Today the U.S. Food and Drug Administration (FDA) issued a
notice, due to publish in tomorrow's Federal Register,
tentatively determining that partially hydrogenated oils (PHOs) are
not generally recognized as safe (GRAS) for use in food. If
this determination is finalized, PHOs would effectively be banned
from use in foods unless they are first approved by the FDA as
"food additives," which would likely be difficult.
This would have a major impact on the food industry. In
particular, products such as donuts, cookies, margarine, microwave
popcorn, frozen pizzas, baked goods, frostings, and many other
foods would need to be reformulated.
The FDA's concern focuses on trans fats, which are
deliberately produced in the manufacturing process for PHOs to help
increase the melting point, shelf life, and flavor stability of the
oil. Although trans fats exist elsewhere in the diet
to some extent, PHOs are the major source. According to the
FDA, trans fats may have adverse effects on blood
cholesterol parameters that affect the risk of coronary heart
disease, and may have other health implications that, as the FDA
acknowledges, are unconfirmed. This tentative determination
that PHOs are not GRAS follows a 2003 rule requiring labeling of
trans fat content in nutrition labeling, as well as
various state and local initiatives that have restricted the use of
PHOs.
The FDA has established a 60-day public comment period from
publication of the notice. Given the complexity and economic
significance of the tentative finding, it is likely that this
period could be extended if requested by stakeholders noting a need
for more time to prepare fulsome comments. Besides requesting
comments on whether the FDA should finalize its tentative
determination, the Agency also requests comments on:
- Other possible approaches to addressing PHOs in food, such as setting trans fat specification levels.
- How long reformulation would take.
- What would be a reasonable compliance date to allow adequate time for reformulation while minimizing market disruption? (The notice hints that a "multi-year compliance period" may be allowed.)
- How can the burden on small businesses be reduced?
- What other challenges may exist, such as products that cannot be reformulated?
- Whether there is a "prior sanction" for the use of PHO in food of which the FDA is unaware.
To view the pre-publication version of the notice, click here.
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