Comments filed with FDA follow a public hearing held in 2006, designed to examine whether the current regulatory framework is suitable for the overview of functional foods, or whether FDA needs to change the way it regulates this new category.
At the public hearing, the agency took into account recommendations from the Government Accountability Office (GAO), the International Life Sciences Institute (ILSI), the Institute of Food Technologists (IFT), and a citizens petition from advocacy group Center for Science in the Public Interest (CSPI). FDA also invited comments on a number of specific issues regarding ingredients, labeling, and the overall regulatory framework for functional foods.
In an e-mail to NutraIngredients-USA.com last week, an agency spokesperson said: “FDA is currently in the process of evaluating comments submitted on this issue and once done with that will then consider further actions, as necessary”.
No timeline was provided.
New regulations required?
The primary challenge facing the category in the US is that FDA does not provide a specific definition for functional foods, nor does it set out a consistent regulatory framework. As such, their regulation depends on how a manufacturer chooses to market the products.
Functional foods can be regulated as conventional foods, food additives, dietary supplements, drugs, medical foods, or food for special dietary use – depending on the type of health claims being used on the product labels.
In 2002, CSPI submitted a citizens petition to FDA, requesting the agency to undertake rulemaking actions with regard to functional foods, and to establish an advisory committee to reevaluate current labeling approaches for foods with novel ingredients.
FDA told NutraIngredients-USA.com that it will respond to CSPI’s petition once it has completed its evaluation of all comments.
The agency has received over 30 comments following the hearing. To access the comments, as well as a transcript of the hearing, click here.
Some comments
Most comments submitted by industry and some health groups suggest that no new regulations are required for the functional foods category.
The food industry trade group Grocery Manufacturers Association/Food Products Association (GMA/FPA) submitted comments stating that: “The current statutory and regulatory frameworks provide the necessary requirements and guidance to address all foods. We see no need to regulate some foods versus others in a separate and distinct regulatory approach.”
"’Functional foods’ are conventional foods. FDA has the authority to enforce legal prohibitions against false or misleading claims, including unsubstantiated claims-and FTC for advertising. Robust enforcement, rather than new regulations, will continue to ensure the integrity of conventional foods with functional benefits.”
The American Dietetic Association (ADA) commented that: “Rather than creating another bureaucratic layer of regulations that essentially subsume existing categories of food and food ingredients, further confused by regulations that address dietary supplements specifically, the ADA advocates for a reasoned review of existing law and regulation to develop modifications that truly address enduring consumer needs over those of market trends.”
The trade group American Herbal Products Association (AHPA) said: “AHPA does not believe that there is a need for a regulatory definition and a distinct regulatory approach to the evaluation of the safety of ingredients added to so-called functional foods. Marketing a food product as a ‘functional food’ does not in any way relieve the marketer of that product of their legal obligation to comply with existing federal law and regulations related to ingredient safety.
“The existing definition of food additive and the provisions in the definition for substances that are generally recognized as safe (GRAS) are fully applicable to products marketed as ‘functional foods’, such that no separate regulatory scheme is required. FDA’s resources would be better used by enforcing current regulations than in creating new, redundant regulations.”
To read our article on ‘Functional foods: What they mean around the world’ click here .To read our article on 'Regulation and health claims for functional foods' click here .To read our article on 'Types of research needed for functional food claims' click here .