FDA WARNING_LETTER - World Health Products, Inc.

The FDA issued a Warning Letter to World Health Products, LLC, regarding their Detoxamin Oral, Detoxamin Suppositories, and Metal Detector test kit, marketed on www.detoxamin.com. The products are marketed in violation of the Federal Food, Drug, and Cosmetic Act.

Detoxamin products are deemed unapproved new drugs because they are intended to diagnose, cure, mitigate, treat, or prevent diseases (e.g., heart disease, autism, cancer, lead toxicity) and/or affect body structure/function. They are not generally recognized as safe and effective for their stated uses and lack FDA-approved applications, violating sections 301(d) and 505(a) of the Act. Furthermore, these drugs are misbranded under section 502(f)(1) as they address conditions not amenable to self-diagnosis, thus lacking adequate directions for lay use. The claim that Detoxamin is a "viable alternative to IV EDTA" is false and misleading, as oral/suppository EDTA is poorly absorbed, misbranding the product under section 502(a).

The Metal Detector test kit is an adulterated and misbranded device. It is intended for diagnosing heavy metals in urine but lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application, violating section 501(f)(1)(B). It is also misbranded under section 502(o