Formulife, Inc.Purus Labs, Inc.d.b.a. Dark Cyde Supplements – FDA Warning Letter, May 19, 2011

On April 26-May 19, 2011, the FDA inspected Formulife, Inc. (d.b.a. Dark Cyde Supplements) in Dallas, TX, a distributor of dietary supplements manufactured by a contract facility. The inspection revealed multiple violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering products like Fat Smack, Halovar InSLINsified, Muscle Marinade, Organ Shield, Recycle, and SLINshot adulterated under 21 U.S.C. § 342(g)(1).

Key violations include: 1. **No Finished Product Specifications:** The firm lacked specifications for identity, purity, strength, composition, and contamination limits for its finished dietary supplements (21 CFR 111.70(e)). 2. **Lack of Written Procedures:** No written procedures were established for handling returned dietary supplements (21 CFR 111.503) or for reviewing and investigating product complaints (21 CFR 111.553).

Additionally, several products (Fat Smack, Organ Shield, Recycle, Muscle Marinade, SLINshot) were deemed unapproved new drugs and misbranded. The website www.puruslabs.net promoted these products with therapeutic claims (e.g., treating obesity, liver ailments, BPH, cardiovascular disease, common cold, managing blood glucose