Researcher Wants FDA to Ban Trans Fat

URBANA, Ill. (CN) - A 98-year-old researcher who specializes in heart disease sued the U.S. Food and Drug Administration for refusing to ban artificial trans fat from the food supply; he claims they cause 100,000 deaths a year and contribute to diabetes, cancer and Alzheimer's disease.

Fred Kummerow sued the FDA, its Commissioner Margaret Hamburg, the Center for Food Safety and Applied Nutrition, its Director Michael Landa, the U.S. Department of Health and Human Services and its Secretary Kathleen Sebelius, in Federal Court.

Kummerow, an emeritus professor of comparative biosciences at the University of Illinois, has studied heart disease for more than 60 years.

His 27-page lawsuit begins: "The use of partially hydrogenated vegetable oils in the American food supply has contributed to a national epidemic of coronary heart disease, causing tens of thousands of excess deaths each year and billions of dollars of additional health care expenditures. The artificial trans fat in these oils is more harmful to cholesterol levels than dietary cholesterol or saturated fat, leading to blocked arteries and heart attacks. Dr. Julie Louise Gerberding, longtime head of the U.S. Centers for Disease Control and Prevention, summarized the scientific consensus in 2009, writing, 'The scientific rationale for eliminating exposure to artificial trans fatty acids in foods is rock solid.'

"In addition to causing as many as 100,000 excess deaths per year from coronary heart disease, artificial trans fat from partially hydrogenated oils causes other deadly diseases, including type 2 diabetes, cancer, and Alzheimer's disease.

"The statutory mission of defendant the Food and Drug Administration (FDA) includes the duty to 'protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled. ...' 21 U.S.C. § 393(b)(2).

"The Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 331, 342, 346, 348 and 393, requires the FDA to prohibit adulterated foods containing any poisonous or deleterious substances. Artificial trans fat is a poisonous and deleterious substance, and the FDA has acknowledged the danger: 'There is a positive linear trend between trans fatty acid intake and LDL cholesterol concentration, and therefore there is a positive linear relationship between trans fatty acid intake and the risk of CHD. ... The [Institute of Medicine] sets tolerable upper intake levels (UL) for the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects to ... the general population. In their 2005 report, the IOM does not set a UL for trans fatty acid because any incremental increase in trans fatty acid intake increases the risk of CHD. 75 Fed. Reg. 76526, 76542 (Dec. 8, 2010).

"The FDA's failure to ban the use of partially hydrogenated oils containing artificial trans fat in food for human consumption constitutes an agency action unlawfully withheld in violation of the Administrative Procedure Act (APA), 5 U.S.C. § 706(1), and the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 331, 342, 346, 348, and 393.

"On August 4, 2009, Plaintiff Dr. Fred Kummerow submitted a citizen petition (the 'Petition') to the FDA requesting that the agency ban the use of partially hydrogenated fats from food for human consumption. The Petition was assigned docket number FDA-2009-P-0382-0001/CP and accepted as filed on August 7, 2009. The FDA has never issued a final response to the Petition.

"The FDA has unreasonably delayed ruling on the Petition in violation of the APA, 5 U.S.C. §§ 555(b) and 706, and the Food and Drug Act's implementing regulations, 21 C.F.R. § 10.30(e)1.

"Plaintiff Dr. Kummerow seeks a judgment declaring that the FDA's failure to ban the use of partially hydrogenated oils and its delay in issuing a final response to the Petition violate the APA and the FDCA. Plaintiff also seeks an order compelling the FDA to respond to the Petition and to ban partially hydrogenated oils unless a complete administrative review finds new evidence for their safety, all by specific Court-ordered deadlines."

Kummerow is represented by Gregory Weston in San Diego.

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