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Consumer Health Digest #17-47
December 24, 2017

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FDA proposes new homeopathic product regulations

The U.S. Food and Drug Administration has proposed what it calls "risk-based guidelines" that give enforcement priority to homeopathic products with the greatest potential risk to patients.
[FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589243.htm
FDA news release, Dec 18, 2017]

The FDA intends to focus on:

products with reported safety concerns
products that contain or claim to contain ingredients associated with potentially significant safety concerns
products for routes of administration other than oral and topical
products intended for the prevention or treatment of serious and/or life-threatening diseases and conditions
products for vulnerable populations
products that do not meet legally required standards of quality, strength, or purity.

Although homeopathic products have no proven effectiveness and their theoretical basis is senseless, a complete ban is not politically feasible.
[Barrett S. Homeopathy: The ultimate fake
http://www.quackwatch.org/01QuackeryRelatedTopics/homeo.html
Quackwatch, Aug 25, 2016]

However, the FDA can easily limit their marketing to single-ingredient products that strictly comply with the Homeopathic Pharmacopeia. No health claims should be permitted for homeopathic products unless they are approved through the FDA's standard drug approval process. The only statements that should be permitted in labeling or advertising are the chemical name, the dilution, and that fact that the product is homeopathic. Products consistent with the Pharmacopeia could still be marketed, so consumers who want homeopathic products could still obtain them. But unapproved health claims—including implied claims in product names—should be banned. If you agree with this suggestion, please read Dr. Barrett’s full explanation
https://www.homeowatch.org/reg/fda_hearing_2015/comment.html
and post a comment in your own words to the FDA comments page
https://disq.us/url?url=https%3A%2F%2Fwww.regulations.gov%2Fdocument%3FD%3DFDA-2017-D-6580-0002%3AxUC9I4lr0UX4MtftaOhLryNKi1o&cuid=3540134


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Stephen Barrett, M.D.
Consumer Advocate
287 Fearrington Post
Pittsboro, NC 27312

Telephone: (919) 533-6009

http://www.quackwatch.org (health fraud and quackery)
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