FDA WARNING_LETTER - Kamerycah Inc - May 20, 2019

On December 2, 2019, the FDA issued a Warning Letter to Kamerycah Inc. following an inspection on May 1, 3, and 20, 2019. The inspection and subsequent review of product labeling, including a brochure and Amazon storefront, revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The FDA determined that Kamerycah Inc.'s Umi No Shizuku Fucoidan and Umi No Shizuku Essential Nutrition products are unapproved new drugs and misbranded drugs. Claims on product labeling, such as those found in the "Essential Nutrition Umi No Shizuku" booklet and on the Amazon storefront (e.g., "Fucoidan . . . has been shown in clinical trials to support the body against cancer"), indicate the products are intended for disease treatment, cure, mitigation, or prevention. Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" under 21 U.S.C. 321(p) and require prior FDA approval, which they lack. Additionally, they are misbranded under 21 U.S.C. 352(f)(1) because they lack adequate directions for use by a layperson, as they are intended for conditions requiring professional supervision.

Furthermore, the inspection revealed multiple Current Good Manufacturing Practice (CGMP) violations for dietary supplements