” defense to class-action lawsuits, which attempt to piggyback off of FTC pleadings and FDA warning letters.

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The Federal Food Safety Working Group (“FSWG”) yesterday released a progress report highlighting the groups accomplishments over the last two years and outlining priorities for the future. Established by President Obama in 2009, the FSWG is responsible for building a modern food safety system. Secretary for Health and Human Services Kathleen Sebelius noted in a conference call that until recently, the federal government had been “monitoring a 21st century food system with 20th century tools.” The purpose of the FSWG is to correct that deficiency.

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The FDA has published an interim final rule amending definitions related to required notifications regarding drug shortages. 21 C.F.R. 314.81(b)(3)(iii) requires an applicant who is the sole manufacturer certain approved drug products to notify FDA in writing at least 6 months prior to discontinuing manufacture of the drug product. 21 C.F.R. 314.81(b)(3)(iii) now refers to “discontinuance of manufacture” rather than “discontinuing manufacture,” and defines “discontinuance” as “any interruption in manufacturing of a drug product described in paragraph (b)(3)(iii)(a) of this section for sale in the United States that could lead to a potential disruption in supply of the drug product, whether the interruption is intended to be temporary or permanent” and “sole manufacturer” as “an applicant that is the only entity currently manufacturing a drug product of a specific strength, dosage form, or route of administration for sale in the United States, whether the product is manufactured by the applicant under contract with one or more different entities.”

These changes broaden the scope of reporting required under § 314.81(b)(3) and are intended to help FDA provide better information to physicians and patient organizations and to work with stakeholders to respond to potential drug shortages. Under § 314.81(b)(3)(iii)(a), the reporting requirements apply to drug products that are “life supporting, life sustaining, or intended for use in the prevention of a serious disease or condition” and “w[ere] not originally derived from human tissue and replaced by a recombinant product.” All drug manufacturers should review the revised regulation to determine if their products now fall within the scope of § 314.81(b)(3).

The interim final rule is effective January 18, 2012, and comments are due by February 17, 2012.
 

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The Presidential Commission for the Study of Bioethical Issues has released its report “Moral Science: Protecting Participants in Human Subjects Research.” The report was requested by President Obama to determine if current regulations adequately protect human subjects in federally funded research. The Commission determined that current regulations “generally appear” to protect participants from harm or unethical treatment, “as far as is feasible given limited resources,” but that it cannot say if current regulations are optimal for protecting against avoidable harm and unethical treatment because some agencies have limited ability to identify basic information about all human subject research.

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On December 14, 2011, the Inspector General of the Department of Health and Human Services issued a report finding that the Food and Drug Administration (FDA) failed to properly oversee food facility inspections conducted by states because FDA had not ensured the requisite number of inspections and failed to follow-up appropriately when inspections occurred. The report was issued in response to a request from Rep. Rosa L. DeLauro (D-CT), Ranking Member on the Labor, Health and Human Services Appropriations Subcommittee of the House Committee on Appropriations, following a salmonella outbreak attributed to a Georgia peanut processing plant in 2009.

FDA enters into contracts with state agencies where FDA pays the state to conduct inspections of its food facilities. FDA relied on states for a total of 59 percent of the agency’s food inspections in FY 2009, as opposed to only 42 percent in FY 2004, and spent over $8 million on such inspections.

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On December 13, 2011, FDA announced the availability of a draft report entitled “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review” for public comment. The literature review was conducted pursuant to section 3507(a) of the Patient Protection and Affordable Care Act (Affordable Care Act) which required the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to determine whether the addition of quantitative summaries of the benefits and risks of prescription drugs in standardized format (e.g., similar to the “Drug Facts” on over-the-counter-products) to the promotional labeling or print advertising of such drugs would “improve health care decision-making by clinicians and patients and consumers.”

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Responding to a letter from eight trade associations asking for more time to prepare for compliance, the Food Safety and Inspection Service (FSIS), an agency within the Department of Agriculture, has decided to delay the effective date of final regulations requiring nutrition labeling for major cuts of single-ingredient raw meat and poultry from January 1, 2012 until March 1, 2012. The regulation also mandates that ground or chopped products bearing a “lean percentage statement” include a statement of fat percentage if they do not meet the criteria to be considered “low fat.”

In its preamble to the final rule, FSIS indicated its intention to conduct meetings and webinars on the final rule in advance of its effective date to facilitate compliance. Specifically, FSIS stated that it would provide examples of notices to be used at the point-of-purchase (POP) which would satisfy the labeling mandates for single-ingredient raw meats and also include examples of acceptable labels for ground or chopped products. The agency noted that it had provided such guidance, and additionally held numerous public meetings to answer questions about the rule’s requirements.

However, in their August 12, 2011 letter to the FSIS, eight trade associations cited the agency’s delay of one or two months in making such information available as the basis for their request that FSIS exercise enforcement discretion for a six month period following January 1, 2012, the rule’s initial effective date. While FSIS conceded some delay, it noted that postponing the regulation’s effective date two months would provide ample time for industry to ready for compliance. FSIS indicated that it could provide approval of any labels submitted prior to January 1, 2012 before the regulations became effective. Additionally, the agency explained that it would continue to conduct education and outreach activities to assist in compliance in advance of the new March 1, 2012 effective date.

The notice was published in the Federal Register on December 9, 2011 and is available here.

This post was written by Sarah Roller and Donnelly McDowell.

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On December 9, 2011, the Food & Drug Administration (FDA) issued a notice announcing that a proposal to collect information for a “Experimental Study of Comparative Direct-to-Consumer Advertising” had been submitted to the Office of Management and Budget (OMB). FDA is required to submit the proposal to OMB for review and clearance under the Paperwork Reduction Act of 1995. FDA’s submission reveals its intent to study direct-to-consumer marketing of FDA-regulated products, with a focus on prescription drug advertising.

According to FDA, research findings on the effects of comparative versus noncomparative ads on purchase intentions indicate that comparative ads result in greater purchase intentions than noncomparative ads. Given the prevalence of comparative advertising, "FDA is embarking on the proposed research to ensure that it has adequate information to assess whether prescription drug comparative DTC ads provide truthful and nonmisleading information to consumers."

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On November 30, 2011, the Food and Drug Administration (FDA) held a public meeting to consider the need to amend pre-existing guidelines or adopt new ones addressing microbiological safety in cosmetics. The FDA presented the meeting as an opportunity for industry and other stakeholders to provide input on whether current guidelines sufficed to address cosmetic microbiological safety.

The FDA and industry members have long acknowledged the capacity for microorganisms to grow and reproduce in cosmetics if certain precautions are not taken. This growth can cause chemical changes to the products, which may adversely affect the consumer. In explaining the impetus behind the meeting, FDA representatives noted that current FDA guidelines on microbiological safety have not been revised in some time. These guidelines include the Cosmetic Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist (2008) and the Bacteriological Analytical Manual (BAM), Chapter 23 “Microbiological Methods for Cosmetics” (2001). FDA representatives stated that they were in the process of revising these guidelines and also considering issuing entirely new guidelines on microbiological safety.

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Responding to a request from Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ), and John Dingell (D-MI), on October 24, 2011, the United States Government Accountability Office (GAO) issued a report which examines how the Food & Drug Administration (FDA) has addressed “economic adulteration” affecting the products it regulates and makes recommendations for strengthening regulatory and enforcement policies.

For purposes of the GAO evaluation and report, the GAO defined economic adulteration as “the fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e. economic gain.” The GAO study highlighted two specific cases of economic adulteration as indicators of the need for stronger policies to prevent economic adulteration of FDA regulated products. First, in 2007, vegetable protein products were found to contain melamine and cyanuric acid, industrial chemicals, in order to give the products an appearance of a higher protein content. The protein products were subsequently used in pet food and caused an unknown number of illnesses and deaths to dogs and cats. Notably, the melamine contamination case helped to inspire a number of food safety policy reforms, including the enactment of the Food Safety Modernization Act on January 4, 2011, which includes mandatory HACCP-type preventive controls and establishes new safeguards to prevent intentional adulteration of food products. The second case occurred in 2008, and involved the blood thinner known as heparin, which was found to contain oversulfated chondroitin sulfate, a toxic contaminant which was later linked to multiple human illnesses and deaths.

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On November 18, 2011, President Obama signed into law H.R. 2112, the Consolidated and Further Continuing Appropriations Act (Pub. L. 112-055), which, among other things, provides funding for the U.S. Department of Agriculture (“USDA”) for Fiscal Year 2012. The law includes policy “riders” blocking funding for key provisions of a rule proposed by USDA that is intended to improve the dietary habits of school children. Published in January 2011, the USDA’s proposed rule would enact more stringent nutrition quality standards for the National School Lunch Program (“NSLP”) and the School Breakfast Program (“SBP”), which applies to school children in grades K-12. Specifically, the rule would adopt recommendations from the Institute of Medicine (“IOM”) that call for increased servings of fruits, vegetables, and whole grain-rich foods, establish new minimum and maximum calories levels for meals, minimize consumption of trans fats, and substantially reduce the amount of sodium in kids’ meals over the next 10 years.

The law prohibits USDA from implementing several prominent provisions from the proposed rule, including the proposed limits on servings of starchy vegetables such as potatoes, the long-term sodium reduction requirements, the increase in servings of whole grain foods for breakfast and lunch, and certain proposed vegetable serving requirements.

The USDA proposal would represent a substantial shift in the nutritional composition and quantity of a number of food items and would have far-reaching implications for companies that make or market food products for use in school breakfast or lunch programs. Please see Kelley Drye’s February 2, 2011 Client Advisory for more information on the USDA proposal.

This blog post was written by Sarah Roller and Matt Sullivan.

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On November 9, 2011, the Committee for the Right to Know, a consumer advocacy group that focuses on consumer, public health, environmental, and food issues, submitted the California Right to Know Genetically Engineered Food Act to the California state attorney general for title and summary--a necessary step needed to place citizen-created initiatives on the California state ballot. The Committee is preparing the Act for California voter consideration in the November 2012 election. For the Act to qualify for the November 2012 ballot, the Committee must circulate a petition regarding the Act and gather over 500,000 signatures of registered, California voters within 150 days of receiving title and summary from the California state attorney general.

The Act would require genetically engineered or modified foods or foods containing genetically engineered ingredients to be clearly labeled as containing genetically engineered material in a manner similar to nutrition information labeling. The Committee describes genetically engineered food as "[a] plant or meat product that has had its DNA artificially altered in a lab with genes from other plants, animals, viruses, or bacteria, in order to produce foreign compounds in that food." The FDA currently does not require genetically engineered foods or foods that contain genetically engineered ingredients to bear labeling regarding genetic modification.

The full text of the Act, as submitted to the California Attorney General on November 9, 2011 is available here.

This blog post was written by Sarah Roller and Megan Olsen. 

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Yesterday, the Federal Trade Commission (“FTC”) approved a final settlement with marketers of the “Acne Pwner” and “AcneApp” mobile applications (“apps”). This is the first FTC settlement targeting health claims by mobile app developers/marketers, but one of several FTC mobile app enforcement actions.

In the AcneApp case, the defendants claimed that their apps could treat acne with colored lights emitted from a mobile device. To support the claim, the AcneApp marketers relied on a study published by the British Journal of Dermatology, claiming that the study showed blue and red light treatments eliminated p-bacteria (a major cause of acne) and reduced skin blemishes. The FTC determined that AcneApp falsely claimed that the British Journal of Dermatology study proves that red and blue light therapy is an effective acne treatment.

The FTC order prohibits Acne Pwner and AcneApp “from making acne-treatment claims about their mobile apps and other medical devices” without at least two adequate and well controlled human clinical studies. The requirement for two clinical studies is the same standard that the FTC applied in recent settlements with a dietary supplement manufacturer over weight loss claims for its dietary supplements, and with a food marketer over its claims that one of its products reduced the duration of acute diarrhea and reduced school absences. In another recent settlement, FTC ordered Reebok to provide one clinical study to substantiate fitness claims for its toning shoes.

The marketers of Acne Pwner and AcneApp were also ordered to pay the FTC $1,700 and $14,294, respectively.

This blog post was written by Bridget Richardson, Alysa Hutnik and Sarah Roller.
 

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Today, the Food and Drug Administration (“FDA”) released a guidance document for industry titled “What You Need to Know About Administrative Detention of Foods.” The guidance comes just a week after the FDA announced its first administrative detention under the expanded authority granted by Congress in the Food Safety Modernization Act. The FDA will issue an administrative detention order when it has reason to believe that an article of food is adulterated or misbranded, and the adulterated or misbranded food is found during an inspection, examination or investigation under the FD&C Act.

This blog post was written by Sarah Roller and Bridget Richardson.
 

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On October 20, 2011, the Institutes of Medicine (“IOM”) issued Phase II of a two-part report regarding front-of-package nutrition labeling systems and symbols. The report, created by an IOM Committee convened in response to a 2009 Congressional request, provides recommendations regarding implementation of a front-of-package nutrition rating system designed to “encourage healthier choices and purchase behaviors.” Key recommendations include the following:

• Federal agencies should use the IOM Committee’s recommendations to develop a single, simple front-of-package nutrition rating system with symbols that graphically convey calorie information and a “point” value showing whether nutrients of concern (i.e., saturated and trans fat, sodium, and added sugars) are below threshold levels (as established by the Food and Drug Administration (“FDA”) and other federal agencies); and
• The front-of-package system developed by federal agencies should apply to all food and beverage products and replace any other symbol currently being used on the front of packaging.

According to the Committee, a front-of-package system should be modeled off of current government front-of-package ratings programs, like the Environmental Protection Agency’s Energy Star program, which has been “highly successful in changing consumer purchase patterns for household appliance and electronics.” The Committee’s recommendations are intended to serve as the starting point for federal agencies to “develop, test, and implement a single, standard front-of-package system to appear on all products.” As federal agencies review the IOM Committee’s report and determine how a front-of-packaging system should be implemented, food and beverage manufacturers, food retailers, and other entities in the food industry should monitor the agencies' progress and be prepared to provide comments and other information as necessary.

More information regarding the IOM Committee’s report can be found in Kelley Drye and Warren’s October 24, 2011 Client Advisory.  

This blog post was written by Sarah Roller and Megan Olsen. 
 

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On October 19, 2011, the Food and Drug Administration (“FDA”) published a final rule amending its bottled water quality standard regulations by establishing an allowable level of di (2-ethylhexyl)phthalate (“DEHP”). The new DEHP limit and related requirements will take effect on April 16, 2012.
Under Section 410 of the Food, Drug, and Cosmetic Act (“FDCA”), the FDA is required to promulgate bottled water regulations whenever the Environmental Protection Agency (“EPA”) creates or revises its standards for drinking water. The FDA’s final rule, which will be codified at 21 C.F.R. 165.110(b)(4)(iii)(C), is designed to ensure that bottled water meets the same DEHP limits as those set by the EPA for drinking water. The FDA’s final rule also is consistent with the standards set by the International Bottled Water Association for its members. Specifically, the FDA’s new rule includes the following:

• Bottled water may not contain more than 0.006 milligrams/liter (mg/L) of DEHP or the product will be deemed misbranded under Section 403(h)(1) of the FDCA;
• In accordance with FDA current good manufacturing practice (“CGMP”), bottled water manufacturers will be required to monitor their source water for DEHP as often as necessary, but at least once a year, unless they meet the criteria for exemptions under 21 C.F.R. § 129.35.
• Manufacturers will also be required to monitor finished products for DEHP at least once a year; and
• The FDA will determine compliance with the new rule by using the EPA’s analytical methods for measuring DEHP in bottled water.

This blog post was written by Sarah Roller, Bridget Richardson, and Megan Olsen.

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The Food and Drug Administration (“FDA”) has released a question and answer guide to its implementation of the fee provisions of the Food Safety Modernization Act of 2011. The purpose of the fee provisions is to allow the FDA to recover reinspection, recall noncompliance, and importer program related costs from domestic and foreign facilities and importers.

Persons responsible for facilities subject to the fees should review the guidance and note that although the FDA began assessing fees for reinspection of domestic and foreign facilities and for failure to comply with a recall order on October 1, 2011, the fees for import reinspection will not be assessed until the FDA has resolved the issues raised in comments on the fee schedule released in the August 1, 2011 Federal Register.
 

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The Food and Drug Administration (“FDA”) recently completed an evaluation of the legal basis for federal preemption policy statements the agency has issued under the Federal Food, Drug & Cosmetic Act (“FDCA”) during the past 10 years. FDA initiated the review in response to a memorandum issued by President Obama in May 2009 which directed federal agencies to undertake a review of their policy statements concerning federal preemption to ensure that such statements have “a sufficient legal basis.”

In follow-up to the agency’s review, on September 28, 2011, FDA issued a notice that is intended to clarify past FDA federal preemption policy statements. Such statements characterize the scope of implied and express federal preemption that applies to FDA regulations implementing particular FDCA provisions that concern prescription drug and biological product labeling, nonprescription drug products, food standards of identity, and food and dietary supplement product labeling. For more information on the specific policy statements affected by the FDA notice, read the Kelley Drye client advisory.

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Posted by Sarah Roller and Raqiyyah Pippins

On August 18, 2011 the FTC issued a request for public comment and advance notice of proposed rulemaking (ANPR) as part of the Commission's review of the costs, benefits, necessity, and regulatory and economic implications of its “Retail Food Store Advertising and Marketing Practices” rule, commonly called the “Unavailability Rule,” 16 C.F.R. Part 424.

Currently, the Unavailability Rule states that it is an unfair or deceptive act or practice for “retail food stores” to advertise “food, grocery products or other merchandise” at a stated price if those stores do not have the advertised products in stock and readily available to consumers during the effective period of the advertisement. The Rule includes a provision that permits stores that do not have the advertised products in stock and readily available to comply with the Rule if “the advertisement clearly and adequately discloses that supplies of the advertised products are limited or the advertised products are available only at some outlets.” In addition, the rule provides that it would not be a rule violation if: (1) The store ordered the advertised products in adequate time for delivery in quantities sufficient to meet reasonably anticipated demand; (2) the store offers a “rain check” for the advertised products; (3) the store offers a comparable product at the advertised price reduction; or (4) the store offers other compensation at least equal to the advertised value.

According to the ANPR, “the Commission now solicits comments on, among other things, the economic impact of, and the continuing need for, the Unavailability Rule; the benefits of the Rule to consumers purchasing products at retail food stores; and the burdens the Rule places on firms subject to this requirement.”  The Commission also is considering whether to broaden the Rule to include stores not currently covered, such as drugstores, department stores, and electronic retailers. Comments can be filed online or on paper and must be received by the FTC on or before October 19, 2011.
 

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The FDA announced that it will host a public workshop on September 12th and 13th, 2011 to gather input on the agency’s recently issued draft guidance document, “Mobile Medical Applications.” The FDA issued the guidance last month to inform manufacturers, distributors, and other stakeholders about how the FDA intends to apply its medical device regulatory authority to software applications (“apps”) that are deployed on mobile devices.

Mobile apps increasingly are being used by individuals as a tool to manage personal health and wellness, as well as to help monitor and manage disease conditions. Mobile apps also are being used by healthcare professionals to assist them in providing medical care to individual patients. Certain apps, for example, allow a user to view radiological images or analyze electrocardiogram data on a mobile device, such as a smart phone or tablet computer, to facilitate a patient diagnosis. While the new FDA draft guidance recognizes that mobile medical apps can provide significant health benefits, mobile apps also may present certain health risks. In addition, the FDA guidance emphasizes that the same mobile medical app may pose additional or different risks depending on the particular mobile device, and features including screen size, contrast ratio, and the environmental conditions in which the device is used (e.g. uncontrolled ambient light).

The new FDA guidance defines a “mobile medical app” as a software application on a mobile platform that is “either (1) used as an accessory to a regulated medical device; or (2) transforms a mobile platform into a regulated medical device.” The “mobile medical app” must also meet the definition of “device” under Section 201(h) of the Federal Food, Drug, and Cosmetic Act, which includes an instrument, apparatus, machine, or a related article that is “intended for use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease” for humans or other animals.”

The planned FDA workshop is intended to provide a forum for public discussion on the FDA’s Mobile Medical Application draft guidance document. Specifically, the FDA is seeking the public’s perspective on how the agency should regulate mobile medical apps to reasonably ensure their safety and effectiveness, particularly those mobile medical apps that are accessories to other medical devices. The FDA is requesting discussion and comments on the following key issues:

• What factors should FDA consider in determining the risk classification of different types of software that provide clinical decision support (“CDS”) functionality?
• How should the FDA assess stand-alone software that provides CDS functionality to reasonably ensure its safety and effectiveness?
• Are there specific controls that manufacturers should implement that could change the risk classification or reduce the premarket data requirements for particular types of stand-alone software that provide CDS functionality?

Interested stakeholders can either make an oral presentation during the workshop or submit public comments for the record on these issues or any aspect of the draft guidance. The deadline to request an oral presentation during the workshop is September 9, 2011, and public comments must be submitted to the FDA by October 19, 2011. Interested parties can visit the FDA website for specific details on registering for the workshop or submitting public comments.
 

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On June 23, 2011, the Supreme Court rendered its decision in Pliva, Inc. v. Mensing holding that FDA regulations governing generic drug products directly conflict with and preempt state laws that would require generic drug manufacturers to modify the FDA-authorized labeling for their products to provide "adequate warnings" as defined by state law. The Court distinguished its earlier decision in Wyeth v. Levine, 21 U.S.C. 555 (2009), which held that similar state law requirements were not preempted by federal drug regulations that apply to brand-named prescription drug products. Justice Thomas authored the majority opinion, which reverses rulings by the Fifth and Eighth Circuits, and Justices Ginsburg, Breyer, and Kagan joined Justice Sotomayor's dissenting opinion.

The federal preemption decision is helpful to generic drug manufacturers, and the ruling has broader implications for companies that confront conflicts between the requirements imposed by federal versus state law. Click here for more information about this case.

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Consumers around the world are increasing their use of dietary supplements. In the United States alone, consumers spend almost $27 billion per year on dietary supplements, and the EU and China are also rapidly developing and promising markets for supplements. With growing demand, dietary supplement companies have diversified their product portfolios and expanded their manufacturing and sales distribution to existing and emerging markets. In so doing, these same companies are confronted with myriad regulations that apply to the registration, sale and advertising of their products, each of which must be evaluated on a country by country or regional basis, as in the case of the EU.

A new article from the Food and Drug Law Institute Update magazine explores the differences between the U.S. system of regulating sale and advertising of dietary supplements with those of the EU and China, which have regulations that limit products and claims to defined categories in the name of consumer protection. Click here to access the full article, “It’s All Local: What You Need to Know About the Law Relating to the Marketing of Dietary Supplements in the United States, the European Union and China,” with permission from FDLI.

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Last week, the Center for Environmental Health, a non-profit organization, filed a complaint in California Superior Court alleging that 34 cosmetics companies violated the California Organic Products Act of 2003 (“COPA”) by selling, labeling, or marketing cosmetic products containing less than 70% organic ingredients as “organic.” The Center seeks an order enjoining the defendants from further false and misleading labeling.

The USDA has jurisdiction over agricultural products and regulates the term “organic” as it applies to agricultural products through the National Organic Program (“NOP”). Consequently, the USDA has no statutory authority over the production and labeling of cosmetics that are not made up of agricultural ingredients or that do not claim to meet NOP organic standards. Cosmetics that contain or are made up of agricultural ingredients that satisfy NOP organic production, handling, processing, and labeling standards are, however, eligible for organic certification under USDA’s NOP regulations. Certification is based on the product’s organic content and other factors.
In contrast to the USDA’s organic standards, COPA applies to all cosmetics that are sold in California and are represented to be “organic” or contain organic ingredients, including those that contain no ingredients that are agricultural products. Thus, even if a cosmetic product is not within the USDA’s jurisdiction, sellers may still be liable under COPA for any representations that the product is organic. More specifically, COPA requires cosmetics that are sold, labeled, or represented as “organic,” or made with organic ingredients to contain at least 70% organically-produced ingredients. Multi-ingredient products containing less than 70% organically-produced ingredients may either identify each organically-produced ingredient in the ingredient statement, or display the total percentage of organic ingredients if they are so referenced in the label. Notably, any person may file a suit under the statute, and the statute does not require a plaintiff to demonstrate damages to obtain injunctive relief.

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Senators Hatch and Harkin, the principle architects of the Dietary Supplements Health and Education Act (DSHEA) (amending the Federal Food Drug and Cosmetic Act (FDCA)), submitted a letter yesterday to FDA Commissioner Margaret Hamburg "exress[ing] their support for the upcoming new dietary ingredients (NDI) guidance." The Senators stated that the guidance should reflect the intent of DSHEA to "give FDA the tools necessary to help ensure the safety of dietary supplements and the accuracy of the limited claims allowed for them," and "minimize regulatory burdens that might inhibit consumer access to lawfully manufactured and labeled supplement products."

FDA plans to release the guidance on July 8, 2011, in accordance with the FDCA amendments made by section 113 of the Food Safety Modernization Act (FSMA). The FSMA amendments require the agency's guidance to clarify the circumstances under which a dietary supplement ingredient qualifies as a "new dietary ingredient" and companies are required to submit a new dietary ingredient notification to FDA which includes, "the evidence needed to document the safety of new dietary ingredients," and "appropriate methods for establishing the identity of a new dietary ingredient."

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It is no secret that marketers are striving for ways to legally and effectively educate consumers about the health benefits provided by food and dietary supplement products. In fact, Natasha Singer of the New York Times recently reported on the growth of "functional foods" marketed with health benefit claims -- a $37.3 billion market in the United States in 2009.

However, marketers must proceed with caution when considering advertising strategies that can sustain heightened regulatory scrutiny. Increased collaboration between FDA and the FTC is creating a notable shift in regulatory enforcement that blurs the jurisdictional lines between the agencies and requires a new assessment of potential liabilities for companies making health-benefit claims for their products.

For more information regarding this trend and important considerations for food and dietary supplement companies, please see the May 2011 article in Nutritional Outlook written by Kelley Drye attorneys John E. Villafranco, Raqiyyah R. Pippins, and Kristi L. Wolff entitled "Working Together: How Growing FDA and FTC Collaboration Changes the Regulatory Landscape for Food and Dietary Supplement Marketers."

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The Food and Drug Administration (FDA) is expected to issue guidance and possibly regulations regarding use of social media. These policies will only be enforceable on marketers of prescription drugs and restricted medical devices; however, industry can expect that the rationale and policy behind the guidance and regulations will apply across the board to consumer health products generally, including over-the-counter (OTC) drugs, food, dietary supplements and cosmetics.

FDA and the Federal Trade Commission (FTC) have demonstrated interest in marketers' online content, including social media, as a means of investigating product claims. As social media proliferates, marketers of consumer health products should take specific steps to be sure that their companies' use of it does not raise red flags for regulators.

For more on this issue, see the Food and Drug Law Institute Update article, “FDA’s Policy on Social Media: Why It Matters for Marketers of OTC Drugs, Food, Dietary Supplements and Cosmetics.”

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Late last month, the U.S. Supreme Court ruled on a significant federal preemption case concerning an individual’s right to sue a vaccine manufacturer for injury that is alleged to have resulted from a defect in a vaccine’s design. The 6-2 decision (Justice Kagan recused herself) in Bruesewitz v. Wyeth held that a provision within the National Childhood Vaccine Injury Act of 1986 (NCVIA) preempts all design-defect tort claims against vaccine manufacturers brought by plaintiffs seeking compensation for injury or death caused by vaccine side effects. The NCVIA was originally enacted to establish a no-fault compensation program that serves as an alternative to the traditional tort system for resolving vaccine injury claims.

In 1995, the parents of Hannah Bruesewitz claimed that their daughter became disabled after receiving a vaccine manufactured by Lederle Laboratories (now owned by Wyeth). In response, they filed a vaccine-injury petition in the U.S. Court of Federal Claims, which the NCVIA designated to decide which vaccine injury claims should be compensated. After the Bruesewitz’s claim was denied, the parents sued Lederle in Pennsylvania state court alleging that Lederle was subject to strict liability and liability for negligent product design under Pennsylvania common law. The case was removed to the U.S. Third Circuit Court of Appeals, which sided with Wyeth on its summary judgment motion and held that the state law claim was preempted by the NCVIA.

The Supreme Court affirmed the Third Circuit decision based on a textual analysis of the NCVIA preemption provision, which reads:

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Last month, the U.S. Department of Agriculture ("USDA") Food Safety and Inspection Service ("FSIS") issued a proposed rule that is intended to ensure that commercial catfish products are properly marked, labeled, and packaged, and are not adulterated. The rule implements recently enacted legislation which was advocated by U.S. catfish producers, and singles out domestic and imported catfish for regulation by FSIS under a “continuous inspection” program that is comparable to the FSIS programs governing meat and poultry products. Specifically, the proposed rule issued by FSIS would implement provisions of the Food, Conservation, and Energy Act of 2008 (the Farm Bill), which amended the Federal Meat Inspection Act (FMIA) to specify that catfish “is an amenable species,” thereby subjecting catfish to FMIA continuous inspection requirements.

The proposed rule represents a shift in the regulatory regime applied to commercial catfish production that will have a substantial impact on both domestic and foreign catfish and catfish product producers. As such, affected companies must prepare for a greater regulatory burden in the form of continuous inspection, new recordkeeping requirements, the pre-approval of labeling, and additional requirements for importers of foreign catfish. Affected companies are advised to evaluate the legal and business implications of the USDA proposal now, and bring issues and concerns to the attention of appropriate policymakers, including by submitting written comments to USDA on or before the June 24, 2011 deadline.

See the Kelley Drye client advisory for more information, and please contact us if you have questions concerning the USDA FSIS proposal or other matters.

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This Monograph, published by the Food and Drug Law Institute, is designed to assist lawyers, regulatory advisors and marketing professionals answer the question "Can we say that?" as they design and execute programs to promote consumer health products such as foods, dietary supplements, non-prescription drugs and medical devices, cosmetics and pet care products. It serves as a practical guide to substantiating the advertising and labeling claims so fundamental to product development, including:

• An overview of the legal and regulatory structures governing foods and other consumer health products
• Key considerations for evaluating marketing concepts and claims
• An outline for establishing effective pre-launch review procedures
• A guide to determining the kinds of substantiation required to support different types of claims
• Discussion of claims and consumer deception issues pertaining to the different categories of foods and other consumer health products
• Discussion of how to challenge questionable claims being made by others

Co-Editors:
Sarah Roller, Kelley Drye & Warren LLP
Melanie Fairchild-Dzanis, Regulatory Discretion, Inc.

Click here to download a preview. And visit the FDLI website for more on this publication or to subscribe to the FDLI Monograph Series.

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On February 1, 2011, the Food and Drug Administration (FDA) issued a warning letter to dietary supplement maker Tennessee Scientific, Inc., relating to a number of product claims on the company’s website. The letter states that the products are unapproved drugs and that the claims are unauthorized disease claims. The claims at issue involve treatment and mitigation of a host of diseases including numerous cancers, inflammatory conditions, and heart disease.

What is unusual about this particular warning letter is that the FDA cites the Federal Trade Commission’s (FTC) advertising standards as a further basis for challenging the company’s conduct. The letter states: “In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating the claims are true at the time they are made.”

FTC enforcement actions pertaining to Nestlé, Iovate and Dannon have garnered significant attention in the food and dietary supplement communities because the consent orders in these cases require the advertiser to obtain FDA approval before making certain health benefit claims in advertising.

For marketers of foods and dietary supplements, the Tennessee Scientific warning letter is notable for the following points:

• it further confirms the high level of cooperation ongoing between the FDA and FTC given that this is the second joint warning letter issued by the agencies in recent months;
• it confirms that websites may be considered both labeling and advertising, and that features such as product name, website name, metatags and clinical study titles on websites may give rise to actionable claims by either agency; and
• by sending a joint letter, the FTC has already established a record that Tennessee Scientific does not have FDA approval for their products or their product claims. Although FTC Consumer Protection Bureau Director David Vladeck recently stated that FDA approval is not a prerequisite to health benefit advertising claims, a joint letter sets an easy stage from which the FTC can take the position that unauthorized disease claims violate the FTC Act. This action further supports the conclusion that the drug-like substantiation provisions in the Nestlé, Iovate and Dannon orders are the new de facto standards for all advertisers making similar claims.

Industry stakeholders should evaluate the substantiation behind their products’ health benefit claims in light of these recent developments and fully consider FDA and FTC standards when creating website or other claims content that could be considered advertising or labeling.

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The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, requires the Food and Drug Administration (FDA) to undertake sweeping regulatory action to strengthen the safety of the nation’s food supply. Many of the items on FDA’s “to do” list require significant and swift action. Over the next two years, FDA must engage in a number of rulemakings and issue several guidance documents to implement the FSMA.

FDA must take certain actions in 2011, including:

• Issue guidelines regarding new dietary ingredients in dietary supplements
• Promulgate facility registration suspension guidelines

Several of FDA’s action items must be completed by January 4, 2012, including:

• Issue notice of proposed rulemaking regarding safe fruit and vegetable harvest and processing
• Designate high-risk foods requiring additional recordkeeping
• Promulgate rules establishing the foreign supplier verification program for importers
• Develop and publish a list of acceptable customer notification methods that grocery stores may use to post recall information

Other action items affecting a large portion of the food industry have a July 4, 2012 deadline:

• Promulgate regulations establishing science-based minimum standards for hazard analyses and preventive controls
• Promulgate rules regarding the sanitary transportation of food

Industry stakeholders should determine how the new law affects them and prepare to participate in the notice and comment process. For a copy of the Kelley Drye client advisory regarding the FSMA, please click here. For a timeline of all FDA actions required under the FSMA, please click here.

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Last month, the Food and Nutrition Service of the U.S. Department of Agriculture (“USDA”) issued a proposed rule that would revise the meal patterns and nutrition requirements for the National School Lunch Program (“NSLP”) and the School Breakfast Program (“SBP”). The proposed rule, which is intended to improve the dietary habits of school children, would align the NSLP and SBP with the 2005 “Dietary Guidelines for Americans,” as required by the Richard B. Russell National School Lunch Act (“NSLA”).

The proposed rule represents a substantial shift in the nutritional composition and quantity of a number of food items that make up current school breakfast and lunch meals and is likely to have far-reaching implications for companies that make or market food products for use in school breakfast or lunch programs. Affected companies are advised to evaluate the legal and business implications of the USDA proposal now, and bring issues and concerns to the attention of the appropriate policymakers, including by submitting written comments to USDA on or before the April 13, 2011 deadline.

See the Kelley Drye client advisory for more information, and please contact us if you have questions concerning the USDA proposal or other matters.

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Written by Sarah Roller and Raqiyyah Pippins.

On January 31, 2011 the U.S. Department of Agriculture (USDA) and U.S. Department of Health and Human Services (HHS) issued the Dietary Guidelines for Americans, 2010. A copy of the executive summary is available here. Supporting documents include Questions and Answers on the 2010 Dietary Guidelines, a Backgrounder regarding the History and Process for the Dietary Guidelines, and Selected Messages for Consumers.

The Dietary Guidelines for Americans (Dietary Guidelines) are reviewed by USDA and HHS every five years, pursuant to Public Law 101-445. Traditionally, the Dietary Guidelines recommendations have been intended for healthy Americans ages 2 years and older. “[R]ising concern about the health of the American population,” however, has led the USDA and HHS to publish Dietary Guidelines for all Americans ages 2 years and older, including those at increased risk of chronic disease.

Taken together, the 2010 Dietary Guidelines recommendations encompass two overarching concepts, encouraging Americans to:

• "maintain calorie balance over time to achieve and sustain a healthy weight," by decreasing calorie consumption and increasing the calories expended through physical activity; and
• "focus on consuming nutrient-dense foods and beverages," by reducing intake of sodium and calories from solid fats, added sugars, and refined grains, and increasing consumption of nutrient-dense foods and beverages such as vegetables, fruits, whole grains, fat-free or low-fat milk products, seafood, lean meats and poultry, eggs, beans and peas, and nuts and seeds.

The 2010 Dietary Guidelines note that while “nutrient needs should be met primarily through consuming foods,” in some cases “fortified foods and dietary supplements may be useful in providing one or more nutrients that otherwise might be consumed less than recommended amounts.” The Dietary Guidelines also encourage consumer education on food preparation and preservation to promote food safety and prevent foodborne illness.

The information in the 2010 Dietary Guidelines is used in developing educational materials and aiding policymakers in designing and carrying out nutrition-related program, including federal food, nutrition education and information programs. In addition, the 2010 Dietary Guidelines has the potential to offer authoritative statements as provided for in the Food and Drug Administration Modernization Act (FDAMA), which, in some cases may be used by food marketers to substantiate use of new health claims or nutrient content claims in food labeling.

More information regarding the 2010 Dietary Guidelines is available here.

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Companies marketing functional foods or dietary supplements should be aware of the Federal Trade Commission’s new regime for using health-related advertising claims and the Food and Drug Administration’s heightened scrutiny of health-related front-of-package (FOP) labeling claims.

In two game-changing settlement orders, issued in July of this year, the FTC, for the first time, required that the companies under order (1) possess two clinical trials for weight loss claims and certain disease claims, (2) have FDA approval for most other disease claims, and (3) follow a new standard for relying on ingredient testing as claim substantiation. The FTC has indicated that it intends to include similar requirements in its future food and supplement orders, suggesting that these new standards soon could set the bar for all companies, regardless of whether they are under order or not.

Similarly, FDA has issued a series of warning letters challenging the use of nutrient content claims, health claims, and other health benefit claims in food and beverage product labeling. Recent FDA warning letters challenge a number of claims appearing on the principal display panel of food and beverage product labels, underscoring the agency’s enforcement and policy development priorities concerning the standards governing FOP labeling systems.

Kelley Drye's Advertising and Marketing practice group has prepared several articles to help companies navigate the new terrain successfully:

• “The FTC’s New Take on Health-Related Advertising: What Companies Facing FTC Enforcement Need to Know” provides strategies for companies that are faced with FTC action and includes summaries and analysis that will be useful for anyone trying to wrap their head around the new standards.
• “Ingredient Testing for Food and Supplement Advertising Claims: Keeping Up with an Evolving Standard” presents a comparison of the old ingredient testing standard versus the new standard from the recent orders. This article also provides practical pointers for how to base claims on ingredient testing within FTC’s current guidance.
• “Marketing Nutrition & Health-Related Benefits of Food & Beverage Products: Enforcement, Litigation & Liability Issues” examines key developments over the past year and a half involving food and beverage product marketing claims. This examination suggests that FDA and FTC enforcement priorities have contributed to increasing liability trends associated with nutrition and health-related product benefit claims.

With increasing enforcement and litigation activity, food and supplement companies should stay informed about government scrutiny of health-related claims and the standards for competent and reliable scientific evidence.

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This post was written by Sarah Roller and Raqiyyah R. Pippins.

On October 26, 2010, the Institute of Medicine held the first meeting of its Phase II “Examination of Front-of-Package Nutrition Rating Systems and Symbols.” As discussed in our client advisory regarding IOM’s Report on Phase I of the “Examination of Front-of- Package Nutrition Rating Systems and Symbols,” Phase II will focus on consumer understanding and use of front-of-package systems and symbols. IOM is charged with considering which icons are the most effective with consumer audiences, developing conclusions about the systems and icons that best promote health and how to maximize their use, and assessing the potential benefits of a single, standardized front-label food guidance system regulated by the Food and Drug Administration (FDA).

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This post was written by Sarah Roller and Raqiyyah R. Pippins.

In response to the disturbing rates of overweight, obesity, and diet-related chronic disease among Americans, Congress requested an Institute of Medicine (IOM) study that would examine “front-of-package” (FOP) nutrition labeling systems and symbols and the effects that FOP labeling could have on consumer food choices. With sponsorship from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), IOM launched the requested FOP labeling study to be conducted in two phases. On October 13, 2010, the results of the first phase of the IOM study (Phase I study) were published in a report entitled, “Examination of Front-of-Package Nutrition Rating Systems and Symbols: Phase I Report” (Phase I Report).

The report concluded, among other things, that for FOP labeling systems to be helpful to consumers in making food choices that are consistent with the Dietary Guidelines for Americans, FOP labeling should focus on conveying a limited set of information concerning the nutrients that are most strongly linked to significant diet-related disease risks that affect the greatest number of Americans.

For more information, please see our advisory regarding the IOM study and related report.
 

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This post was written by Sarah Roller and Raqiyyah R. Pippins.

The U.S. 8th Circuit Court of Appeals recently ruled that certain false advertising claims based on state consumer protection and anti-deception statutes were not preempted by the Organic Foods Production Act of 1990 (OFPA)— a federal Act that establishes national standards for the sale and labeling of organically produced agricultural products, and creates a certification program through which agricultural products may be certified to produce organic products. The court reversed and remanded the district court’s ruling that the false advertising claims were preempted by the OFPA, holding that, while claims challenging certification of a product as organic (e.g., alleging that a defendant’s products are falsely represented as organic when in fact the products were not organic), are preempted by the OFPA, false advertising claims challenging the facts underlying an organic certification (e.g., alleging that a defendant’s advertisements “misrepresent[] the manner in which its dairy cows were raised and fed,” and “suppress[ ] or omit[ ] material facts regarding the production of its ‘organic’ milk or milk products, specifically that . . . the dairy cows were not raised at pasture”) are not preempted by the OFPA.

As background, following a 2007 consent agreement between USDA and Aurora Dairy Corporation (Aurora) regarding Aurora’s violations of the OFPA and related implementing regulations, known as the National Organic Program (NOP), nineteen class action lawsuits were brought in federal district courts on behalf of organic milk consumers (class plaintiffs) against Aurora and various retailers, claiming violations of state law arising from Aurora’s alleged failure to comply with the OFFPA and the NOP. The U.S. Judicial Panel on Multi-District Litigation (JPMDL) consolidated these cases in the Eastern District of Missouri. In June 2009, the Eastern District court dismissed the case, finding the OFPA preempted all of the class plaintiffs claims.

The 8th Circuit’s decision distinguishes between “state law challenges to [organic] certification determination, itself, which conflict with the OFPA, and state law challenges to the facts underlying certification,” taking the position that state law “challenges to the underlying facts do not necessarily conflict with the OFPA’s purposes,” in a manner justifying preemption of such claims. A copy of the 8th Circuit’s decision is available here.

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This post was written by Dana Rosenfeld and Kristi Wolff.

The National Advertising Review Board (“NARB”) recently added fuel to a growing fire in the food and beverage industry regarding the meaning of “natural” claims. The NARB decided an appeal filed by Heartland Sweeteners, LLC (“Heartland”) regarding its Ideal sweetener product, which Heartland claimed was “more than 99% natural.” The National Advertising Division (“NAD”) previously recommended that Heartland modify or discontinue the “more than 99% natural” claim because although Ideal is 99% natural by ingredient weight, the majority of its sweetness is derived from sucralose, a high-intensity artificial sweetener that makes up about 1% of Ideal’s weight but supplies 80% of its sweetness.

The NARB shared NAD’s concern about implied claims conveyed by “more than 99% natural” insofar as consumers could understand it to mean that all or virtually all of Ideal’s sweetness comes from natural ingredients. The NARB’s decision, like NAD’s, relates the “natural” claim to the main product attribute, sweetness, rather than the natural or artificial classification of the ingredients that make up the finished product.

The FDA outlined its policy on use of “natural” in 1993 but has not officially defined the term. As use of “natural” claims have proliferated, scrutiny has increased as well. The makers of Snapple and AriZona Iced Tea have been the target of consumer class actions relating to claims that their products are “natural” despite containing high fructose corn syrup.

Advertisers need to be fully aware of the messages and risks created by use of the term “natural.” The Heartland decision demonstrates that the intended message is not always the only message. Further, advertisers can expect that a “natural” claim will draw not only the eyes of potential consumers but those of critics as well.

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This post was written by Sarah Roller and Kristi Wolff.

Last week, the Food and Drug Administration (FDA) took the first steps needed to implement the new restaurant food labeling requirements of the Federal Food, Drug & Cosmetic Act (FDCA), requesting public comment on a number of regulatory issues that will affect compliance burdens and liability risks for companies subject to the new requirements. Submissions responding to the FDA notice can be made until September 7, 2010.

The new labeling requirements were established under FDCA amendments adopted as part of the recently enacted health care reform legislation (i.e., section 4205 of the Patient Protection and Affordable Care Act of 2010). The amendments expanded the scope of mandatory nutrition labeling requirements under FDCA section 403(q)(5), and require restaurants and other retail food establishments with at least 20 or more locations to provide “clear and conspicuous” calorie information to consumers. The FDA is specifically seeking information relating to the following issues:

• Chain Retail Food Establishments
• Determination of Calorie Content of Foods Offered by Chain Retail Food Establishments
• Vending Machine Operations
• Implementation and Enforcement

For further information about the new nutrition labeling requirements, or assistance in responding to the FDA notice, please contact one of the Kelley Drye attorneys listed above.

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This post was written by Sarah Roller and Megan L. Olsen.

On June 15, 2010, the Dietary Guidelines Advisory Committee issued the “Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010” (“Advisory Report” or “Report”). The Advisory Report is intended to provide the United States Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) “with a strong foundation for preparing the 2010 Dietary Guidelines for Americans,” which will be released at the end of 2010. The Dietary Guidelines, which are jointly issued by USDA and HHS and updated every five years, provide diet-related recommendations for promoting public health, guide Federal food and nutrition policies governing foods served in schools, food assistance and nutrition education programs, and Food and Drug Administration (FDA) regulation of food and dietary supplement products.

The overall theme of the Report focuses on addressing an overweight and obese American population. The Advisory Committee noted “that this report is unprecedented in addressing the obesity epidemic, and stated that the obesity epidemic is the single greatest threat to public health in this century. Every section of the report was developed in a way that addresses the challenges of obesity. [The Committee] noted that this was especially true for children, whose prevalence of obesity has tripled in the past 30 years.”

The 2010 Report includes new chapters focused on a “total diet” approach and integrating the Report’s recommendations and a second chapter translating the scientific findings into practical advice. The “total diet” approach focuses on helping Americans achieve “good health and optimal functionality across their life span,” through a diet that is energy balanced and nutrient-dense. The Report also makes several key recommendations aimed at improving the nutritional quality of the overall “food environment,” particularly for vulnerable populations, including by enabling lower income Americans to gain better access to fresh fruits and vegetables and limiting the access children have to foods that are higher in fat and added sugars. Additionally the report makes several recommendations concerning specific nutrients and food components, including recommendations to decrease intake of solid fat and added sugars, fatty acids and cholesterol, and refined grains. In addition, the report recommends that sodium limits be reduced from 2,300 to 1,500 milligrams/day for U.S. adults, and endorses the recent IOM report recommending that FDA modify the GRAS status of salt to limit sodium in the U.S. food supply.

The Report’s recommendations and anticipated changes to the 2010 Dietary Guidelines are expected to have an impact on food labeling and advertising regulation, especially in light of the Obama Administration’s emphasis on combating obesity and encouraging healthier lifestyles (see our blog post regarding the Obama Administration's Task Force to combat childhood obesity here). Click here for more information regarding the Advisory Report.

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This post was written by Sarah Roller and Katie Bond.

On May 27, 2010, the U.S. District Court for the District of Columbia issued a decision in Alliance for Natural Health U.S. v. Sebelius, Civ. Action No. 09-10470 (ESH) (D.C. Dist. May 27, 2010) ("Natural Health"). Relying on a string of earlier decisions, including Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) ("Pearson I"), the court ruled that the Food and Drug Administration's ("FDA") refusal to grant several health claims characterizing the disease prevention benefits of selenium consumption violated First Amendment standards that protect freedom of expression in commercial speech. The earlier cases also held that FDA policies restricting the use of health claims in food labeling failed to satisfy First Amendment standards. 

Alliance for Natural Health U.S. v. Sebelius

• "Selenium may reduce the risk of certain cancers. Scientific evidence supporting this claim is convincing but not yet conclusive."
• "Selenium may produce anticarcinogenic effects in the body. Scientific evidence supporting this claim is convincing but not yet conclusive."
• "Selenium may reduce the risk of lung and respiratory tract cancers. Scientific evidence supporting this claim is convincing but not yet conclusive."
•  "Selenium may reduce the risk of colon and digestive tract cancers. Scientific evidence supporting this claim is convincing but not yet conclusive."

Click here to read more on the FDA Ban on Selenium/Cancer Health Claims.
 

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This post was written by Dana B. Rosenfeld and Raqiyyah R. Pippins.

On May 26, 2010, the GAO submitted testimony to the U.S. Senate Special Committee on Aging, entitled “Herbal Dietary Supplements: Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice.” The testimony was requested by the Special Committee on Aging, because “recent studies have shown that use of herbal dietary supplements…by the elderly within the United States has increased substantially.”

According to the report, “the GAO was asked to determine (1) whether sellers of herbal dietary supplements are using deceptive or questionable marketing practices and (2) whether selected herbal dietary supplements are contaminated with harmful substances.”

The GAO concluded that “certain dietary supplements commonly used by the elderly were deceptively or questionably marketed,” with claims the supplements could treat, prevent, or cure conditions such as diabetes, cancer, cardiovascular disease, high cholesterol or Alzheimer’s disease—claims that, under the Federal Food Drug and Cosmetic Act, and related FDA implementing regulations, are not permitted for use in the labeling or marketing of dietary supplements. The GAO referred the names of companies that made these claims to FDA and the FTC “for appropriate action.”

The GAO’s testimony also states that while the GAO “found trace amounts of at least one potentially hazardous contaminant in 37 of the 40 herbal dietary supplements products tested,” no contaminants were found “in amounts considered to pose an acute toxicity hazard.” The GAO noted that “the levels of heavy metals found do not exceed any FDA or Environmental Protection Agency EPA) regulations governing dietary supplements or their raw ingredients, and FDA and EPA officials did not express concern regarding any immediate negative health consequences from consuming [the tested] supplements.”

Click here for more information about the GAO’s study, including a full copy of the testimony.

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This post was written by Sarah Roller and Megan L. Olsen.

On May 19, 2010, the Federal Trade Commission (FTC) approved a final settlement order with the Indoor Tanning Association charging that the association exaggerated the health benefits of indoor tanning and misrepresented that indoor tanning increases the risk of skin cancer. The settlement bars the Association from making misrepresentations about the health and safety of indoor tanning and requires that future advertisements from the association that make health or safety claims be accompanied by clear and prominent disclosures about the risks of indoor tanning. The Indoor Tanning Association represents tanning facilities and suppliers of tanning equipment.

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In a previous post we discussed the “preliminary vote” by the Santa Clara County, California, Board of Supervisors to institute a new ordinance which prohibits restaurants from "providing" toys, coupons, or other "incentive items linked to the purchase" of any product containing “excessive” calorie, fat, saturated fat, sodium, added sugars, or prohibited levels of trans fat, non-nutritive sweeteners, or caffeine.

On May 11, 2010, the Board passed the new ordinance. Click here to read more about the criteria for prohibited single food items, meals, and beverages in the Kelley Drye client advisory.

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This post was written by Sarah Roller and Raqiyyah R. Pippins.

On May 11, 2010, the White House Childhood Obesity Task Force submitted a report to President Obama titled, “Solving the Problem of Childhood Obesity Within A Generation.” The report was submitted in response to President Obama’s February 9, 2010 Memorandum Establishing a Task Force on Obesity, which also requested a “comprehensive interagency plan” for attacking the obesity epidemic from the Task Force within 90 days.

The Task Force report reinforces the authoritative public health recommendations that have developed in the United States since 2001, when Former Surgeon General David Satcher issued the nation's “Call to Action To Prevent and Decrease Overweight and Obesity,” including recommendations made in the Institute of Medicine’s reports entitled, “Action Plan for Obesity Prevention” (2005) and “Food Marketing to Children and Youth: Threat or Opportunity?” (2005). The Task Force report elaborates upon previous recommendations aimed at fostering a healthy environment for children at school and elsewhere, and extends the range of specific public health intervention strategies considered to include regulation of obesogenic chemical exposures, front-of-package and menu labeling, and various economic incentives (taxes, subsidies, licensing standards) to encourage the marketing of food products that support dietary patterns that meet U.S. Dietary Guidelines standards. In addition, the Task Force report recommends "concrete actionable benchmarks " for marking progress and determining success, and “defines solving the problem of childhood obesity in a generation as returning to a childhood obesity rate of just 5 percent by 2030.”

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 This post was written by Sarah Roller and Raqiyyah R. Pippins.

On April 27, 2010, the Board of Supervisors for Santa Clara County, California, conducted its “preliminary vote” to institute a new ordinance which prohibits restaurants from "providing" toys, coupons, or other "incentive items linked to the purchase" of any product containing “excessive” calorie, fat, saturated fat, sodium, added sugars, or prohibited levels of trans fat, non-nutritive sweeteners, or caffeine.  More information regarding the specified nutritional criteria is available here.  The ordinance includes no food labeling requirements and provides that the requirements must be construed in a manner that is consistent with state and federal law.

In order for an ordinance to go into effect in Santa Clara, it must undergo both a “preliminary” and “final” vote before Santa Clara’s Board of Supervisors. The “final vote” will be held Tuesday, May 11, 2010. If the ordinance passes again on May 11, enforcement will begin 90 days later (August 11, 2010). If the ordinance does not pass it will be removed from the docket and would have to undergo another “preliminary vote” before it could be presented to the Board of Supervisors for a “final vote” again.

The ordinance would ban the use of incentive items for products based on nutrient and ingredient content, including coupons and other items that constitute commercial speech, presenting significant First Amendment issues. The ordinance would define "incentive item" broadly to include "any toy, game, trading card, admission ticket or other consumer product, whether physical or digital… or any coupon, voucher, ticket, token, code, or password redeemable for or granting digital access to any [of the aforementioned items].”

Restaurants that violate the new ordinance would be subject to administrative and civil penalties, including fines. The county would use fines collected under the ordinance to fund obesity prevention programs conducted by the county public health department. The Board of Supervisors found that “restaurants encourage children and adolescents to choose specific menu items by linking them with free toys and other incentives,” citing 2006 data regarding fast food child-directed promotional expenditures published by the Federal Trade Commission.

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This post was written by Sarah Roller and Kristi L. Wolff.

The Food and Drug Administration (“FDA”) issued a notice last week seeking public comment and consumer research data in support of the agency’s initiative to improve the usefulness of nutrition information provided to consumers at the point-of-purchase, including through front-of-package (“FOP”) labeling and shelf tags in retail stores (“FOP initiative”). FDA’s request for information comes while a related study by the Institutes of Medicine (“IOM”) remains pending. The IOM Committee on Examination of Front-of-Package Nutrition Rating Systems and Symbols currently is evaluating scientific evidence concerning the nutrition information and ranking systems that currently are used by food manufacturers and retailers for FOP labeling, shelf tags, and other food marketing purposes.

The FDA notice specifically requests research data and other information addressing the following matters:

• Data and information on the extent to which consumers notice, use, and understand nutrition symbols on front-of-pack labeling of food packages or on shelf tags in retail stores;
• Research assessing and comparing the effectiveness of particular possible approaches to front-of-pack labeling;
• Graphic design, marketing, and advertising data and information that can inform and guide the development of better point-of-purchase nutrition information; and
• The extent to which point-of-purchase nutrition information may affect decisions by food manufacturers to reformulate products.

Click here to see the specific elements of each of these categories of interest to FDA.

FDA will consider public comment submitted in response to its notice until July 28, 2010.

For more detail, please reference the Kelley Drye client advisory. 

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This post was written by Sarah Roller and Raqiyyah R. Pippins.

In conjunction with the First Lady’s “Let’s Move” campaign  and related federal regulatory efforts focused on nutrition and marketing to children, the USDA Center for Nutrition Policy and Promotion is instituting a new program, titled “Innovations for Healthy Kids Challenge,” intended to “motivate the creation of innovative, fun, and engaging applications or games that encourage children, especially “tweens” (aged 9-12), to eat more healthfully and [to] be more physically active.” USDA is seeking public comment on the paperwork and regulatory burdens associated with the program until June 28, 2010.

The purpose of the challenge is to develop new and innovative technology to “not only increase access to socially relevant technologies that seek to improve eating and physical activity behaviors among children, but…also expand the tools available through the MyPyramid Website.” Through this program, USDA encourages developers to use recently released USDA nutrition data, data the USDA has pre-calculated for common portion sizes and portion increments including solid fats, added sugar, and sugar alcohol content, to design games, applications, and other programs aimed at promoting at least one of the following behavioral objectives:

· Teaching kids to eat more whole grain

· Increasing fruit and vegetable consumption

· Focusing on consuming more low-or non-fat milk

· Choosing lean sources of protein (meat and beans)

· Making food group education fun

· Understanding calories and energy balance

· Increasing choices of foods with high nutrition value and decreasing amounts of foods with solid (saturated) fats and added sugars (i.e., “extra” calories), and decreasing amounts of sodium

· Identifying and consuming proper food portion sizes

· Being more physically active

· Balancing physical activity and food intake.

More information on the program can be found at http://www.appsforkids.com.

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This post was written by Kristi L. Wolff and Sarah Roller.

Despite all the publicity over the recently-passed health care legislation, one provision that was “tacked on” received little note but will clearly affect the vast majority of franchise restaurants and many other food retailers across the country.

Section 4205 of the Patient Protection and Affordable Care Act amends the Federal Food Drug and Cosmetic Act (FDCA) by adding to the existing nutritional requirements for restaurants. The new provision requires restaurants and similar retail food establishments with at least 20 or more locations to provide clear and conspicuous information to consumers, including:

• declaring the number of calories each standard menu item provides as it is typically prepared, and
• presenting the required calorie information in terms of suggested caloric intake in the context of an overall diet.

The caloric information must be adjacent to the name of the standard menu item as it is usually prepared and placed on the actual menu or menu board, including a drive-through menu board, as well as in written form available on premises upon consumer request. Food sold at a salad bar, buffet line, cafeteria line, or similar self-service facility, and for self-service beverages or food that is on display and that is visible to customers and some vending machines are also explicitly covered by this provision.

Affected companies can prepare to participate in the FDA rulemaking process that will define compliance standards by determining the calorie content of their affected food products and evaluating the options available for disclosing the required calorie information.

For more information, please reference the Kelley Drye client advisory.
 

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This post was written by Sarah Roller and Raqiyyah R. Pippins.

On March 26, 2010, the Food & Drug Administration (FDA), issued a final rule titled, "Listing of Color Additives Exempt From Certification; Bismuth Citrate,”  amending the color additive regulations to increase the permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp.

This regulation follows the initial notice published by FDA on February 25, 2008, which announced that a color additive petition (CAP 8c0286) had been filed by Combe, Inc. to amend the color additive regulations at 21 CFR 73.2110 for bismuth citrate to increase the maximum permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp from 0.5 percent (weight per volume (w/v)) to 2.0 percent (w/v).  Bismuth citrate is commonly used as an active ingredient in hair dyes used to darken hair on the scalp.

After reviewing the data in the petition and other materials related to the safety of the use of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp, FDA concluded that use of bismuth citrate at levels up to 2.0 percent (w/v) “is safe and…will achieve its intended technical effect.” The rule will go into effect on April 27, 2010, "except as to any provisions that may be stayed by the filing of proper objections."

More information about the regulation, including information on submitting objections or requests for hearings, is available here.

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This post was written by Raqiyyah R. Pippins and Sarah Roller.

On March 25, 2010, FDA announced its new guidance for industry entitled, “Guidance for Industry on Submitting a Report for Multiple Facilities to the Reportable Food Electronic Portal as Established by the Food and Drug Administration Amendments Act of 2007.” 75 Fed. Reg. 14445 (March 25, 2010).

The new FDA guidance provides for the submission of a single report to FDA’s Reportable Food Registry by a company when a reportable food is located in more than one of that company’s food facilities. The new FDA guidance addresses Reportable Food Registry requirements for companies with multiple food facilities, clarifying procedures that were addressed in previous FDA guidance issued in June 2009 and amended September 2009. 

Submitting One Comprehensive Report for All Company Facilities Holding a Reportable Food

Under section 417 the Federal Food, Drug, and Cosmetic Act1 (FDCA), within 24 hours after a “responsible party” for a company determines that an article of food is a “reportable food,” the responsible party is required to submit a report to FDA through the electronic portal the agency has established for this purpose. Since the statute defines the “responsible party” to be the person a company has charged with the responsibility of registering a food facility, companies with more than one facility may have more than one “responsible party.”

The new FDA guidance makes clear that, in the case that a reportable food report is required for a food that is located in more than one facility of a single company, separate reports need not be submitted by each facility and that, in alternative, it is permissible for a single “combined” report to be submitted which covers all of the company’s facilities in which the reportable food is being held. In addition, the guidance specifies that the combined report:

• must include all of the required data elements concerning the reportable food located in each company facility2;
• may be prepared by one authorized individual (e.g., the responsible party for one company facility) who completes the data entry screens presented in FDA’s electronic portal by providing the required information for only one of the facilities and attaching the required information concerning the reportable food located in all other company facilities in a table or spreadsheet3 format that clearly identifies each facility and the associated reportable food held in the respective facility.

1  The Reportable Food Registry was established under the Food and Drug Administration Amendments Act of 2007, which added new section 417 to the FDCA. FDA began to enforce the new requirement on December 8, 2009. See 21 USC 350f.

2  See “Increasing Transparency and the Reportable Food Registry,” Kelley Drye and Warren LLP Client Advisory dated June 23, 2009, for a listing of these required data elements.

3  If using a tabular or spreadsheet format, FDA recommends that responsible parties use the following column headings, in the order listed, for the required (*) and optional information for each facility: Name of facility*, Food facility registration number* , Contact name, Contact phone number, Street address*, City*, State* and Zip code*.

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Representatives from the FTC and FDA offered valuable insight into the agencies’ current thinking on immune system claims for food and dietary supplement products last week. Richard Cleland, Assistant Director of the FTC Division of Advertising Practices, and Robert Moore of the FDA’s Center for Food Safety and Applied Nutrition confirmed that immune system claims are on the radar screens of both agencies.

Speaking at an FDLI webinar, Mr. Cleland stated that, under a new standard the FTC is looking to set for claim substantiation, products that claim to do anything more than simply support a healthy immune system will be subject to a standard of evidence only previously seen in the drug testing world. He further confirmed that probiotics, the healthy bacteria found in many yogurt products as well as in dietary supplements, are high on the agency’s radar screen and that enforcement is coming.

On behalf of the FDA, Mr. Moore also indicated that claims such as “Boost immune defenses” may be implied disease claims. He further noted that the agency is looking beyond the much-publicized Front of Packaging Labeling Initiative to the metatags on websites and reliance on disease treatment studies to determine whether a product is being properly marketed as a food/dietary supplement or as a drug.

Neither representative discussed whether consumers actually rely on these messages in deciding whether to purchase products. Regardless, it is clear that both agencies are looking closer than ever at what is behind the claims on food labels.

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This post was written by Raqiyyah R. Pippins and Sarah Roller.

On March 5, 2010, the General Accountability Office (GAO) issued a report evaluating the Food and Drug Administration’s (FDA’s) policies concerning food ingredients that have been determined to be “Generally Recognized As Safe” (GRAS). GRAS ingredients are excluded from premarket clearance requirements for food additives under the Federal Food, Drug, and Cosmetic Act (FDCA). The GAO report was prepared at the joint request of Sen. Tom Harkin (D., Iowa), Chairman of the Senate Committee on Health, Education, Labor and Pensions, and Rep. Rosa DeLauro (D., Conn.), Chair of the House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, and was prompted by apparent congressional interest in FDA oversight of food ingredients, including those developed through nanotechnology and other emerging technologies.

The GAO evaluation considered data on FDA’s voluntary notification program from the first year a GRAS notice was submitted, 1998, through 2008; laws and regulations regarding GRAS substances; the 11 citizen petitions related to GRAS substances that were submitted to FDA between 2004 and 2008; information from FDA officials regarding the agency’s response to the 11 citizen petitions; FDA’s policies and guidance to companies regarding engineered nanomaterials; the activities of foreign governments—namely, Canada and the European Union—that have been particularly active in considering regulation of engineered nanomaterials in food; and interviews with a wide range of stakeholders, including officials from FDA, industry and trade organizations, consumer advocacy groups, academia, and foreign governments.

Based on the evaluation, the new GAO report concludes that greater FDA oversight is needed with respect to GRAS determinations concerning both (a) food ingredients and components that previously were determined to be GRAS ingredients and for which GRAS status has been challenged in pending citizen petitions (e.g., high fructose corn syrup, salt, hydrogenated oils), and (b) ingredients and components that are the subject of new GRAS determinations, including those developed through nanotechnology and other emerging technologies.

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