By Wes Siegner –
FDA held a public hearing titled “Homeopathic Product Regulation” on April 20 and 21 of this year. Now the FTC has announced that it will hold a “Workshop” to examine advertising for over-the-counter (OTC) homeopathic products on September 21.
FDA’s Federal Register Notice for the hearing identified issues to be discussed that were careful to avoid indicating that may FDA intend to make significant regulatory changes for homeopathic products. FTC’s Press Release was more direct, stating that “The workshop will cover topics including:
- A look at changes in the homeopathic market, its advertising, and what consumers know;
- The science behind homeopathy and its effectiveness;
- The effects of recent class actions against homeopathic product companies;
- The application of Section 5 of the FTC Act to advertising claims for homeopathic products; and
- Public policy concerns about the current regulation of homeopathic products.”
Bottom line, if the FTC holds homeopathic products to the same scientific standards that are applied to claims for other OTC products like dietary supplements, as the FTC appears inclined to do (see, for example here), few if any homeopathic products will pass the test.
The practice of homeopathy and the products this practice has inspired are a fascinating enigma to the uninitiated. The pre- and post-regulatory history of homeopathy is too long and too complex to cover here, but for an excellent review of this history, read Dr. Susan White Junod’s “An Alternative Perspective: Homeopathic Drugs, Royal Copeland, and Federal Drug Regulation.”
When attempting to regulate homeopathic preparations, the agencies are forced to address questions they never face with other regulated products, such as: How does “like cure like”? How does a substance diluted beyond detectable limits have curative powers? How do you label a product when it contains ingredients that, after dilution, you cannot prove are in the product? Nevertheless, over the past 30 years, we have seen a substantial growth in the number and variety of homeopathic products, and the size of the homeopathic market. This growth is undoubtedly what has spurred the recent FDA and FTC interest in reexamining the regulation of homeopathic preparations.
Historically, regulators have accepted that homeopathic drugs, while presenting difficult questions and considerable skepticism with respect to efficacy, deserved regulatory leeway because of their safety. This explains why FDA did not require proof of safety after the enactment of the Federal Food, Drug, and Cosmetic Act (FDC Act) in 1938, or proof of efficacy after the 1962 Kefauver-Harris Amendments to the FDC Act, and why the FTC has historically pursued only those homeopathic products, such as HCG, that are blatant frauds. This permissive regulatory posture has allowed the market for safe, properly manufactured homeopathic products to expand as the public interest in nutrition and alternative therapies has grown.
The question now is whether this 70-plus year old climate of regulatory tolerance has ended, and whether one or both agencies will severely limit or perhaps close down the market for homeopathic products by applying regulatory standards that the practice cannot survive.