A heart disease researcher who became fed up of waiting for the FDA to respond to his 2009 citizen petition calling for a ban on artificial trans fats has now followed up with a lawsuit.
98-year-old Dr Fred Kummerow is an emeritus professor of comparative biosciences at the University of Illinois who has studied heart disease for more than 60 years.
He is seeking a judgment declaring that the FDA's failure to ban the use of partially hydrogenated oils (the source of 'artificial' trans fats), and its delay in issuing a final response to his 2009 petition, violate the Administrative Procedure Act and the Food, Drug, and Cosmetic Act.
He is also seeking an order compelling the FDA to respond to his petition and to ban partially hydrogenated oils “unless a complete administrative review finds new evidence for their safety”.
The FDA has unreasonably delayed ruling on the petition
In a complaint filed with Illinois Central District Court on August 9, Dr Kummerow claimed that the “use of partially hydrogenated vegetable oils in the American food supply has contributed to a national epidemic of coronary heart disease” and also contributed to diabetes, cancer and Alzheimer's disease.
Yet the Food, Drug, and Cosmetic Act prohibits the sale of foods that contain substances known to be poisonous or deleterious, he added.
“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 and the Food, Drug, and Cosmetic Ac
"It would be simple as a legal matter for the FDA to ban partially hydrogenated oils and the artificial trans fats they contain, thus leaving natural sources of trans fat [found in dairy products and some meats from ruminant animals in the form of vaccenic acid] unregulated."
In his 2009 citizen's petition, which you can read here , Dr Kummerow wrote: "Trans fat calcifies both the arteries and veins and causes blood clots. Trans fat leads to the reduction of pro stacyclin that is needed t o prevent blood clots in the coronary arteries. A blood clot in any of the coronary arteries can result in sudden death."
The Petition was filed on August 7, 2009, but the FDA "never issued a final response", despite the fact that it is legally required to respond within a reasonable period of time (180 days), claimed Dr Kummerow.
The FDA told FoodNavigator-USA it was not able to comment on pending litigation.
Progress in replacing pHVOs has slowed in recent years
Partially hydrogenated vegetable oil is made by heating liquid oils in the presence of hydrogen and a catalyst, which makes them more solid. However, the process creates harmful trans fatty acids.
In the US, foods with trans fatty acids must be labeled, although products containing less than 0.5 g/serving can be labeled as trans free.
The labeling requirement, along with growing awareness of the dangers of trans fats, has prompted sharp reductions in the use of partially hydrogenated vegetable oils (pHVOs) in recent years, with other techniques such as interesterification and fractionation being used instead to make liquid oils more solid at room temperature.
Some firms have also switched back to animal fats or used palm oil, which are more solid, but are high in saturated fats.
However, progress in reducing or removing pHVOs has slowed in recent years, according to a recent report in the journal Preventing Chronic Disease. Click here for details.
The case is Kummerow v. US Food and Drug Administration et al, filed August 9th, 2013 (2:2013cv02180).