Health Claims Top Agenda at FDA Hearing on Functional Foods

Last December, a panel of experts mulled over a menu of options during a public meeting at the FDA's Center for Food Safety and Nutrition in College Park, MD. More than 230 government officials, consumer advocates, and industry representatives debated how FDA should regulate functional foods. The conversation is shaping up to be the defining moment for functional foods with wide-reaching consequences on regulations and market practices. 

Laura Tarantino, PhD, director of FDA's Office of Food Additive Safety, noted: "there are no statutory or regulatory definitions for functional foods." She and Barbara Schneeman, PhD, director of FDA's Office of Nutritional Products, Labeling, and Dietary Supplements, provided a brief overview of FDA's current regulatory approach, representatives from the Institute of Food Technologists (IFT; Chicago) and the Center for Science in the Public Interest (CSPI; Washington, DC) offered opposing views of what FDA should do. 

Barbara Petersen, PhD, a member IFT's expert panel on functional foods, said that while functional foods can provide positive benefits, the way information about the products is presented to consumers needs to be improved. Petersen outlined the recommendations contained in Functional Foods: Opportunities & Challenges (see sidebar 1), a 2004 report from the IFT panel. 

"Current policies limit addressing the full scope of benefits and potential developments for functional foods," Petersen said, noting that the existing terminology and regulatory framework for functional foods hinders product development and marketing. 

Petersen added that the convoluted wording of health claims required to prevent foods from being classified as drugs can lead to inaccurate or misleading statements. "As long as claims are scientifically valid, enormous public health benefits would result from consumers understanding and acting on the claimed product benefit," she said. 

Petersen also noted that in its 2004 report, IFT proposed establishing independent expert panels that could make generally recognized as efficacious (GRAE) determinations for novel ingredients in functional foods. The GRAE panels, modeled after generally recognized as safe (GRAS) expert panels, would notify FDA of their conclusions. At various points in the hearing, speakers proposed that GRAE panels be allowed to draft some types of health claims. 

For instance, George Burdock, PhD, president of the Burdock Group (Vero Beach, FL), suggested that independent expert panels could submit dossiers about ingredient safety and effectiveness to FDA (see sidebar 2). If the dossiers persuaded FDA, the agency could post information online about the product’s name, manufacturer, and safety but keep efficacy data confidential. Unpersuasive dossiers would be sent back to the panels without prejudice. 

Burdock added that keeping efficacy data confidential was essential for fueling investment in research. He also suggested that organizations involved in developing GRAE determinations should receive a term of exclusivity for claims that arise from the process. "This system would respond to demands for consumer empowerment and demands for commercial free speech, and would relieve a potential logjam of petitions," Burdock said. 

But FDA officials at the hearing appeared skeptical, asking how the panels fit into the current regulatory system, how generally recognized data could be kept confidential, and if there would be an opportunity for the public to comment on GRAE determinations. 

While some experts called for greater flexibility for functional food health claims, others called for tighter regulation and more vigorous enforcement. 

CSPI legal affairs director Bruce Silverglade began his presentation by announcing that CSPI plans to sue Coca-Cola (Atlanta) and Nestlé (Vevey, Switzerland) to stop the companies from claiming that their new Enviga green tea beverage burns more calories than it contains. He then dismissed another energy product, Arizona Beverage Co.'s (Lake Success, NY) ice tea as "21st century quackery." 

While acknowledging that functional foods are "a potentially useful idea," Silverglade said the marketplace was bloated with "dubious" products that fail to address major health concerns. He added that a new regulatory category for functional foods was not needed but noted "FDA regulation can be improved." 

CSPI senior staff attorney Ilene Ringel Heller echoed Silverglade's concerns, noting that Mars Inc. (McLean, VA) continued to sell its CocoaVia line of cholesterol-lowering confections even after receiving an FDA warning letter in May 2006. "I guess a warning letter is just an invitation to be a pen pal with FDA," she said. 

Silverglade proposed that manufacturers be required to notify FDA of new ingredients and said the agency should use the significant scientific agreement standard, rather than the less-stringent weight of the evidence standard, when evaluating health claims for functional foods. "FDA's only study on qualified health claims shows that consumers don't understand them," he said. 

Similarly, Mary Hager, senior manager for regulatory affairs at the American Dietetic Association (ADA; Chicago), cited recent research indicating that consumers don’t distinguish between health and structure/function claims. Hager said ADA supports the use of preauthorized claims on food products as long as the claims aren't preliminary or speculative. 

"ADA recommends that all foods and dietary supplements, including functional foods, be regulated to ensure that the products are safe, that the products have been manufactured using good manufacturing practices, and that all label claims—health, nutrient content, and structure/function—are truthful, not misleading, and based on significant scientific agreement," Hager said. 

Not every speaker called for extensive changes to the way FDA regulates functional foods. Several industry representatives said no new regulatory changes were necessary and that FDA already had the ability to oversee the products. They did, however, offer some advice to FDA. One suggestion was to proceed with care. 

Andrew Shao, PhD, vice president of scientific and regulatory affairs at the Council for Responsible Nutrition (CRN; Washington, DC), called on FDA to "consider and review carefully all of the issues and ramifications of any decision on both conventional foods and dietary supplements before proceeding with any action." 

Shao noted that while there are many similarities between functional foods and supplements, there are some important differences, including different safety standards, manufacturing standards, allowable claims, labeling requirements, and uses. 

"In the end, FDA's most important concern should be assuring consumers that they receive safe products and sufficient truthful information to make informed purchase and usage decisions—regardless of which category the product is regulated under," Shao said. 

Similarly, Daniel Fabricant, PhD, vice president of scientific affairs at the Natural Products Association (Washington, DC), stressed that dietary supplements have their own regulatory category under DSHEA. He also noted that FDA and FTC recently have increased their scrutiny of product claims, demonstrating that they have adequate authority to take action when necessary. 

"Additional regulation would simply be over-regulation and result in limited access to products that may provide a health benefit beyond the nutritive value," Fabricant said. "The solution is not more regulation but rather stronger enforcement of current food safety and fraud laws to address problems that may exist in the marketplace." 

A key point raised by several speakers was that functional food labels should list more information about ingredients. For instance, Annette Dickinson, PhD, former president of CRN, said many energy beverages don't list how much caffeine is derived from natural ingredients and some omega-3 products don't identify which omega-3 fatty acids are present. Dickinson suggested that such information be contained in the Nutrition Facts box. 

"Consumers need to be provided with material information about the identity and quantity of nutritional ingredients," Dickinson said. 

Anthony Young, general counsel for the American Herbal Products Association (AHPA; Silver Spring, MD), also noted that AHPA labeling guidelines require the amount of caffeine to be listed on some product labels and suggested that FDA create a similar rule. Young also stated that the current GRAS system works well for novel ingredients and proposed that FDA establish a voluntary food claims notification process for manufacturers that want "the added assurance of FDA review." 

Despite the fact that many questions still need to be answered, some attendees said they were impressed with FDA's willingness to hear all sides of the debate. 

"Yesterday's meeting was refreshing in that there was a good exchange of information between the agency and all interested parties," Fabricant said, adding that it was "a more cooperative environment" than recent public hearings. 

"I thought it was good meeting for FDA," said Steven Shapiro, a partner at Ullman, Shapiro & Ullman (New York City). "I also appreciate the fact that Michael Landa, CFSAN’s deputy director, very clearly stated at the beginning of the meeting that there's no hidden agenda and that FDA wants to listen and help industry and the consumers. I thought the meeting was very positive." 

Shapiro said he believed it would take an act of Congress to create a definition for functional foods. He added, however, that he also believed FDA currently has adequate authority to regulate functional foods and that Tarantino and Schneeman confirmed that point during their presentation. 

"Clearly, FDA's biggest concern was what changes, if any, could be permitted under the existing Food and Drug Act, or whether a change in the law by Congress would be required," Shapiro said. 

John Venardos, vice president of Herbalife (Century City, CA), agreed that some of the proposals mentioned during the meeting seemed unlikely to happen unless the law were changed. "I was of the personal view that the presentation by our friends at IFT really wasn't compelling from a legal standpoint that explained how they could carve out the authority without some kind of change in statute," Vernardos said. "But it's an early stage in the process." 

One sore subject for some of the speakers and attendees was the lack of progress on good manufacturing practices (GMPs) for dietary supplements. In his presentation, Fabricant observed that the GMPs still had not been released by the Office of Management and Budget (OMB) and noted that their absence raises questions about how to regulate certain ingredients that are used in both supplements and functional foods. 

Venardos, who did not make a presentation at the meeting, also expressed disappointment that the GMPs are more than a decade overdue. "From the standpoint of someone in the dietary supplement industry, we want to see the same effort that FDA put into the meeting applied to releasing appropriate supplement GMPs in a timely fashion," he said. 

GMPs aside, the meeting seemed to be a positive experience for most attendees. "It's always a refreshing opportunity to have an open discussion with FDA," Venardos said. 

FDA will accept written or electronic comments until January 5, 2007. For more information, visit www.fda.gov. To submit a comment electronically, visit www.fda.gov/ohrms/dockets. The docket number is 2002P-0122. 

A Seven-Point Plan for Functional Foods 

In its 2004 report, Functional Foods: Opportunities and Challenges, an 18-member IFT expert panel listed seven recommendations for encouraging the development of functional foods:

1. Modify the definition of nutritive value
2. Expand research on nutritional components and the intersection of genomics and molecular nutrition
3. Expand research on biomarkers and physiological endpoints
4. Use GRAE panels to evaluate health claims
5. Allow full health claims based on significant scientific agreement and qualified health claims based on weight of the scientific evidence, but do not allow claims based on preliminary evidence
6. Allow health claims to accurately reflect data
7. Develop economic incentives for functional foods R&D

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