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Looking to support our message to legislators? Click here to send your message.
Looking to support our message to legislators? Click here to send your message.
Help us tell the president that the FDA draft guidance fails to regulate homeopathic medicines in accordance with the law.
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The FDA has submitted its Draft Guidance for Drug Products Labeled as Homeopathic to the Office of Information and Regulatory Affairs (OIRA) which operates by law within the Executive Office of the President. OIRA reviews significant regulatory changes to make sure 1) that they are consistent with the law, 2) that there has been a proper analysis of both costs and benefits, and 3) that the FDA has made a “reasoned determination that the benefits justify the costs.”
The Draft Guidance will only be under review for a short time. The sooner we communicate our concerns, the better! Use our ready-made message to contact the President and OIRA. Just fill out the form below and when you are ready, click submit and your comment will automatically be sent.
This is a unique opportunity to communicate with the president and his advisors regarding the draft guidance. The Draft Guidance is anything but “reasoned.” We need to request that OIRA send the Draft Guidance back to the FDA with the recommendation that the agency adopt an alternative approach that comports with law and protects access to safe and genuine homeopathic medicines.
We are in one of the most critical times in history to advocate for access to homeopathic medicines. In 2017 FDA released a policy document–currently in draft form–that categorizes all homeopathic medicines as “unapproved new drugs” and therefore illegally marketed. This has allowed the FDA to remove homeopathic medicines, one at a time, for any reason or no reason at all.
Which homeopathic medicine are you willing to lose? We have already lost access to some medicines and the FDA has specifically mentioned Belladonna, Nux vomica, and others as concerns.
We need you to join in our efforts because your voice will change history. You are needed now more than ever!