Both Global Sweet Polyols, LLC and Golden Temple of Oregon, LLC received warning letters for inadequate responses to prior cGMP violations. Both firms submitted responses to the agency in June but the agency has now deemed the companies’ proposed corrective action as “inadequate”.
The latter company also received a warning for claims being made on its website about its products that “are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act”, said the FDA.
Two other companies - Nenningers Naturals, LLC from East Setauket, NY and Med-Chem Labs from Farmington, MI – also received warning letters from FDA about claims being made on websites and social media sites.
Nenningers Naturals was warned over the presence of “at least one component of the [“Triple Flu Defense”] product [that] is recognized in the Homeopathic Pharmacopeia of the United States (HPUS)”.
“Triple Flu Defense is a drug under section 201(g) of the FD&C Act […] The information on your website is false or misleading. For example, your website makes effectiveness claims, but it lacks adequate descriptions of the risks, warnings, and contraindications of your product. Consequently, your product is misbranded under sections 502(a), 502(f)(1), and 201(n) of the FD&C Act, and is marketed in violation of sections 301(a) and 301(b) of such Act.”
Nenningers Naturals’ Facebook and Twitter feeds also came under FDA scrutiny, with the agency noting that claims made on the company’s Facebook account included: “School has started! Now is the time to think about flu prevention. The new formula is out on the shelves at your local stores and practitioners offices. Start your weekly prevention dose now.”
This claim is also found on the Twitter account (@TripleFluDefens), said the agency.
“Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)].”
For Med-Chem Labs , the FDA said that having reviewed the company’s website for its Lauricidin product (www.lauricidin.com ) it determined that ‘Lauricidin’ is “promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].
“The claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act.”