This is a guest blog post by Richard Perlmutter, MS.
In November last year, the federal Food and Drug Administration (FDA) published a proposal to revoke the Generally Recognized As Safe (GRAS) status of partially hydrogenated oils (PHOs). These oils typically have a high level of trans fat.
A GRAS food ingredient may be used in almost any food without prior FDA approval. Based on past use and agreement among experts in the field, a GRAS ingredient is considered to not pose a hazard to health as typically used in food and beverages. If GRAS status is revoked, the FDA must authorize each intended use of the ingredient. Loss of GRAS status would effectively end the widespread use of PHOs in food.
America’s past embrace of PHOs was largely due to two completely unrelated events, forty-nine years apart.
In 1906 Upton Sinclair published his famous expose, The Jungle, of the dangerous and unsanitary conditions in Chicago’s meat packing plants. In one particularly gruesome scene, the author describes how a worker lost his footing, fell into a vat, and became part of a batch of Dunham’s Pure Leaf Lard.
Five years later Crisco shortening was introduced to the American public by the Procter & Gamble Company. Here was a clean, pure, white frying and baking fat made from vegetable oil (that was partially hydrogenated). It had no association with the meat packing industry.
The President’s Heart Attack
In 1955, during his third year as President, Dwight D. Eisenhower suffered a heart attack. Heart attack rates had been increasing; and the President’s heart attack brought intense focus to finding causes and cures.
Medical professionals and public health officials eventually decided that the consumption of cholesterol and saturated fat were largely to blame. Both are abundant in fat derived from meat and dairy sources. These pronouncements were a boon to the manufacturers of shortening and margarine, who saw their partially hydrogenated vegetable oil laden products become more and more popular.
Most vegetable oils are liquid; and they have a tendency to become rancid. Partial hydrogenation decreases the amount of the types of fat in these oils that are most likely to become rancid. At the same time it ‘hardens’ oils, giving them a semi-solid texture, which is advantageous in baking applications.
But the process is not benign. Typically thirty to forty percent of the oil is converted to a trans form. Almost all of it is unlike any molecules in food that the human body recognizes and is designed to utilize. How this fat is metabolized and how it affect health were questions without answers.
Two complimentary lines of research sought answers – one on a macro scale and the other on a micro scale.
Thanks to the number crunching power of computers, researchers could track the diet, markers of health (like cholesterol levels in the blood), and incidence of disease among tens of thousands of individuals thru their entire adult life.
Emerging from all of the data was a correlation between intake of PHOs, elevated LDL-cholesterol (the ‘bad’ kind), and heart disease. Researchers at Harvard University did much of this work.
Other researchers fed laboratory animals PHO-containing food and monitored their health. When they died, the animals were dissected to find changes in internal body structures.
One investigator, Professor Fred Kummerow of the University of Illinois, has been especially active in this line of investigation. His observations have helped to explain the outcomes noted by the Harvard researchers.
Dr. Kummerow found that trans fat in the blood stream promotes arterial calcification, especially in the coronary arteries. The trans fat also increases the tendency of blood to clot.
The FDA’s Slow Motion Response
In spite of the findings about their risk, the FDA continued to allow PHOs to retain their GRAS status. Even the National Institutes of Health, in 2002, recommended that the intake of trans fat be as low as possible.
But the FDA was not totally indifferent. In 1999 it proposed that trans fat be added to the Nutrition Facts panel on packaged foods. Eventually, in July 2003, this proposal was accepted. In the same year Denmark became the first of several European countries to ban PHOs from their food supply. Enforcement of the FDA’s 2003 trans fat rule began January 1, 2006.
With all of the media attention that accompanied the listing of trans fat, consumers began to avoid foods that contained them. Many, many food manufacturers reformulated their products to remove or greatly reduce trans fat content. At the same time restaurants and restaurant chains replaced their partially hydrogenated frying oils with trans fat free frying oils.
These changes led to a dramatic reduction in how much trans fat is consumed. Back in the 1980′s, before most people were aware of the dangers of PHOs, adults typically consumed about 9 grams of trans fat a day. In 2003 it was about 4.6g, and in 2012 only 1g.
Suing the FDA
Because he was so concerned with their dangers, in 2009 Professor Kummerow petitioned the FDA to ban the use of PHOs in food. The FDA is required by law to respond to such a petition within 180 days. But it did not, and has not.
In August 2013 he actually sued the Agency. Specifically he is seeking judgment declaring that the FDA’s failure to ban PHOs, and its delay in issuing a final response to his 2009 petition, violates 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.
Of course the FDA does not comment on current litigation, but it appears the Agency is now doing almost exactly what Professor Kummerow had petitioned for.
Richard Perlmutter is the owner of Abington Nutrition Services LLC which prepares nutrition labeling for products manufactured by food and beverage companies. He also takes an interest in seeing that government nutrition policy is in line with nutritional science.