Pristine Nutraceuticals, LLC. – FDA Warning Letter

The FDA issued a Warning Letter to Pristine Nutraceuticals, LLC, following a review of their website, http://www.digestaqure.com, in October 2014. The FDA determined that the product "DigestaCure [or DigestaQure]" is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims on the website and in promotional literature, including testimonials on the linked website thecodeoflife.info and claims in "The Code of Life" book, establish the product's intent for use in the cure, mitigation, treatment, or prevention of disease. Examples of claims include "If you suffer from an Autoimmune Condition, we have your Solution," and testimonials for conditions like Celiac Disease, Gout, Ulcerative Colitis, Lupus, Epilepsy, Crohn's disease, and Hashimoto's Disease. The website also features a "Symptoms and Conditions Submission Form" listing various diseases for "analysis." Meta tags used for website searches also indicate drug-like claims.

The FDA states that DigestaCure is a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for its intended uses. Introducing a new drug into interstate commerce without prior FDA approval violates section 505(a) and