Homeopathy is a federally recognized form of medicine, backed by thousands of research studies and clinical trials. The Food, Drug, and Cosmetic Act (FDA), established in 1906, the federal agency which governs drugs includes homeopathic medicines. Homeopathy is widely accepted, legally and competently practiced, available to those who want to use it, and is thriving in North America. It provides a safe, gentle, and natural system of healing with none of the side effects of many conventional medications. Homeopathic remedies have been manufactured under guidelines set by the Homeopathic Pharmacopoeia of the United States (HPUS) since 1897. Since 1906, the FDA set further regulations in 1988 and a revision in 1995, with the FDA issuing CPG 400.00, which stipulated conditions under which homeopathic drugs could be marketed.
During the past 24 to 30 years, homeopathic remedies have been proven to be safe and effective treatment, with no harmful side effects reported. The FDA did issue a warning for potential adverse effects from teething tablets, however this was a result of improper manufacturing. Beginning in 2015, the FDA held a two day public forum for comments on homeopathic products. New guidelines were issued by the FDA in 2017 that would overturn the previous CPG 400.400, and change the status of homeopathic remedies. This would give the FDA the power to ban properly formulated homeopathic products that are currently legal. After a comment period, the FDA withdrew the original draft and issued a revised draft in 2019. The revised guidelines would also change the status of homeopathic remedies from a special category of medicine and put them into a group considered “unapproved.” This means that all homeopathic remedies could potentially be banned.
As a result of the new proposed draft guidelines, HNA is collaborating with other organizations to post comments in support of homeopathy and encourage the FDA to maintain access for the production of homeopathic remedies. Along with 16 other organizations, HNA endorsed October 2019 FDA Draft Guidance on Homeopathy.
More recently, Americans for Homeopathy Choice, submitted a Citizens Petition, requesting the FDA revise its draft guidance. The petition outlines specifics on protecting consumers from improperly manufactured and/or labeled products. It also asks for assurances of continuing access to the full range of non-toxic, affordable, and safe homeopathic medicines on the market today. In addition, it seeks clear regulations for manufacturers that tell them what they should do in order to adhere to the law and meet the FDA’s expectations for quality and purity. HNA has endorsed the citizens' petition, along with 19 other organizations. View the endorsed statement HERE. The full Citizens' Petition can be viewed by clicking this LINK.
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