Two recent actions by the FDA pave the way for what is purportedly more stringent regulation of homeopathic remedies:
- announcement of an interim, and a revised proposed permanent, “risk-based” enforcement policy; and,
- withdrawal of Compliance Policy Guide Sec. 400.400 (“Conditions Under Which Homeopathic Drugs May be Marketed”)
Though an improvement over the FDA’s decades-long benign neglect of the burgeoning homeopathic drug industry, the FDA’s step-upped enforcement still falls far short of doing what Congress authorized the agency to do: Regulate homeopathic remedies just like any other prescription or over-the-counter (OTC) drug. Instead, the FDA will concentrate on homeopathic remedies posing significant safety and quality issues, ignoring their lack of effectiveness and the consequent bamboozlement of the public wrought by a multi-billion-dollar industry and its minions in the healthcare practitioner and retail pharmacy sectors of the snake-oil industrial complex.
(If you are unfamiliar with homeopathy and the pseudoscientific principles upon which it is based, you can find out more here.)
As the FDA itself admits, per the Federal Food, Drug and Cosmetics (FD&C) Act of 1938, the definition of “drug” includes any homeopathic remedy recognized in the Homeopathic Pharmacopeia of the United States (HPUS). Thus, according to the FDA,
homeopathic drugs are subject to the same regulatory requirements as other drugs: nothing in the FD&C Act exempts homeopathic drug products from any of the requirements related to approval, adulteration, or misbranding, including labeling requirements.
Yet, the agency also admits, the “FDA has not reviewed any homeopathic drug products under the OTC Drug Review” nor has it approved any prescription homeopathic drug, meaning “there are currently no homeopathic drug products that are approved by the FDA.” In other words, all OTC and prescription homeopathic remedies on the market today are illegal for lack of FDA approval.
With that in mind, let’s take a look the revised risk-based enforcement plan, including a brief review of the policy it replaces.
For 50 years, despite the passage of the FD&C Act in 1938, the FDA pretty much ignored homeopathic remedies. Thus, any homeopathic remedy recognized by the HPUS could be marketed, not only sans FDA approval, but basically without the FDA’s involvement at all, including post-market regulation. Recognition of a homeopathic remedy by the HPUS was, and still is, totally controlled by the homeopathic industry, in the form of the Homeopathic Pharmacopoeia Convention of the United States [HPCUS],
a private organization answerable to no one, [which] decide[s] what homeopathic drugs are on the market. The HPCUS is rife with conflicts of interest. Decisions on the content of the HPUS are made by either practicing homeopaths, homeopathic pharmacists, or current or former officials or owners of homeopathic products manufacturing companies. It is totally controlled by industry insiders. One can only imagine the outcry if a similar organization of Big Pharma companies were calling the shots in deciding which drugs made it to market.
In 1988, the FDA issued CPG Sec. 400.400, which described the “conditions under which homeopathic drug products may ordinarily be marketed”. The new policy basically continued the FDA’s benign neglect of the illegal homeopathic drug traffic, generally limiting the agency’s enforcement actions to inappropriately labeled products or those manufactured in violation of good manufacturing practice (GMP) regulations.
This left the homeopathic industry with little to fear from the FDA. Indeed, as one federal judge ruled, in 2011, in a case against homeopathic remedy manufacturer Boiron,
As evidenced by the FDA guidance documents . . . the Court concludes that the FDA has largely abdicated any role it might have had in creating standards for homeopathic OTC drugs, and has instead attempted to delegate this authority to the non-governmental organization [the HPCUS] that determines whether homeopathic substances should be included in the HPUS. In addition, the FDA explicitly states that it makes no guarantee about the safety or efficacy of homeopathic OTC drugs even if they meet the unknown standards for inclusion in the HPUS.
The court also remarked that it could find
no record of any [FDA] investigation of homeopathic remedies due to a reported lack of efficacy.
In 2015, the FDA suddenly woke up and realized that, while the agency was looking the other way, the homeopathic remedy market had grown tremendously. It therefore decided to hold a hearing “to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products”. (You can read the comment filed by the Society for Science-Based Medicine here.)
Despite a lot of handwaving about hormesis, special pleading, and cherry-picked evidence presented at the hearing by the homeopathic industry and its acolytes (e.g., naturopaths and “integrative” physicians), the FDA finally decided that, while actual compliance with the FD&C Act was not yet warranted, it would propose a new risk-based enforcement policy and open it for public comment.
Published in 2017, almost three years after the hearing, the draft “Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry” elicited thousands of comments, many deriding the FDA for its “lack of authority” to regulate homeopathic remedies, despite the FDA having carefully explained, right there in the proposed guidance, how it was pulling its punches even though it possessed the legal authority to pull the plug on the entire homeopathic industry for lack of compliance with federal law. Many others claimed that the FDA should not regulate homeopathic remedies at all, because “it worked for me,” in spite of the fact that the FDA didn’t even hint that it would heretofore require a demonstration of effectiveness for homeopathic remedies to remain on the market, despite (once again) the clear language of the FD&C Act.
While the proposed guidance marinated in this public outrage, the FDA decided that the industry-friendly CPG Sec. 400.400 would remain in place.
Then, last month, the FDA issued “Revision 1” to the 2017 draft guidance. The new draft guidance does not amend the substance of the old draft guidance. Instead, for some reason, the FDA decided it needed to beef up the rationale for its proposed risk-based approach. This means a new round of public comment has been opened, ending January 23, 2020, which will undoubtedly lead to further railing against the FDA and its “lack of authority” and so on.*
The 2019 version simply repeats the FDA’s intent to “prioritize enforcement and regulatory actions” for products falling within the following categories:
- Products with reports of injury that, after evaluation, raise potential safety concerns (e.g., MedWatch reports).
- Products that contain or purport to contain ingredients associated with potentially significant safety concerns, such as infectious agents (like rabid dog saliva), controlled substances, and ingredients that pose a risk of toxic effects, particularly when manufactured in low dilutions (e.g., 1X, 2X, or 1C).
- Products for routes of administration other than oral and topical, like injectables and ophthalmic remedies (like eye drops).
- Products intended to be used for the prevention of serious and/or life-threatening diseases or conditions, in part because they may cause users to delay or discontinue proven medical treatments. (There’s plenty to work with on this front: Homeopathic remedies for autism, the flu, adjunctive breast cancer therapy, and vaccine-preventable diseases, for starters.)
- Products for vulnerable populations, like infants, children, pregnant women and the elderly.
- Products with significant quality issues (e.g., contamination with bacteria) such as those made in facilities with significant deviations from current good manufacturing practices.
In addition to adding a definition of “homeopathic drug product” to the 2019 version of the draft guidance, the FDA further explained why it found this new approach to regulation necessary: Since it issued CPG Sec. 400.400, there have been multiple situations in which homeopathic drug products posed a significant risk to patients even though the product was in compliance with CPG Sec. 400.400. For example, the FDA identified 99 cases of adverse events “consistent with belladonna toxicity” and possibly related to homeopathic teething products, including infant deaths and seizures. Poisonous belladonna alkaloids in some products far exceeded the amounts stated on the label. The FDA also received more than 130 reports of loss of the sense of smell associated with the use of Zicam homeopathic remedies containing zinc. These are only two examples among many, according to the FDA. Others include “many serious violations of Current Good Manufacturing Practice requirements”.
As it did in the 2017 version, the FDA justifies its actions by saying that it employs this risk-based approach to regulation “in many instances”. Yet, as the FDA itself notes, in cases involving other types of unapproved new drugs, using this risk-based approach prioritizes actions based not only on potential safety risks, but also on lack of evidence of effectiveness and potential health fraud, circumstances certainly present with homeopathic remedies but curiously ignored by the agency in this instance. And, in those other cases of unapproved drugs, the FDA is not effectively exempting an entire category of drugs with perhaps thousands of products used by millions of Americans, a multi-billion dollar market, from the FD&C Act.
In a separate decision, also issued in October, the FDA announced the withdrawal of CPG Sec. 400.400, meaning it is no longer in effect. So, how will the FDA regulate homeopathic remedies in the interim between withdrawal of CPG Sec. 400.400 and the finalization of its 2019 draft guidance, an interim presumably of several years duration considering the glacial pace of agency action?
FDA intends to apply its general approach to prioritizing regulatory and enforcement action, which involves risk-based prioritization in light of all the facts of a given circumstance. Risk-based enforcement best reflects FDA’s public health priorities.
To me, this sounds like the agency will simply employ the risk-based approach announced in the draft guidance until the draft guidance becomes final.
Although the FDA maintains that “any homeopathic drug product that is being marketed illegally is subject to FDA enforcement action at any time,” it also says that “many homeopathic drug products will fall outside” its new risk-based enforcement policy, meaning that the majority of these admittedly illegal drugs will remain on the market with little fear that the FDA will enforce the law. In other words, as it ever was, the homeopathic industry will, for the most part, regulate itself.
*Per the Federal Register, the comments on Revision 1 to “Drug Products Labeled as Homeopathic: Draft Guidance for Food and Drug Administration Staff and Industry” (posted Oct. 25, 2019) are due on Jan. 23, 2020. But, for some reason, the FDA’s announcement of Revision 1 gives the comment due date as Dec. 24, 2019.