Secret Garden of Health & Healing, LLC – FDA Warning Letter, Aug 29, 2017

The FDA issued a Warning Letter to Secret Garden of Health & Healing following an inspection from August 21-29, 2017, and a review of their website and product labels. The letter identifies serious violations of the Federal Food, Drug, and Cosmetic Act.

Several products, including Osha Root, S.G. Cough Syrup, and Bac-ta-Bitters, are deemed unapproved new drugs and misbranded drugs. This is due to therapeutic claims on their labels and website, such as treating coughs, infections, shingles, kidney stones, and endometriosis, which establish them as drugs intended for disease treatment or prevention. These products are not generally recognized as safe and effective, making them "new drugs" requiring FDA approval. Additionally, some products like Anti-Viral and Staph/Strep are misbranded because they are intended for conditions not amenable to self-diagnosis, making adequate directions for layperson use impossible.

The company also committed significant Current Good Manufacturing Practice (CGMP) violations for dietary supplements, rendering their products adulterated. Deficiencies include failure to establish written procedures for quality control operations, material review, and reprocessing decisions (21 CFR 111.103, 111.140(b)(1)). They failed to establish specifications for components and finished dietary supplements (21 CFR 111.70(a), (b), (e)). The firm did not prepare and follow