Comment on the Homeopathy Petition
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Docket # FDA-2018-P-2962-0001
As a user of homeopathic remedies, I urge the FDA to act on the requests contained in this petition swiftly in order to protect the integrity of homeopathic remedies and provide certainty to the homeopathic marketplace. Adopting CPG 400.400 as a regulation will put in place a framework that assures that the trust which has been built up by this guidance over the past 30 years will continue far into the future.
In addition, an advisory committee made up of homeopathic professionals and users will provide the FDA with timely and competent advice on policy and enforcement in all matters homeopathic. There are no people more committed to maintaining the high standards of quality now present in the industry and the homeopathic community than those whose health and livelihoods depend on homeopathy.
Thank you for considering this petition. I urge you to implement its recommendations.
1. Include your name, state, email, and phone number (if desired).
2. Select “Individual Consumer” as the Category, unless you are submitting your comment as a more suitable selection. This is a required field.
Why you should comment on the petition:
Your right to choose homeopathy is under threat. But, you have a chance to make your voice heard by the U.S. Food and Drug Administration (FDA). The FDA is seeking powers that could result in a ban on many popular homeopathic remedies. The more people who comment on our petition filed with the FDA, the more seriously the agency and the U.S Congress will take us.
Unlike many petitions these days, this one is an officially recognized petition filed under the federal Administrative Procedure Act. The FDA is required to respond to the 23-page petition before moving ahead on its proposed new guidelines.
The key recommendations in the petition are:
• Formation of an FDA advisory committee on homeopathy made up of homeopathic professionals and consumers.
• Withdrawal of the FDA’s Draft Guidance on Homeopathy dated December 2017 which threatens to restrict the availability of homeopathic remedies.
• Conversion of Compliance Policy Guidance 400.400 (with minor changes) into a regulation. This is the policy that has guided the agency since 1988 and resulted in high standards of quality assurance in the manufacture of homeopathic remedies even as choice and availability continue to grow.
Right now the FDA has no systematic way to get input from the homeopathic community. The advisory committee would solve that. Withdrawing the Draft Guidance would lift the threat to homeopathy. Converting the current policy guidance into a regulation would solidify a system that has worked for 30 years. It would create predictability for manufacturers who could then confidently maintain and expand the variety of remedies they make.
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