FDA Public Meeting Will Explore Regulatory Options For Functional Foods

A distinct regulatory scheme for "functional foods" could benefit both industry and consumers, according to some analysts.

FDA will hold a public hearing Dec. 5 to describe the regulatory framework and reasons behind safety evaluation and labeling for functional foods, and solicit comments on how these foods should be regulated, the agency announced in the Oct. 24 Federal Register.

"Although we are confident that the existing provisions of [the Food, Drug & Cosmetic Act] are adequate to ensure that conventional foods being marketed as 'functional foods' are safe and lawful, we believe that it would be in the best interest of public health to begin a dialogue with industry, consumers and other stakeholders regarding regulation of these products," FDA stated in the announcement.

During the meeting, FDA will not consider dietary supplements within the functional foods category. Some labeling provisions of the Dietary Supplement Health & Education Act, however, are relevant to issues the hearing targets and are described in the Federal Register notice.

FDA opens this door more than six years after the General Accounting Office recommended that Congress amend the FD&C Act to require functional foods meet the same regulatory standards that dietary supplements meet (¹ (Also see "Supplement Labeling Safety One Of Six Guidance Topics Raised By GAO" - Pink Sheet, 17 Jul, 2000.), p. 12).

Additionally, the notice comes more than four years after the Center for Science in the Public Interest submitted a citizen petition making several requests concerning FDA regulation of functional foods (² 'The Tan Sheet' March 25, 2002, In Brief.)

Industry analysts say the sooner FDA adopts regulations specifically to address functional foods, the better it will be for the industry and for consumers.

The most recent research available from Mintel Consumer Intelligence estimated that sales in the functional food market would grow from $8.9 bil. in 1999 to $10.4 bil. in 2004.

"I think the regulatory protocol is to the good because that way we can define what a functional food is. Consumers like to have clear direction and definition when it comes to things they may wonder about," said Marcia Mogelonksy, a nutrition and foods market researcher for Mintel.

Ron Bailey, president of California Functional Foods market consultants, noted Japan has a head start on the U.S. of at least 15 years in regulating functional foods.

"In the meantime. [the U.S. is] fooling around and there's a lot of lost opportunities," Bailey said.

European countries' regard for regulating functional foods resembles the U.S., he added. Europe is "pretending like they're moving ahead but they really aren't," according to Bailey.

FDA could learn from Japan's regulatory approach, said Bailey, who researches the country's food and drug industries. Japanese regulators have made nearly 600 approvals for functional food products while annual sales in the country for the market now exceed $5 bil. (597 bil. Yen as of Oct. 27), he said.

"They just have not had any consumer problems or scandals or adulterations or manipulation in this whole category," Bailey observed. "It has worked really well in Japan."

Regulation could boost U.S. sales for some functional food products, but it could also hurt some, Mogelonksy said.

Some consumers buy functional foods because of the health-benefit claims the products make, particularly to help prevent certain diseases or conditions. Many claims, however, are not substantiated by tests, according to Mogelonsky. FDA regulation, though, likely would restrict the functional-food benefits products could claim, Mogelonksy said.

"Until the function of functional food is actually determined through scientific research, without regulations people can say whatever they want about it," she said.

"There's omega-3 in all sorts of things. Do we know that it's truly good? It looks like the scientific findings are pointing to omega-3 being a very important thing for various groups of the population. But if this is true, then why not make that a functional food? Make all foods with omega-3 functional foods and people would buy them with confidence."

An example of how some functional food products would fare in a regulated market is the history of soy products, Mogelonksy added. After tests showed soy does not provide all the health benefits providers advertised, sales slowed significantly, she said.

The functional food market "started off small, and when the Birkenstock-wearing hippies used to buy it in the health food stores no one cared too much," she said. "But now that Mr. Average American is looking for omega-3, there's too many people buying it not to be sure that you're giving them something they think they're getting."

When Mintel researchers asked 382 adults in July 2004 about why they do not buy functional foods, 25% responded that they "don't know enough about" the products and 16% said they "don't believe the claims [the products] make." Also, 31% said they already have healthy diets and 10% said the products are overpriced.

FDA's upcoming public hearing is scheduled for 9 a.m. to 4:30 p.m. at the Center for Food Safety & Applied Nutrition's Harvey W. Wiley Auditorium, 5100 Paint Branch Parkway, College Park, Md.

Notices to make oral presentations at the meeting must by submitted by Nov. 14, while all other notices to participate are due Nov. 28. FDA will accept written comments, submitted electronically or by delivery, through Jan. 5, 2007.

The questions FDA plans for the hearing include whether there is a need for a regulatory definition and a distinct regulatory approach to evaluating the safety of ingredients added to functional foods, and whether companies that market ingredients for addition to functional foods should be required to notify FDA prior to introducing the ingredients into interstate commerce.

FDA also seeks comments on what types of data and information are appropriate to demonstrate ingredients added to foods marketed as functional foods meet the safety standard of ''reasonable certainty of no harm," and how the agency could partner with stakeholders to develop recommendations or other information regarding the safety assessment of ingredients.

The notice includes a request for comments on whether FDA should provide manufacturers with incentives to conduct further research on substance/disease relationships.

Comments also are sought on whether conventional foods marketed as functional foods can be adequately addressed through current regulations for food additives, GRAS substances and labeling claims.

- Malcolm Spicer