FDA WARNING_LETTER - NutraCore Health Products

The FDA issued a Warning Letter to Nutracore Health Products, LLC, on January 11, 2018, following a December 2017 review of their website (www.nutracorehealthproducts.com) and product label for "Opiate Detox Pro." The FDA determined that "Opiate Detox Pro" is an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act (the Act).

The product is deemed a drug under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] due to claims on its website and label, such as "OPIATE DETOX PRO ADVANCED ADDICTION WITHDRAWAL FORMULA" and "help reduce withdrawal symptoms related to listed drugs, alcohol and tobacco." These claims indicate intent for use in the cure, mitigation, treatment, or prevention of disease.

As a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)], "Opiate Detox Pro" lacks FDA approval, violating sections 301(d) and 505(a) [21 U.S.C. 331(d), 355(a)]. Furthermore, it is misbranded under section 502