On more than one occasion, Hsu’s Ginseng Enterprises, Inc. has been investigated and cited by the U.S. Food & Drug Administration Inspections, Compliance, Enforcement and Criminal Investigations Divisions. As seen in these letters this company has been cited for selling contaminated products (“adulterated: chemical residue”) faulty employee training and false advertising – i.e. advertising their products with unapproved or unsubstantiated claims: | www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm512780.htm | www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm256575.htm | Hsu’s has been notified “You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction. ” | “Furthermore, claims made on your Facebook page, www.facebook.com/hsuge provide additional evidence that your products are intended for use as drugs: | On January 14, 2016, your company shared a photo which states: “American ginseng…can be used…conditions like high blood pressure…or ulcers” | A drug is misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1), if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions by which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act, 21 U.S.C. § 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.” | Shortly before reading the FDA publicly available information, I had recently been gifted 2 packages of Hsu’s Enterprises, Inc. American Ginseng. Sensing that it is not safe to ingest Hsu’s Enterprises, Inc. products, I wrote to them, asking for a refund:
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