On FDA Issues Final Determination Concerning Partially Hydrogenated Oils
The U.S. Food and Drug Administration (FDA) has long reacted to the public concern over trans fatty acids (also known as TFA or trans fats) found in foods as a part of Partially Hydrogenated Oils (PHOs). FDA recently issued its final decision on how it would categorize PHOs. Following through on an effort the FDA began in 2013, the categorization of PHOs officially changed to not generally recognized as safe (GRAS) for use in food, effectively banning trans fats. This change in categorization now puts PHOs under the regulations that govern food additives. Current registrations of foods containing PHOs and their labeling must eliminate PHOs by June 2018. The FDA will allow registrants to obtain new registration of use of PHOs in foods under much stricter guidelines.
FDA’s Long Pursuit of Trans Fats – A Troubled Relationship
The FDA began its relationship with trans fats and PHOs in 2006 when the FDA required that the amount of trans fats in a food be put onto the ingredients listing of the FDA-required Nutrition Facts label. Trans fat is listed as a part of the Saturated Fat listing. Since trans fat is typically a percentage of Saturated Fat, trans fat could list at zero grams but still be present in the food, up to 0.5 grams of trans fat, and allow the continued use of PHOs. This is no longer the case.
The reason PHOs became important in the food industry is that PHOs have a longer shelf life and are cheaper than other fats and oils to use in recipes. Removal of PHOs from a food means potential changes to the Nutrition Facts label for that food. Additionally, for an imported food currently containing PHOs, the importer will be responsible for getting its food source manufacturer to reformulate and eliminate the PHOs.
FDA’s Scope on PHOs and Trans Fat is Black and White
Using the Federal Register to issue a Declaratory Order, rather than proceeding through formal rulemaking (with the necessary notice and comment periods) the FDA has set its boundaries on what is non GRAS, on what must be eliminated, and what occurs outside these boundaries. One boundary is that this order is for PHOs only and excludes FHOs, fully hydrogenated oils. The Order also excludes naturally occurring trans fats, those that are not a part of PHO manufacture. The Order clearly defines PHOs as “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.” The Order also provides that “Any 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).”
FDA’s follow-up … What’s Next?
The FDA will be busy from now through June 2018 with updates to a multitude of Nutrition Fact labels, as well as new and revised food additive submissions seeking FDA’s approval to use PHOs in some “safe” manner. For food imports containing PHOs, this means an updated recipe with an updated Nutrition Fact label, otherwise the importer may lose the ability to import. FDA will then be able to seize imported foods and additives containing unapproved PHOS, categorizing them as adulterated, illegal imports. With three years available to make necessary changes, violators will get little sympathy from the FDA, and may be subject to warning letters and seizure for continued non-compliance.
We can help you comply this order and other FDA regulations by reviewing the legal and regulatory basis for your updated Nutrition Facts label and determine the appropriate measures that need to be taken in order to reestablish compliance with federal laws and FDA regulations, if necessary. For more information about hiring a FDA regulatory lawyer to help you respond to this FDA Declaratory Order or how you can achieve FDA compliance, please contact us at [email protected].
