FDA WARNING_LETTER - Maine Natural Health, Inc.

On April 10-12, 24-26, and May 3, 2017, the FDA inspected Maine Natural Health, Inc., finding numerous violations of dietary supplement CGMP regulations (21 CFR Part 111). Products like Vanilla Recovery Whey Protein and Peppermint SO3+D3 Fish Oil were deemed adulterated.

Furthermore, FDA review of product labels and the website www.sfh.com revealed that SO3 + D3 Fish Oil, Fuel Whey Protein, Strong Strength + Muscle, Pure Whey Protein, and Push Pre-Workout products violate Section 403 of the Act (21 U.S.C. § 343) regarding food labeling. Additionally, SO3 + D3 Fish Oil, SO3 Fish Oil, Recovery Whey Protein, Strong Strength + Muscle, and Pure Whey Protein are considered unapproved new drugs under Section 201(g)(1)(B) of the Act due to disease treatment claims on the website, making their interstate commerce introduction illegal.

Key CGMP violations include: 1. Failure to establish adequate specifications for components and finished products (21 CFR 111.70(a), (b)(1), (b)(2), (e)). 2. Failure to collect and test representative samples of finished batches (21 CFR 111.80(c)). 3. Failure to reject or properly document the