CAM and the Law Part 4: Regulation of Supplements and Homeopathic Remedies

Another major set of legal standards that apply to alternative medicine are the laws and regulations that govern the manufacturing and availability of homeopathic and herbal remedies and dietary supplements. Although there is less ambiguity in these standards than in some of the areas I’ve covered previously, there are certainly loopholes aplenty available to avoid the need for any truly scientific standards of evaluating safety and efficacy. This is perhaps the area in which the triumph of politics over science is most vivid.

Regulation of Homeopathic Remedies

The Food and Drug Administration was constituted as the agency responsible for regulating medicines and most foods by the Food, Drug, and Cosmetic Act (FDCA) of 1938. The FDCA has been updated and amended in various ways since then, but it is still the primary law governing the regulation of prescription and non-prescription substances used to treat illness. The law identifies substances acceptable for sale as medicines as those listed in its official compendia, the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was a list of homeopathic remedies first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897 and now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.” The inclusion of homeopathic remedies as accepted drugs in the original legislation was primarily due to the efforts of Senator Royal Copeland, a physician trained in homeopathy and one of the principle authors of the FDCA.¹

Most homeopathic remedies are available as over-the-counter products, though at least theoretically some homeopathic drugs do require a prescription. The distinction between ordinary drugs that can be sold over-the-counter and those available only by prescription is made by the FDA based on the history of use of the particular ingredients, the nature of the complaint for which they are used and, in the case of new OTC drugs, the scientific evidence concerning safety and efficacy. However, with respect to homeopathic products, the distinction seems to depend solely on the intended use of the remedy. If a complaint is expected to be easily recognized by a lay person and self-limiting or not life-threatening, then a homeopathic remedy for such a complaint can be sold without a prescription. However, remedies intended for use in conditions that are serious, not self-limiting, and not easily diagnosed by laypeople require a prescription. 

The HPCUS has promulgated detailed guidelines for approving new homeopathic drugs. According to one review:

The clinical benefits of the new drug must be established in one of the following ways: through clinical verification acceptable to HPCUS, after which there is a period of clinical verification; through published documentation that the substance was in use prior to 1962; through use established by at least two adequately controlled double-blind clinical studies using the drug as the single intervention; or through use established by data gathered from clinical experience encompassing the symptom picture before and after treatment, including subjective and any available objective symptoms.[citation omitted]

The criterion of clinical use prior to 1962 was used to grandfather many drugs during the 1970s and 1980s into acceptance. This criterion is now rarely, if ever, used, and HPCUS is rereviewing [sic] many monographs accepted under this approach. HPCUS reports that the criterion of clinical experience has never been used. Consequently, only the criteria of homeopathic drug “proving” and establishment by two adequate clinical studies are currently in actual use [citation omitted].¹

This sounds very impressive and scientific if we ignore the fact that the vast majority of the “drugs” we are talking about are identical and contain nothing but water. It is a testament to the power of cognitive dissonance and faith that a complex set of laws and regulations as well as scores of dedicated professionals in government and the private sector are devoted to regulating the use of over 1200 differently labeled preparations of water. It is also a reminder that scientific facts are not as persuasive in the legal and political arenas as we might hope.

The FDA guidelines for marketing of homeopathic drugs specifies the labeling and manufacturing requirements for homeopathic remedies, but it is most interesting for the inclusion of a definition of Health Fraud:

The deceptive promotion, advertisement, distribution or sale of articles, intended for human or animal use, that are represented as being effective to diagnose, prevent, cure, treat, or mitigate disease (or other conditions), or provide a beneficial effect on health, but which have not been scientifically proven safe and effective for such purposes. Such practices may be deliberate, or done without adequate knowledge or understanding of the article.

The inclusion of this definition without any apparent acknowledgement of its clear application to the practice of homeopathy being regulated by the document is as fine an example of the disconnect between scientific and legal reasoning.

Regulation of Herbal Remedies and Other “Therapeutic” Dietary Supplements

Much has previously been written here at Science-Based Medicine on the subject of the Dietary Supplement and Health Education Act of 1994 (DSHEA) (e.g. 1, 2, 3, 4), and I don’t have a great deal to add. In brief, the supplement industry and sympathetic lawmakers created this law to pretend to regulate herbal remedies and other dietary supplements while effectively stripping the FDA of the ability to control the sale of these products for the  prevention or treatment of disease. This was accomplished by classifying all such products as foods and codifying the principle that they must be assumed to be safe unless the government can generate substantial evidence to the contrary. There are some restrictions on the medical claims manufacturers can make on the labels of these remedies, but they are routinely ignored and the resources and will behind enforcement of them are manifestly inadequate.

It is instructive to look at some of the judicial opinions that have been rendered in cases where the FDA did attempt to restrict the use of supplements that had clear potential to be harmful or to challenge unsupported label claims. When the FDA banned the sale of the supplement Ephedra in 2004, for example, due to strong evidence of adverse effects and deaths due to use of the supplement, the company sued and the district court ruled in the manufacturer’s favor. The argument made by the company, and accepted by the district court, was that “by injecting a risk-benefit analysis, the FDA required [the manufacturer] to make a showing of the benefits of its product.” This would be inappropriate because in passing DSHEA “Congress expressly placed the burden of proof on the government to determine whether a dietary supplement” is unsafe.² 

The Tenth Circuit court agreed with the interpretation that the law requires no burden of proof be placed on supplement manufacturers to demonstrate the safety or efficacy of their products. However,  it upheld the FDA ban on the basis that because the agency gathered all the data and conducted the analysis at its own expense and without requiring the company to prove any benefit to justify the risks identified, no inappropriate burden was placed on the manufacturer.² At the risk of injuring myself, I have tried to imagine the public reaction to such a one-sided, industry-friendly regulatory system applied to the pharmaceutical companies, but the image of the resulting rhetorical conflagration is simply too horrible to contemplate.

In another case, a supplement manufacturer was denied permission to market their products with certain health claims on the label, due to a lack of sufficient scientific evidence to support the claims. The company sued the FDA, and the court of appeals found that denying the claims violated the company’s First Amendment commercial speech rights because the alternative of allowing the unproven claims accompanied by a disclaimer was not offered. The court did not challenge, or even address, the quality of the evidence for or against the specific claims. It simply ruled that not allowing them to be made, with appropriate disclaimers indicating the weakness of the evidence or the lack of FDA approval, was unduly restrictive of the company’s speech rights and represented a “simplistic view of human nature or market behavior” that did not give adequate credit to the ability of consumers to judge the merit of such claims for themselves.³

These cases illustrate, yet again, the priorities and concerns of justices and lawmakers with regard to the use of alternative medicine, which are often quite different from those of scientists and healthcare providers.

Where Do We Go From Here?

This series has been a relatively superficial survey of a complex subject, but hopefully I have been able to illustrate a few key issues. First, the scientific facts of claims made about alternative therapies, and the importance of using appropriate and effective epistemological methods to establish those facts, must be the foundation of a rational public policy concerning these therapies. Whether an intervention helps or harms or both is vital to the process of determining how government should approach regulating that intervention. However, the lawmakers and justices who shape public policy towards medicine are seldom themselves experts in scientific methods and the information they generate. To effectively argue the case for science-based medicine, we must understand the way the processes and data of science appear to smart, educated non-scientists, and we must be effective in communicating about science to such people. 

While I don’t want to wade too far into the debates surrounding science communication, I would recommend looking at the work of Michael Nisbet, Randy Olson, and Chris Mooney, all somewhat controversial figures who make a variety of interesting arguments about the most effective ways to communicate about science to the general public. If nothing else, these arguments are good for stimulating a healthy debate about how to promote science and science-based medicine in a culture not as friendly to science as it once was.

In addition to not necessarily understanding the nuances of scientific evidence, policy makers also have other agendas and sometimes have to serve their constituencies even when that means promoting policies based on unscientific or even irrational foundations. There are legitimate philosophical questions about the rights of the individual versus the power of the government, the most effective way to organize and run healthcare delivery systems, and other issues that are not primarily scientific but which influence law and policy concerning science and medicine. In promoting  science-based and rational policies, we must take these other issues into account. And the plain political reality remains that if enough people, or people with enough influence, support an idea, it is unlikely to be effectively combated through law and regulation even if it is inherently unscientific and not in the best interest of the public health. Such ideas are better addressed through education and lobbying to alter public opinion rather than through legal or regulatory avenues.

I’ve tried in these posts to provide a rudimentary familiarity with the basics of how the laws that govern medicine in this country relate to the practices of alternative medicine. Hopefully, this will be useful in informing our efforts to advocate for science-based medicine and further marginalize unsafe and ineffective medical approaches.

References

1. Borneman JP, Field RI. Regulation of homeopathic drug products. Amerian Journal of Health-System Pharmacy 2006;63:p. 86-91. Return to text.
2. Nutraceutical Corporation v Von Eschenbach, Tenth Circuit Court of Appeals, 459 F.3d 1033 (2006). Cited in: Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 208-10. Return to text.
3. Pearson v. Donna Shalala, Secretary, United States Department of Health and Human Services United States Court of Appeals for the District of Columbia 164 F.3d 650 (1999). Cited in: Jesson LE, Tovino SA. Complementary and alternative medicine and the law. Durham (NC), USA: Carolina Academic Press, 2010. p. 214-17. Return to text.