FDA WARNING_LETTER - Moon Valley Natural Products LLC - February 28, 2017

On February 14-28, 2017, the FDA inspected Moon Valley Organics' manufacturing facility and website (www.moonvalleyorganics.com). The inspection found that products like Muscle Rub, Rejuvenating Rub, PsoriaSoothe, Herbal Heal, and Peppermint Foot Rub are marketed with claims establishing them as unapproved new drugs under the Federal Food, Drug and Cosmetic Act (the Act).

Violations include claims on product labels, brochures, and the website, such as "deeply penetrate into muscles and joints to warm and comfort sore areas" for Muscle Rub, "temporary relief to minor aches and pains and bruised areas" for Rejuvenating Rub, and "soothe itchy, dry and flaking skin" for PsoriaSoothe. The product name "PsoriaSoothe" also suggests drug intent. Claims about ingredients like arnica (e.g., "used to treat uterine hemorrhage") and customer testimonials further support the drug classification.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their intended uses and lack FDA approval. Introducing them into interstate commerce without approval violates sections 301(d) and 505(a) of the Act.

Furthermore, Muscle Rub and Rejuvenating Rub are misbranded under section 502(f)(1) of