Following FDA Warning, Blossom Nature Hit with Class Action Over Sale of St. John’s Wort Extract

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A proposed class action alleges Full Spectrum-brand St. John’s Wort Extract sold by Blossom Nature, LLC is misbranded and therefore unlawful to sell. 

According to the 10-page complaint, defendant Blossom Nature was among two sellers warned in February 2021 by the FDA that its St. John’s Wort product was misbranded as a “new drug” under the federal Food, Drug, and Cosmetic Act (FDCA) in that it is intended for use in the cure, mitigation, treatment, or prevention of disease, in particular mental health issues. 

The lawsuit contends that because the product is “not generally recognized as safe and effective” by the FDA and fails to bear adequate directions for its intended use, it is therefore misbranded, unlawful to sell and worthless. 

“Your St. John’s Wort product is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner,” the FDA wrote in its February 18 letter. “Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes.” 

Per the suit, Full Spectrum St. John’s Wort is advertised with the claims that it is a “natural treatment for mental health problems,” “best known as a treatment for depression, anxiety and stress,” effective in fighting Seasonal Affective Disorder and as effective as prescribed antidepressants but with no side effects. The FDA stressed, however, that the marketing claims for the supplement indicate that it is, in truth, a “new drug” that may not be legally introduced or delivered into interstate commerce without approval from the agency. 

The suit looks to represent all consumers who bought Blossom Nature’s Full Spectrum St. John’s Wort Extract within the last four years and until the date notice is sent to the class. 

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