WARNING LETTER
North American Hirudin Biotech Products Inc.
MARCS-CMS 613103 —
April 21, 2021
Delivery Method:
Overnight Delivery
Product:
Drugs
Recipient:
Recipient Name
Zengxun An
Recipient Title
President
North American Hirudin Biotech Products Inc.
2531 Broadway, Suite A
Everett
,
WA
98201
United States
Issuing Office:
Office of Regulatory Affairs
United States
April 21, 2021
In reply, refer to CMS 613103
WARNING LETTER
Dear Mr. An:
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address http://ushirudin.com/ in February and April 2021, and has determined that you take orders there for your products “Hirudin” and “Red 65”. We also reviewed your websites at http://www.naturalhirudin.com/ and http://buyred65.com/, both of which contain links to http://ushirudin.com/ where the products can be purchased. The claims on your websites 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:
Hirudin
On the http://ushirudin.com/ website:
• “Blood-thinning: Hirudin is a Natural Blood Thinner . . . help normalize the blood sugar level in your blood”
• “Hirudin . . . has unique abilities to . . . dissolve the . . . cholesterol in your blood so your blood flows unrestricted.”
• “[S]trengthens your body’s defense capability against common viruses and bacteria.”
• “Is hirudin a potential therapeutic agent for arthritis?”
• “[H]irudin . . . are alternatives to heparin for the treatment of: 1) unstable angina, 2) abrupt closure and restenosis following coronary angioplasty, and 3) prevention of deep vein thrombosis after major orthopedic surgery . . . They are fast becoming the drugs of choice for the anticoagulant treatment of patients with heparin-induced thrombocytopenia with thromboembolic complications.”
On the website http://www.naturalhirudin.com/:
• “Hirudin has been scientifically proven to be the most potent anti-coagulant.”
• “Hirudin is . . . the most effective natural anticoagulant. Hirudin has been hailed as the promising molecule in the fight against cardiovascular and blood-related disease.”
• “Hirudin Tablet is based on . . . its powers in promoting blood-thinning . . ..”
• “In the early days of the twentieth century, medical pioneers used leeches to treat cardiovascular disease primarily due to the natural anticoagulant, hirudin . . . Hirudin has a system wide anticoagulation effect . . . mechanisms that contribute to the treatment of cardiovascular diseases or conditions such as a stroke or a heart attack.”
On the webpage for your Hirudin product at http://ushirudin.com/hirudin-the-original-formula/:
• “Hirudin has been recognized by scientists and medical professionals alike as the most effective natural anticoagulant. Hirudin has been hailed . . . in the fight against cardiovascular and blood-related disease.”
• “Hirudin Tablet is based. . . its powers in promoting blood-thinning . . ..”
• “Benefits of Hirudin Tablet:
o [N]aturally lowers cholesterol content from your blood system.
o Blood-thinning . . . help normalize the blood sugar level in your blood.
o [D]issolve the . . . cholesterol in your blood . . .
o [S]trengthens your body’s defense capability against common viruses and bacteria.”
Red 65
On the website http://buyred65.com/:
• “Red 65 blood cleanser for better heart health natural blood thinner natural lower cholesteral [sic] and natural prevent diabetes”
• “[N]aturally lowers cholesterol content from your blood system.”
• “Blood-thinning . . . help normalize the blood sugar level in your blood.”
• “[S]trengthens your body’s defense capability against common viruses and bacteria.”
• “RED65 Offers Amazing Results for . . . Pain Relief . . . Anticoagulation - Binds Itself to Thrombins, Inhibiting Coagulation, Dissolving Existing Blood Clots . . . Blood Thinner . . . a Potent Anti-Coagulant that Thins the Blood . . . Vasodilator - Widens Vessel Walls . . .”
• “Hirudin [an ingredient in Red 65] has been scientifically proven to be the most potent anti-coagulant.”
On the webpage for your Red 65 product at http://ushirudin.com/red-65-natural-blood-thinner/:
• “North American Hirudin Red 65 a Natural Blood Thinner . . .”
• “Red 65 is a natural blood thinner . . . Hirudin has been recognized by scientists and medical professionals alike as the most effective natural anticoagulant. Hirudin has been hailed . . . in the fight against cardiovascular and blood-related disease.”
• “. . . Red 65 is based on . . . its powers in promoting blood-thinning . . ..”
• “Benefits of Red 65:
o Blood-thinning . . . help normalize the blood sugar level in your blood. Some diabetic patients have reported that Red65 is a natural diabetes control. Others have described Red65 as a natural Coumadin . . .
o [D]issolve . . . cholesterol in your blood. . .
o [S]trengthens your body’s defense capability against common viruses and bacteria.”
On the webpage titled “HOW DOES HIRUDIN DETOXIFY OUR BODIES?” at http://ushirudin.com/how-does-hirudin-detoxify-our-bodies-2/, which contains links to purchase Hirudin and Red 65 products:
• “In the early days of the twentieth century, medical pioneers used leeches to treat cardiovascular disease primarily due to the natural anticoagulant, hirudin. Hirudin has . . . mechanisms that contribute to the treatment of cardiovascular diseases or conditions such as a stroke or a heart attack.”
• “. . . hirudin specifically targets, prevents and dissolves the formation of clots . . . It is commonly used to treat other blood coagulation disorders, skin hematomas, and superficial varicose veins.”
On the webpage titled “WHAT IS HIRUDIN AND WHAT DOES IT DO?” at http://ushirudin.com/what-is-hirudin-and-what-does-it-do/, which contains links to purchase Hirudin and Red 65 products:
• “Since 1853 Hirudin has been recognized by scientists and medical professionals alike as the most effective natural anticoagulant. Hirudin has been hailed . . . in the fight against cardiovascular and blood-related disease.”
• “Hirudin Tablet is based on . . . its powers in promoting blood-thinning.”
On the webpage titled “THE TABLET” at http://ushirudin.com/the-tablet/, which contains links to purchase Hirudin and Red 65 products:
• “Hirudin has long been established in medical literature and research as a beneficial anticoagulant treatment . . ..”
• “Hirudin supplement tablet is . . . helping to maintain a normal blood pressure and blood sugar level which lowers the risk of developing cardiovascular and cerebrovascular diseases.”
On the webpage titled: “Hirudin Evolution” at http://ushirudin.com/hirudin-evolution/, which contains links to purchase Hirudin and Red65 products:
• “Thrombosis is a major cause of death and disability from myocardial infarction, stroke, peripheral ischemia, and pulmonary embolism.”
• “Hirudin is the most potent non-covalent inhibitor of thrombin.”
• “[Hirudin and synthetic analogues of hirudin] are alternatives to heparin for the treatment of: 1) unstable angina, 2) abrupt closure and restenosis following coronary angioplasty, and 3) prevention of deep vein thrombosis after major orthopedic surgery. They are also used as adjunct to fibrinolytic therapy. They are fast becoming the drugs of choice for the anticoagulant treatment of patients with heparin-induced thrombocytopenia with thromboembolic complications.”
Your “Hirudin” and “Red 65” 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)]. 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 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 “Hirudin” and “Red 65” products 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, “Hirudin” and “Red 65” products 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)].
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 injunction.
Please notify FDA in writing, within 15 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 15 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 Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Jinkee M. Vila-Binayug, Compliance Officer, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4421. If you have any questions regarding this letter, please contact Compliance Officer Vila-Binayug at 425-302-0413.
Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director
Content current as of:
05/18/2021
Regulated Product(s)
Drugs