On 21 May 2018, the U.S. Food and Drug Administration (“FDA”) rejected a food additive petition by the US Grocery Manufacturers Association (“GMA”) seeking amendment of a 2015 rule banning added partially hydrogenated oils (“PHOs”) from food products. PHOs are found naturally in many foods, including red meat. However, the baking or frying of prepared foods in certain oils can result in addition of PHOs. As with many food substances, when taken in high levels, PHOs are associated epidemiologically with increased heart disease. However, FDA concluded that the GMA petition did not contain sufficient scientific information to overturn the rule based on the legal standard used in the prior rule-making. To FDA, insufficient information exists to establish that PHOs are generally recognized as safe. FDA has the authority to ban added (but not naturally occurring) food substances that are not generally recognized as safe.
GMA sought approval for addition of PHOs in certain minor uses including as a diluent for coloring or flavoring agents, as a processing aid with minimal carry-through to the final product, and as an agent released for pans after baking. Most importantly, for the latter category, the production of PHOs appear to be specific to the use of soy, cottonseed, coconut, canola, palm, palm kernel and sunflower oils or blends of these oils in baking.
FDA did extend the compliance date for the ban to 18 June 2019. FDA has extended the due date to exhaust inventory to 1 January 2021 if the product was made before June 2018. After that date, the products must be removed from the market. The new dates are summarized in the table below:
|Product uses|| Original
Manufacturing of food with non-petitioned
|18 June 2018||Not extended|
Foods manufactured with non-petitioned uses of PHOs
|18 June 2018||1 January 2020|
|Manufacturing of food with petitioned uses of PHOs||18 June 2018||18 June 2019|
| Foods manufactured with petitioned uses of PHOs
before 18 June 2018
|18 June 2018||1 January 2021|
While the market for oils used in baking has already undertaken shifts, with corresponding effect in market prices, the FDA is going further in its ban than many companies may have expected. Additionally, the blanket condemnation of PHO safety creates risks for recalls in the future if products are incidentally found to have PHOs. Should companies test or quality assure for PHOs or just avoid use of materials that create risk? These are questions that intertwine with other food safety regulations beyond labeling and food additives. What may be the implications for other product lines that could result in PHO ingestion such as lipsticks?
How can Baker McKenzie help?
For assistance in understanding the obligations and how they may affect your business in or with the US food industry, we have attorneys across the globe available to help. Please get in touch with your regular Baker McKenzie contact or the specified contacts.