FDA hears views on what to do about functional foods

The hearing was designed to initiate debate and provide suggestions on how the federal authority should tailor regulations for a food category that has grown in importance and is regarded by some to occupy a grey area between conventional foods and dietary supplements.

In particular, there has been concern from some quarters that food products are being marketed as 'functional' without strong enough evidence that they actually deliver on their promise. Two products that have recently come under fire are Nestle/Coca-Cola's Enviga beverage, and Masterfoods' CocaoVia chocolate.

Moreover, the energy drinks market has become confused by products that genuinely can provide nutrition and energy to sportspeople, for example, and those designed solely to appeal to the fickle tastes of trendy youngsters - such as the Cocaine drink marketed to young people as a legal alternative to the drug of the same name.

Opinions presented by the various organizations veered from calls for qualified health claims for functional foods - in order to avoid a misinformed public - to allowing the system that has allowed beneficial foods to come to market to continue as it has for decades.

The FDA has borrowed the Institute of Food Tecnologists' loose definition of functional foods as: "foods and food components that provide a health benefit beyond basic nutrition"​, including: conventional, fortified, enriched and enhanced foods.

The government agency is responsible for ensuring that all foods (bar meat, poultry and eggs) are safe, sanitary, secure and properly labeled. Under the Food, Drug and Cosmetics Act the authority regulates conventional foods and dietary supplements, the latter through the 1994 amendment the Dietary Supplement Health and Education Act.

But as foods have started bearing claims for health benefits, they have trodden more and more on the ground of dietary supplements. Thus, the FDA hearing served to open up debate on the possibility for tighter regulations.

"The Institute of Food Technologists commends the Food and Drug Administration for holding this public hearing on functional foods as we believe that a few changes in regulatory policies could provide very positive benefits to society,"​ panelist Dr. Barbara Petersen addressed the hearing on behalf of the international scientific society of food professionals.

The 22,000-member strong organization was one of several to put forth testimony along the lines that specific regulations and processes for bringing functional foods to market would protect those companies that do make scientifically valid claims.

"IFT does not support some claims on foods marketed today because they are not supported by today's science,"​ said Dr. Petersen.

However, the organization was clear in its support for the majority of companies making claims and said that uses for food go beyond basic nutrition and are driving a need for regulated claims.

"The IFT Expert Panel recommends that FDA apply a more appropriate policy that health claim benefits for functional foods be based on "nutritive value or through the provision of a physical or physiological effect that has been scientifically documented or for which a substantial body of evidence exists for plausibility."​ said Dr. Petersen.

The IFT Expert Panel also suggested a process for overseeing functional foods being brought to market: Identification of a potential new bioactive ingredient; evaluation of an ingredient's efficacy and safety; selection of the appropriate food vehicle for a bioactive substance taking into consideration characteristics of the food, the ingredient and the intended consumer; independent peer review and, if required, regulatory oversight to ensure the accuracy of health claims; and post-market surveillance to confirm the pre-market assessments

The American Dietetic Association (ADA) went so far as to hint at a pre-market regulatory approach for functional foods.

ADA president Judith Gilbride said in a statement. "To address the ambiguities and complexity regarding the labeling of functional foods, ADA recommends cautious evaluation of the clinical efficacy of individual products and dietary supplements before recommending their use to promote a specific health outcome."​

Conversely, the Natural Products Association, which represents the dietary supplement industry, presented a more status quo approach.

"The current food safety regime works, and has allowed Americans safe access to the greatest food supply in the world,"​ NPA vice president scientific affairs Daniel Fabricant said in his address. "Both FDA and the Federal Trade Commission (FTC) have increased enforcement action against false claims and unsafe products, thus, demonstrating that the current system provides these agencies with adequate authority to take action when necessary."​

The argument rings of that used against those who call for stricter regulations for the dietary supplements industry, in the manner of the expensive pre-market process for bringing pharmaceuticals to market.

"Additional regulation would simply be over regulation and result in limited access to products that may provide a health benefit beyond the nutritive value,"​ said Fabricant.

The American Herbal Products Association took a stance in line with NPA. At the hearing, the organization's general counsel, Anthony Young, argued that functional foods such as Total cereal, launched in 1961, and Gatorade, introduced in 1965, have been safely consumed for decades.

"The GRAS [generally recognised as safe] notification system works, and it works well,"​ said Young. "AHPA recommends FDA use current law to address the use of novel ingredients in functional food. No new system is required."

The Food Products Association/Grocery Manufacturers Association took the status quo argument one step further and branded all foods as being functional.

"All conventional foods and beverages are functional and have functional ingredients,"​ said the organizations' senior vice president and chief science officer Pat Verduin. "We believe there is no value in having a separate and distinct regulatory approach for some foods versus others."​

"Consumers will be best served by the robust enforcement of existing provisions governing the safety of ingredients and the substantiation of claims,"​ continued Verduin.

"IFT's Expert Report on Functional Foods was written by an expert panel of 18 members.

The FDA has given no indication of what the next step may be in considering regulation functional foods.

But in its announcement of the meeting six months ago it was clear not to imply that the lack of recognition to date means they present a risk.

"Although we are confident that the existing provisions of the 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 dialog with industry, consumers, and other stakeholders regarding the regulation of these products,"​ said the agency.