Date: Jun 18, 2015
On June 16, 2015, FDA published its final determination that trans fats are no longer generally recognized as safe ("GRAS") and therefore can only be used in food if approved through a food additive petition. Trans fats are contained in partially hydrogenated oils (PHOs), which are the primary dietary source of industrially-produced trans fatty acids. They are used in the food industry in baked goods and other products. FDA allowed food manufacturers to continue to use PHO's for three years while they either petition FDA or phase out the ingredient. However, we expect to hear from the plaintiffs' bar before that.
FDA's action may provide an entirely new basis for consumers to attack products with trans fatty acids. Until now, suits against products with trans fatty acids have focused primarily on label claims. Products were the subject of suit because of allegedly false claims of "No Trans Fats," "0 grams trans fat," or "healthy" or "wholesome" even though the products allegedly contained trans fats. However, now plaintiffs may argue that the presence of PHOs in food makes them adulterated and therefore "illegal" under applicable state and federal laws. This argument is based on the fact that FDA's conclusion means that PHOs will now be regulated as food additives, which - unlike GRAS substances - require premarket approval by FDA prior to use in food. No PHO's currently have such approval so arguably they cannot be used in food and any food containing them is "adulterated" as that term is defined under the Food, Drug, Cosmetic Act. Whether FDA's decision to allow the continued use of PHO's for three years can be seen as a temporary regulatory approval remains to be seen.
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 Final Determination Regarding Partially Hydrogenated Oils, 80 Fed. Reg. 34,650 (June 17, 2015).
 See, e.g., Kaufer v. KIND, LLC, No. 2:15-cv-02878 (C.D. Cal. filed Apr. 17, 2015); Backus v. General Mills, Inc., No. 3:15-cv-01964 (N.D. Cal. filed Apr. 30, 2015); Backus v. Nestle USA, Inc., No. 3:15-cv-01963 (N.D. Cal. filed Apr. 30, 2015); Smedt v. Hain Celestial Grp., Inc., No. 5:12-cv-03029 (N.D. Cal. filed June 12, 2012).
 See, e.g., Thomas v. Costco Wholesale Corp., No. 5:12-cv-02908 (N.D. Cal. filed June 5, 2012); Wilson v. Frito-Lay N. Am., Inc., No. 3:12-cv-01586 (N.D. Cal. filed Mar. 29, 2015).
 See, e.g., In re Quaker Oats Labeling Litig., No. 5:10-cv-00502 (N.D. Cal. filed Feb. 3, 2010); Caldera v. J. M. Smucker Co., No. 2:12-cv-04936 (C.D. Cal. filed June 6, 2012).