FDA Finalizes Rule Prohibiting Certain Nutrient Content Claims for Omega-3 Fatty Acids

On April 28, 2014, the Food and Drug Administration (FDA) published a final rule that will prohibit certain nutrient content claims for foods and dietary supplements containing the omega-3 fatty acids docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), and alpha-linolenic acid (ALA).[1] As identified in the public comments regarding the proposed rule, a growing number of products, including seafood, pasta, eggs, fresh and shelf-stable milks, spoonable yogurts, yogurt drinks, fermented milk drinks, cheeses, butters, fat-based spreads, juices, juice smoothies, soy milks, packaged breads, meats from grass-fed animals, packaged meats, baby foods, chocolate confections, cooking oils, packaged soups, ice creams, nutritional bars, and frozen pizzas, may use these claims. In summary, FDA’s rule eliminates a number of proposed nutrient content claims for DHA, EPA, and ALA, but agrees to not take action against certain ALA nutrient content claims at this time.

As background, Section 403(r)(1)(A) of the Federal Food, Drug, and Cosmetic Act (the Act) permits the use of nutrient content claims only where a reference level for the nutrient of interest has been established, such a Reference Daily Intake (RDI) or a Daily Reference Value (DRV). FDA reviews nutrient content claims either through a formal petition process or a premarket notification process set forth in Section 403(r)(2)(G) of the Act. Under the premarket notification process, a nutrient content claim may be based on authoritative statements made either by a scientific body of the U.S. Government with official responsibility for public health protection or research directly relating to human nutrition or by the National Academy of Sciences (NAS) or any of its subdivisions. The authoritative statements must identify the nutrient level to which the claim refers and the claim must accurately represent the authoritative statement in a manner that enables the public to comprehend the claim and its relative significance in the context of the total daily diet.

FDA’s final rule regarding nutrient claims for DHA, EPA, and ALA responds to three premarket notifications that were submitted to FDA in 2004 and 2005. Specifically, FDA has addressed nutrient content claims regarding (1) DHA, EPA, and ALA, as submitted by Alaska General Seafoods, Ocean Beauty Seafoods, Inc. and Trans-Ocean Products, Inc. on January 16, 2004, (2) DHA, EPA, and ALA, as submitted by Martek Biosciences Corp. on January 21, 2005, and (3) DHA and EPA, as submitted by Ocean Nutrition Canada, Ltd. on December 9, 2005. The nutrient content claims presented in the notifications included statements regarding the percent daily value of DHA, EPA, and/or ALA contained in the food, as well as other statements indicating that the foods are “high,” “rich in,” or an “excellent source of” the omega-3 fatty acids.

The final rule regarding the omega-3 fatty acid nutrient content claims is substantively unchanged from the proposed version of the rule that FDA released in 2007.[2] In keeping with the proposed version of the rule, FDA is taking action against the nutrient content claims for DHA and EPA contained in the three notifications because the claims are not based on an authoritative statement that identifies a nutrient level to which the claim refers, as required by the Act. Specifically, the Agency concluded that the statements of the Institute of Medicine of the National Academies (IOM) on which the nutrient content claim notifications were based do not reflect a recommended or defined intake level of DHA and/or EPA that could be used to establish a daily value (DV) for these substances for purposes of nutrition labeling. 

The Agency also is taking action against statements regarding ALA that were presented in the January 16, 2004 notification, which presented the contents of ALA in either milligram or percent, and related this level to a DV for ALA. FDA determined that these claims regarding ALA were based on reference values determined by a different approach than FDA would otherwise use for nutrients. FDA concluded that the use of a different method to establish the reference values for ALA prevents the public from comprehending the claims and understanding the significance of the information in the context of the daily diet.

FDA has decided to take no regulatory action at this time with respect to the ALA nutrient content claims that were set forth in Martek’s January 21, 2005 notification. As provided in the table below, which appears in FDA’s final rule, foods making the following nutrient claims will be allowed to remain on the market at this time:

FDA’s rule regarding nutrient content claims for DHA, EPA, and ALA will become effective on the next uniform compliance date for labeling regulation, January 1, 2016, which pertains to all food labeling regulations that FDA issues between January 1, 2013 and December 31, 2014. 

FDA’s new rule provides further information regarding the Agency’s interpretation of Section 403(r)(2)(G) of the Act, which describes the premarket notification process for new nutrient content claims. In promulgating the rule, FDA has expressed its view that nutrient content claims must be based on a discrete intake level that could be used to set a DV for nutrition labeling purposes. In addition, FDA has taken issue with the use of a population-weighted approach to establish a reference level for the nutrient content claims; the Agency relies on a population-coverage approach to establish nutrient reference level. FDA has stated that the use of the alternative population-weighted model would not allow consumers to understand the significance of the nutrient content claim in the context of the daily diet.

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