FDA WARNING_LETTER - GnuPharma Corp. - April 13, 2017

On April 11-13, 2017, the FDA inspected GnuPharma Corporation's facility in Owasso, Oklahoma, identifying violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111). These violations render GnuPharma products adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Additionally, a review of GnuPharma's websites (www.gnupharma.com and www.gnuwellness.com) and product labels in June and November 2017 revealed that products such as Relief, Foundation, Aller-geez, Fit capsules, and various teas and aromatherapy products are marketed with claims that establish them as unapproved new drugs under section 505(a) of the Act. Examples of drug claims include "assists with daily pain," "assists with inflammation," and "natural allergy relief."

Furthermore, Relief, Foundation, Fit, and Sleep capsules are deemed misbranded under section 403 of the Act due to various labeling deficiencies. These include failure to declare all common or usual names of ingredients (e.g., capsule ingredients, incorrect botanical names), failure to list all dietary ingredients and their quantities, failure to identify plant parts for botanical ingredients, incorrect presentation of nutrition information, and incorrect serving sizes.

Specific CGMP violations include: 1. Failure