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Posted February 22, 2021

FDA Warns Sellers of St. John's Wort

On February 18, 2021, the FDA issued warning letters to two companies following reviews of the companies' websites, which found statements made about the companies' St. John's Wort products to be drug claims. These products include St. John's Wort from Blossom Nature, LLC and Full Spectrum St. John's Wort Extract from ProHealth Inc.

More information about each warning is below (use the links to read the full warning letter):

  • Blossom Nature, LLC (St. John's Wort) was promoted with statements such as "St. John's Wort is best known as a treatment for depression, anxiety and stress" and "St. John's Wort is effective as prescribed antidepressants but with no side effects."

  • ProHealth Inc. (Full Spectrum St. John's Wort Extract) was promoted with statements such as "Effective for mild to moderate depression" and "Reduces anxiety."

See ConsumerLab's St. John's Wort Supplements Review for tests of related products.

Also see the CL Answer What are the best supplements for depression and anxiety? for more information.

In addition, the products were found to be misbranded because they do not contain adequate directions for safe use, as required by federal regulations.

See related warnings:

Seller of BioCBD+ Products Warned for COVID-19 and Drug Claims

Seller of Aloe Products Warned for Claiming to Treat Joint Stiffness

FDA Warns Seller of Reishi Mushroom Supplements

FDA Warns Seller of Ginger, Echinacea, and More

Seller of Omega-3 Warned for Making Claims to Treat Focus, Mood