FDA WARNING_LETTER - YoungYou International Inc - October 31, 2013

The FDA inspected YoungYou International, Inc. from October 28-31, 2013, finding serious violations of the Federal Food, Drug and Cosmetic Act. The company's Slimbyonicx Weight Loss Pills were deemed an unapproved new drug due to therapeutic claims (e.g., "LOWERS CHOLESTEROL") on their websites (www.youngyoucorp.com, www.slimbionic.com), making it misbranded as it lacks adequate directions for layperson use.

Additionally, the inspection revealed multiple Current Good Manufacturing Practice (CGMP) violations for dietary supplements, rendering products adulterated. Deficiencies included: 1. Failure to protect products from contamination and mix-ups during holding (21 CFR 111.165(e), 111.455(c)), specifically unlabeled bulk products. 2. Failure to establish specifications for incoming packaged products (21 CFR 111.70(f)). 3. Failure to establish and keep written procedures and records for labeling operations (21 CFR 111.403, 111.430). 4. Failure to establish and follow quality control operations for packaging and labeling, including approval and release from quarantine (21 CFR 111.127). 5. Failure to maintain documentation for complete manufacturing history and control through distribution (21 CFR 11