The US Food and Drug Administration announced today it will take steps to curb the use of partially hydrogenated oils from processed foods. The Agency proposed a new rule that would deem PHOs, a primary source of trans fat, no longer generally recognized as safe (GRAS). GRAS is a legal standard to determine the safety of food additives. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive. Removing the GRAS approval of PHOs will mean any manufacturer seeking their use must petition the FDA. A petition which is unlikely to meet with success. The rule is unlikely to be met with resistance with many food companies already phasing out trans fats.
More information is included in the press release below.
From the FDA’s press release:
The U.S. Food and Drug Administration announced its preliminary determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” for use in food. The FDA’s preliminary determination is based on available scientific evidence and the findings of expert scientific panels.The agency has opened a 60-day comment period on this preliminary determination to collect additional data and to gain input on the time potentially needed for food manufacturers to reformulate products that currently contain artificial trans fat should this determination be finalized.“While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern,” said FDA Commissioner Margaret A. Hamburg, M.D. “The FDA’s action today is an important step toward protecting more Americans from the potential dangers of transfat. Further reduction in the amount of trans fat in the American diet could prevent an additional 20,000 heart attacks and 7,000 deaths from heart disease each year – a critical step in the protection of Americans’ health.”Consumption of trans fat raises low-density lipoprotein (LDL), or “bad” cholesterol, increasing the risk of coronary heart disease. The independent Institute of Medicine (IOM) has concluded that trans fat provides no known health benefit and that there is no safe level of consumption of artificial trans fat. Additionally, the IOM recommends that consumption of trans fat should be as low as possible while consuming a nutritionally adequate diet.In recent years, many food manufacturers and retailers have voluntarily decreased trans fat levels in many foods and products they sell. Trans fat can be found in some processed foods, such as certain desserts, microwave popcorn products, frozen pizzas, margarines and coffee creamers. Numerous retailers and manufacturers have already demonstrated that many of these products can be made without trans fat.Thanks to these efforts, along with public education, the consumption of trans fat in American diets has been significantly reduced. Since trans fat content information began appearing in the Nutrition Facts label of foods in 2006, trans fat intake among American consumers has declined from 4.6 grams per day in 2003 to about 1 gram per day in 2012.“One of the FDA’s core regulatory functions is ensuring that food, including all substances added to food, is safe,” said Michael Taylor, the FDA’s deputy commissioner for foods and veterinary medicine. “Food manufacturers have voluntarily decreased trans fat levels in many foods in recent years, but a substantial number of products still contain partially hydrogenated oils, which are the major source of trans fat in processed food.”Following a review of the submitted comments, if the FDA finalizes its preliminary determination, PHOs would be considered “food additives” and could not be used in food unless authorized by regulation. If such a determination were made, the agency would provide adequate time for producers to reformulate products in order to minimize market disruption. The FDA’s preliminary determination is only with regard to PHOs and does not affect trans fat that naturally occurs in small amounts in certain meat and dairy products.More information about trans fat and information the FDA is seeking is available through a Federal Register notice. The docket will be open for comment for 60 days.
Leave a comment