Docket # 94P-0316/CP 1
Filed August 29, 1994
- Dockets Management Branch,
- Food and Drug Administration
- Room 1-23
- 12420 Parklawn
- Rockville, MD 20857
The undersigned, as agent for 42 individuals, hereby submits this petition pursuant to FDA laws and regulations that require all commercially available drugs to be proven safe and effective and be adequately labeled for their intended uses.
The FDA Commissioner should initiate a rulemaking procedure, similar to the OTC Review, to require that all OTC homeopathic drugs meet the same standards of safety and effectiveness as nonhomeopathic OTC drugs. In the interim, the Commissioner should issue a public warning that although the FDA has permitted homeopathic remedies to be sold, it does not recognize them as effective.
Statement of Grounds
Although homeopathic products are not recognized as effective by the scientific community, the FDA has tolerated their marketing because a provision of the 1938 Food, Drug, and Cosmetic Act recognized substances listed in the Homeopathic Pharmacopeia as drugs. However, nothing in the law prohibits the FDA from requiring homeopathic remedies to be proven effective to remain on the market.
FDA Compliance Policy Guide 7132.15, issued in 1988, states that “nonprescription homeopathics may be sold only for self-limiting conditions recognizable by consumers . . . [Their] labeling must adequately instruct consumers in the product’s safe use.” However, the guide warns that compliance with its requirements “does not establish that [a product] has been shown by appropriate means to be safe, effective, and not misbranded for its intended use.”
The FDA’s laissez-fair regulatory policy has enabled dozens of companies to market hundreds of products with claims (often simply in the name of the product) that are unsubstantiated. All of these products are misbranded because they do not indicate on their label that they can remedy nothing. Nor do they state how much of any ingredient the product contains in a way that the average consumer can understand. Nor can adequate directions for use be written for products that don’t work. Because the FDA permits their sale, consumers are being misled into thinking that the remedies are effective, not only for symptomatic relief but for the treatment of serious diseases.
Products designated as 24X, 12C, or higher, should contain no molecules of the original substance from which they are prepared. Yet they are being marketed as though they are potent remedies.
One homeopathic manufacturer even advertises that “unlike most over the counter medicines, Medicine from Nature works in harmony with the body’s natural defenses and gets to the cause of your illness or discomfort.” [See Exhibit A] Many other manufacturers have made similar claims.
Exhibit B provides an overview of the homeopathic marketplace.
Exhibit C is the National Council Against Health Fraud’s position paper.
We certify that this petition includes all data, information, and views upon which this petition relies, and that we know of no reliable scientific data or other information that are unfavorable to this petition.