United States: When Labeling And Education Are Not Enough Declare It Illegal

Last Updated: November 12 2013
Article by Michael A. Walsh

FDA is set to declare what every American already knows; much of what we love to eat is not safe. Thanks to the FDA's interpretation of the 2011 Food Safety Modernization Act (FSMA), those cherished foods that once

More than 100 years after its formulation, trans fat, an American staple, is relegated to the hazardous waste trash bin. In a notice posted on the Food and Drug Administration (FDA) website on November 7, 2013, the FDA has stated that it is "targeting" trans fats as no longer generally recognized as safe (or GRAS in FDA parlance). FDA also posted notice in the Federal Register and is opening a 60 day docket for comments.  The FDA docket will be available at FDA-2013-N-1317.
 

The Notice May Have Already Achieved Its Purpose

Trans fat is not in everything we eat, but it is in many things we like. We can live long, happy productive lives without crackers, cookies, cakes, frozen pies, baked goods, snack foods, microwave popcorn, frozen pizza, vegetable shortenings and stick margarines, coffee creamers, refrigerated dough products, biscuits and cinnamon rolls, and ready-to-use frostings. We won't mention that trans fats are still used in shortenings for deep-frying in some restaurants.  While it may seem that the threat of removing these items from menus and dinner tables across America threatens our very existence, fear not, FDA's declaring trans fat "unsafe" will not happen overnight. The FDA proposal is to phase out trans fat. More importantly, over the past decade, industry has been reacting to consumer and regulatory pressure worldwide and removing the product from its formulations. Widespread media attention from FDA's plan to ban, will undoubtedly advance the agenda to remove the substance from the US food supply far in advance of formal action by the FDA.

If and when FDA ultimately determines that trans fat/PHO (i.e. partially hydrogenated oils or PHOs) is not GRAS, it will fall under the definition of unsafe additives pursuant to 21 USC 348 and food manufacturers (and restaurants) will be required to obtain premarket approval from the federal government before using the trans fat/PHO ingredient in a food product. According to Dennis M. Keefe, Ph.D., director of FDA's Office of Food Additive Safety, if FDA determines that trans fat/PHOs are not safe (i.e. GRAS), it will mean "in effect, mean the end of artificial, industrially-produced trans fat in foods."   

In support of taking action against trans fat products, FDA cites a 2002 report by the National Academy of Science's Institute of Medicine that "found a direct correlation between intake of trans fat and increased levels of low density lipoprotein (LDL) cholesterol, commonly referred to as "bad" cholesterol, and, therefore, increased risk of heart disease. The study further notes:

Trans fatty acids are not essential and provide no known benefit to human health. Therefore, no [Adequate Intake] or [Recommended Daily Allowance] [levels] is set. As with saturated fatty acids, there is a positive linear trend between trans fatty acid intake and LDL cholesterol concentration, and therefore increased risk of Coronary Heart Disease.


The FDA notice says that "the Centers for Disease Control and Prevention estimates that a further reduction of trans fat in the food supply can prevent an additional 7,000 deaths from heart disease each year and up to 20,000 heart attacks each year." Death is no joking matter, and those susceptible to heart problems or otherwise concerned about high cholesterol and obesity should already have these foods out of their diet. Epidemiology makes sense when applied to populations as a whole, and the science does not account for that not insignificant  portion of the population who will suffer no ill effects from a solid diet of trans fat foods. Because is it bad for many, it is to be illegal for all.

Also unknown is whether the products and formulations that are used to substitute for trans fat will, decades from now, prove as great if not a greater risk. What the FDA and CDC omit from their morbidity calculus is death from food boredom and having food ingredients dictated by the federal government.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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