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A rare win for science: The FTC issues its enforcement policy on homeopathic remedies [Respectful Insolence]

Wednesday, November 16, 2016 1:57
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(Before It's News)

Whenever I write about homeopathy, I almost always refer to it at least once as “The One Quackery To Rule Them All.” It’s a phrase I’ve used to describe homeopathy for several years now, and for good reason. Of all the quackery out there, with the possible exception of reiki, homeopathy is the one that is most obviously quackery. Its two main “Laws” are so clearly pseudoscience that you’d think it incredibly unlikely that anyone would fall for such nonsense, but fall for it they do.

I’ll briefly show you what I mean. That I can do so this briefly should show those unfamiliar with homeopathy how ridiculous it is. All I have to do is to describe the Two Laws of Homeopathy. The first is the Law of Similars, which states that to relieve a symptom you must use a substance that causes that symptom. Not only does this law make no sense on an intuitive level, but there is no biological or medical basis for it. Of course, the Law of Similars doesn’t really matter, because the second law of homeopathy renders it completely irrelevant. The Second Law, the Law of Infinitesimals, states that diluting a remedy makes it stronger. That’s not nearly enough pseudoscience, though. Because of this law, homeopaths often dilute remedies to, in essence, nonexistence. For example, a typical 30C dilution (where C=100) means thirty 100-fold dilutions, which, if you do the math, you’ll find to be a 10-60 dilution. Avogadro’s number is only on the order of 6 x 1023, which means that a 30C dilution is at least 1036-fold higher than a dilution where we’d expect to see a single molecule of the original substance; that is, if you start with what chemists call a mole of starting compound. No wonder homeopathy is considered the king of pseudoscience, and that’s not even considering that some homeopathic remedies (like Oscillococcinum, the infamous homeopathic flu remedy) use starting ingredients like extract of duck liver and heart—and at 200C (10-400), yet!

That is why I greeted an enforcement policy statement from the FTC regarding regulation of health claims for homeopathic remedies. It’s more or less win for skeptics, but it’s not perfect. Even so, it’s definitely way better than the situation that existed before, because it provides clarity and states clearly that advertising claims for homeopathic remedies will be held to the same standards as advertising claims for any other over-the-counter (OTC) medicine.

By way of background, in January I asked the question: Will 2016 be the year when the FDA and FTC finally crack down on homeopathy?, a question that was asked in the New England Journal of Medicine as well. I based that question on hearings about homeopathy held by both the FDA and the FTC. First, the FDA announced that it was considering modernizing how it regulates homeopathic remedies and held a hearing for public input. Not surprisingly, there were few skeptics and plenty of industry representatives and homeopaths who testified. Ironically, the FTC submitted testimony to the FDA hearing that echoed the testimony of skeptics.

Basically, the FTC recommended that the FDA reconsider the framework that it uses to regulate homeopathic medication because that framework may appear to conflict with the FTC’s advertising substantiation doctrine, which requires that health-related efficacy claims be “supported by competent and reliable evidence,” in ways that could harm consumers and cause confusion for advertisers. The FTC also noted that supplement manufacturers could get around even the lax FDA regulations on dietary supplements by having their product classified as a homeopathic remedy by adding homeopathic remedies to it. Basically, the FTC told the FDA to do its job regulating homeopathy because lax FDA regulation of homeopathic remedies interferes with FTC regulation of advertising claims for them. Part of the problem comes from a quirk in the law authorizing the FDA, an amendment to which was passed in the 1930s that defined any remedy listed in the Homeopathic Pharmacopeia of the United States (HPUS) as a drug. Consequently, any magic pixie dust homeopaths want to call a remedy and put it into the HPUS gets a pass from the FDA, even though, as Jann Bellamy argues, just because the law defines anything in the HPUS as a drug doesn’t mean the FDA can abdicate its responsibility to regulate it. As I’ve pointed out before, one of the charges of the FDA is to require that drugs be safe and effective before they are marketed, and it doesn’t do that for homeopathy, even for homeopathic asthma remedies.

Even though the representatives of the homeopathic remedy industry who testified before the FDA workshop last year made a rather poor showing, relying a lot of special pleading and bad science, nothing much has happened at the FDA in terms of making actual policy changes or changing its regulations on homeopathic medicines in over a year. True, it recently did warn about homeopathic teething products but mainly because such products actually tend to contain actual belladonna in them, sometimes toxic amounts.

The FTC, in essence, has beaten the FDA to the punch, publishing its enforcement policy statement. The complete statement here. The FTC notes first:

The FTC’s authority over disease and other health-related claims comes from Sections 5 and 12 of the FTC Act. Section 5, which applies to both advertising and labeling, prohibits unfair or deceptive acts or practices in or affecting commerce, such as the deceptive advertising or labeling of OTC drugs.3 Section 12 prohibits the dissemination of false advertisements in or affecting commerce of food, drugs, devices, services, or cosmetics. Under these provisions, companies must have a reasonable basis for making objective product claims, including claims that a product can treat specific conditions, before those claims are made.

Homeopathy, which dates back to the late-eighteenth century, is based on the view that disease symptoms can be treated by minute doses of substances that produce similar symptoms when provided in larger doses to healthy people. Many homeopathic products are diluted to such an extent that they no longer contain detectable levels of the initial substance. In general, homeopathic product claims are not based on modern scientific methods and are not accepted by modern medical experts, but homeopathy nevertheless has many adherents.

This is, in a nutshell, the whole basis of the FTC’s decision boils down to the contrast between the FTC’s mission and the lack of science behind homeopathy. A major part of the FTC’s mission is to protect the public against false advertising claims and false marketing. When it comes to OTC medications, in order to do that it has traditionally relied on its advertising substantiation doctrine. However, it notes:

The FTC Act does not exempt homeopathic products from the general requirement that objective product claims be truthful and substantiated. Nevertheless, in the decades since the Commission announced in 1972 that objective product claims must be substantiated the FTC has rarely challenged misleading claims for products that were homeopathic or purportedly homeopathic.

Personally, I wondered why this might be. Why, over 46 years, has the FTC rarely challenged claims for homeopathic remedies that are not infrequently overblown and virtually never based on science. (It is, after all, homeopathy.) Perhaps it wasn’t a priority. Perhaps the FTC used to defer more to the FDA, whose authority overlaps that of the FTC. Remember what skeptics like to call the “Quack Miranda Warning”? That’s a statement that sellers of dubious medical therapies frequently append to their advertising or their claims saying roughly, that the claims have not been evaluated by the FDA and that the product is not intended to treat, diagnose, or prevent any medical disease. The words are supposed to inoculate the company selling such products from legal action by the FDA because, whatever load of nonsense the company has laid down before about its wonder supplement or product, it just denied that it was making any health claims. Let the buyer beware!

As a result, as the FTC notes, consumers are confused by these advertising claim. They do not know what homeopathy is, which is not surprising because my experience with medical students and residents tells me that even they do not know what homeopathy is or about how many homeopathic remedies are diluted to the point where no starting material remains. They also assume that because these products are permitted to be sold in pharmacies. This is a telling passage from the workshop:

Focus group participants in both groups were likely to group or categorize products in a number of ways including conventional versus non-conventional. They tended to group all non- conventional products, including homeopathic products, into a single category, using the terms “natural,” “herbal,” and “homeopathic” interchangeably. Most adults and parents struggled when asked to distinguish between herbal and homeopathic products. They did not understand what “homeopathic” means. Most participants associated homeopathic products with natural or “non-chemical” products.

Many adults and parents did not readily differentiate between different product types in terms of the evidentiary requirements for product claims or regulatory oversight. While they generally believed that manufacturers of conventional non-prescription products were required to support their claims with scientific evidence, they had varying opinions regarding the evidentiary requirements and federal oversight for herbal and homeopathic products. Some participants indicated there were no requirements, others insisted there must be some governmental oversight, and still others were unsure but hopeful that there were requirements.

Whatever the reason for the FTC’s laissez-faire attitude in the past towards claims made for homeopathic remedies, those days appear to be over. In this statement, the FTC clearly states that advertising claims for homeopathic remedies used for self-limited conditions must meet the same standards as advertising claims for other OTC drugs used for self-limited conditions:

The policy statement explains that the FTC will hold efficacy and safety claims for OTC homeopathic drugs to the same standard as other products making similar claims. That is, companies must have competent and reliable scientific evidence for health-related claims, including claims that a product can treat specific conditions.

That’s pretty clear, as is this:

For health, safety, or efficacy claims, the FTC has generally required that advertisers possess “competent and reliable scientific evidence,” defined as “tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons and [that] are generally accepted in the profession to yield accurate and reliable results.”12 In general, for health benefit claims, particularly claims that a product can treat or prevent a disease or its symptoms, the substantiation required has been well-designed human clinical testing

This is not what homeopathic remedies have to support them, of course. The FTC notes that homeopathic remedies are “based solely on traditional homeopathic theories and there are no valid studies using current scientific methods showing the product’s efficacy” and that marketing claims therefore “lack a reasonable basis and are likely misleading in violation of Sections 5 and 12 of the FTC Act.”

There is a caveat, though, a way for the manufacturers of homeopathic remedies not to be considered to be misleading by the FTC. Those manufacturers aren’t going to like it much though. Behold, the one way that the FTC says that claims for a homeopathic remedy won’t be considered misleading, barring strong clinical trial evidence for efficacy and safety (which none of them have):

Accordingly, the promotion of an OTC homeopathic product for an indication that is not substantiated by competent and reliable scientific evidence may not be deceptive if that promotion effectively communicates to consumers that: (1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. To be non-misleading, the product and the claims must also comply with requirements for homeopathic products and traditional homeopathic principles. Of course, adequately substantiated claims for homeopathic products would not require additional explanation.

Ouch. That one’s going to leave a mark. So will these additional observations. Here are the first two:

  • Any disclosure should stand out and be in close proximity to the efficacy message; to be effective, it may actually need to be incorporated into the efficacy message.
  • Marketers should not undercut such qualifications with additional positive statements or consumer endorsements reinforcing a product’s efficacy.

These are, of course, time-dishonored advertising techniques. Basically, the Quack Miranda Warning is an example of this. Supplement manufacturers make claims based on little or no evidence and push the limit of what is permitted (i.e., “structure-function claims” such as “supports the immune system”) and then say in fine print at the bottom of the page or web page that the FDA hasn’t examined these claims.

Then there’s this:

  • In light of the inherent contradiction in asserting that a product is effective and also disclosing that there is no scientific evidence for such an assertion, it is possible that depending on how they are presented many of these disclosures will be insufficient to prevent consumer deception. Marketers are advised to develop extrinsic evidence, such as consumer surveys, to determine the net impressions communicated by their marketing materials.
  • The Commission will carefully scrutinize the net impression of OTC homeopathic advertising or other marketing employing disclosures to ensure that it adequately conveys the extremely limited nature of the health claim being asserted. If, despite a marketer’s disclosures, an ad conveys more substantiation than the marketer has, the marketer will be in violation of the FTC Act.

So, it’s not enough for marketers of homeopathic remedies just to say there’s no evidence that their products work or that they’re based on 18th century ideas and not accepted by science. Marketers will also be expected to show that their positive messages aren’t preventing the disclaimers from etting true, that its customers understand that there’s no scientific evidence to support their assertions.

I was happy to see the FTC statement, because in it the FTC does what should have been done long ago and what the FDA should have done by now. I was not happy to see close to zero news coverage on this, which struck me as distinctly weird. All I could find was a law review article and an article in a website on regulatory affairs. This is in marked contrast to when the FDA and FTC both held their workshops to consider more rigorously regulating homeopathic products, when there were lots of news articles and coverage. It’s almost as though the FTC’s decision was anticlimactic. Or maybe the news coverage was drowned out by the continuing news coverage of the 2016 election. Whatever the reason, people need to know: The FTC will now regulate advertising claims for homeopathic remedies the same way it treats advertising claims for OTC medications.

Now if only the FDA would follow suit and do its job with respect to homeopathic remedies.

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