FDA Proposes to Nix Use of Nutrient Content Claims for EPA and DHADecember 5, 2007
On Nov. 27, 2007, FDA published a proposed rule to restrict the use of nutrient content claims for the omega-3-fatty acids, alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA). The Agency proposes to prohibit notified nutrient content claims for EPA and DHA and certain claims for ALA because these claims do not meet the requirements of the Federal Food, Drug, and Cosmetic Act.
A nutrient content claim expressly or implicitly characterizes the level of a nutrient (e.g., “high in vitamin C,” “low in sodium”). Such a claim generally may not be used in food labeling unless the claim is made in accordance with authorizing FDA regulations or the claim has been notified to FDA. FDA has approved certain nutrient content claims for substances for which reference daily intakes or daily reference values have been established.
In 1997, the Food and Drug Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to allow use of a nutrient content claim on foods provided that this claim is based on authoritative statements from certain federal scientific bodies. 21 U.S.C. 343(r)(2)(G). Before such claims may be used, a notification must be submitted to FDA. If FDA does not object to the notification within 120 days, the claims may be used. After the 120 days expired, FDA can overturn the claim only if the Agency issues a regulation or obtains a court order. Id. 343(r)(2)(H).
Between 2004 and 2006, FDA has received three nutrient content notifications for omega-3-fatty acids: a notification for nutrient content claims for ALA, DHA, and EPA submitted collectively by Alaska General Seafoods, Ocean Beauty Seafoods, Inc., and Trans-Ocean Products, Inc. (the “Seafood Processors notification,” permitted since May 16, 2004); a notification for nutrient content claims for ALA and DHA submitted by Martek Biosciences Corp. (the “Martek notification,” effective since May 22, 2005); and a notification concerning nutrient content claims for DHA and EPA submitted by Ocean Nutrition Canada, Ltd (permitted since April 9, 2006 All three notifications were based on “authoritative” statements by the Institute of Medicine (IOM) in its September 5, 2002 Prepublication Report, Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids (IOM Report). Yet, each notification proposed different claims and criteria for products qualified to carry the claim.
As explained in the proposed rule, FDA has concluded that the IOM Report does not contain authoritative statements identifying a nutrient level, or reference value, for EPA and DHA. Moreover, the nutrient content claims for ALA set forth in the Seafood Processors notification are based on a daily value determined by a population-weighted average adequate intake level whereas the daily values FDA established for other nutrients are based on a population coverage approach. (Note, however, that FDA recently published an Advanced Notice of Proposed Rulemaking requesting public comments on the recommendation by IOM to base daily values on a population-weighted average rather than on a population coverage approach.)
FDA is proposing to take no regulatory action with respect to the nutrient content claims for ALA set forth in the Martek notification. Martek used the population coverage method to establish the reference daily value. Thus, if the proposed rule is finalized without change, the claims for ALA described in the Martek notification will be the only claims allowed to remain on the market. The Martek notification defines "high," "good source" and "more” claims for ALA. based on a daily value for ALA of 1.6 grams.
The proposed rule does not limit the use of structure/function claims concerning omega-3-fatty acids, or the use of the qualified health claim about the relationship between EPA and DHA and the reduced risk for coronary heart disease. Also, truthful, factual statement about the amount of EPA and DHA present in a food (e.g., "Contains x mg of EPA and DHA omega-3 fatty acids per serving") and comparative percentage claims for omega-3-fatty acids remain lawful.
The comment period closes February 11, 2008.