The U.S. Food and Drug Administration, or FDA, continues its look at manufacturers of small-batch toiletries with an official warning letter to Washington-based Moon Valley Natural Products. The company, which is owned by Kimberly Otto and her husband, Aaron Otto, was called out mainly for claims made about their company’s skin rubs.
From the letter, we learn that Moon Valley Natural Products was the focus of a multi-day inspection back in February. What, if anything, prompted that visit is unknown but during the inspection, agency representatives collected product labels and, at some point, took a look at how the Ottos marketed those products through their website, MoonValleyOrganics.com.
In all, five products were found to be marketed with product labels, website spiel and/or customer testimonials that the FDA says push the products into “new drug” territory.
Moon Valley’s Muscle Rub
The company’s Muscle Rub product was touted on its label as a remedy for muscle soreness, sprains, strains, arthritis and pain. It was also marketed with customer testimonials involving diabetes and osteoarthritis.
Moon Valley’s Rejuvenating Rub
The Rejuvenating Rub product was also sold as a multi-purpose muscle rub but was additionally suggested as a headache remedy. And it, too, got the Ottos in trouble for testimonials–again for diabetes, but also about a condition the customer described as TMJ.
Moon Valley’s PsoriaSoothe
Even the very name of this product got the company in trouble. It suggests, says FDA, that the product is a treatment for the skin condition psoriasis. That claim was also supported by a customer testimonial.
Herbal Heal And Peppermint Foot Rub
The company’s Herbal Heal and Peppermint Foot Rub products also got an agency finger-wag for claims of skin benefits and skin healing.
FDA, of course, says that none of the products has been officially recognized as safe or effective for any of those medical conditions. And some of the products are even further in violation of the Federal Food, Drug and Cosmetic Act because they’re hyped for medical conditions that the average person cannot safely or accurately self-diagnose or self-treat with over-the-counter products.
Moon Valley Natural Products was further warned to discontinue using informational pages like its All About Herbs page, which lists the traditional and folklore uses for several herbal ingredients. That page, too, is officially considered to be marketing, says FDA, and any “claim” made on the page would cause any Moon Valley product containing that herb to be in violation of agency regulations:
The Ottos were given the standard 15 working days to address the agency’s allegations. The FDA’s warning letter to Moon Valley Natural Products was dated August 11, 2017. As of my visit to the site this morning, I found the claims I looked up still visible, as this screengrab of the Muscle Rub product page demonstrates:
Categories: FDA Warning Letters