FDA WARNING_LETTER - Brower Enterprises - December 07, 2012

An FDA inspection of Brower Enterprises in December 2012 revealed significant violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR 111), rendering products like Myristoleate PLUS Cetyl Myristoleate (CMO), Coral Calcium Formula, Ultra Ellagic Plus Formula, and WOW adulterated. Subsequent labeling reviews in 2013 found these products promoted with disease claims (e.g., for arthritis, cancer) on websites, classifying them as unapproved new drugs (21 U.S.C. §§ 321(g)(1)(B), 321(p), 355(a)) and misbranded (21 U.S.C. § 352(f)(1)) due to inadequate directions for use. CGMP deficiencies included lacking written procedures for quality control (21 CFR 111.103, 111.140(b)(1)), holding/distributing (21 CFR 111.453), returned products (21 CFR 111.503), and product complaints (21 CFR 111.553, 111.560). The firm also failed to establish product specifications (21 CFR 111.70(f)) and collect reserve samples (21 CFR 111.83(a)). The FDA emphasized the firm's ultimate responsibility as a distributor for CGMP compliance. Additionally, products were misbranded (21 U.S.C. § 343(q)(5)(F)) due to non-compliant labeling under 21 CFR 101.36, including incorrect ingredient listing, missing Daily Value information, improper nutrition panel formatting, incorrect serving sizes, and failure to identify products as "dietary supplement" (21 U.S.C. § 343(s)(2)(B)). Other misbranding issues involved non-compliant nutrient content claims (21 U.S.C. § 343(r)(1)(A)), unlisted capsule ingredients (21 U.S.C. § 343(i)(2)), and missing botanical plant parts (21 U.S.C. § 343(s)(2)(C)). The firm's initial response was inadequate. Brower Enterprises must promptly correct all violations, prevent recurrence, and notify FDA within 15 working days, with potential regulatory actions including seizure, injunction, and re-inspection fees.