Aug 27 2015

FTC Responds to FDA on Homeopathy

The FDA (Food and Drug Administration) recently asked for public comment on its regulatory policies regarding homeopathy. They probably didn’t figure that a fellow federal agency, the FTC (Federal Trade Commission) would respond.

The FTC also recently asked for public comment on how it can better regulate homeopathic product advertising. While the FDA regulates food and drugs (including supplements), the FTC regulates claims that sellers can make about those foods and drugs. The FTC is now complaining to the FDA that their policies are in inherent conflict. They write:

The staff comment notes that the FDA’s regulatory framework for homeopathic drugs, set forth in a 1988 Compliance Policy Guide, does not require that over-the-counter (OTC) homeopathic drugs be approved by FDA as safe and effective if they satisfy certain conditions, including that the product’s label contains an indication for use. Yet the policy guide does not require sellers to have competent and reliable scientific evidence to support the indication for use.

The comment states that given the FTC’s long-standing advertising substantiation policy that health claims must be substantiated by such evidence the FDA’s current regulatory framework may harm consumers and confuse advertisers.

The FTC requires scientific evidence to support health claims for products, while the FDA does not require scientific evidence to support health claims made for homeopathic products.

The FTC cites complaints they have received by consumers who were under the false impression that “homeopathic” simply meant “natural” or that the product was an herbal supplement. Those consumers were surprised to find that homeopathic products are complete frauds that are literally nothing but sugar pills.

For anyone not aware, homeopathy is a 200 year old system of medicine that predates scientific understanding of things like biology, health, and disease. It is founded on two main principles. The first is “like cures like” – which is a belief in essence or sympathetic magic and not based on any scientific principles. The notion is that a substance that causes a symptom will cure that symptom in extremely low (even non-existent) doses.

The second homeopathic principle is that dilution potentiates a remedy and makes it stronger.  Many homeopathic preparations are diluted to such a degree that no original substance is left behind. Homeopaths claims that the substance leaves behind its magical “essence.” Some modern homeopaths have tried to rescue this idea by claiming that the water “remembers” the signature of the substance, but this is implausible pseudoscience without scientific support.

Unsurprisingly, homeopaths have been unable to demonstrate, given 200 years, that any homeopathic preparation is effective in treating any indication. Systematic reviews of modern scientific studies of homeopathy show it is indistinguishable from placebo.

Why, then, does the FDA allow it to be marketed as a medicine at all? That’s a good question. Homeopathy might be considered a “legacy” product, written into FDA regulations by senator Royal Copeland, who was a homeopath.

Interestingly, the law only indicates that the FDA must regulate homeopathic products as if they were drugs. Jann Bellamy, our legal expert at SBM, reviewed the FDA regulations and found that the FDA is required by its own laws to regulate homeopathy. In the words of one federal judge, the FDA has:

largely abdicated any role it might have had in creating standards for homeopathic OTC [over-the-counter] drugs, and has instead attempted to delegate this authority to the non-governmental organization 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.

Jann believes that the FDA is violating its own rules and that it is acting outside of the statutory framework established for it by congress. In other words – it does not have the authority to neglect homeopathy regulation the way it has been for the last half century.

Likely, the FDA decided that the homeopathy market was simply too small to allocate resources to properly regulate, so they let the homeopathy industry regulate themselves – really, that is what’s happening. Now the FDA is responding to the exploding homeopathy market and reconsidering this position, which is a good thing.

It is really good to see the FTC get involved, and put pressure on the FDA to do the job that the law requires that they do. The FTC is essentially saying that they cannot properly do their job with respect to homeopathy unless the FDA does their’s.

Conclusion

The FDA recently announced it will reopen its comment period for another 60 days. I urge all consumers to demand that the FDA do its job, and require at least a minimal amount of scientific evidence that any homeopathic product is safe and effective prior to allowing that product onto pharmacy shelves with health claims, sitting beside real medicine.

The comments are currently full of anecdotes supporting homeopathy that completely miss the point, and also from homeopaths defending their turf. The Society for Science Based Medicine has commented, and there are other scientific comments as well. It would be nice to shift the balance a little, and let the FDA know there are consumers who want scientific regulation of health products.

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