FDA Proposed Updated Regulation of Homeopathy- Time to Comment Again!

The wheels of government turn slowly, but they turn. Over the last several years, we’ve seen a number of governments around the world catch up to the science that shows homeopathy is worthless quackery. In Europe, the UK, and Australia, both human and veterinary medical organizations have been acknowledging this simple fact and taken steps to discourage people from being fooled into using this pointless treatment. Even here in the US, where regulation in general is widely resisted and there is robust anti-science sentiment in many quarters, the Federal Trade Commission (FTC) has acknowledge that homeopathy is nothing more than a placebo and should not be marketed as effective medicine. Such consistent, broad-based progress gives me reason for hope that science and reason can still have a positive impact on people’s beliefs and actions.

One critical agency that has chosen to re-examine how it regulates homeopathy is the Food and Drug Administration (FDA). Under the standards the FDA uses to determine whether medicines can be sold as safe and effective, homeopathy could never be allowed. Unfortunately, a politician who was a homeopath snuck the practice into the original law establishing the FDA in 1938. The last time the FDA reviewed its non-regulation of homeopathy, in 1988, it chose to continue the practice to be used regardless of the evidence it is ineffective.

In March, 2015, I wrote about a public comment process the FDA had initiated in order to review its regulation of homeopathy. More than two years later, the FDA has issued a draft guidance updating that issued in 1988. This document does not establish legal mandates regarding homeopathy, but indicates the general posture of the agency towards the subject and hints at what kinds of actions the FDA might be willing to take in the future.

What I recommended in my comments to the agency in 2015 was the following:

1. Draft and submit to Congress a report identifying homeopathy as ineffective and recommending changes in the agency’s authorizing legislation to prohibit the marketing and use of homeopathy without fulfillment of the same new drug licensing requirements applied conventional drugs.
2. Produce educational materials for healthcare providers and patients in both human and animal health fields identifying the ineffective nature of homeopathy for the treatment or prevention of human and animal disease.
3. Require all OTC homeopathic products to carry a label similar to that required for dietary supplements under DSHEA, “This/these statement(s) have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
4. Vigorously enforce regulations in both human and animal health fields prohibiting treatment and prevention claims for homeopathic remedies without fulfillment of the requirements of a NDA.

Not surprisingly, the draft guidance doesn’t go nearly as far as I would have liked. Still, it is an improvement on the existing policy, and it might help reduce the harm done by homeopathy if it is actually carried out.

The agency begins by asserting that it has authority to regulate homeopathic products and that it could, if it chose, prohibit the marketing of any without completion of a new drug application requiring the same standards of proof for safety and efficacy as required for real medicine:

…all drug products labeled as homeopathic are subject to the premarket approval requirements in section 505 of the FD&C Act or section 351 of the PHS Act. There are no drug products labeled as homeopathic that are approved by FDA.

The FDA further acknowledges that the failure of homeopathic remedies to be held to this standard means they cannot be considered safe and effective and that this presents a potential hazard to public health:

Drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. The continued marketing of products that have neither been approved by FDA nor found to be 82 GRAS/E is a public health concern.

While the FDA does not yet intend to require this standard of evidence, this guidance makes it clear that it could and that no homeopathic remedy has ever met this standard. Instead, the FDA indicates that it considers some homeopathic practices more dangerous than others and intends to focus on discouraging those most likely to cause harm:

The Agency generally intends to apply a risk-based enforcement approach to the manufacturing, distribution, and marketing of drug products labeled as homeopathic…FDA intends to prioritize enforcement and regulatory actions involving drug products labeled as homeopathic and marketed without the required FDA approval in the following categories:

• Products with reported safety concerns. For example, MedWatch reports or other information submitted to the Agency can indicate or signal a potential association between the product and an adverse event, medication errors, or other safety issues.
• Products that contain or purport to contain ingredients associated with potentially significant safety concerns. For example, potentially significant safety concerns are raised by products that contain or purport to contain:
• An infectious agent with the potential to be pathogenic
• A controlled substance, as defined in the Controlled Substances Act, 21 U.S.C. 147 812; 148
• Multiple ingredients that, when used in combination, raise safety concerns due to possible interactions, synergistic effects, or additive effects of the various ingredients
• Ingredients that pose potential toxic effects, particularly when those ingredients are concentrated or in low dilution presentations (e.g., 1X, 2X, or 1C), or are not adequately controlled in the manufacturing process.
• Products for routes of administration other than oral and topical. For example, unapproved injectable drug products and unapproved ophthalmic drug products pose a greater risk of harm to users due to their routes of administration (e.g., bypassing some of the body’s natural defenses, differences in absorption) and the potential risk of harm from contamination.
• Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions. Unapproved products for serious and/or life-threatening diseases and conditions raise public health concerns, in part, because they may cause users to delay or discontinue medical treatments that have been found safe and effective through the NDA or BLA approval processes.
• Products for vulnerable populations. For example, patient populations such as immunocompromised individuals, infants and children, the elderly, and pregnant women may be at greater risk for adverse reactions associated with a drug product, even if it contains only small amounts of an ingredient, due to their varying ability to absorb, metabolize, distribute, or excrete the product or its metabolites. These populations may also be at greater risk of harm as a result of foregoing the use of medical treatments that have been found safe and effective through the NDA or BLA approval processes or under the OTC Drug Review.

 

What all this means is that the FDA recognizes the main causes of harm from homeopathy: direct harm from remedies made improperly or containing dangerous ingredients and indirect harm from delayed diagnosis and effective treatment. The agency is not interested in banning over-the-counter sugar pills used to treat mild, self-limiting problems, but it is willing to intervene when homeopaths make remedies that are actively harmful or when they try to sell them to people who are really sick and need real medical care. It remains to be seen how willing the agency is to enforce such standards if they are adopted.

The next step is for the public to weigh in on this guidance. As usual, the highly motivated proponents of homeopathy are likely to be dis-proportionally represented in such public input. However, the very existence of this draft guidelines suggests that substantive, evidence-based input did have an influence on the FDA during the previous comment period, so we should all continue to participate in this process.

Eventually, comments will be accepted online at https://www.regulations.gov/. I will update this post when the comment page is available.

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