The AAFP recently notified the FDA of its strong support for a tentative determination(www.federalregister.gov) by the agency that, when finalized, stands to severely restrict manufacturers' ability to market foods that contain partially hydrogenated oils (PHOs). These oils represent the chief dietary source of industrially produced trans fatty acids, commonly known as trans fats.
In a Dec. 19 letter(2 page PDF) to FDA Assistant Commissioner for Policy Leslie Kux, J.D., AAFP Board Chair Jeff Cain, M.D., of Denver, responded to the agency's request for comments on the tentative determination. After reviewing new scientific evidence the FDA cited as the basis for its preliminary determination, Cain wrote, "We are pleased to wholeheartedly support the FDA's determination that PHOs are not generally safe for use in food."
According to the FDA, PHOs have been used in a variety of foods for many years based on self-determinations by industry that such use is "generally recognized as safe." However, recent research results and other findings indicate that these substances are not, in fact, safe for use in any food and, therefore, should be considered food additives.
Comment Period Extended
On Dec. 30, the FDA announced(www.fda.gov) it would extend the comment period for the agency's preliminary determination that partially hydrogenated oils are not "generally recognized as safe" for use in food and should be reclassified as food additives. The deadline for submission of comments is now March 8, 2014.
Interested stakeholders may submit comments online(www.regulations.gov) or by mail to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
As part of the AAFP's review of the FDA's new evidence, family physicians serving on the Member Advisory Panel for the Academy's Americans in Motion-Healthy Interventions initiative provided input on the agency's proposal. Specifically, panel members found that PHOs
- contribute to obesity in both children and adults;
- have adverse effects on blood cholesterol levels;
- put patients at risk for coronary heart disease; and
- contribute to insulin resistance, a precursor to diabetes.
In the agency's Nov. 7 announcement of the preliminary determination(www.fda.gov), FDA Commissioner Margaret Hamburg, M.D., pointed to the fact that many manufacturers and retailers already have moved to decrease the amount of trans fat in their products. Still, said Hamburg, "While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern. The FDA's action today is an important step toward protecting more Americans from the potential dangers of trans fat."
Based on FDA data regarding current mean intake of artificial trans fats in the United States and related health outcomes, the CDC has estimated(www.cdc.gov) that eliminating PHOs from the U.S. food supply could prevent as many as 20,000 cardiovascular events -- and avoid about 7,000 deaths from cardiovascular causes -- each year.
If the FDA's tentative determination is finalized as currently presented, food manufacturers would no longer be permitted to market PHOs, either directly or as ingredients in food, without prior approval from the agency. In that case, the agency would provide adequate time for food producers to reformulate their products to minimize market disruption.
The FDA's preliminary determination pertains only to PHOs and does not affect trans fat that naturally occurs in small amounts in certain meat and dairy products.
More From AAFP
FamilyDoctor.org: Trans Fats(familydoctor.org)