July 10, 1981
Bureau of Drugs (HFO-l)
Associate Commissioner for Regulatory Affairs (HFC1)
This is in response to your request made at the July 6, 1981, meeting in your Office that the Bureau of Drugs delineate its position with respect to the domestic marketing of homeopathic drugs without the Rx legend.
As you were informed by our Office of Compliance, since the passage of the Durham-Humphrey Amendment to the FD&C Act, the Agency has consistently stated that homeopathic preparations should be restricted to prescription sale and be labeled with the Rx legend. You were also advised that until now, no compliance program has been developed to regulate the marketing of homeopathic drugs due in large part to the relatively small volume of both imported and domestically marketed drug products. However, during the past several years, we have noted that both the importation and domestic marketing of homeopathic drugs has increased considerably. (See the flyer on the ACH/IPHF LAYMAN’S PROGRAM IN HOMEOPATHIC MEDICINE, just received from Irene Kelly.)
To stem the illegal marketing of homeopathic drugs lacking the Rx legend, the Bureau of Drugs is now prepared to initiate regulatory action against any imported or domestic homeopathic drug lacking the Rx legend.
DETENTIONS OF HOMEOPATHIC DRUGS BY NEW YORK DISTRICT AND OTHER DISTRICT OFFICES
As you are aware, New York District and at least two other district offices have detained certain import shipments of homeopathic drugs under various misbranding charges. The importers have been informed that in order to bring the products into compliance, they must, among several other revisions, relabel the products to bear the Rx legend.
As a result of the New York detention, the Swiss government has contacted the Department of State and has complained that the detention of their products at a time when no action is being taken against domestic homeopathic drugs is a violation of the General Agreement on Trade and Tariffs (GATT). The Office of Compliance has reviewed the GATT, and it is their opinion that a reasonable argument can be made that we have not violated GATT. However, to expend agency resources in arguing whether or not FDA has violated GATT may be counter productive and tends to shift the focus from the real issue; namely, illegal marketing of homeopathic drugs. In order to avoid the confrontation, we may alternatively release the detained lot with comment and initiate an enforcement program covering domestic and imported homeopathic preparations.
The latter alternative will, in our opinion, provide better consumer protection with optimum utilization of Agency resources and also avoid an unnecessary conflict between the Swiss and U. S. Governments.
Because of new developments in increased activities of homeopathic drugs, we believe that time has come to enforce the requirement that homeopathic drugs bear the Rx legend. Since this decision will have far reaching impact, we recommend that we proceed as follows:
1. Release the detained homeopathic drugs with comment. If you agree, our Office of Compliance will contact each District Office and instruct them to release the detained lots.
2. Develop a compliance program to enforce the requirement that homeopathic drugs be marketed only as prescription drugs. This will pertain to both the domestic and import homeopathic drugs. If you agree, Our Office of Compliance will prepare such a program. To inform the district of the agency’s regulatory posture, we have prepared an advisory TWX for your signature to serve as notice our intention to enforce the prescription labeling requirement for homeopathic drugs. This action should blunt further GATT type problems while tile Compliance Policy Guide and class action program is developed and Implemented. Any further Imports of homeopathic drugs will be denied entry unless they bear appropriate prescription labeling. As soon as this course of action is approved, our Office of Compliance will prepare a letter to the State Department reflecting the agency’s position on homeopathic drugs.
If you agree with the recommended course of action, please let me know as soon as possible so that I may instruct our Office of Compliance to implement the appropriate compliance program.
J. Richard Crout, M.D.
Tab A – Flyer
Tab B —TWX to District
AUG – 3 1981
Associate Commissioner for Regulatory Affairs (HFC-l)
Homeopathic Drugs Enforcement Policy
J. Richard Crout, Director, Bureau of Drugs (HFD-1)
This responds to your memorandum of July 10, 1981, and reflects conversations I have had with Jerry Halperin and Dan Michels over the past two weeks. I have concurred in your recommendation that the detained lots of drugs in New York be released with comment, and my office has worked with bureau staff to prepare a statement for that use that I am prepared to issue. EDRO will be asked to prepare an import alert using the same language and directing that subsequent lots of drugs offered for import be treated in the same manner. This will assure a consistent approach on the part of the agency until the Commissioner can decide on any new regulatory initiatives.
I have not concurred in your second recommendation that would have the agency undertake immediately an active enforcement program against both domestic and imported homeopathic drugs. Further, as I mentioned above, I feel strongly that the Commissioner must be involved in any decision that would result in a major change in our enforcement regarding these products. After all, it has been 30 years since the passage of the Durham-Humphrey Amendment; and although over all this time we have held the position that homeopathic drugs should bear the prescription legend, this policy has never, to my knowledge, been publicly announced except through occasional informal correspondence, nor has it ever been actively enforced. The comments to industry have been only to encourage prescription labeling. To abruptly start aggressive enforcement and begin to seize and refuse entry to products without carefully thinking through and planning compliance program would be, in my opinion, completely inappropriate.
The bureau’s expressions of concern and recommendations that the agency undertake more aggressive enforcement are based on the feelings of staff that we are beginning to recognize a dramatic increase in the number and kinds of these products being imported and sold domestically. Yet, when I questioned members of your staff, I found we have not inspected any of the domestic firms since about 1978 (and then only for GMP’s) and know little about the actual marketplace. Further, no one has raised an alarm of widespread hazards to health, but rather only a concern that if the numbers and types of products are increasing, now is the time to begin to assure proper labeling. I do not disagree with that conclusion in principle, but shouldn’t we start any new regulatory program by findng out what is really going on in the profession and industry?
I strongly recommend that the bureau begin immediately to develop a surveillance program that will in a thoughtful and timely way gather the data we all need to make decisions on what should be our homeopathic drug policy and enforcement priority. It would not be unreasonable to meet with the various homeopathic trade and professional associations as part of this effort to better understand their positions on this matter. It may now be appropriate to consider some homeopathic drugs as OTC. It is appropriate to involve the Bureau of Foods since they have some expertise in this area, and also there may be some overlapping of jurisdiction that needs to be resolved. Finally, if the Commissioner concludes that a major change in regulatory activity is appropriate because it will be viewed as such an abrupt change by persons outside of the agency, there must; be some formal public announcement of the new initiatives to the profession and industry by the agency.
Our policy in regard to individual products of any kind that pose a hazard to health is, of course, unchanged, and appropriate regulatory actions should be promptly undertaken to assure proper consumer protection. I can only assume, however, that traditional homeopathic drugs do not pose any severe hazards because we have not taken legal actions against them,
My office is prepared to assist in any way in the development and implementation of a surveillance program. If you would like to discuss this matter further or together talk it over with front office, let me know.
Joseph P. Hile
cc: HF-l; HF-2; HFC-l; HFC-2; HFC-20; HFC:2; (Homeopathic Drugs);
HFC-22; R/F; HFF-300; HFF-310; HFO-20; HFO-400; HFO-410; HF0-415;
HFY-5 (Harty); GCF-l (Levine); HFR-2100; HFA-224
revised & tf:HFC-22:JKelly:ljh:7/31/81
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