FDA Prohibits Nutrient Content Claims for Omegas

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WholeFoods Magazine Staff
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The U.S. Food and Drug Administration is standing by its 2007 proposed rule that denies certain nutrient content claims for foods and supplements that contain DHA, EPA and ALA. This final rule inks the agency’s thinking on the matter without any substantive changes from the 2007 publication.

Manufacturers, the final rule states, cannot indicate their products are “high in,” “rich in” or an “excellent source of” DHA or EPA, and bans some similar language for ALA. The main reason why is that no reference levels have been set for these nutrients, and FDA does not want to establish those created by the Institute of Medicine for EPA and DHA by way of regulation.

One set of nutrient claims (submitted by Martek) for ALA is allowed to remain on the market at this time. Said FDA in the final rule, “We indicated that we would not take regulatory action at this time on the ALA claims set forth in the Martek notification, [6] which used a population-coverage approach that is consistent with the approach that FDA has used in determining DVs to date (see 58 FR 2206 at 2211). We expressed no conclusions as to whether the ALA claims in the Martek notification are supported by an authoritative statement that satisfies the requirements of section 403(r)(2)(G) of the FD Act. Because the proposed rule would neither prohibit nor modify the nutrient content claims for ALA set forth in the Martek notification, we indicated that we would allow these claims to remain on the market at this time (see 72 FR 66103 at 66104).”

Published in WholeFoods Magazine, June 2014