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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FDA draft guidance (8 pages).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: 2) by istartedi on Wednesday December 20 2017, @07:22PM (3 children)

    by istartedi (123) on Wednesday December 20 2017, @07:22PM (#612466) Journal

    The dietary supplement industry lobbying [theatlantic.com] must have passed its expiration date. I distinctly remember this going down during the early days of the Clinton administration. At the time I was much more conservative and living among more left-leaning people in a college town. I expressed my suspicion that a politically well-connected figure with ties to the industry had made some impact. I can't remember the name of that figure; but I remember the reaction I got. There was the sort of "hippie" connection into the Democratic party at the time that actually wanted de-regulation of this market. The Trump administration is the antithesis of that. The early 90s FDA wanted to regulate supplements like food or drugs. Ironically, Trump is following the spirit of the agency mission on this one, and perhaps even the science.

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  • (Score: 0) by Anonymous Coward on Wednesday December 20 2017, @07:30PM

    by Anonymous Coward on Wednesday December 20 2017, @07:30PM (#612470)

    Orin Hatch was, and still is, the well-heeled champion of the "dietary supplement" industry. He's very vigorously defended them for decades. Coincidentally, his family is in the dietary supplement business.

  • (Score: 2) by frojack on Wednesday December 20 2017, @09:14PM

    by frojack (1554) on Wednesday December 20 2017, @09:14PM (#612540) Journal

    Not to mention following those who voted for him.
    Conservatives have ALWAYS known this was voodoo medicine, but they were blocked by big money crossing hands into the Clinton machine coffers for decades. None of this crap is paid for by Medicare/Medicaid (afik) and its time to start treating it as the snake oil it is.

    Can Chrioquacks be far behind? They are better organized, and probably actually help some people.
    But they will still sublux (or whatever they call it these days) your back to fix a bruised foot, and shoot xrays at anything that moves.
    Even confined to their historical alleged area of "expertise" they cause adverse effects in 30% to 61% of all patients. [nih.gov]. Some are life threatening. [washingtonpost.com]

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  • (Score: 0) by Anonymous Coward on Thursday December 21 2017, @12:38AM

    by Anonymous Coward on Thursday December 21 2017, @12:38AM (#612643)

    The legislation you're talking about was created by Orrin Hatch, the conservative Republican from Utah. Utah is home to a lot of homeopathic "cures" and Hatch is personally invested in them. It actually completely removed many of the FDA regulations on homeopathic "medicines".