re:Botanical Laboratories of Bellingham, Wash->Late in 1984, the agency sent regulatory letters to two homeopathic drug companies threatening possible legal action unless the firms changed their marketing practices. The two, Biological Homeopathic Industries (BHI) of Albuquerque, N.M., and Botanical Laboratories of Bellingham, Wash., were judged to be among the most flagrant violators in their marketing of numerous homeopathic drugs for very serious disease conditions.
BHI was warned regarding the labeling of its Anticancer Stimulation Tablets, Antivirus Homeopathic Remedy, and other products promoted for such diseases as mumps, eye infections, inflammation of the ovaries, and whooping cough. The anticancer drug was promoted over-the-counter "to stimulate the body's own natural defense system . . . against degenerative cells." Dosage instructions stated the product could even be given to children under 6. "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," the agency wrote.
Botanical Laboratories was warned about its marketing of homeopathic drugs for treating such conditions as angina, heart irregularities, epilepsy, brain disorders, pneumonia and gout. In its regulatory letter to Botanical Laboratories, FDA said that, as with BHI, none of the firm's products had been proven safe or effective.
The agency told both firms that if they failed to bring their products into compliance with the Food, Drug, and Cosmetic Act, it was prepared to seize the products and/or seek court injunctions.
While the practice of homeopathy enjoys a long history in America, the public has a right to be protected from unsafe or ineffective drugs of any kind marketed in this country.
216.239.37.104 |
