FDA released its’ final determination that Partially Hydrogenated Oils (PHOs) are not Generally Recognized as Safe (GRAS). The determination is based on extensive research into the effects of PHOs, as well as input from stakeholders during the public comment period.
PHOs are the primary dietary source of artificial trans fat in processed foods. Removing PHOs from processed foods could prevent thousands of heart attacks and deaths each year. To learn more about trans fat, see our Trans Fat page.
FDA has set a compliance period of three years. This will allow food companies to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs. Many companies have already been working to remove PHOs from processed foods and the FDA anticipates that many may eliminate them ahead of the three-year compliance date.
It’s important to note that trans fat will not be completely gone from foods because it occurs naturally in small amounts in meat and dairy products, and is present at very low levels in other edible oils.
The FDA encourages consumers seeking to reduce trans fat intake to check a food’s ingredient list to determine whether or not it contains partially hydrogenated oil.
In January 2006, FDA required the food industry to declare the amount of trans fat in food on the Nutrition Facts label. FDA data indicate that many processed foods have been reformulated to reduce the amount of trans fat since the requirement was instituted, but a substantial number of products still contain PHOs.
One of FDA's core regulatory functions is ensuring that food, including all substances added to food, is safe. In November 2013, FDA made a preliminary determination that PHOs are not “generally recognized as safe” (GRAS) for use in food. FDA opened a 60-day public comment period on this measure to solicit data and information on a number of issues, including:
1. Whether FDA should finalize its tentative determination that PHOs are no longer GRAS; and
2. How long it would take producers to reformulate food products to eliminate PHOs.
The comment period was then extended an additional 60 days and closed March 8, 2014.
The final determination was released June 16, 2015. This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period.
- FDA Takes Step to Remove Artificial Trans Fats from Processed Foods June 2015
- FDA to Extend Comment Period on Measure to Further Reduce Trans Fat in Processed Foods - UPDATE December 2013
- FDA to Extend Comment Period on Measure to Further Reduce Trans Fat in Processed Foods December 2013
- FDA Opens 60-day Comment Period on Measure to Further Reduce Trans Fat in Processed Foods November 2013
Federal Register Notices
- Final Determination Regarding Partially Hydrogenated Oils June 2015
- Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information; Extension of Comment Period December 2013
- Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information November 2013
Other Nutrition Initiatives
FDA received questions about the timing of the compliance dates for its various nutrition initiatives and their impact on food manufacturers and is providing the following questions and answers.
Why aren’t the compliance dates for the various nutrition initiatives that manufacturers have to meet more coordinated?
Actually, they are. In summer of 2018, manufacturers will have to comply with key nutrition initiatives. The key dates are as follows:
- On June 18, 2018, manufacturers must ensure that their products no longer contain partially hydrogenated oils for uses that have not been otherwise authorized by FDA.
- On July 26, 2018, manufacturers with $10 million or more in annual food sales will need to comply with the new requirements for the Nutrition Facts label.
- Also on July 26, 2018, vending machine operators with glass front vending machines will have to comply with all requirements of the vending machine labeling rule. FDA delayed the compliance date for calorie declaration requirements for certain food products sold from glass-front vending machines in part to be consistent with the compliance date for the new Nutrition Facts label requirements so that manufacturers can make changes to front-of-pack labeling for products they supply to vending operators at the same time that they make changes to the Nutrition Facts label.
How do menu labeling requirements impact packaged food manufacturers?
The requirements for menu labeling largely affect a different segment of industry—restaurants and similar retail food establishments. We do not expect these requirements to have a great impact on manufacturers. Those establishments that are covered by the menu labeling rule must comply with menu labeling requirements by May 5, 2017.
What about the targets for sodium reduction that FDA is developing?
The targets for sodium reduction that FDA is developing are voluntary so there will be no compliance date. However, we are recommending timeframes for companies that choose to implement the targets, once finalized. FDA has published for public comment draft voluntary targets for reducing sodium in commercially processed and prepared food both in the short-term (2 years) and over the long-term (10 years).