On November 7, the Food and Drug Administration ("FDA"
or the "Agency") announced that it has tentatively
determined that partially hydrogenated oils ("PHOs"),
which are the primary dietary source of industrially produced trans
fatty acids, are not generally recognized as safe
("GRAS"). This tentative finding has no legal
effect—for now. However, if FDA finalizes its determination
that PHOs are not GRAS, food manufacturers would no longer be
allowed to sell the oils, either directly or as ingredients in
other food products, without first obtaining the Agency's
approval to use them as food additives. Food service establishments
that serve food containing PHOs would also be affected.
Under the Food, Drug, and Cosmetic Act, food cannot contain a food
additive unless FDA has approved the use of the additive. However,
a substance that is GRAS is not considered an additive, and the
substance can be used without prior Agency approval. A substance is
GRAS if qualified experts generally recognize it to be safe under
the conditions of its intended use. For decades, industry, with
FDA's acquiescence, has understood PHOs and trans fats to be
GRAS. FDA now tentatively proposes to find that PHOs are not GRAS,
thus relegating PHOs to the status of unsafe food additives. FDA
based its tentative determination on current scientific evidence
demonstrating the health risks associated with consumption of trans
fatty acids, or trans fats, such as the increased risk for coronary
heart disease.
Currently, food products on the market that contain PHOs include
frozen pizzas, microwave popcorn, assorted baked goods, shortening,
frosting, and stick margarine. The Agency has estimated that the
initial costs of removing PHOs from the food supply would be $8
billion, plus any additional costs to small businesses. However,
these efforts would not entirely remove trans fats from the
American diet. Low levels of trans fat can be found in other edible
oils as a result of processing, and trans fat occurs naturally in
beef and dairy products
Stakeholders have the opportunity to submit public comment and
additional scientific data before FDA finalizes its determination.
FDA is soliciting public comment on various topics, including the
amount of time it would take producers to reformulate products to
eliminate PHOs from the food supply, a reasonable deadline for
compliance with the Agency's determination, and other
challenges regarding the elimination of PHOs from food.
Specifically:
- Should FDA finalize its tentative determination that PHOs are no longer GRAS?
- Is there data to support other possible approaches to addressing the use of PHOs in food?
- How long would it take producers to reformulate food products to eliminate PHOs from the food supply? Are there likely to be differences in reformulation time for certain foods or certain types of businesses?
- If FDA finalizes its tentative determination, what would be an adequate time period for compliance?
- Are there any special considerations that could be made to reduce the burden on small businesses that would result from removal of PHOs from foods? Would these considerations be consistent with final determination that PHOs are not GRAS?
- Are there other challenges regarding the removal of PHOs from foods? Are there products that may not be able to be reformulated? What sorts of products and what challenges are faced?
- Is there any knowledge of an applicable prior sanction for the use of PHOs in food?
The deadline for submitting comments and other information to
FDA (Docket FDA-2013-N-1317) is January 7, 2014.
FDA's tentative determination is only one of several actions
the Agency and other stakeholders have taken to reduce the
consumption of trans fat. In 2003, FDA finalized a rule that
requires that trans fat content be provided in the nutritional
label of conventional foods and dietary supplements. This
requirement became effective on January 1, 2006. Based on studies
conducted by the Agency, the overall dietary intake of trans fat
has continually decreased in the United States since the final rule
was released. Additionally, municipalities, states, and other
countries have also taken steps to decrease the use of PHOs in
food. For example, California, New York City, and Baltimore have
restricted the use of trans fat ingredients in food service
establishments.
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