美国中药协会警告信？？这个是中药又被躺枪？？

beiwei5du

American Chinese Medicine Association 6/26/18

	Division of Pharmaceutical Quality Operations III 300 River Place, Suite 5900 Detroit, MI 48207 Telephone: (313) 393-8100 Fax: (313) 393-8139

June 26, 2018

WARNING LETTER

Case# 553834

UPS NEXT DAY
SIGNATURE REQUIRED

Dr. Bob Xu
American Chinese Medicine Association (ACMA), Inc.
(b)(6)

Dear Dr. Xu,                                                                              

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.americanchinesemedicineassociation.org in May 2018, and has determined that you take orders there for numerous drug products intended for use in humans, including but not limited to, “ACMA Brain Tumor Treatment,” “ACMA Breast Cancer Treatment,” “ACMA Colon Cancer Treatment,” “ACMA Multiple Myeloma Treatment,” and “ACMA Lyme Disease Treatment.” FDA has determined that these products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. 352. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

The claims on your website establish that your above-mentioned products are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of claims observed on your website www.americanchinesemedicineassociation.org that establish the intended use of your products as drugs include, but may not be limited to, the following:

ACMA Brain Tumor Treatment

• “More effective and safer than conventional cancer treatments”
• “ACMA treatments selectively kill cancerous cells, either directly or indirectly, and do no harm to normal cells.”
• “ACMA cancer treatments do not have any side effect causing new cancer. On the contrary, ACMA cancer treatment can prevent new cancer from developing or growing.”
• “For most ACMA cancer patients, ACMA cancer treatments have extended their lives, including extending the lives of cancer patients who were sent hospice after orthodox medicine failed to help them.”
• “For stage I, II, III cancer patients after receiving ACMA cancer treatments, the 5-year remission rate is 100%.”
• “Shrink brain tumor without surgery, radiation, and chemotherapy”
• “Save patient’s life”
  
  

ACMA Breast Cancer Treatment

• “Leading cancer treatment in the United States, which enables stage I, II, and III cancer patients to become cancer free without surgery, chemo, or radiotherapy.”
• “ACMA Breast Cancer Treatment is a very effective breast cancer treatment . . .”
• “Remove the enlarged lymph nodes”
• “Prevent cancer metastasis”
  
  

ACMA Colon Cancer Treatment

• “ACMA Colon Cancer Treatment is a very effective colon cancer treatment.”
• “ACMA Colon Cancer Treatment can improve patient’s abnormal bowel movements, reduce the sensation of Incomplete emptying bowel, atop the blood in stool, and remove the narrower or thinner stools.”
• “ACMA Colon Cancer Treatment can shrink the tumor and Improve patient’s colonoscopy and CT scan results. The patient can become cancer free after ACMA Colon Cancer Treatment.”
  
  

ACMA Multiple Myeloma Treatment

• “ACMA Multiple Myeloma Treatment is a very effective treatment . . .”
• “Heal skin lesions”
• “Prevent cancer metastasis (macroglossia)”
• “Save patient’s life”
  
  

ACMA Lyme Disease Treatment

• “ACMA Lyme Disease Treatment has faster and better results in treating Lyme disease.”
• “Not only does the treatment improve Lyme disease symptoms, but it also addresses the root causes of Lyme disease and removes the Lyme disease infection and co-infections.”
• “Repair organ damages caused by the bacterium Borrelia and the co-infections”
  
  

Your products “ACMA Brain Tumor Treatment,” “ACMA Breast Cancer Treatment,” “ACMA Colon Cancer Treatment,” “ACMA Multiple Myeloma Treatment,” and “ACMA Lyme Disease Treatment” are also “new drugs” under 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 use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA. No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355(a), is in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

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 “ACMA Brain Tumor Treatment,” “ACMA Breast Cancer Treatment,” “ACMA Colon Cancer Treatment,” “ACMA Multiple Myeloma Treatment,” and “ACMA Lyme Disease Treatment” are offered for conditions that are not amenable to self-diagnosis and treatment without the supervision of a licensed practitioner; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your above-mentioned products fail to bear adequate directions for their intended uses, and therefore, the products are misbranded within the meaning of 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 FD&C 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 assure that you comply 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 the 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 complete the correction.

Please send your electronic reply to: ORAPHARM3_RESPONSES@fda.hhs.gov.

Attn:  Russell K. Riley
Compliance Officer
U. S. Food and Drug Administration
Division of Pharmaceutical Quality Operations III
           
Refer to the Unique Identification Number (Case# 553834) when replying. If you have questions regarding the contents of this letter, please contact Mr. Riley by phone at (630) 323-2763 ext. 101.


Sincerely,
/S/
Art O. Czabaniuk
Program Division Director
Division of Pharmaceutical Quality Operations III


cc:

Dr. Bob Xu
(b)(6)


Department of Financial and Professional Regulation
Division of Professional Regulation
Attn: Dr. Brian Zachariah
Chief Medical Coordinator
100 West Randolph Street, Suite 9-300
Chicago, Illinois 60601

beiwei5du

ACMA Clinic
https://americanchinesemedicineassociation.org/about-us/

为什么是Chinese medicine,而不是Chinese traditional medicine??


那么应该叫什么呢？？美中药协会？？实际上还是用的holistic and natural medicine进行治病的呢。

beiwei5du

The claims on your website establish that your above-mentioned products are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.Your products “ACMA Brain Tumor Treatment,” “ACMA Breast Cancer Treatment,” “ACMA Colon Cancer Treatment,” “ACMA Multiple Myeloma Treatment,” and “ACMA Lyme Disease Treatment” are also “new drugs” under 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 use under the conditions prescribed, recommended, or suggested in their labeling.
第一，如果有声称 diagnosis, cure, mitigation, treatment, or prevention of disease，且不是针对于标签中标明适应症是generally recognized as safe and effective的话，就必须当做新药对待，就必须走批准程序。所以很多中药在国外不是当药品卖的，而是作为保健品卖的。所以被认定为unapproved drug。

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).
第二，如果其标签中没有针对于其使用目的足够的指导，也是被认为是misbranded。

Doitasyoulike

unapproved drug是指没有通过一致性评价但是的确是在市场上卖的药吧
也指保健品吗？

syhorchid

当做新药对待，就必须走批准程序。

罗伊鲱

FDA还管网站，不错