WARNING LETTER
Bonagens MARCS-CMS 609905 —
- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Product:
- Dietary Supplements
- Recipient:
-
Recipient NameKevin Ho
- Bonagens
4500 Satellite Blvd., Suite 1270
Duluth, GA 30096-5043
United States
- Issuing Office:
- Division of Human and Animal Food Operations East III
United States
November 17, 2020
Reference CMS Case # 609905
WARNING LETTER
Dear Mr. Ho:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address https://bonagensinc.com in July 2020, and has determined that you take orders there for the products “Anti-Aging Supports,” “Cholesterol & Diabetes Control,” “Gout Control,” “Hypertension Control,” “Liver Supports,” “Lungs Supports,” “Vita-V for Men,” and “Weight Lost.” The claims on your website establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Anti-Aging Supports
• “alleviate the effects of menopausal syndrome…menopausal and sleeping disorders”
• “prevent and aid in rehabilitation from strokes”
• “alleviate cataract problems”
• “aide [sic] in osteoporosis”
Cholesterol & Diabetes Control
• “Administration of Cholesterol/Diabetes Control has a significant decrease in fasting blood glucose and suppression of glucose elevation. It also stimulates the insulin secreting cell lines and helps to control blood glucose.”
• “Cholesterol/Diabetes Control will lower the total cholesterol, triglyceride, and LDL level. Consumption of this product will decrease hepatic cholesterogenesis, where as [sic] the triacylglycerol -lowering effect appears to be due to inhibition of fatty acid synthesis.”
• “Cholesterol/Diabetes Control will also help to increase levels of HDL by the synthesize [sic] of more apoA -I, apoA -II from intestines and liver.”
Gout Control
• “Gout Control will help to reduce the uric acid by blocking the enzyme Xanthine dehydrogenase (XDH), this is one of the key enzymes to form uric acid in the liver. Gout Control also helps to increase the excretion of uric acid via gastrointestinal tract and bile.”
• “Gout Control prevents inflammation, infection, …”
Hypertension Control
• “Hypertension Control helps to remove nanoplaque. Nanoplaque is a compound that deposits onto the wall of the cells, which leads to clogged arteries and artherosclerosis [sic]. Hypertension Control will stop blood clots and lower overall cholesterol level, which will stop high blood pressure.”
Liver Supports
• “Control liver enzyme AST/ALT, prevent hepatitis, and liver cancer. Hedyotis diffusa reduced liver cell damage caused by antibody-dependent cell mediated toxicity or activated marcrophage [sic] culture supernatants.”
• “Against chemical-induced liver damage (including industrial chemicals, alcohol and pharmaceutical drugs)”
• “Liver cirrhosis”
• “Hepatitis”
• “Gallbladder dysfunctions”
Lungs Supports
• “Prevent coughing, inflammation, infection, and lung cancer.”
• “Individuals with symptoms of bronchitis”
• “Individuals with symptoms of breath problem, cold, flu, asthma”
• “Individuals with symptoms of respiratory-induced allergies”
• “Individuals working at facilities, considered at risk factor [sic] for respiratory disease”
Vita-V for Men
• “Ginkgo Biloba blocks many of the effects of platelet activating factor PAF (blood clots) which is a common cause for erectile dysfunction and impotence.”
Weight Lost
• “In local tissues, liver, and adipose tissue, Weight Lost administration significantly reduced…abnormal phenotypical changes in both tissues.”
Your “Anti-Aging Supports,” “Cholesterol & Diabetes Control,” “Gout Control,” “Hypertension Control,” “Liver Supports,” “Lungs Supports,” “Vita-V for Men,” and “Weight Lost” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
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 under 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.
Your products, “Anti-Aging Supports,” “Cholesterol & Diabetes Control,” “Gout Control,” “Hypertension Control,” “Liver Supports,” “Lungs Supports,” and “Vita-V for Men” are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, “Anti-Aging Supports,” “Cholesterol & Diabetes Control,” “Gout Control,” “Hypertension Control,” “Liver Supports,” “Lungs Supports,” and “Vita-V for Men” fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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 and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to N’Jere P. English, Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, NE, Atlanta, GA 30309. If you have any questions regarding the content of this letter, please contact N’Jere P. English at 404-669-4450 or email at Njere.English@fda.hhs.gov.
Sincerely,
/S/
Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Food Operations – East Division 3