The Food and Drug Administration
FDA has statutory authority to regulate the marketing of drugs, devices, and biologics in interstate commerce. Many of the best-known unconventional cancer treatments involve drugs, devices, or biologics unapproved by FDA, and these treatments become FDA’s concern when interstate shipment occurs or reports suggest they pose a public health hazard.

Because FDA’sinterest arises from these concerns, FDA may provide the public with almost exclusively negative information about unconventional cancer treatments. To some extent, FDA’s Office of Consumer Affairs both initiates public awareness and responds to occasional public inquiries on unconventional cancer treatments. In the last few years, FDA and the Pharmaceutical Advertising Council (PAC) developed a multi-media public service campaign to teach the public how to recognize, avoid, and help stop what they consider to be ‘health fraud,’ a term that, as used by the FDA, encompasses some of the treatments covered in this report.

In 1986, FDA worked with the National Association of Consumer Agency Administrators (NACAA) to establish an Information Exchange Network. In 1988, the Office of Consumer Affairs contracted with Harris Associates to conduct a national survey documenting the extent and impact of what they defined as health fraud on the U.S. public, focusing on use in the treatment of chronic diseases, such as arthritis and cancer.

A few individuals within FDA are knowledgeable about unconventional cancer treatments and may answer specific inquiries or represent the agency on related matters. Staff from the Office of Health Affairs also respond to inquiries from health professionals and organizations regarding unconventional cancer treatments. An FDA historian may respond to public inquiries about unconventional cancer treatments with articles and reprints. The Office of Regulatory Affairs imposes and publicizes sanctions that may involve unconventional cancer treatments. The office publishes narrative notices of Import Alerts, which have, on occasion, dealt with bans on the importation of unconventional cancer treatments (e.g., IAT, Nieper products).

Under the Commissioner of Regulatory Affairs, staff at regional and district offices specifically monitor health fraud and make enforcement efforts. In this vein, the government has sought injunctions against Dr. Stanislaw Burzynski to prevent shipment of unapproved drugs across state lines, and seized some of his records. The Office of Public Affairs prepares “FDA Talk Papers” which are intended to guide FDA personnel in answering questions posed by the public, and are also available to the public directly. A few recent FDA Talk Papers have discussed unconventional cancer treatments (e.g., live cell therapy, homeopathic remedies).