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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FDA draft guidance (8 pages).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: 0, Troll) by Sulla on Wednesday December 20 2017, @05:40PM
Thats a really interesting read and to me makes a lot of sense. If you are trying to convince someone to fund you it is going to get you a lot further if you provide the details of the science instead of saying it is "science based" or to provide the facts instead of saying "fact based". Science-based/fact-based are appeals to authority where you should assume it is good because someone in-the-know says it is instead of providing the background information.
If you want to sell a liberal program to a republican you don't call it the 'entitlement for aborting fetuses due to mother safety risk' you call it 'emergency procedures to terminate pregnancy to preserve mothers life'.
All marketing bullshit, but effective. Hell you could sell ice to democratic Eskimos if you said it was fair-trade organic pro-impeachment ice packaged by a woman owned company.
Ceterum censeo Sinae esse delendam