In 1984, the U.S. Food and Drug Administration warned Biological Homeopathic Industries (BHI) of Albuquerque, New Mexico, that many of its products were being illegally marketed. The company withdrew a few products, modified its marketing of several others, but basically continued doing business as usual.
In reply please refer to 84-HFN-314-1
Dr. Hans-Heinrich Rechweg, President
Biological Homeopathic Industries, Inc.
11600 Cochiti, SE
Albuquerque NM 87129
Dear Dr. Reckeweg:
An investigation conducted at your firm by investigator H. Tom Warwick of our Dallas office (on November 8 and 13, 1984) indicates that you manufacture and distribute into interstate commerce numerous homeopathic remedies labeled for the treatment of various serious disease conditions.
Our review of the labeling for BHI Anticancer Stimulation Tablets indicates that the products are offered for stimulating the body's own natural defense system against degenerative cells. Also labeling for BHI Antivirus Homeopathic Remedy states that this product is for stimulating the body's own natural defense system through viral toxin elimination. Our review of the labeling for other homeopathic products manufactured and distributed by your firm indicates that they are offered for such disease conditions as mumps, eye infection, inflammation of the ovary, whooping cough, etc.
It is the FDA's position that these products are drugs as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act. Further, we are unaware of any substantial scientific evidence which demonstrates that any of your marketed homeopathic drugs are generally recognized as safe and effective for their intended use. Accordingly, continued marketing of these drugs is a serious violation of the Federal Food, Drug, and Cosmetic Act as follows:
SECTION BRIEF DESCRIPTION 505(a) The products, "BHI Anticancer Stimulation Tablets", "BHI Antivirus Homeopathic Remedy" and all other homeopathic drugs marketed by you are new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (Act) since no approvals of application filed pursuant to section 505(b) are effective with respect to such drugs.
The violation listed above is not intended to be all-inclusive. It is your responsibility as a drug manufacturer and distributor to market drug products which are in compliance with the Federal Food, Drug, and Cosmetic Act.
We request that you take prompt action to correct the above violation. If such action is not taken, the Food and Drug Administration is prepared to invoke regulatory action such as seizure and/or injunction. Please advise us within ten (10) days as to specific actions you have taken to correct the above violation including the discontinuance of all marketed homeopathic drugs.
Your response should be directed to:
William G. Nychis, National Coordinator.
Drugs and Biologics Fraud Branch (HFN-314)
Division of Drug Labeling Compliance
Office of Compliance - CDB
5600 Fishers Lane
Rockville MD 20857
Daniel L. Michels, Director
Office of Compliance
Center for Drugs and Biologics
WGNychis : aah :11/29/84:12/6/84
RID mit: RChastonay: 12/3/84; RApodaca: 12/5/84