Functional Foods Under Consideration

Visit any supermarket and you’ll discover a virtual explosion of products that make claims about enhancing consumers’ health and wellness. Products carry statements that they help maintain healthy skin, aid in dealing with stress, and boost immune systems, to name a few. These products all fall into a new territory, “functional foods.” While increasingly popular both with consumers and manufacturers, who see a growing market for them, these foods and beverages are attracting attention from many different audiences, from consumers and the media to trade groups and government agencies. Their uncertain natures and varied claims are raising questions about the need for additional regulatory oversight.

In December, the U.S. Food and Drug Administration (FDA) held a public hearing to discuss regulation of conventional foods being marketed as functional foods.

As companies continue to innovate and develop new products to meet consumer demand, the beverage industry is keenly interested in how these products are regulated. The public hearing provided an opportunity for groups to exchange ideas with the FDA on what, if any, changes need to be made in the way that these foods are regulated. In particular, the FDA sought
information on how best to determine the safety and effi acy of ingredients and to verify claims for this category of foods. During the hearing, the FDA also solicited questions from presenters on whether the organization currently has the statutory authority to
make any suggested changes to these rules.

The FDA’s preliminary assessment was that the current legal and regulatory framework for functional foods is working and that no additional oversight is necessary. The American Beverage Association (ABA) agrees with this assessment. We believe that all foods and beverages can be categorized as functional, as they provide benefi ts to the body and that developing a separate regulatory scheme for so-called functional foods is not necessary. We also believe that the current legal and regulatory provisions
governing conventional foods, including functional foods, effectively manage ingredient safety and labeling claims. These rules have been in place for decades and have safely protected our nation’s food and beverage supply.

Several groups provided other perspectives at the hearing. The Institute of Food Technologists (IFT) suggested changing current regulations to require the use of certain expert panels to determine effi cacy, through what they termed, “Generally Regarded as
Effi cacious (GRAE)” panels. This new category would be an addition to the current FDA standard, “Generally Regarded as Safe (GRAS).” Additionally, the Center for Science in the Public Interest (CSPI) advocated for the FDA to have a stronger and in the classifi cation and approval of functional foods. Viewing this category as “novel foods,” the group wants FDA re-notification and approval before makers can procede with the manufacturing or labeling of applicable products.

The FDA extended the 30-day public comment period to 60 days, concluding in early March. The agency is reviewing the comments it received, and, after deliberation, will either issue a proposed rule or conclude that no additional regulation is necessary for this category of foods and beverages. The comments will be made public.

On behalf of the beverage industry, ABA submitted comments to support the current legal and regulatory oversight of functional foods. If you would like more information about the FDA’s efforts, visit its web site at

The beverage industry faces other important issues on the regulatory horizon. Recently, the FDA proposed a rule to allow a health claim for foods, beverages and dietary supplements containing both calcium and vitamin D to reduce the risk of osteoporosis.

Developed in response to a health petition submitted by The Coca-Cola Company’s Beverage Institute for Health and Wellness in 2004, the proposal also could potentially eliminate some previously cumbersome – but mandated – language on labels about the health claim. The FDA solicited comments on the proposal, and we submitted a statement advocating for expanding and simplifying the health claims.

The ABA also is working to ensure that the FDA has the necessary funding to implement the current rules and regulations by participating in the “Coalition for a Stronger FDA,” a broad coalition of diverse organizations advocating for increased federal funding for FDA. The coalition’s objective is to insure the FDA continues to be able to successfully protect our
nation’s foods and beverages.

On another front, last December 1 the U.S. Federal Reserve published a proposed amendment to Regulation E of the Electronic Funds Transfer Act to exempt vending machines from providing receipts for debit card transactions under $15. The Act requires that all debit purchases, regardless of size, be accompanied by a paper receipt. A requirement to provide receipts at vending machines would substantially increase costs for operators. The proposed amendment, however, would allow for an exemption to this regulation if the purchase is $15 or less.

We believe the cost of outfitting and maintaining the printers on vending machines would be of serious concern for the beverage industry as it could be a major deterrent to efforts to make payment options at vending machines more diversified. In addition, consumers would be deprived of the convenience of using their debit card, despite the fact that studies show that consumers are increasingly using debit cards, even for small transactions. The ABA supports the amendment and submitted comments to the Federal Reserve advocating an exemption for small purchases.