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WARNING LETTER
 

October 14, 2021

RE: 615846

Dear Xiang Lu Peng:

This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at www.newgreenusa.com in August 2021 and has determined that you take orders there for “Xiao Ke Wan” (aka “XiaoKe Pills”), “Diabetee-Care,” and “Specific Jiang Tang Remedy.” We have also reviewed your social media websites at www.facebook.com/NewGreenNutrition and https://twitter.com/newgreenusa; these social media websites direct consumers to your website www.newgreenusa.com to purchase products. The claims on your website and social media websites establish that your “Xiao Ke Wan,” “Diabetee-Care,” and “Specific Jiang Tang Remedy” products are drugs under section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (the FD&C Act), 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Some examples of claims observed on your websites and in your product labels that establish the intended uses of your above products as drugs include, but may not be limited to, the following:

Xiao Ke Wan
• Product description from your website www.newgreenusa.com/products/xiao-ke-wan: “The classic herbal formula helps maintain blood glucose level.”
• From a July 4, 2021 post on your Facebook account at www.facebook.com/NewGreenNutrition: “These [sic] really help . . . to regulate blood sugars by strengthening the pancreas.”
• From a July 4, 2021 post on your Twitter account at https://twitter.com/newgreenusa: “Helps maintain blood glucose level”
• From your product package insert: “Indicated for . . . type II diabetes . . ..”

Diabetee-Care
• The name of the product from your website www.newgreenusa.com/: “Diabetee-Care”

Specific Jiang Tang Remedy
• Product description from your website www.newgreenusa.com: “A dietary supplement that helps . . . reducing the content of the blood sugar and urine sugar.”

Unapproved New Drugs

Your “Xiao Ke Wan,” “Diabetee-Care,” and “Specific Jiang Tang Remedy” products are also “new drugs” as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for their above referenced uses. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d), 21 U.S.C. 331(d), and 505(a) of the FD&C Act.

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. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) The aforementioned products are offered for conditions that, with certain exceptions not applicable here, are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use the products safely for their intended uses. FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, 21 CFR 201(c)(2) and 201.115, because no FDA-approved applications are in effect for them. 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. Your “Xiao Ke Wan” product label lists the ingredient glibenclamide (also known as glyburide), a blood glucose lowering agent in a class of drugs called sulfonylurea. 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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

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. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration