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
VIA UPS OVERNIGHT
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
ACMA Breast Cancer Treatment
ACMA Colon Cancer Treatment
ACMA Multiple Myeloma Treatment
ACMA Lyme Disease Treatment
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

This page was posted on July 8, 2018.

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