I’ve written previously about the official regulation of homeopathy by the Food and Drug Administration (FDA). The bottom line is that homeopathy was exempted from the standards of proof for safety and efficacy required of all other medications regulated by the FDA due to the efforts of the senator who first introduced the Food, Drug & Cosmetics Act (FD&C), who happened to have practiced homeopathy. It is legal to sell homeopathic remedies without a prescription for conditions people can reasonably be expected to diagnose and treat themselves. And it is legal to claim safety and efficacy and sell such remedies with a prescription for more serious illnesses. Fortunately, few doctors authorized to write such prescriptions are foolish enough to believe homeopathy is appropriate as treatment for such illnesses.
Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 400.400)” (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed; thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG. One of those conditions is compliance with Section 503(b) of the FD&C Act. Under the CPG, only homeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed OTC. Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.
Despite this historical accident, the reality is that the FDA does not endorse the safety and efficacy of homeopathy as homeopaths often claim. Unlike all other drugs and medical devices, FDA approval of homeopathy does not imply any real evidence or scientific testing of safety or efficacy. The FDA says as much on its web site, ““FDA is not aware of scientific evidence to support homeopathy as effective.” With regard to veterinary use of homeopathy, it is technically against the law, but the FDA has bowed to political reality and decided not to enforce this rule.
A recent warning letter issued to one of the largest homeopathy manufacturers in the U.S. emphasizes the fact that the FDA does not consider homeopathy as a valid form of therapy for serious disease despite its formal status as legal under the Food and Drug Act. It reminds the company that marketing homeopathic remedies without prescription for serious health problems is illegal.
Your firm markets numerous drugs that are misbranded in violation of sections 503 and 301 of the Federal Food, Drug, and Cosmetic Act…The products [mentioned in the letter] are prescription drugs within the meaning of section 503(b)(1) of the FD&C Act because they are intended to treat diseases that require diagnosis and treatment by a physician or are intended to provide treatment for symptoms usually caused by an underlying disease process that requires diagnosis and treatment by a physician. Because they may be dispensed only by prescription of a licensed practitioner, these products are misbranded… If an indication requires the supervision of a practitioner licensed to prescribe drugs, adequate directions for use cannot be written for an OTC drug product for that indication.
Furthermore, your products listed above are misbranded within the meaning of section 502(a) of the FD&C Act [21 U.S.C. 352 (a)] in that their labeling is false or misleading because the labeling represents the products as suitable for use by consumers to treat conditions which the Agency has found not appropriate for OTC drug treatment.
In this letter, the FDA also addresses the issue of testimonials, that meaningless yet ubiquitous and persuasive form of marketing preferred by purveyors of unproven or bogus alternative therapies. The agency recognizes that such testimonials are presented with the intention of suggesting that the products are safe, effective, and appropriate for the conditions customers claim to use them for, and that this creates a false, and in this case illegal, impression even if the words used are not those of the company itself.
We also note that you include customer reviews of products on your websites. These customer reviews are evidence of the intended uses of your products; your firm is responsible for ensuring that statements made by customers and included on your websites do not cause your product to be misbranded…
So the next time you hear a homeopathy advertise their magic water as “FDA Approved,” remember this does not in any way suggest that homeopathy has been scientifically proven to work or that the FDA believes it to be an effective therapy for any condition.