What happened
Original notice title
New Green Nutrition, Inc. MARCS-CMS 615846, October 14, 2021
From the archived source record
Misbranded Drugs Your “Xiao Ke Wan,” “Diabetee-Care” and “Specific Jiang Tang Remedy” products are misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions use. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Furthermore, prescription drugs, as defined in section 503(b)(1) of the FD&C Act, 21 U.S.C. 353(b)(1), include those that, because of their toxicity or other potentiality for harmful effect, and/or the collateral measures necessary for their use, are not safe for use except under the supervision of a practitioner licensed by law to administer them. By offering a drug containing glyburide, an active pharmaceutical ingredient in multiple FDA-approved drug products, without requiring a prescription, you are jeopardizing patient safety and misbranding the drug under section 503(b)(1) of the FD&C Act, 21 U.S.C. 353(b)(1). Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act, 21 U.S.C. 331(k). This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 3ae3d94488af
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →