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We are proud to announce a new blog from Kelley Drye & Warren LLP:  Food and Drug Law Access.

This sister blog to Ad Law Access provides news and commentary concerning food and drug law and public policy developments, including legislative, regulatory, enforcement, and case law developments relating to the federal laws administered by the FDA, USDA, and related state laws. It also provides timely reports concerning the international programs and policies of the FDA and USDA, and foreign governments.

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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.

Continue Reading GAO Report Recommends FDA Adopt Definition of Economic Adulteration and Take Steps to Combat Independently from Other Types of Adulteration

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.

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.


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 Alysa Hutnik and Sarah Roller.

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.

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.


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.

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.

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.