FDA Modernization Act (FDAMA) Claims Main Page

Under section 403(r)(2)(G) (21 U.S.C. §343(r)(2)(G)) of the Federal Food, Drug, and Cosmetic Act (Act), a manufacturer may submit to the Food and Drug Administration (FDA) a notification of a nutrient content claim based on an authoritative statement from an appropriate scientific body of the United States Government or the National Academy of Sciences (NAS) or any of its subdivisions. The notification must be submitted to FDA at least 120 days before the food is introduced into interstate commerce. The claim may be made after 120 days from the date of submission of the notification until such time as 1) FDA issues a regulation prohibiting or modifying the claim or finding that the requirements for making the claim have not been met, or 2) a district court in an enforcement proceeding has determined that the requirements for making the claim have not been met.^[1]

On August 25, 2014, Unilever United States, Inc. (Unilever) submitted to the agency a notification containing proposed nutrient content claims for conventional foods and dietary supplements containing linoleic acid (LA). The 120-day period from the date of receipt of the submission of the Unilever notification was December 23, 2014. Therefore, after this date, manufacturers may use the claim specified in the notification on the label and in labeling of any conventional food or dietary supplement product that meets the eligibility criteria described below, unless or until FDA or a court acts to prohibit or modify the claim.

The notification cited statements from Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Food and Nutrition Board, Institute of Medicine (IOM), NAS, 2005, pages 8 and 423) as the authoritative statements that identify the LA level to which the claims refer. The statements related to the Adequate Intake Level (AI) for LA are "The AI for linoleic acid is 17 and 12 g/d for men and women 19 through 50 years of age, respectively (Table S-5).” and “The AI for linoleic acid is based on the median intake in the United States where an n-6 fatty acid deficiency is non-existent in healthy individuals. The AI is 17 g/d for young men and 12 g/d for young women.” These statements serve to provide the 17g Daily Value that is the basis for the nutrient content claims proposed for LA. Determining the Daily Value for LA based on the AI level established for young males aged 19-50 is consistent with the agency’s traditional method to setting Daily Values using a “population coverage” approach.^[2]

The notification proposed that a conventional food or dietary supplement product may provide on their labels or labeling the following nutrient content claims to characterize the level of LA:
"Excellent source,” “Good source,” and “More” (and appropriate synonyms). These claims would include one of the following statements:

1. “[‘Excellent source of LA,’ ‘High in LA,’ or ‘Rich in LA’]. Contains ___g of LA per serving, which is ___% of the 17 g Daily Value for LA.”
   The blank spaces would be filled in with the specific gram amount of LA in the product and the percentage of the Daily Value.
2. “[‘Good source of LA,’ ‘Contains LA,’ or ‘Provides LA’]. Contains ___g of LA per serving, which is ___% of the 17 g Daily Value for LA.”
   The blank spaces would be filled in with the specific gram amount of LA in the product and the percentage of the Daily Value.
3. “[‘More LA,’ ‘Fortified with LA,’ Enriched with LA,’ ‘Added LA,’ ‘Extra LA,’ or ‘Plus LA’]. Contains ___% more of the Daily Value for LA per serving than [reference food]. This product contains ___g of LA per serving, which is ___% of the Daily Value for LA (17g).”
   The blank spaces would be filled in with percentage 10% or greater of the Daily Value per serving more than a [reference food], the specific gram amount of LA in the product, and the percentage of the Daily Value.

In May, 1997, the National Research Council (NRC) Governing Board of NAS approved a policy statement regarding authoritative statements made by NAS or its subdivisions, the NRC, and the IOM. According to the policy, authoritative statements “are limited to those that represent the consensus of a duly-appointed principal investigator so that they appear explicitly as findings, conclusions, or recommendations in a report that has completed the institutional report review process.”^[3] Consistent with the policy statement, the statements related to the AI for LA in Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids published by the IOM qualify as authoritative statements.

FDA reviewed the authoritative statements from Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids in its context. FDA has not acted to prohibit or modify the claim. Accordingly, after December 23, 2014, manufacturers may use the specified claims on the label and in labeling of any food or dietary supplement product that qualifies for the claims described in the notification. Under the provisions of FDAMA, when the claims are used, they must appear exactly as stated in the notification. One example of a nutrient content claim characterizing the level of LA is “Good source of LA. Contains 1.7g of LA per serving, which is 10% of the 17g Daily Value for LA”.

This notification and materials regarding the claim are publicly available from the FDA Division of Dockets Management (Docket No. FDA-2014-N-2185). Persons interested in these documents may view them at the Dockets Management Branch, from 9 am to 4 pm, Monday through Friday at 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The Dockets Management Branch may be contacted at 240-402-7500. FDA intends to make the documents available on http://www.regulations.gov.

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