In joint comments filed last week, IDFA and the National Yogurt Association urged the Food and Drug Administration to narrow its interpretation of a congressional mandate that could severely restrict the marketing of foods with added biological ingredients. Under a broad interpretation, dairy foods with functional ingredients, like omega-3 fatty acids, plant sterols and probiotics cultures, might have to receive drug approval and be marketed as drugs, not food.
Congress passed the "Food and Drug Administration Amendments Act of 2007" in September 2007. Charged with its implementation, FDA issued a call for comments in July and will review all responses before determining a course of action.
One section of the act calls for prohibiting products containing an added drug or biological product that has undergone "substantial clinical investigations." In their comments, the associations ask FDA to exclude foods and ingredients that were clinically studied to substantiate health claims.
"Clinical trials are vitally important in developing the necessary substantiation to support health and structure/function claims that are appropriate and expressly permitted for use in food labeling," the comments state.
The comments also point out that too broad an interpretation could stifle heath-related research on foods with functional benefits and deprive consumers of food products that could help them achieve a healthy diet and reduce the risk of disease.
Functional foods and ingredients are products that provide a health benefit beyond basic nutrition. Some examples of functional foods include yogurt containing probiotics and some types of cheese, lowfat yogurt and lowfat milk that contain plant sterols and stanols. Products with added probiotics, or beneficial bacteria, often aid with food digestion and immune response. Food products with added sterols or stanols have been found to reduce the risk of heart disease.
"What's really at issue is the definition of the products that would be prohibited," said Michelle Matto, IDFA assistant director of nutrition and labeling. "The current interpretation is so broad and vague that it's hard for our members to know which products are included."
The original deadline for comments was October 27, but FDA has granted a request from NYA to extend the comment period until November 25, 2008. IDFA will continue to be engaged and may consider submitting additional comments.
For more information, contact Matto at firstname.lastname@example.org or 202-737-4332.