Kimberly Otto and Aaron Otto were ordered to cease medical claims for, among others, their PsoriaSoothe and Herbal Heal product.
FDA Warning Letters

Moon Valley Natural Products

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.

Additional Warnings

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:

Screengrab of archived web page taken by Lisa Barger.
Moon Valley Natural Products’ ALL ABOUT HERBS page is full of statements the FDA claims are essentially being used to market products in a non-allowed way. The FDA’s warning letter to Moon Valley Natural Products specifically mentioned these arnica claims.

 

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:

Screengrab of Moon Valley Natural Products' Muscle Rub page with FDA-warned claims clearly visible.
The allegedly violating, and still visible, claim is the line,  “. . .  penetrate into sore muscles and joints to stimulate circulation and relieve minor aches and pains.”

 


Help us stay ad-free with a 99-cent purchase for your Kindle, Nook or Kobo. Or share our work: