FDA WARNING_LETTER - Reishi D. International, Inc. - August 07, 2017

On August 2-7, 2017, the FDA inspected Reishi D. International, Inc.'s dietary supplement facility. The inspection revealed serious violations of cGMP regulations (21 CFR Part 111), causing the Reishi D. product to be adulterated under 21 U.S.C. § 342(g)(1). Additionally, product labels and brochures contained violations of the Federal Food, Drug, and Cosmetic Act.

The FDA determined that claims on product brochures, such as "Chinese medicine" and "Propolis...help to neutralize the free radicals and prevent cell damage," establish Reishi D. as an unapproved new drug under 21 U.S.C. § 321(g)(1)(B) and § 321(p)(1), as it is intended for disease treatment or prevention and is not generally recognized as safe and effective. Introducing such a product into interstate commerce without FDA approval violates 21 U.S.C. § 331(d) and § 355(a).

Even if not an unapproved drug, the product is adulterated due to cGMP violations. The firm, as a distributor, is ultimately responsible for ensuring compliance. Significant violations include: 1. Failure of the quality control unit to approve or reject packaged and labeled dietary supplements for distribution, as required by 21 CFR 11