FDA WARNING_LETTER - Total Body Nutrition - March 31, 2017

The FDA inspected Total Body Nutrition (Edgewood, NY) from February to March 2017, identifying significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111) for dietary supplements, rendering products adulterated. Samples of 1,3D Nox Xtrim Green Apple, Adrenal Pump, Shredder, and Tummy Tuck contained DMAA, an unsafe food additive, causing adulteration under 21 U.S.C. § 342(a)(2)(C)(i).

Additionally, Omega-3 Fish Oil and Total Estro (3,3 Diindolymethane) were deemed unapproved new drugs (21 U.S.C. § 321(p)) due to disease treatment claims, and misbranded (21 U.S.C. § 352(f)(1)) for lacking adequate directions for use.

CGMP deficiencies included failures to establish specifications for finished products and components (21 CFR 111.70(e), 111.70(b)(1)), and to implement written procedures for quality control, product complaints, and equipment calibration (21 CFR 111.103, 111.553, 111.25(a)).

Numerous products were also misbranded (21 U.S.C. § 343) for various labeling issues: undeclared/improperly named ingredients, false claims (methylsynephrine), missing manufacturer details, incorrect net quantity, improper nutrition information format, failure to identify botanical plant parts, and absence of domestic adverse event reporting contact. Other misbranding included incorrect FDA disclaimer text, missing disclaimer symbols, intermingled label information, and improper ingredient listing.

Total Body Nutrition must promptly correct all violations and submit a written response with corrective actions and documentation within 15 working days. Non-compliance could result in legal action and re-inspection fees.