Wednesday 24 January 2018

Misbranding – FDA Issues Warning Letter on “All Natural” Claim

The FDA issued a warning letter to food manufacturer, Alexia Foods Inc., for labeling as “all natural” a product that contained a chemical preserative.

The FDA under the Food, Drug and Cosmetic Act can regulate labeling that is false or misleading. Any label that is false or misleading is “misbranded” (see 403(a)(1) of the FD&C and 21 U.S.C. 343(a)(1)). The Warning Letter goes on to make clear it considers use of the term “natural” on a food label to be truthful and non-misleading when “nothing artificial or synthetic…has been included in, or has been added to, a food that would not normally be expected to be in the food.” [58 FR 2302, 2407, January 6, 1993].

Alexia used disodium dihydrogen pyrophosphate, purportedly a synthetic chemical preservative.  The letter cites an alleged violation of FDC Act § 403(a)(1), under which a food is deemed misbranded if its labeling is false or misleading in any particular.  The letter is notable for the fact that the “all natural” claim is the only violation cited.  This suggests, the FDA considers the misuse of a “natural” claim significant enough to warrant the issuance of a warning letter, even in the absence of other violations.  The letter closes with good general advice on labeling: “We recommend that you review all of your product labels to be consistent with our policy to avoid additional misbranding of your food products.”

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