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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FDA draft guidance (8 pages).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: 1) by fustakrakich on Friday December 22 2017, @06:23PM (2 children)

    by fustakrakich (6150) on Friday December 22 2017, @06:23PM (#613274) Journal

    Not unique. Just a minority.

    Please, permit me some license for minor embellishment.. but, it is not too harsh to say that people who continue to vote for the political status quo have no taste for the truth.

    --
    La politica e i criminali sono la stessa cosa..
  • (Score: 2) by DannyB on Friday December 22 2017, @06:51PM (1 child)

    by DannyB (5839) Subscriber Badge on Friday December 22 2017, @06:51PM (#613293) Journal

    I am unclear what you are trying to say.

    I would rather have the truth, however unpleasant, to the best extent that I am able to discern and understand what is true.

    As for voting for status quo. That can refer to so many things. One candidate may make some changes. The other candidate may make some different changes. But neither of them are going to change the things that really matter -- because they are in the pockets of the rich and powerful.

    A change that no candidate will ever make, for example, is working for the common people and not the rich and powerful people. It's not that rich and powerful should be treated unfairly. But they can shoulder a much greater tax burden and still have more money than they will ever spend before they die, and vastly more than most people. So I would hardly call it unfair.

    But wandering out of the weeds, I would rather know an unpleasant truth that climate is going to change in some very bad ways, than have someone tell me a pleasant lie that everything is going to be just great!

    Or maybe I am simply too dense to understand what you are getting at.

    --
    Santa maintains a database and does double verification of it.
    • (Score: 1) by fustakrakich on Friday December 22 2017, @08:04PM

      by fustakrakich (6150) on Friday December 22 2017, @08:04PM (#613340) Journal

      Or maybe I am simply too dense to understand what you are getting at.

      No, you're just taking it personally. I don't know why, but shit happens, I guess.

      --
      La politica e i criminali sono la stessa cosa..