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

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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