FDA WARNING_LETTER - Maxam Nutraceutics

The FDA issued a Warning Letter to Maxam Nutraceutics/Maxam Laboratories for marketing numerous products, including PCA-Rx, PC3x, AFX, and others, as well as the Heavy Metal Screening Test, in violation of the Federal Food, Drug, and Cosmetic Act.

The products are marketed on www.maxamlabs.com with claims indicating they are intended to affect body structure/function or to cure, mitigate, treat, or prevent diseases (e.g., autism, Alzheimer's, herpes, diabetes, cancer). Despite being marketed as dietary supplements, their labeling indicates transmucosal (sublingual) and topical administration, which means they are not dietary supplements but unapproved new drugs. These products are considered "new drugs" because they are not generally recognized as safe and effective for their stated uses, and no FDA-approved applications are in effect for them, violating sections 301(d) and 505(a) of the Act.

Furthermore, these products are misbranded under section 502(f)(1) because they address conditions not amenable to self-diagnosis/treatment, thus lacking adequate directions for laymen. The Heavy Metal Screening Test is an adulterated device under section 501(f)(1)(B) due to the lack of an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o)