FDA WARNING_LETTER - Nature Essence Small Molecule Co., LTD - May 20, 2019

The FDA inspected Ms. Zheng's establishment at 3475 Lyon Drive, Apartment 62, Lexington, Kentucky, on May 6, 14, and 20, 2019, regarding ready-to-eat, raw, fermented product manufacturing. The inspection, product labels, and emails revealed serious violations of the Federal Food, Drug and Cosmetic Act.

The products "Fruit Enzyme," "Ginkco Enzyme," "Saponin Enzyme" (aka "Soap Enzyme"), "Environmental (Clean) Enzyme," and "Bath Enzyme" are deemed unapproved new drugs due to therapeutic claims on labels and in emails (e.g., treating cardiovascular disease, tuberculosis, skin diseases, removing toxins, anti-cancer). These products are not generally recognized as safe and effective for their claimed uses and lack FDA approval. They are also misbranded drugs because they lack adequate directions for use by a layperson, as their intended uses require professional supervision.

Even if not drugs, "Fruit Enzyme," "Edible Enzyme," and "Ginkco Enzyme" are misbranded foods for failing to declare all ingredients, place of business, and net quantity of contents. "Saponin Enzyme" and "Environmental (Clean) Enzyme" are misbranded cosmetics for lacking a statement of identity, ingredient list, place of business, and net quantity of contents.

Furthermore, food products ("Fruit Enzyme," "Ginkco Enzyme," "Edible Enzyme")