Mega Pro International – FDA Warning Letter, Apr 25, 2017
On April 24-25, 2017, the FDA inspected Mega-Pro Nutrition, Inc.'s facility, identifying significant violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products adulterated. A May 2017 review of their website, www.mega-pro.com, revealed additional violations.
The FDA determined that products like Chromium Picolinate, Creatine, and DHEA are unapproved new drugs under Section 201(g)(1)(B) of the Act due to therapeutic claims on their website, such as "lowering cholesterol, normalizing high blood sugar" for Chromium Picolinate and links to treating degenerative diseases for Creatine. These products are not generally recognized as safe and effective, making them "new drugs" under Section 201(p)(1) and requiring FDA approval before interstate commerce. Furthermore, Chromium Picolinate and Creatine are misbranded under Section 502(f)(1) because they lack adequate directions for use by a layperson, as they are intended for conditions requiring professional supervision.
Even if not unapproved drugs, Chromium Picolinate, Creatine, DHEA, Mega Cut Fat Burner, Stim & Trim Fat Inferno, and Inosine are adulterated dietary supplements due to CGMP violations. Mega-Pro Nutrition failed to establish and follow written procedures for: quality control operations (2
ID · 19ef92e2-0ec4-413e-9bab-8981e7c0c410
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