Liquid Health, Inc. – FDA Warning Letter, Aug 24, 2012

The FDA conducted an inspection of Liquid Health, Inc. from August 7 to August 24, 2012, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. Several products, including Attention, Calcium and Magnesium, Diabetic Support, Immune Balance, and Ultra-Antioxidant, were found to be promoted with disease claims, rendering them unapproved new drugs under sections 201(g)(1) and 201(p) of the Act. These products are also misbranded under section 502(f)(1) due to inadequate directions for use. Additionally, the products are adulterated dietary supplements under section 402(g)(1) for failing to comply with Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Specific CGMP deficiencies included failure to verify dietary ingredient identity (21 CFR 111.75(a)(1)(i)), establish and maintain finished product specifications (21 CFR 111.70(e), 111.95(b)(1)), and verify finished batches met specifications (21 CFR 111.75(c)). Quality control personnel failed to reject non-conforming products and released them for distribution (21 CFR 111.77(a), 111.123(b)(2)). The firm also failed to qualify component suppliers and maintain documentation (21 CFR 111.75(a)(2)(ii)(A), 111.75(a)(2)(ii)(C)). Finally, the firm failed to report a Serious Adverse Event Report (SAER) within 15 business days, as required by Section 761 of the Act. The FDA deemed the firm's response inadequate and requires a prompt written response detailing corrective actions to prevent future violations, warning of potential enforcement actions like product seizure, injunction, and re-inspection fees.