Homeopathy: FDA Grants Brief Extension for Comments on Draft Guidance – But More Time Still Needed

IMPORTANT UPDATE: Our voices were heard and the FDA has granted an extension – a brief one – for comments on their proposed guidance for “Drug Products Labeled as Homeopathic.” The comment period has been extended to March 23rd. This is a step in the right direction, but not enough. We desperately need a full 180-day extension to July 23rd in order to respond effectively, and firmly believe an issue this important deserves sufficient time for all stakeholders to be heard.
stay tuned for updates, and please use the information below to submit your comments today asking for a full 180-day extension to the comment period. Our original post follows for convenience.

We alerted you in December about our alliance with Americans for Homeopathy Choice and the effort to preserve access to homeopathy for all. The FDA’s draft guidance on Homeopathy threatens access for everyone and must be revised. CFH and AFHC are calling for an extension to the comment period so the FDA has time to hear more from concerned Health Freedom Fighters, and to issue a guidance that preserves our access to properly formulated homeopathic products currently legal under the Food Drug & Cosmetic Act. Read more here.

There are still four days remaining as of this post, and we urge that you do two very important things:

  1. Submit a comment to the FDA docket about homeopathy telling the agency that we appreciate the brief extension but that we need a full 180-day extension in order to respond adequately to the FDA’s latest proposed rules. When you’re ready to do that, you can click the button below.
  2. Share this page with your contacts and get every family member in each household—regardless of age—to submit a comment to the docket.

Here’s a summary of the most important talking points:

  1. The new Draft Guidance, if adopted, will allow the FDA to withdraw even properly manufactured and labeled homeopathic medicines from the marketplace. This is peculiar because these have never posed any sort of safety concern according to an initial review of public FDA records by Americans for Homeopathy Choice.
  2. It is clear that the FDA intends to use this authority and has even mentioned specific medicines such as Belladonna, Nux vomica and Lachesis muta in its public statements regarding enforcement.
  3. The authority for this kind of assault on homeopathy will result from the declaration by the FDA that all homeopathic medicines are “new drugs.” We all know that legally speaking, this is nonsense. Homeopathic medicines have been around for 200 years.

If you already commented in response to our alert in December – excellent, and thank you!

The Good News: You can comment again, and now share your message with Congress and the President

The comment form has been updated to allow for your comments to not only reach the FDA, but Congress and the President as well. We need to pull out all the stops and share the appeal with as many policy-makers as we can. The message to the FDA must be loud and clear, and come from all sides:

We must preserve and protect access to the full range of homeopathic medicines while safeguarding the quality and purity of the products containing them.

Help us get an extension so that there will be enough time to prepare a response properly. We need the time in order to show the FDA step-by-step how to change the Draft Guidance in ways that will protect rather than imperil homeopathy. Please click the button below for our ally’s page for submitting comments, and urge the FDA to preserve homeopathy for all.

Deadline for comments is March 23rd!

Please note: The page for submitting comments is maintained by AFHC. Please direct any comments or questions about the page or how it is functioning to AFHC using their contact form, found here: https://homeopathychoice.org/contact/.

To submit comments directly to the FDA docket, or for instructions for sending written comments by traditional US mail, visit https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-products-labeled-homeopathic-guidance-fda-staff-and-industry.

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