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posted by Fnord666 on Wednesday December 20 2017, @04:21PM   Printer-friendly
from the who-defines-serious? dept.

The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):

To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.

Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.

"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."

FDA draft guidance (8 pages).

Also at Ars Technica and STAT News.

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  • (Score: 3, Insightful) by requerdanos on Wednesday December 20 2017, @07:48PM (5 children)

    by requerdanos (5997) Subscriber Badge on Wednesday December 20 2017, @07:48PM (#612481) Journal

    ...homoepathic drug...

    A "drug" is a particular substance, or combination of substances, that has some effect on the body.

    A "homeopathic" composition is woo-woo [inscientioveritas.org] that has meticulously had anything that might possibly (but probably not) have had any effect carefully removed by means of dilution [rationalwiki.org] to oblivion.

    It's like saying "the wet sun" or "the blinding brightness of the dark." Might sound real impressive until you think about it: One or the other. Can't be both. Either something is homeopathic, or it's not and therefore possibly a drug.

    People who believe that "homeopathic" "drugs" exist are to be pitied, but not encouraged. People who encourage others in this belief are to be actively discouraged.

    Since any such products "have not been shown to offer clinical benefits" and never will be, it can only be a good thing that they are now required to put up or shut up.

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  • (Score: 0) by Anonymous Coward on Wednesday December 20 2017, @09:56PM (2 children)

    by Anonymous Coward on Wednesday December 20 2017, @09:56PM (#612571)

    Thanks for that, I never bothered to look into it and just assumed homeopathy and herbal medicines were basically the same thing.

    • (Score: 2) by MichaelDavidCrawford on Thursday December 21 2017, @01:35AM

      by MichaelDavidCrawford (2339) Subscriber Badge <mdcrawford@gmail.com> on Thursday December 21 2017, @01:35AM (#612667) Homepage Journal

      .. that might actually kill you. You're lucky if you only get sick.

      At least with homeopathic "drugs" they have the benefit of not poisoning you.

      --
      Yes I Have No Bananas. [gofundme.com]
    • (Score: 0) by Anonymous Coward on Monday December 25 2017, @04:03AM

      by Anonymous Coward on Monday December 25 2017, @04:03AM (#614008)

      Some things that are labelled homeopathic, actually aren't. So don't assume that just because something is called homeopathic, that it follows homeopathic principles and is essentially harmless (aside from any potential harm caused by it being used as an alternative to actually effective treatments).

  • (Score: 2) by takyon on Wednesday December 20 2017, @11:09PM (1 child)

    by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Wednesday December 20 2017, @11:09PM (#612605) Journal

    Take it up with the FDA, I used their words.

    --
    [SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
    • (Score: 2) by requerdanos on Thursday December 21 2017, @01:31AM

      by requerdanos (5997) Subscriber Badge on Thursday December 21 2017, @01:31AM (#612662) Journal

      Take it up with...

      I frequently use these comment areas as a forum for addressing the subjects (or authors) of T-various-FAs. This is no exception; it was their words I quoted, and to their words I spoke. No offense to any editors intended.