The Food and Drug Administration (FDA) has been subject to frequent criticism for its lax oversight of food safety, and particularly of food additives. However, this morning the agency stepped out ahead of most of its international peers, submitting for public comment a new determination that would effectively remove partially hydrogenated oils (PHOs), the primary source of trans fats, from the U.S. food supply.
Trans fats are a particularly harmful type of food additive. Although found naturally in very small amounts, the vast majority of U.S. consumption comes from artificially produced PHOs. There is no safe level of trans fat consumption, and these fats have no apparent nutritional benefit. However, consumption of trans fats causes a great deal of harm, particularly by raising LDL cholesterol. The Centers for Disease Control and Prevention (CDC) estimates that, in the United States, artificial trans fats are responsible for between 10,000 – 20,000 heart attacks and 3,000 – 7,000 deaths from coronary heart disease each year.
The FDA is the U.S. agency primarily responsible for ensuring the safety of the country’s food supply (although other agencies, such as the U.S. Department of Agriculture, share some responsibility). Under the FDA’s enabling act, the Federal Food, Drug and Cosmetic Act, a food manufacturer is required to show that any food additive (any substance it intentionally adds to food) is “generally recognized as safe” (GRAS), or else submit the additive for pre-market approval (analogous to the FDA’s drug approval process). To demonstrate an additive is GRAS, a manufacturer must point to scientific evidence—typically peer-reviewed scientific studies—demonstrating its safety. However, food additives in common use before 1958 are grandfathered in, and need not demonstrate they are GRAS or go through pre-market approval.
The FDA is proposing to remove PHOs from the GRAS list, making the addition of PHOs to food illegal unless they gain pre-market approval. If the rule goes into effect, the weight of scientific evidence against trans fats virtually guarantees that they will fail to achieve this approval, thus eliminating nearly all trans fats from the U.S. food supply. Public comment will be open for 60 days, after which the agency plans to promulgate a final rule. Instructions for submitting a comment to the FDA can be found here.
The scientific community has understood the health risks of trans fats for more than a decade, and this new regulation would bring policy into line with the overwhelming weight of scientific evidence. Let’s hope the FDA ultimately decides on a speedy exit for this harmful food additive.
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.