FDA Issues Warning Letter to Mushroom Supplements Company

WASHINGTON Mushroom Wisdom, Inc. last month received a warning letter from FDA following an April 2012 inspection of its manufacturing facility in New Jersey.

FDA cited violations of the Federal Food, Drug, and Cosmetic Act and relevant regulations. Mushroom Wisdom, a developer of mushroom supplements, was accused of making unlawful claims that it could treat diseases and violating current good manufacturing practice (CGMP) regulations, including failing to investigate complaints from customers over adverse effects from certain products.

In the Oct. 18 letter, FDA advised the 21-year-old company it is ultimately responsible for meeting CGMP requirements even if it contracts with other businesses to perform operations for manufacturing, packaging and labeling of dietary supplements.

"This letter really shows how the FDA is viewing the obligations of companies with respect to CGMPs just because you don't manufacture the product at your facility, it doesn't mean that the FDA isn't going to hold you accountable," wrote attorney Justin Prochnow, a partner with Greenberg Traurig, LLP, in an email to clients. "We have been involved with numerous companies that have discovered this after the FDA has inspected and they have received 483s or worse."

Earlier this year, FDA warned Mushroom Wisdom that some of its products were being unlawfully promoted for use in the cure, mitigation, treatment or prevention of disease. The agency sent the letter after collecting marketing material from a trade show and on the company's website.