Press Release
June 03, 2020

Jennifer Allen Discusses FDA Misbranding Regulations

“But I Didn't Mean to Mislead!”
A refresher on FDA's misbranding regulations


FDA prohibits any statements on labels and labeling that are false or misleading “in any particular.”  Those three words matter; the most carefully worded labels can still lead to unwanted attention from FDA, even if the consumer hasn’t suffered any harm.  In contrast, the FTC won’t come knocking unless your statements have actually harmed the consumer.

Since 2002, FDA has looked at whether a label is false or misleading from the perspective of the reasonable consumer.  This is because, in FDA’s words, this standard “more accurately reflects FDA’s belief that consumers are active partners in their own health care who behave in health-promoting ways when they are given accurate health information.” (See 67 Fed. Reg. 78002-78004 [Dec. 20, 2002]).  This is the same standard that the FTC has used since 1984 (See 103 FTC 100, 174 [1984]).


Read Jennifer's full article in Quality Assurance & Food Safety magazine.

Jennifer L. Allen

Jennifer Allen has a dual focus on litigation and food regulation, combining her litigation skills with her knowledge of FDA and USDA regulations to assist a variety of clients.

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