Pharmaceutical

FDA warns nutritional supplement company to stop making false claims

dietary supplements pills probiotics FDA warns nutritional supplement company to stop making false claimsThe Food and Drug Administration (FDA) issued a warning letter to Aurora Health and Nutrition after reviewing the company’s website at www.aurorahealthandnutrition.com, and finding several of the products offered for sale violate the Federal Food, Drug and Cosmetic Act because the agency considers them “unapproved new drugs and misbranded drugs marketed as dietary supplements.”

“Based on the labeling claims on your website, your marketed products, the Argentyn 23 product line, Artecin 90 Vegetarian Capsules, and Ozonated Olive Oil, are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or articles intended to affect the structure or any function of the human body,” the letter stated.

Some examples of these violations include claims that the product “treats all known infections,” and “there is no known virus, bacteria yeast or fungus resistance, and there are no known side effects of this form of silver.” Some products claim to cure “life threatening MRSA infection in 3-4 days” or be “highly effective for sinus problems, sinus infections, and prevention of upper respiratory infections…”

The company also sells a so-called homeopathic product called Cold Sore Rescue that claims, among other things, to treat genital herpes. “Genital herpes is not amenable to self-diagnosis and treatment by individuals who are not medical practitioners,” the FDA cautioned.

The agency gave the company 15 working days to take prompt action to correct the violations cited in its warning letter. “Failure to promptly correct these issues may result in legal action without further notice, including, without limitation, seizure and inunction,” the FDA warned.

Source: FDA