St. John’s Wort Seller ProHealth Hit with Class Action Following FDA Warning Letter

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ProHealth is at least the second St. John’s Wort extract seller to face a proposed class action in the wake of an FDA warning that the company’s labeling of the supplement runs afoul of federal regulations. 

The nine-page case cites a February 18, 2021 FDA warning letter in which the agency stated that ProHealth’s St. John’s Wort supplement, touted as a remedy for mental health issues, is misbranded under the Federal Food, Drug, and Cosmetic Act (FDCA) and “not generally recognized as safe and effective” for its stated purposes. The lawsuit alleges that because ProHealth’s supplement is misbranded, “it is a worthless product,” and buyers have been harmed financially.  

According to the case, the FDA warned ProHealth that its St. John’s Wort extract is considered to be a “new drug” given it is “not generally recognized as safe and effective” by the agency. As such, the FDA wrote, the product must receive FDA approval before it can legally be sold for the purposes for which it is advertised. From the FDA warning letter:  

“Your Full Spectrum™ St. John’s Wort Extract Product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a ‘new drug’ under section 201(p) of the Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.”  

The FDA went on to warn ProHealth that its St. John’s Wort is intended for treatment for one or more diseases that “are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.” As such, it is impossible to write adequate directions for use, the FDA said, meaning the product is misbranded.  

The case alleges ProHealth’s St. John’s Wort extract is deceptively advertised and labeled given the fact that the supplement is considered a “new drug” by the FDA and it is “impossible to write adequate directions for a layperson to use [the P]roduct safely for its intended purposes.”   

According to the suit, ProHealth has violated a California consumer protection law by deceptively marketing, advertising and selling a product that is not effective for its promoted use, includes false and deceptive instructions for use on its label and is a misbranded drug under the FDCA.  

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