FDA WARNING_LETTER - PRL Inc - October 26, 2018

The FDA inspected PRL, Inc. in Lobelville, TN, from October 16-26, 2018, revealing serious violations of Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products adulterated. Additionally, a review of product labels and the website www.forestcenterherbs.com identified serious violations of the Federal Food, Drug, and Cosmetic Act.

The products SpiroNIL, General Formula, Black Walnut, Alfalfa Herbal Tonic, Kidney Formula #1, Kidney Formula #2, and MicroNIL are deemed unapproved new drugs and misbranded drugs due to therapeutic claims on the website, indicating intended use for disease cure, mitigation, treatment, or prevention. These products are not generally recognized as safe and effective for such uses and lack FDA approval. General Formula, SpiroNIL, and Kidney Formula #2 are also misbranded as they are intended for conditions not amenable to self-diagnosis or treatment, making adequate directions for layperson use impossible.

Significant CGMP violations include: 1. Failure to establish finished product specifications for identity, purity, strength, composition, and contaminant limits for FlorAlive and Forest Center Herbs brand dietary supplements (21 CFR 111.70(e)). 2. Failure to establish packaging and labeling specifications for finished dietary supplements (21 CFR 111.70(g)). 3.