FDA WARNING_LETTER - Confidence Inc. - November 02, 2010

On October 25-29 and November 2, 2010, the FDA inspected Confidence Inc., an own-label dietary supplement distributor. The FDA considers Confidence Inc. a manufacturer due to its ultimate responsibility for products released under its name. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering products adulterated under Section 402(g)(1) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. Failure to establish specifications for components (e.g., gelatin capsules) (21 CFR 111.70(b)). 2. Failure to establish specifications for dietary supplement labels (21 CFR 111.70(d)). 3. Absence of written procedures for quality control operations (21 CFR 111.103, 111.140(b)(1)). 4. Lack of written procedures for holding and distributing operations, including appropriate conditions (21 CFR 111.453). 5. Failure to collect and hold reserve samples for each lot of distributed dietary supplements (21 CFR 111.83(a)).

Additionally, several products (Dr. Brain with Huperzine A, pH Balance, Glucosamine Plus, Full-Bloom Topical Breast Cream) are promoted with