FTC Homeopathic Advertising Regulation
Comment by Stephen Barrett, M.D.
The 1938 Federal Food, Drug, and Cosmetic Act permits all substances included in the Homeopathic Pharmacopeia of the United States to be marketed as drugs, but the FDA has not held homeopathic products to the same standards as other drugs. In June 2015, the Federal Trade Commission announced that it would hold a hearing on September 21 to discuss homeopathic regulation. Since I was unable to attend, I submitted this comment through the FTC's comment portal. As of September 27, 2015, about 60 other comments were posted.
Federal Trade Commission
Washington, DC 20580
Re: Comments and proposed testimony for the FTC workshop on advertising
for over-the-counter (OTC) homeopathic products
Homeopathic "remedies" don't work. They provide risk without benefit. They are usually harmless, but their associated misbeliefs are not. When people are healthy, it may not matter what they believe. But when serious illness strikes, false beliefs can lead to disaster. In 1986, Consumer Reports engaged me to do a year-long investigation in which I collected product literature, proponent writings, and books; attended homeopathic meetings; visited homeopathic clinics; and interviewed industry leaders and FDA regulatory officials. Since that time, I have continued to track the homeopathic marketplace closely. Not much has changed.
Homeopathic products are sold mainly through homeopathic pharmacies, mainstream pharmacies, health food stores, and Internet outlets. Industry insiders estimate that more than 99% of these products sold in the United States are sold as OTC drugs.
The marketing of homeopathic products in the United States was enabled by of a provision of the 1938 Food, Drug and Cosmetic Act that recognized substances listed in the Homeopathic Pharmacopeia of the United States (HPUS) as drugs subject to FDA regulation. This book contains 1-page "monographs" that describe physical characteristics and manufacturing procedures for about 1,300 substances of plant, animal, and mineral origin.
HPUS monographs contain no information about how the products should be used. Their intended uses are determined by manufacturers and prescribers based mainly on "provings," that were conducted more than a century ago. Provings are events in which people record what they feel during a predetermined time period after swallowing a substance.
Homeopathy's fanciful "law of similars" asserts that substances that can cause symptoms in healthy people can, if sufficiently diluted, effectively treat health problems that produce such symptoms. Based on this notion, combinations of symptoms noted during provings have been compiled into books called materia medica" that are used to guide remedy selection. Homeopathy's even more fanciful "law of infinitesimals" asserts that the greater the dilution, the more potent the product and that even products so dilute that they contain no molecules of the original ingredient can be potent drugs.
Prevailing Scientific Opinion
The prevailing view of the scientific community toward homeopathy is unfavorable. Well-established procedures exist for determining whether drugs are safe and effective. Many types of studies can be done, but the ultimate test is whether people who use a product do better than similar people who do not. Because many ailments are variable and/or self-limiting, it would be necessary to demonstrate that apparently positive outcomes are the result of treatment rather than the natural course of the ailment. Homeopathic products have not met this standard; and no homeopathic product is supported by evidence of safety and effectiveness for its intended purposes that would be required to gain FDA approval. In fact, the vast majority of substances listed in the Homeopathic Pharmacopeia have never been tested. Nor have combination OTC or dietary supplement products that contain one or more homeopathic ingredients.
In 1999, The Medical Letter on Drugs and Therapeutics, which is the medical profession's most trusted drug advisory newsletter, concluded:
The chemical content of homeopathic products is often undefined, and some are so diluted that they are unlikely to contain any of the original material. These products have not been proven effective for any clinical condition. There is no good reason to use them. (See attachment.)
This message is still valid today.
During the past two years, the Australian Government's National Health and Research Council conducted a comprehensive review of the scientific literature and concluded that there were no health conditions for which there was reliable evidence that homeopathy was effective. [See NHMRC Information paper: Evidence on the effectiveness of homeopathy for treating health conditions. (March 2015) and Optum'sOverview Report: Effectiveness of Homeopathy for Clinical Conditions: Evaluation of the Evidence(October 2013)] These reports provide sufficient detail for the FTC to judge the scientific status of homeopathy.
The percentage of consumers who buy homeopathic products is low. Most of them probably (a) perceive them as "natural," (b) don't know or understand that homeopathy's underlying principles are far-fetched, and (c) don't realize that many homeopathic preparations contain no traces of the supposedly active ingredient. Some purchasers are strong believers; others assume the products are effective because the FDA permits them to be sold and they encounter them in drugstores. Homeopathic manufacturers base their claims on (a) what they think will appeal to consumers and (b) what they think they can get away with.
Lax FDA Regulation
Although homeopathic drugs were within the FDA's regulatory scope, the agency did not promulgate regulations for nearly fifty years. From 1938 to 1988, the FDA essentially regulated homeopathic pharmaceuticals through informal "understandings" between the FDA and the industry. The 1962 Kefauver-Harris amendments to the Federal Food, Drug, and Cosmetic Act require that all drugs be effective as well as safe. Passage of this law triggered an extensive review of prescription drugs that was followed by an extensive review of OTC ingredients. However, homeopathic products were exempted from these reviews.
In the 1980s, discussions between members of the FDA's Compliance Office and homeopathic industry leaders led to the development of a formal FDA regulatory policy. The resultant Compliance Policy Guide CPG 7132.15 was implemented in 1990. This document states that homeopathic products can be marketed OTC for the treatment of "self-limiting disease conditions amenable to self-diagnosis (of symptoms)." Homeopathic products intended for the treatment of more serious conditions must meet the standards applicable to all prescription drugs. CPG 7312.15 further states:
A product's compliance with requirements of the HPUS . . . does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use. A guide to the use of homeopathic drugs (including potencies, dosing, and other parameters) may be found by referring to the following texts: A Dictionary of Practical Materia Medica by John Henry Clarke, M.D., (3 volumes; Health Science Press) and A Clinical Repertory to the Dictionary of Materia Medica by John Henry Clarke, M.D. (Health Science Press). These references must be reviewed in conjunction with other available literature on these drug substances.
Clarke's Dictionary of Practical Materia Medica illustrates the wildness of homeopathic claims and the need for greater regulation. Published in 1900, it contains more than 1,600 pages that describe "characteristics" and symptoms associated with about 450 homeopathic substances that had been subjected to provings. The total number of symptoms described in the book appears to be well over 100,000. The six pages about arnica included in Clarke's Dictionary (attached) illustrate why it is absurd to permit materia medica to be used as a basis for labeling or advertising claims.
CPG 7132.15 has facilitated the marketing of thousands of products for huge numbers of symptoms that were compiled long ago in materia medica. Many of these symptoms occur in diseases that are neither self-limiting nor amendable to self-diagnosis, but the FDA has shown little inclination to look closely at OTC homeopathic claims. CPG 7132.15 does not protect consumers. It protects sellers by telling them that if they do not claim to prevent or cure serious diseases, the FDA will leave them alone.
Homeopathic manufacturers base their claims on (a) what they think will appeal to consumers and (b) what they think they can get away with. The FDA has issued some warning letters ordering companies to stop false claims that homeopathic products can prevent or treat serious diseases. Some of these letters were jointly issued with the FTC. However, neither agency has made a systematic attempt to identify or stop the vast majority of sellers from making untrue preventive or therapeutic claims. Class-action suits have limited what a few companies can say about certain products. But their overall impact on the homeopathic marketplace has been small.
Throughout the U.S., thousands of practitioners are using bogus "electrodermal screening" devices to diagnose nonexistent health problems and persuade patients to buy homeopathic products to fix them. [See Barrett S. Quack "Electrodiagnostic" Devices. Quackwatch Web site, July 7, 2012.] Many of these devices have achieved FDA 510(k) marketing clearance to measure galvanic skin resistance. However, they are bundled with "diagnostic" software that is not disclosed during the 510(k) application process. During the past 25 years, I have received more than 300 reports of harm due to these devices and have complained repeatedly to the FDA. Most of the improper activity would cease if the FDA performed 510(k) re-evaluations that considered the software. This would require only minimal use of agency resources, but the FDA's device regulators don't seem to care about this problem.
Applicable FTC Law
Section 5 of the FTC Act requires that advertising claims be truthful and non-misleading. For certain types of claims, such as health benefit claims, an advertiser must possess competent and reliable scientific evidence substantiating the claims prior to dissemination. An advertisement would also be deceptive if it omits material information and that omission is likely to mislead a consumer acting reasonably under the circumstances. The only way a homeopathic product could meet these standards is to make no health claims and disclose that the product provides no health-related benefit.
Regulatory Policy Considerations
Many homeopathic products offer the illusion of effectiveness through product names and statements such as "for the symptoms of …" Since these are never truthful, they do not help consumers make informed decisions. There are only two ways that homeopathic product labels and advertising can help consumers to make informed decisions. One is to ban all health claims. The other is to tell consumers that there is no logical reason to believe that the product is effective for any health-related purpose.
Because a complete ban of homeopathic products is probably not politically feasible, the FDA should limit their marketing to single-ingredient products that strictly comply with the Homeopathic Pharmacopeia.
FTC regulation should begin with a strict definition: Homeopathic products should be defined as "products that contain one or more ingredients listed in the Homeopathic Pharmacopeia." All products that are identified as homeopathic or that contain one or more ingredients that are labeled as homeopathic should be covered by this policy.
The FTC does not have the resources to enforce the law on a case-by-case basis. There are too many manufacturers, too many sellers, and too many products to get into the type of endless wrangling that can occur in court cases.
It is neither necessary nor possible to establish rules through which claims for ineffective products can be safely made. I believe that the only practical way to protect consumers would be to ban all efficacy claims that have not been approved by the FDA through its regular drug approval processes. There is no reason to consider indications that are based on homeopathic "provings."
- The term "homeopathic" should be limited to products with only homeopathic ingredients listed in the Homeopathic Pharmacopeia
- The FTC should not permit homeopathic product claims that have not been approved through the FDA's standard drug approval process. In other words, no health claim (cure, treatment, prevention, mitigation) can be advertised without FDA approval as safe and effective.
- Claims that imply safety (safe, gentle, no side effects) may not be used without FDA approval as safe and effective.
- Testimonial claims shall be considered to be explicit health claims.
- Any name that implies a claim will be considered an explicit health claim.
- Implied health claims ("felt better") shall be considered explicit health claims.
- Lacking approval, the only information that should be permitted in labeling or advertising is the monograph (chemical) name, the dilution, and that fact that the product is homeopathic.
- The FTC should advise consumers not to buy homeopathic products.
- The FTC should give high priority to stopping the false advertising of "electrodermal screening" devices that are used to misdiagnose disease and sell homeopathic products.
Thank you for considering my ideas.
Stephen Barrett, M.D.
This article was posted on September 27. 2015.