Food Labels Can Make Claims Without Specific FDA Authorization Under FDA Reform Legislation

Nov 25, 1997

Food manufacturers will be able to place health and nutrient content claims on their labels without specific authorization from the Food and Drug Administration (FDA), provided the claim accurately depicts an official statement of the National Academy of Science (NAS), the National Institutes of Health (NIH), the Center for Disease Control and Prevention (CDC), or any other federal agency with responsibility for public health or research related to human nutrition. Prior to passage of the Food and Drug Administration Modernization Act of 1997 (FDAMA), all such claims had to have advance approval from FDA, often a lengthy process.

Under the FDAMA amendments to the Food, Drug, and Cosmetic Act, health and nutrient content claims may be made if they are based on an authoritative statement by NAS or one of its subdivisions, NIH, CDC, or other federal scientific agency regarding the relationship between the nutrient and a disease or health or that refers to the nutrient level required for human nutrition. (Note that although statements from subdivisions of NAS are acceptable, statements from subdivisions of NIH or CDC do not satisfy this requirement.) The statements used for these claims must be published by the agency and be currently in effect. Statements of individual employees of these agencies (rather than the agencies themselves) are not considered authoritative statements for this purpose.

At least 120 days prior to using the claim on a food label, the manufacturer or other person must notify FDA. The notice must include the exact wording of the claim and the concise basis for the claim. At the conclusion of the 120-day period, the person or company filing the notification may use the claim on its label unless FDA has issued a final regulation prohibiting or modifying its use. Use of the claim under this procedure is limited to the person or company that filed the notification.

This 120-day procedure can take the place of the health and nutrient content claims petition process, when authoritative statements are available. However, if the full petition process must be utilized, FDAMA has created incentives to expedite FDA action.

Time Lines Established for FDA Action on Health and Nutrient Content Claims

Under the law prior to FDAMA, which was signed on November 21, 1997, FDA is required to either file or deny health and nutrient content claims petitions within 100 days of receipt. However, the current law does not address the status of a petition if FDA fails to act within the 100-day time period. Effective 90 days from enactment of FDAMA--

• All petitions not denied or accepted for filing by FDA within 100 days will be deemed denied. The time period may be extended by mutual agreement of the agency and the petitioner.
  



• All petitions accepted for filing by FDA but not acted upon by the agency within 90 days will be deemed denied. The time period may be extended by mutual agreement of the parties.
  



• If FDA issues proposed rules within 90 days of accepting a petition, the agency must complete the rulemaking within 540 days of receipt of the petition or report to Congress on the reasons for the delay.
  
  

FDA's failure to act within the designated time periods is considered final agency action, subject to review by the appropriate federal court.

For the full text of FDAMA, go to http://thomas.loc.gov and type S. 830 in the box marked "Search by Bill Number."

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