FDA WARNING_LETTER - Medicus Holistic Alternatives LLC

On January 11, 2018, the FDA issued a Warning Letter to Medicus Holistic Alternatives LLC dba Natracet, specifically Phillip Knab, regarding their product "Natracet." The FDA reviewed the company's website (www.natramedicus.com) and Facebook page (www.facebook.com/Natracet) in December 2017, along with the product label.

The FDA determined that "Natracet" is an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act (the Act). This determination is based on claims made on the websites and product label, which indicate the product is intended for the cure, mitigation, treatment, or prevention of disease, specifically related to opiate withdrawal and addiction. Examples of such claims include "Natural Withdrawal Support," "Natural Opiate Withdrawal Support Supplement," and statements about addressing anxiety, cravings, and helping to "STOP using painkillers."

As a "new drug," "Natracet" is not generally recognized as safe and effective for its intended uses and lacks prior FDA approval, violating sections 201(p), 301(d), and 505(a) of the Act. Furthermore, the product is misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as its intended uses (treatment of addiction/withdrawal) require