FDA WARNING_LETTER - MYA International, Inc. - September 10, 2021

On February 24, 2022, the FDA issued a Warning Letter to MYA International, Inc. following an inspection from August 30 to September 10, 2021. The inspection and subsequent review of product labeling revealed significant violations of the Federal Food, Drug, and Cosmetic Act.

Nine products (Hygly, Diapro-Z, Bioampixilina, Penalin, Colloidal Silver, Tea (Tea Cellular), Quiebra Piedras, Shark Cartilage, and Helper) were identified as unapproved new drugs and misbranded drugs. Their labeling claims, such as "Diabetes Problems Assistant," "Natural Antibiotic Qualities," and "Assistant in Cancer and Tumors Problems," indicate intended use for disease treatment, cure, mitigation, or prevention, classifying them as drugs under section 201(g)(1)(B) of the Act. As they are not generally recognized as safe and effective for these uses, they are "new drugs" under section 201(p) and lack FDA approval, violating sections 301(d) and 505(a). Furthermore, these products are misbranded under section 502(f)(1) because they lack adequate directions for layperson use, as their intended uses require professional supervision.

The inspection also uncovered serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111),