FDA Homeopathic Product 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 March 2015, the agency announced that it would hold a hearing on April 20 and 21 to discuss homeopathic regulation. Details of the proceeding were published in the Federal Register. Since I was unable to attend the hearing, I submitted this comment through the FDA's docket portal.
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852.
Re: Docket No. FDA-2015-N-0540,
Homeopathic Product Regulation
Homeopathic "remedies" 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.
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 survival of these products in the United States is the result 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.
The HPUS monographs contain no information about how the products should be used. Their intended uses are determined by manufacturers and prescribers. These determinations are based on "provings," most of which 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 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 scientific community has established procedures 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 is 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 as required to approve new drugs. In fact, the vast majority of substances listed in the Homeopathic Pharmacopeia have never been tested.
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's Overview Report: Effectiveness of Homeopathy for Clinical Conditions: Evaluation of the Evidence (October 2013)]
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: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.
The above-mentioned Clarke's Dictionary of Practical Materia Medica," published in 1900, 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 drug label 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.
In the mid-1980s, when I won an FDA Commissioner's Special Citation Award for Public Service for fighting quackery, I learned that the FDA's drug enforcement policies were shaped primarily by the agency's Associate Commissioner for Enforcement, Joseph P. Hile. In 1986, I had the pleasure of asking Hile in person why the agency did not hold homeopathic products to the same standards as other drugs. He replied that if he ordered that, Congress would probably rescue the industry. He may have been correct, but there is no reason why the FDA could not issue a public warning that the products don't work.
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 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.
#1. What are consumer and health care provider attitudes towards human drug and biological products labeled as homeopathic?
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 farfetched, 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.
The prevailing view of the scientific community is unfavorable. Knowledgeable health care providers recognize the nonsensical nature of homeopathy, but many know little and don't realize how vulnerable consumers are to deceptive marketing.
#2. What data sources can be identified or shared with FDA so that the Agency can better assess the risks and benefits of drug and biological products labeled as homeopathic?
Because homeopathic products don't work, they provide risk without benefit. Clarke's Dictionary of Practical Materia Medica illustrates the wildness of homeopathic claims and the need for greater regulation. The Australian Government's report and its underlying technical report provide sufficient information that the FDA needs to look no further.
#3. Are the current enforcement policies under the CPG appropriate to protect and promote public health in light of the tremendous growth in the homeopathic drug market? Are there alternatives to the current enforcement policies of the CPG that would inform FDA's regulatory oversight of drugs labeled as homeopathic? If so, please explain.
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. 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.
#4. Are there areas of the current CPG that could benefit from additional clarity? If so, please explain.
You could add a statement that the products don't work but the FDA permits their marketing because it does not want to fight with homeopathic community. That would clarify the true significance of CPG 7132.15.
#5. A large majority of human drug products labeled as homeopathic are marketed as OTC drugs. These products are available for a wide variety of indications, and many of these indications have never been considered for OTC use under a formal regulatory process. What would be an appropriate regulatory process for evaluating such indications for OTC use?
There is no reason to consider indications that are based on homeopathic provings. At the present time, there is nothing else to review.
#6. Given the wide range of indications on drug products labeled as homeopathic and available OTC, what processes do companies currently use to evaluate whether such products, including their indications for use, are appropriate for marketing as an OTC drug?
Homeopathic manufacturers base their claims on (a) what they think will appeal to consumers and (b) what they think they can get away with.
#7. Do consumers and health care providers have adequate information to make informed decisions about drug products labeled as homeopathic? If not, what information, including, for example, information in labeling, would allow consumers and health care providers to be better informed about products labeled as homeopathic?
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 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.
In 1999, The Medical Letter on Drugs and Therapeutics, which is the medical profession's most trusted drug advisory newsletter, summed up what health professionals should be should be telling patients:
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.
This message remains timely and would be appropriate for consumers too.
The bottom line is that homeopathy is senseless and its survival in today's marketplace is the result of political maneuvering rather than scientific validity.
- CPG 7132.15 should be scrapped.
- The distinction between OTC and prescription homeopathics should be abandoned because it serves no 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.
- No health claims should be permitted for homeopathic products unless they are approved through the FDA's standard drug approval process.
- Products that combine a homeopathic ingredient with any other ingredient (homeopathic or not) should be considered new drugs that require premarket approval.
- 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 FDA should advise consumers not to buy homeopathic products.
- The FDA should give high priority to ridding the marketplace of "electrodermal screening" devices that are used to misdiagnose disease and sell products.
Thank you for considering my ideas,
Stephen Barrett, M.D
This article was posted on April 17. 2015.