FDA WARNING_LETTER - American Chinese Medicine Association, Inc - May 31, 2018

The FDA issued a Warning Letter to Dr. Bob Xu of American Chinese Medicine Association (ACMA), Inc. following a May 2018 review of their website, www.americanchinesemedicineassociation.org. The FDA determined that ACMA was selling unapproved new drug products, including "ACMA Brain Tumor Treatment," "ACMA Breast Cancer Treatment," "ACMA Colon Cancer Treatment," "ACMA Multiple Myeloma Treatment," and "ACMA Lyme Disease Treatment."

These products are considered drugs under section 201(g)(1)(B) of the FD&C Act due to claims on the website establishing their intended use for disease diagnosis, cure, mitigation, treatment, or prevention. Examples of such claims include "More effective and safer than conventional cancer treatments" for ACMA Brain Tumor Treatment, and "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" for ACMA Breast Cancer Treatment.

The products are also deemed "new drugs" under section 201(p) of the FD&C Act because they are not generally recognized as safe and effective for their advertised uses. Their introduction into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the FD&C Act.

Furthermore, these products are misbranded under section 502(f)(1