HOT TOPIC!!!!!!!!  FDAFood Labeling: Nutrient Content Claims; Alpha-Linolenic Acid,
Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug Administration (FDA) proposes to issue this
rule finding that certain nutrient content claims for foods, including
conventional foods and dietary supplements, that contain omega-3 fatty
acids, do not meet the requirements of the Federal Food, Drug, and
Cosmetic Act (the act) and may not appear in food labeling. This rule
is being proposed in response to three notifications submitted to FDA
under the act. One notification concerning nutrient content claims for
alpha-linolenic acid (ALA), docosahexaenoic acid (DHA), and
eicosapentaenoic acid (EPA) was submitted collectively by Alaska
General Seafoods, Ocean Beauty Seafoods, Inc., and Trans-Ocean
Products, Inc. (the seafood processors notification); a second
notification concerning nutrient content claims for ALA, DHA, and EPA
was submitted by Martek Biosciences Corp. (the Martek notification);
and a third notification concerning nutrient content claims for DHA and
EPA was submitted by Ocean Nutrition Canada, Ltd. (the Ocean Nutrition
notification).
    FDA has reviewed the information included in the three
notifications and is proposing to prohibit the nutrient content claims
for DHA and EPA set

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forth in the three notifications because they are not based on an
authoritative statement that identifies a nutrient level to which the
claims refer, as required by the controlling statutory authority. FDA
is also proposing to prohibit the nutrient content claims for ALA set
forth in the seafood processors notification because they are based on
a daily value that was determined by a different method than daily
values already established for other nutrients. Because of the
different methodology used to set the daily value, the ALA claims set
forth in the seafood processors notification do not enable the public
to comprehend the information provided in the claims and to understand
the relative significance of such information in the context of the
daily diet, as required by the controlling statutory authority. FDA is
proposing to take no regulatory action with respect to the nutrient
content claims for ALA set forth in the Martek notification. Therefore,
if this proposed rule is finalized without change, these claims will be
allowed to remain on the market.
 
FOR MORE INFORMATION VIEW THIS LINK  http://www.cfsan.fda.gov/~lrd/fr071127.html