FDA Sends Warning Letter to KY Firm

Nature Essence Small Molecule Co., Ltd., Lexington, KY, has received a warning letter from the FDA regarding claims that designate some of its products as unapproved new drugs and misbranded drugs. Additionally, the agency found adulterated products.
 
Specifically, FDA said it reviewed labels for Nature Essence Small Molecule’s “Ginkco (sic) Enzyme” and “Saponin Enzyme” (“Soap Enzyme”) following the inspection. The claims on your product labels establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. 
 
Examples of some of the claims made for Ginkgo Enzyme included drinking and applying Ginkgo Enzyme to the skin to treat tuberculosis, E. coli., skin fungus, skin disease, muscle pain, bone pain, headaches, colds, respiratory disease, and acute gastroenteritis; and spraying or applying it like a lotion to relieve muscle pain. Regarding Ginkgo effect, the claims suggested it can kill tuberculosis, Escherichia coli, skin fungus, 88%-100% of apple anthracnose, etc., effectively remove various skin diseases, small molecules of enzymes, decomposition function, deep penetration and remove muscle pain. Bone headache substances, etc., relieve muscles, bone headache.”
 
The company’s Saponin Enzyme (Soap Enzyme), claims included that there was no itching, no dandruff.
 
FDA said the Ginkgo Enzyme and Saponin Enzyme products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under Section 201(p) of the Act [21 U.S.C. § 321(p)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. No FDA approved applications are on file for these products.
 
In addition, a review of emails to the FDA establish that your Saponin (or Soap) Enzyme, Environmental (Clean) Enzyme, and Bath Enzyme products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. 
 
During the inspection, an FDA investigator observed and documented insanitary conditions, including “apparent filth on manufacturing equipment and insect contamination in the production area.” For example, FDA noted insect contamination in the processing area  fruit flies in the processing area and flying around open buckets of fermenting product during testing) and holding/fermentation containers encrusted with old material residues and not adequately maintained, cleaned, sanitized and/or sterilized. Further, the investigator noted the equipment is not sanitized prior to use.

Furthermore, FDA said that even if the products were not drugs, they are misbranded cosmetics. The Saponin (or Soap) Enzyme and Environmental (Clean) Enzyme products are misbranded within the meaning of section 4 of the Fair Packaging and Labeling Act (FPLA) in that the products are not labeled with a statement of identity which is the common or usual name of the cosmetic; is an appropriately descriptive name or, when the nature of the cosmetic is obvious, a fanciful name understood by the public to identify such cosmetic; or an appropriate illustration or vignette representing the intended cosmetic use, as required by 21 CFR 701.11(b).

The  Saponin (or Soap) Enzyme and Environmental (Clean) Enzyme products are misbranded within the meaning of section 4 of the Fair Packaging and Labeling Act (FPLA) [15 U.S.C. 1454(c)(3)(B)] as the label does not include a statement of the ingredients as required by 21 CFR 701.3(a).

Further, FDA said it noted that products are not consistently manufactured with the same ingredients and vary depending on what is available in the neighborhood flora. The Saponin (or Soap) Enzyme and Environmental (Clean) Enzyme products are misbranded as the label does not include a statement of the place of business for the manufacturer, as required by 21 CFR 701.12 and net quantity of contents statement, as required by 21 CFR 701.13, said FDA.