The Food and Drug Administration (FDA) has issued a final rule restricting the nutrient content claims that may be made for omega-3 fatty acids. Specifically, FDA is prohibiting existing nutrient content claims for the two omega-3s found in fish oil, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and is restricting nutrient content claims for alpha-linolenic acid (ALA), the omega-3 found in flaxseed, nuts, and certain other plant foods.
FDA has authorized several nutrient content claims for EPA, DHA, and ALA. These nutrient content claims were authorized under a special provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), Section 403(r)(2)(G) (21 U.S.C. § 343(r)(2)(G)). Because this provision was added by the Food and Drug Administration Modernization Act of 1997 (FDAMA), such claims are sometimes referred to as “FDAMA claims.” A listing of FDA’s FDAMA nutrient content claims and health claims can be found here.
Under that provision, any person may submit a notification to FDA that it intends to make a nutrient content claim based on an authoritative statement of a scientific body of the U.S. government with official responsibility for public health protection or human nutrition research or the National Academy of Sciences. If the notification is submitted at least 120 days before introduction of the product bearing the claim into interstate commerce, the claim is authorized and may be made unless: (a) FDA informs the notifier during the 120-day period that required information is missing from its notification; (b) FDA issues a regulation prohibiting or modifying the claim; (c) FDA issues a regulation finding that the statutory requirements have not been satisfied; or (d) a federal district court determines the statutory requirements have not been satisfied. FDA refers to this as an “alternative, expedited notification process to allow certain nutrient content claims to be made without going through the petition process.”
FDA received three separate notifications in 2004 and 2005 for nutrient content claims about EPA, DHA, and ALA. All three were based on authoritative statements made in a report of the Institute of Medicine, Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. When FDA did not object, the nutrient content claims set forth in these notifications were authorized and have been used in labeling for a variety of food products.
Today’s final rule is the first time that FDA has issued a regulation prohibiting a FDAMA nutrient content claim or health claim. It therefore offers insight into how FDA views such claims.
First, FDA says that the authoritative statement that serves as the basis for a FDAMA nutrient content claim must identify a “single, precise nutrient level” that could serve as the basis for a Daily Value for use in nutrition labeling. Under FD&C Act Section 403(r)(2)(G)(i), a FDAMA nutrient content claim must be based on an authoritative statement “which identifies the nutrient level to which the claim refers.” According to FDA, the term “nutrient level” in the statute refers to a reference value “that reflects a recommended or defined intake level that could serve as the basis for setting a DV” for use in nutrition labeling. Because the authoritative statements relied on by the notifications for the EPA and DHA nutrient content claims did not identify a precise level of EPA or DHA, they do not satisfy this statutory requirement and cannot be the basis for nutrient content claims about EPA and DHA. FDA also notes that the authoritative statements relied on do not appear to be authoritative statements at all, because they do not “appear explicitly as findings, conclusions, or recommendations” and therefore do not meet the National Research Council Governing Board’s definition of “authoritative statement.”
Second, FDA states that the single nutrient level that serves as the basis for a FDAMA nutrient content claim must be determined using the same approach FDA has used to determine Daily Values (DVs) for other nutrients, i.e., the “population-coverage approach.” Under the population-coverage approach, the reference value for a nutrient is set at a level sufficient to cover all gender and age groups. Because some of the nutrient content claims authorized for ALA (i.e., those based on a Daily Value of 1.3 g) used a “population-weighted approach,” those claims are prohibited. According to FDA, using two different approaches to set a reference value for the same nutrient would result in inconsistent and conflicting nutrient content claims on foods, which would confuse consumers and make meaningful product-to-product comparisons impossible.
Although the agency is prohibiting nutrient content claims about EPA and DHA, food manufacturers may continue to make the following labeling claims about EPA and DHA omega-3 fatty acids:
- The qualified health claim authorized by FDA about EPA and DHA and reduced risk of heart disease. That claim reads:
“Supportive but not conclusive research shows that consumption of
EPA and DHA omega-3 fatty acids may reduce the risk of CHD. One
serving of [name of food] provides __ gram(s) of EPA and DHA
omega-3 fatty acids. [See nutrition information for total fat, saturated
fat, and cholesterol content].”
The criteria a food must meet to be eligible for this claim can be found here.
- A permissible structure/function claim about EPA and/or DHA (e.g., “EPA and DHA omega-3s help maintain a healthy circulatory system”).
- A factual statement about the amount or percentage of EPA and/or DHA (or of omega-3 fatty acids generally) in the food, provided such statement is truthful and not misleading and does not in any way implicitly characterize the level of EPA or DHA in the food (e.g., “Contains __ mg of EPA and DHA omega-3s per serving,” “__ mg of omega-3s”).
- For dietary supplements, a simple percentage claim (e.g., “40% EPA and DHA omega-3 fatty acids”) or comparative percentage claim (e.g., “four times the EPA and DHA omega-3s per capsule (80 mg) as in 100 mg of menhaden oil (20 mg)”).
FDA also notes that interested persons are free to submit petitions for nutrient content claims for EPA and DHA if they believe the scientific evidence warrants them.
As a result of the final rule, only the following nutrient content claims about ALA will be permitted:
FDA says it is expressing no opinion as to whether the above ALA nutrient content claims are supported by an authoritative statement that meets the statutory requirements.
The final rule will become effective on January 1, 2016, which is the uniform compliance date for food labeling rules issued between January 1, 2013 and December 31, 2014. The rule finalizes, without change, a proposed rule that was published in November 2007.
