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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FDA draft guidance (8 pages).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: 1, Interesting) by Anonymous Coward on Wednesday December 20 2017, @06:18PM
Uh hey
did you not notice that *all* of the department of Stuff are adhering to the conservative agenda in order to keep their funding and protect against the chopping block?
Ignorance may be bliss--but with significantly smaller tax revenue forcasts, ignorance won't pay for anything. They have to be smart about it.
News is news, and someone at a number of news corporations decided to try to make a big deal out of it.
The REAL NEWS is that the SAME IDEAS can be phrased in a way that people will accept, when previously using DIFFERENT WORDS they rejected due to deep seated bias!
that's the issue. The framing of the terms is relevant only to keep the process operational. Every governmental department has to cater to those in charge, even if it means altering their vocabulary to say the same things in a different way. ANd it's not 1984 newspeak -- they are not censoring or eliminating terms -- they're using marketing and advertising to sell their needs to the ones that pay them.
You won't sell your services to someone who says they'd fire you for doing it, but you might if you tell them you actually are doing something else...
I mean, think about it -- they don't read the bills they vote into laws, they don't understand any of this stuff. tell them what they want to hear and you can stay in business.