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Nature Essence Small Molecule Co. Pinged by FDA Warning Letter

Contact Author Rachel Grabenhofer
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Dandruff and itch are the core 'symptoms' reportedly mitigated by Nature Essence Small Molecule Co., Ltd.'s, Saponin Enzyme (aka Soap Enzyme) cosmetic product.

However, according to the U.S. Food and Drug Administration, in its warning letter to the company, "Your Fruit Enzyme, Ginkco (sic) 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)]."

The agency notes it approves new drugs on the basis of scientific data and information demonstrating that the drug is safe and effective. However, no FDA-approved applications are on file for these products. "In addition, a review of your 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."

According to the agency, examples of claims provided in an email to the FDA and offering further evidence included benefits from the Saponin Enzyme (aka Soap Enzyme):

  • “For skin: deeply sterilize; relieve skin itching, sores, inflammation, ulcer, and lesion. Improve the immune system. Anti-lesion, see relevant research report, as well as anti-cancer and improve immunity of AIDS"; and
  • “[A]nti-itching, and remove dandruff.”

During the FDA's inspection, the investigator also observed and documented unsanitary conditions whereby the “Saponin Enzyme,” “Environmental (Clean) Enzyme” and “Bath Enzyme” products may have become contaminated or rendered injurious to health. 

Per the FDA warning letter, the company has fifteen days withing receipt of the letter to correct and notify the agency of correction measures.

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