Matthew Martin, president and CEO of Health Habits LLC, received a warning letter from the Food and Drug Administration (FDA) over claims that products sold by the company can treat medical conditions. The company’s claims that its products – Dermatox Ointment and DermaTox – can diagnose, cure, mitigate, treat or prevent disease establishes them as drugs, and marketing drugs without FDA approval is a violation of the Federal Food, Drug and Cosmetic Act, according to the letter.
The company’s website at healthyhabits.com claims that DermaTox can “speed healing, soothe the pain of a burn or bed sores, diminish irritation associated with eczema, psoriasis, rashes, cuts, bites, scrapes, spray on liver spots, moles, etc.”
The company also posted so-called testimonials from users of DermaTox Ointment claiming the product helped with diabetes-related skin conditions and sores, help vanish surgery scars and swelling, and removed moles. Other testimonials claim the product could treat severe shingles and staph infections.
“Your products are not generally recognized as safe and effective for the above referenced uses,” the warning letter states. “It is your responsibility to ensure that all products marketed by your firm comply with the (Federal Food, Drug and Cosmetic) Act and its implementing regulations. We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.”
The FDA is requiring Healthy Habits to take prompt action to correct all violations associated with its products. Failure to do so may result in enforcement actions without further notice.
Source: FDA Warning Letter