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Volume XI, Number 27

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The Hain Celestial Group Briefs the Court on FDA’s Characterizing Flavor Regulations in a Motion to Dismiss the False Advertising Class Action Against ‘Organic Plus Vanilla Soy Milk’

Our readers may recall that a lawsuit filed June 26, 2020 against The Hain Celestial Group, involving Organic Plus Vanilla Soy Milk, avoided some of the pleading issues that doomed some of the numerous class action lawsuits, filed mostly by a single firm, involving other products that are claimed to contain deceptive and misleading information on their labels regarding vanilla.  Plaintiffs alleged that the disclosure of “Vanilla Flavor With Other Natural Flavors” in the soy milk’s ingredient list indicated that the product contained non-vanilla flavor and that this non-vanilla flavor contained vanillin.  The plaintiffs also alleged that because vanilla is governed by standards of identity (see 21 CFR 169.175 (“Vanilla extract); 21 CFR 169.177 (“Vanilla flavoring”)), the general flavoring rules of 21 CFR 101.22, including the designation of “with other natural flavors,” do not apply and any non-vanilla flavor must be disclosed as an artificial flavor.

A November 23, 2020 memorandum filed in support of The Hain Celestial Group’s motion to dismiss, characterizes the plaintiffs’ case as one of “over 91 other lawsuits their counsel have filed against producers of vanilla-containing products” and asserts they are attempting to “hold-up” food companies for expensive settlements based on what “they believe is a technical violation of FDA flavoring regulations.”  In addition to arguing that the plaintiffs’ false advertising claims are preempted to the extent they assert that the product labeling does not comply with the Federal Food, Drug, and Cosmetic Act’s (FDCA) food labeling requirements and is, therefore, automatically deceptive, the defendant’s memorandum directly attacks the plaintiffs’ conclusion that “vanilla” in the product name violates FDA’s food labeling regulations, arguing that under FDA’s regulations, the statement of identity in the product’s name is “Soymilk” and “Vanilla” is a flavor designation, not subject to the standards of identity cited by the plaintiffs.

It is yet to be seen whether the New York federal court hearing this case will reach the issue of whether the soy milk labeling complies with the FDCA and FDA’s characterizing flavor regulations.  FDA has not issued any warning letters that would clarify the matter of product labeling involving vanilla. 

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© 2020 Keller and Heckman LLPNational Law Review, Volume X, Number 335
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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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