Letter to FDA
February 8, 2018
Scott Gottlieb, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Dr. Gottlieb and FDA Staff,
The American Institute of Homeopathy (AIH) is our nation’s oldest extant national medical association. We represent licensed health care professionals (MD, DO, ND, DDS, NP, PA) who practice homeopathy, and the pharmacists who dispense it. Our society is extremely concerned about the FDA’s recent actions and we vigorously oppose plans to withdraw the current Compliance Policy Guidance (CPG) 400.400, and replace it with a “risk based” guidance. We have repeatedly advised that this document be revised, amended and improved, but it should remain in place.
FDA adopted CPG 400.400, Conditions Under Which Homeopathic Drugs May Be Marketed, in 1988 to eliminate confusion concerning “the regulation of OTC and prescription homeopathic drugs and delineate those conditions under which these drugs may ordinarily be marketed in the U.S.” CPG 400.400 resolved confusion that affected FDA personnel, the pharmaceutical industry, as well as the public. For nearly 30 years, it has established clear, measurable, and enforceable standards for the manufacture and sale of homeopathic drugs and has contributed significantly to improving cost, quality and access to safe homeopathic drug products that provide consumer choice for the American public.
In 2015, FDA announced that it planned to reexamine CPG 400.400 and convened a two-day public hearing where many stakeholders presented and nearly 9,000 public comments were submitted. The AIH and many other organizations suggested ways in which the existing CPG 400.400 could be modified and improved, but without responding to any of these suggestions, or heeding the thousands of public comments, FDA, in December 2017, chose to rescind this guidance in its entirety, and put in its place “risk based” guidelines that alters interpretation of an 80-year old Act of Congress and declares all homeopathic drugs illegal.
The newly proposed “risk based” guidance, which eliminates all guidance for manufacturers and the public, repeatedly states that all homeopathic drugs will be required to have FDA approval, or they will be considered illegal and subject to regulatory action. This change in wording is a shocking reversal, not only of the CPG 400.400, but of the Food Drug and Cosmetic Act (FDC) of 1938, an Act of Congress which “recognizes as official the drugs and standards of the Homeopathic Pharmacopeia of the United States (HPUS) and its supplements.”
The new FDA guidance will require more than 3,500 homeopathic drugs in the HPUS to be painstakingly approved. This will have a chilling effect on the practice of homeopathy in the U.S. since the task of applying for approval for these drugs, most of which are not patentable, is beyond the resources of the entire homeopathic community combined.
FDA’s action stands as a bold departure from the Act of Congress that established the HPUS as an independent compendium more than 80 years ago; it is an act of defiance against the best interests of the millions of Americans who regularly benefit from homeopathic health care, the thousands of licensed healthcare professionals who currently prescribe these medicines, and the homeopathic pharmacies that painstakingly produce them.
FDA’s actions, in this guidance, represents one of the most hostile and aggressive actions ever taken against homeopathy by any federal institution. This outrageous redefinition of homeopathic drugs is unprecedented, and can only be interpreted as FDA’s total lack of understanding about homeopathy, or their intent to end its use in the U.S.
Abandoning the CPG 400.400, which establishes clear guidelines that protect manufacturers and the public, and replacing it with a directive that provides no guidance, but declares homeopathic medicines to be illegal is unacceptable. The American Institute of Homeopathy strongly objects to FDA’s recent proposal to rescind the CPG 400.400 or to put policies in place that alter the status of homeopathic medicines, established by an Act of Congress, and make them illegal for the first time in the history of the United States.
Ronald D. Whitmont, MD
President, American Institute of Homeopathy