On June 16, 2015, the U.S. Food and Drug Administration (FDA) finalized its 2013 tentative determination that partially hydrogenated oils (PHOs), which are the primary dietary source of artificial trans fat in processed foods, are not generally recognized as safe (GRAS) for use in human food. In the simplest terms, this means food manufacturers have three years to remove PHOs from human food products.
While many news sources bill this as a major development, this is more of a natural evolution in the regulation of human food. Since 2006, manufacturers have been required to include trans fat information on the Nutrition Facts label. By FDA's own estimates, consumer consumption of trans fat deceased about 78% between 2003 and 2012. They credit the labeling rule and corresponding industry reformulation as key factors in this reduction. In response to FDA's 2013 tentative determination, FDA received over 6,000 responses from individuals, consumer and advocacy groups, health professional groups, and state/local governments expressing a variety of views and recommendations. A careful review of FDA's Final Determination in the Federal Register, in which FDA responded to some of these comments, reveals FDA's current thinking and can be used to help guide compliance.
FDA defines PHOs as "those fats and oils that have been hydrogenated, but not to complete or near complete saturation, and with an iodine value (IV) greater than 4." 80 F.R. 34651. This definition extends to only artificial trans fat (also known as industrially-produced trans fatty acids, or IP-TFA) and does not apply to ingredients that contain naturally-occurring trans fat, fully hydrogenated oils, or edible oils that contain IP-TFA as an impurity.
FDA has acknowledged that manufacturers who have previously added PHOs to food will be most affected by this order and plans to focus "our outreach and enforcement resources accordingly." 80 F.R. 34655. However, FDA asserts that in addition to manufacturers, other parties, such as distributors, may be subject to injunction and the adulterated food subject to seizure. This determination also trumps pre-existing standards of identity that explicitly mention PHOs in allowing partially hydrogenated vegetable oil as an optional ingredient. For example, the standards of identity for peanut butter (21 C.F.R. § 164.150) and canned tuna (21 C.F.R. § 161.190) allow for the optional use; however, because the standards do not require the use of PHOs, the standards can still be complied with. While FDA says the agency will consider taking "further action" regarding ingredient designations for PHOs, manufacturers of these products should pay careful attention to this determination.
Additionally, FDA did identify a route for manufacturers to keep PHOs in their products, namely, submission of a food additive petition; however, companies should keep in mind that this route will require FDA approval for a specific use. Ultimately, this requires a showing that the proposed use would not be a harm to public health—a very high burden. In fact, FDA acknowledged that this was one of the reasons a three-year time frame was established, as the agency believes that three years is sufficient time for preparation, submission, and agency review of a food additive petition. As FDA said, "[a]ny interested party may seek food additive approval for one or more specific uses of PHOs with data demonstrating a reasonable certainty of no harm of the proposed use(s)." 80 F.R. 34651.
Finally, FDA's comments also reveal that the agency considered the burdens this ban could place on small business. However, unlike previous rules which have provided alternative timelines for small business compliance, the effective date for the final determination of three years is universal. FDA explained this decision, indicating that the agency believes that three years is sufficient time for small businesses to gain timely access to suitable alternatives and complete testing.
Accordingly, it is important that not only food manufacturers, but also distributors and others in the industry, be aware of the ingredients in their products. If PHOs are used, they must be removed within three years. Additionally, labels must be modified and product inventories must be depleted for affected products before June 18, 2018. If you have questions about this final determination or would like to discuss seeking food additive approval, please contact Venable.
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.
