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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:
- there is no scientific evidence that the product works
- 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.
(Score: 2) by jdavidb on Monday November 28 2016, @04:00PM
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(Score: 2) by EvilSS on Monday November 28 2016, @05:04PM
Also the FDA doesn't have the authority to issue recalls on most homeopathic products. So if it was pulled, it was done at the behest of either the stores selling it, or the company that manufactured it. They can only take action after investigating and finding a clear danger with a specific product or ingredient.
(Score: 2) by jdavidb on Monday November 28 2016, @10:39PM
The only homeopathic med I know of recently pulled for infants was a teething remedy that contained very non-homeopathic levels of belladonna and was linked to over 400 hospitalizations and 10 deaths.
Yep, that's the one.
You can be assured that anything that is actually homeopathic and that isn't a cure for thirst, does not work. They are literally water with some supposed ingredient diluted down so far that the odds are there isn't a single molecule of it in the solution.
I know!
Also the FDA doesn't have the authority to issue recalls on most homeopathic products. So if it was pulled, it was done at the behest of either the stores selling it, or the company that manufactured it.
You're right - I went back and reread original announcement [hylands.com]. Basically the FDA has scared them out of the U.S. market.
They can only take action after investigating and finding a clear danger with a specific product or ingredient.
They don't feel the need to publish their data, though.
ⓋⒶ☮✝🕊 Secession is the right of all sentient beings