FDA WARNING_LETTER - Ayuryoga, Inc. - May 24, 2022

The FDA issued a Warning Letter to Ayuryoga, Inc., d/b/a Kottakkal Ayurveda USA, on May 19, 2022, following a March 2022 review of their websites (kottakkalusa.com, kottakkal.shop) and social media (Facebook, Instagram, LinkedIn, Twitter). The FDA determined that various "Kottakkal ayurvedic products," including "Arjuna Arishtam," "Ashtavargam Kwatham," and "Amritamehari Churnam," are unapproved new drugs.

The products are deemed drugs under section 201(g)(1) of the FD&C Act because their labeling, through claims on the company's websites and social media, indicates intended use for diagnosing, curing, mitigating, treating, or preventing diseases, and/or affecting body structure or function. Examples of such claims include "Arjuna Arishtam" for diabetes, high blood pressure, and cardiac disorders; "Ashtavargam Kwatham" for arthritis and rheumatism; and "Amritamehari Churnam" for reducing high blood sugar and diabetes.

These products are also considered "new drugs" under section 201(p) of the FD&C Act, as they are not generally recognized as safe and effective for their intended uses. Introducing or delivering new drugs into interstate commerce without prior FDA approval violates sections 30