Will 2018 be the year that the FDA finally regulates homeopathic remedies as drugs?

Regular readers might have wondered why I haven’t posted in a few days. The reason is simple and the same as it usually is whenever I disappear for a while: Grant deadlines. But the grant has been submitted, and I’m finally free to get back to my little hobby. As I approached this post, I noted that there were several things that happened during or near my time away. One thing that happened demands some coverage because it allows me to update a story that I actually participated in a couple of years ago. Granted, it was a small role, assisting in writing statements to the FDA, but it’s always intersting to see what ultimately happened.

Nearly two years ago now, I asked the question, “Will 2016 be the year when the FDA and FTC finally crack down on homeopathy?” The reason was that earlier that year, in the wake of the stinging rebuke of the pseudoscience of homeopathy in the UK by the Science and Technology Select Committee in a report called Evidence Check 2: Homeopathy, our FDA started making noises about regulating the magic that is homeopathy. Throughout the year, there was frequently false balance in reporting on the issue, but ultimately the FTC also joined the fray, submitting a comment to the FDAduring its public evaluation period, recommending that the FDA reconsider its lax regulation of homeopathic products. As was noted at the time, it’s highly unusual for one government agency to recommend that another government agency reconsider its regulatory framework. A year later, in November 2016, the FTC issued a statement that it would be holding efficacy and safety claims for homeopathic drugs to the same standards that it does for other products making similar claims. Not surprisingly, the response of homeopaths to the statement was epic in its scientific ignorance.

So, as I disappeared into my grant-induced cocoon of web hibernation, to be roused only briefly for brief bursts of frustration-reducing rants on Twitter and to repurpose posts published on my not-so-secret other blog rather than writing fresh material, it had been over a year since the FTC action and response of homeopaths, and the FDA still hadn’t decided on a policy for regulating homeopathy. Then, on Monday, the FDA proposed a “new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs.” As you will see, it’s a good start but doesn’t go nearly far enough.

Of course, whenever I write about homeopathy, I feel obligated to include a brief explanation of why homeopathy is such ridiculous, vitalistic pseudoscience. I know my regular readers know why, but, as happened with my post on Charlie Goldsmith a month ago, sometimes I get an influx of newbies. In any case, there’s a reason why I nearly always refer to homeopathy as The One Quackery To Rule Them All, and that’s because it’s a near-perfect quackery. It’s generally water. Of course, these days, I sometimes view reiki as a worthy competitor for the title, but in general homeopathy still reigns supreme.

Here are the basics. Homeopathy was invented in the late 18th century by Samuel Hahnemann, based on two laws, neither of which are in any way scientific. The first law is the Law of Similars, and states that “like cures like”; i.e., to relieve a symptom you use a substance or compound that causes those symptoms. We now know this to be a ridiculous law, with no scientific reason to think that it would be true as a general principle of medicine. The second law is the Law of Infinitesimals, which posits that, to make a homeopathic remedy more potent, you dilute the remedy. This takes the form of serial dilutions of 10- or 100-fold, each with vigorous shaking (“succussion”) to “potentize” the remedy. These dilutions often reach ridiculous extremes, to the point where there isn’t likely to be a single molecule of original substance left. For instance, a 1C dilution is a 100-fold dilution. Frequently, remedies are 30C, which is thirty 100-fold (10²) serial dilutions, or (10²)³⁰ = a 10⁶⁰-fold dilution. This is so far beyond a point where there’s likely to be anything left that, for all intents and purposes, there is nothing left. For example, one mole of a substance equals roughly 6 x 10²³ molecules, and one mole will have a mass in grams equal to the molecular weight of the molecule, which can range from a few to hundreds of grams, depending on how big the molecule is. That’s more than 10³⁷-fold more dilutions than are particles in a mole, and rarely is the starting material even a mole’s worth. It’s utter pseudoscience, and I haven’t even gotten into the utter ridiculousness of homeopathic provings, the method by which homeopaths claim to determine which remedies are good for which conditions.

As I’ve said many times before, homeopathy is sympathetic magic, and homeopathic remedies are magic potions. Yes, I know that most homeopathy is sold in the form of pills, but that just involves taking the water or ethanol that remains after the whole dilution-succussion-dilution process and adding it to sugar or other fillers to press into pills.

The other thing you have to know about homeopathy is why the FDA has for so long taken a hands-off approach to something that is unabashedly magical nonsense. It’s a issue baked right into the heart of the Food, Drug, and Cosmetic Act of 1938. Basically, the inclusion of homeopathic remedies as accepted drugs in this legislation was due to the efforts of a single Senator. This Senator, Royal Copeland, was one of the principal authors of the FDCA and was a physician trained in homeopathy. Basically, the FDCA identifies substances acceptable for sale as homeopathic medicines as those listed in the United States Pharmacopeia-National Formulary (USP-NF) and the Homeopathic Pharmacopeia of the United States (HPUS). The HPUS was first published by the American Institute of Homeopathy, a professional body for homeopaths, in 1897. It’s now published and maintained by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS), an independent organization of homeopathic “experts.”

Now, the FDA appears to have decided that homeopathic products should be regulated. The reason is simple:

Until relatively recently, homeopathy was a small market for specialized products. Over the last decade, the homeopathic drug market has grown exponentially, resulting in a nearly $3 billion industry that exposes more patients to potential risks associated with the proliferation of unproven, untested products and unsubstantiated health claims. During this time, the FDA has seen a corresponding increase in safety concerns, including serious adverse events, associated with drug products labeled as homeopathic. In addition, the agency has also found an increasing number of poorly manufactured products that contain potentially dangerous amounts of active ingredients that can create additional risks.

So these days, homeopathic remedies are big business. Also, most people don’t know the true ridiculousness of homeopathy. They think homeopathy is nothing more than herbal or natural remedies. You might be asking, though: If homeopathy is just water, what’s the harm? Besides fraudulently claiming or implying that magic water and magic pills might have therapeutic effects, unfortunately homeopathic remedies as manufactured today are not always just water:

In September 2016, the FDA warned against the use of homeopathic teething tablets and gels containing belladonna, a toxic substance that has an unpredictable response in children under two years of age, after the products were associated with serious adverse events, including seizures and deaths, in infants and children. An FDA lab analysis later confirmed that certain homeopathic teething tablets contained elevated and inconsistent levels of belladonna. A similar issue occurred in 2010 when Hyland’s Teething Tablets were found to contain varying amounts of belladonna. An FDA inspection of that product’s manufacturing facility indicated substandard control of the product’s manufacturing.

The FDA has issued warnings related to a number of other homeopathic drug products over the past several years. These include certain homeopathic zinc-containing intranasal products that may cause a loss of sense of smell, homeopathic asthma products that have not been shown to be effective in treating asthma and various homeopathic drug products labeled to contain potentially toxic ingredients, like nux vomica, which contains strychnine (a highly toxic, well-studied poison often used to kill rodents).

Yes, sometimes there are actual drugs in products labeled as “homeopathic.”

So what does the FDA plan to do? It is proposing a “risk-based” approach:

• products with reported safety concerns;
• products that contain or claim to contain ingredients associated with potentially significant safety concerns;
• products for routes of administration other than oral and topical;
• products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions;
• products for vulnerable populations; and
• products that do not meet standards of quality, strength or purity as required under the law.

As I said at the beginning, I don’t think these proposed changes go far enough, but I can understand the political decision to prioritize the biggest threats to the public. I can also understand it from a consideration of available resources, given that the FDA is chronically underfunded and understaffed to carry out its mandate as vigorously as it should.

If you look at the full text of the proposed new guidelines document, you’ll see that basically the FDA now considers homeopathic products drugs. It has traditionally deferred to the the HPUS, but no longer. Noting that a drug, including a homeopathic drug, is considered a “new drug” if it is not “generally recognized as safe and 63 effective (GRAS/E) by qualified experts for use under the conditions prescribed, recommended, 64 or suggested in the labeling (section 201(p) of the FD&C Act) (21 U.S.C. 321(p))” and that that the FDA “makes 65 GRAS/E determinations for OTC drugs marketed under the OTC Drug Review,” the FDA observes that it has “has 66 not reviewed any drug products labeled as homeopathic under the OTC Drug Review, because 67 the Agency categorized these products as a separate category and deferred consideration of them. 68 (37 FR 9464, 9466 (May 11, 1972)).” The FDA has, however, determined a rationale that it believes to allow it to change this, noting that “absent a determination that a drug product labeled as homeopathic is not a 74 “new drug” under section 201(p), all drug products labeled as homeopathic are subject to the 75 premarket approval requirements in section 505 of the FD&C Act or section 351 of the PHS Act.”

Not surprisingly, there are no drug products that are homeopathic that are FDA-approved, nor have any been determined to be GRAS/E.

Of course, where the rubber hits the road, so to speak, is how the FDA will act on these new regulatory guidelines. Actually, given that these are draft guidelines, the FDA has to adopt the new guidelines. Indeed, there is a 90 public comment period beginning the date the proposed regulations were anounced (December 18). What should happen is that the FDA should start taking these items off the market, starting with the most potentially harmful and working their way down to the merely ineffective.

I’ve pointed out that the new FDA Commissioner Scott Gottlieb is basically a pharma shill in favor of less regulation; so it is a hopeful sign that he has decided to let the regulatory process begun under his predecessor reach its fruition:

“In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren’t adequately tested or disclosed to patients,” said FDA Commissioner Scott Gottlieb, M.D. “Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm.”

Ugh. The weasel words just had to be there, “We respect that some individuals want to use alternative treatments.” However, the rest is good.

Of course, the response of homeopaths to the proposed regulations is, as usual, comedy gold. The National Center for Homeopathy Board of Directors issued a statement:

The National Center for Homeopathy supports the FDA’s efforts to ensure safety and good manufacturing practices in the industry. We are committed to working with industry partners to protect consumer access to homeopathic medicines, and we are hopeful that this action will not impede access. Homeopathic medicines are safe, gentle and effective when products are manufactured in accordance with HPUS (Homoeopathic Pharmacopoeia of the United States) guidelines under CGMPs (Current Good Manufacturing Practices). We welcome the opportunity to educate consumers and healthcare professionals about the unique aspects of homeopathic medicine.

“We are hopeful that this action will not impede access” to homeopathic medicines? I am hopeful that this action will very much impede access to homeopathic medicines. I also can’t wait for homeopaths to “educate consumers and healthcare professionals about the unique aspects of homeopathic medicine” in response to this draft guidance. I foresee blogging material aplenty.

In the meantime, we can’t rest. You know that the homeopathy industry is going to be burying the FDA with comments about these guidelines. We need to do the same thing.