The U.S. Food and Drug Administration (FDA) recently prohibited labels on food and dietary supplement products that claim to be "high in," "rich in," or an "excellent source of" omega-3 fatty acids. FDA stated that it has not set a daily value for omega-3s, and the claims are not based on an authoritative statement that identifies a nutrient level to which the claims refer, as required by the federal Food, Drug, & Cosmetic Act (FD&C Act). Products bearing these claims must be removed from the market by January 1, 2016, when the rule goes into effect.
The FD&C Act allows on food labels certain "nutrient content claims" that characterize the level of a nutrient in a food. For example, a product may claim to be "high in calcium" or "low fat." Under federal regulations, however, only those nutrient content claims specifically defined in FDA's regulations may be used. All other claims are prohibited, including claims regarding levels of omega-3s, though FDA allows companies to petition for new claims.
The FDA Modernization Act of 1997 (FDAMA) establishes an alternative to the petition process for new nutrient content claims, providing for claims based on an authoritative statement published either by a scientific body of the federal government that has official responsibility for public health protection or research directly relating to human nutrition, or by the National Academy of Sciences and its subdivisions. Food companies must submit the proposed nutrient content claim to FDA at least 120 days before the product can be introduced to the market. The proposal must contain: (1) the exact wording of the prospective nutrient content claim; (2) a concise description of the authoritative statement upon which the claim is based; (3) a copy of the authoritative statement; and (4) a balanced representation of the scientific literature relating to the nutrient level for the claim.
This final rule takes action on three proposals submitted to FDA regarding the three types of omega-3 fatty acids: alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA). The first proposal was submitted collectively by a group of seafood processors on January 16, 2004 and covered all three types of omega-3s. The second proposal came from Martek Biosciences Corp. on January 21, 2005 and set forth "high in" nutrient content claims for DHA and ALA. Finally, Ocean Nutrition Canada submitted a third notification on December 9, 2005, proposing "high in" nutrient content claims for DHA and EPA.
FDA prohibited all proposed claims regarding DHA and EPA because the authoritative statements upon which the claims are based do not meet the statutory requirements. The law requires an authoritative statement to establish a reference level for the nutrient similar to a food label reference label. In other words, the authoritative statement reference level should be able to serve as the basis for setting a daily value for the nutrient. In this case, the authoritative statement does not establish a reference level for DHA or EPA and thus fails to satisfy the statutory requirements.
For the ALA claims, FDA prohibited the nutrient content claim proposed by the seafood processors. According to FDA, the claim was based on a reference value that was determined by a completely difference methodology than is used to establish reference values for other nutrients. The claim thus fails to satisfy the requirements of the FDAMA. Conversely, FDA chose to exercise its enforcement discretion on Martek's ALA claim, which used a methodology similar to FDA's calculations to set a reference value. This claim will be allowed to remain on the market.
The final rule was published on April 28, 2014, and can be found here.