Industry has weighed in with a wide variety of opinion at a public hearing convened by the US Food and Drug Administration (FDA) into the manner in which functional foods should be regulated.
The meeting was held in reaction to the greater numbers of foods and beverages carrying health claims and which some feel fall into a regulatory grey area between regular foods and beverages and food supplements. Conventional foods are regulated by the Food, Drug and Cosmetics Act while supplements are governed by the controversial 1994 Dietary Supplement Health and Education Act (DSHEA).
Some critics, such as the Illinois-based Institute of Food Technologists' (IFT), pointed out that established processes for bringing foods with health claims to market were not stringent enough. This had the unintended effect of discrediting all health claims — even those with strong clinical backing.
"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 IFT panelist Dr Barbara Petersen. "IFT does not support some claims on foods marketed today because they are not supported by today's science."
Daniel Fabricant, vice president of scientific affairs at the Washington DC-based Natural Products Association, which represents major supplements makers, defended the existing system. "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," he said. "Additional regulation would simply be over-regulation and result in limited access to products that may provide a health benefit beyond the nutritive value."
The Utah-based American Herbal Products Association (AHPA) agreed, stating, "The GRAS [Generally Recognized As Safe] notification system works, and it works well. AHPA recommends FDA use current law to address the use of novel ingredients in functional food. No new system is required."