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posted by cmn32480 on Sunday November 27 2016, @01:02PM   Printer-friendly
from the truth-in-labeling dept.

Homeopathic medicines make up a multi-billion dollar industry in the United States. Despite being included in the Food, Drug and Cosmetic Act, the Food and Drug Administration (FDA) has never enforced the requirement that the homeopathic industry demonstrate safety or efficacy of its products prior to putting them on the market. Although drug regulation falls within the purview of the FDA, labeling the products is regulated by the Federal Trade Commission (FTC).

In 2015 both the FDA and FTC announced workshops to review how over the counter (OTC) homeopathic products are marketed. Both agencies have the authority to increase the regulation and labeling requirements for these products. The reviews generated thousands of public comments, and the FTC is the first to release their decision in a Staff Report and an Enforcement Policy Statement.

In summary, there is no basis under the FTC Act to treat OTC homeopathic drugs differently than other health products. Accordingly, unqualified disease claims made for homeopathic drugs must be substantiated by competent and reliable scientific evidence. Nevertheless, truthful, nonmisleading, effective disclosure of the basis for an efficacy claim may be possible. The approach outlined in this Policy Statement is therefore consistent with the First Amendment, and neither limits consumer access to OTC homeopathic products nor conflicts with the FDA's regulatory scheme. It would allow a marketer to include an indication for use that is not supported by scientific evidence so long as the marketer effectively communicates the limited basis for the claim in the manner discussed above.

Essentially, any homeopathic product that isn't backed up by competent and reliable scientific evidence must communicate on its label that:

  1. there is no scientific evidence that the product works
  2. the product's claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

Though largely seen as a win for consumer awareness, Slate notes the potential for this to backfire by noting that those who seek out homeopathic medicine will only have their resolve strengthened by seeing a statement pointing out that the contents of the bottle they are holding are not endorsed by the scientific community.


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  • (Score: 3, Informative) by fishybell on Sunday November 27 2016, @06:35PM

    by fishybell (3156) on Sunday November 27 2016, @06:35PM (#433701)

    From the FTC [ftc.gov]:

    It applies only to OTC products intended solely for self-limiting disease conditions amenable to self-diagnosis of symptoms and treatment.

    Bone spurs are typically self-limiting, can be self-diagnosed (as in, before going to the doctor, and especially if you've had them before, you can think you have bone spurs), and are typically self-treated with non-steroidal anti inflammatory drugs. Self-treating with magnesium and calcium likely had no effect other than in your head. The symptoms likely would have gone away in the same amount of time with no help. Of course, you can't go back in time and not treat it, so there's no way of knowing...which is pretty much exactly why homeopathic remedies are so popular: the, "it can't hurt," and the "I think it helped me" trains of thought.

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  • (Score: 0) by Anonymous Coward on Sunday November 27 2016, @06:44PM

    by Anonymous Coward on Sunday November 27 2016, @06:44PM (#433707)

    Which is why I take a prophylactic 2-4 liters of beer daily to prevent... whatever, man. It would have been worse without it, I KNOW that.

  • (Score: 0) by Anonymous Coward on Sunday November 27 2016, @11:33PM

    by Anonymous Coward on Sunday November 27 2016, @11:33PM (#433821)

    [...] why homeopathic remedies are so popular: the, "it can't hurt," and the "I think it helped me" trains of thought.

    The latter applies to conventional medicine.