To submit a comment to the FDA in support of homeopathy, follow the instructions on this page. Submitting a comment will take only a few minutes if you copy the comment text provided in the box below. To learn more about the situation we are facing in the United States, click here. Otherwise, continue reading to make your comment.
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Thank you for helping to defend homeopathy in America
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I commend the FDA for listening to the homeopathy community and posting a revised Draft Guidance rather than finalizing the previous one. However, I believe the FDA has not understood the homeopathy community completely. Though the agency purports to take a risk-based approach to policing homeopathic medicines, the new Draft Guidance would threaten the future of all homeopathy while increasing risk to consumers.
THE DRAFT GUIDANCE THREATENS ALL OF HOMEOPATHY
The Draft Guidance, if adopted, will allow the FDA to withdraw nontoxic, inherently safe generic name homeopathic medicines from the marketplace, not just particular brands or lots that have been improperly manufactured and/or labeled.
An initial review of public FDA records by Americans for Homeopathy Choice shows that safety concerns about properly manufactured and labeled homeopathic medicines appear nowhere. All of the FDA’s concerns relate to improperly manufactured and/or labeled products which do not meet homeopathic standards.
If the FDA does not intend to withdraw properly manufactured and labeled generic name homeopathic medicines, why does it seek the authority to do so? It seems 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.
The FDA claims that its authority to withdraw generic name homeopathic medicines completely from the market results from the designation of homeopathic medicines as “new drugs.” Nowhere in federal law are homeopathic medicines designated as “new drugs.”
First, homeopathic medicines are not new in any sense of the word. Many of them pre-date the Pure Food and Drug Act of 1906 and the Food, Drug and Cosmetic Act of 1938 and most pre-date the 1962 amendments. Second, those amendments are designed to deal with inherently dangerous substances in order to determine whether the benefits of a particular substance used as a drug outweigh the risks.
Since properly manufactured and labeled homeopathic medicines are nontoxic and inherently safe when used as directed, these amendments do not apply to homeopathic medicines. There is no risk to weigh against the benefit of a properly manufactured and labeled homeopathic medicine used as directed. We know this from the rigorous reviews including human trails which homeopathic medicines undergo for safety and efficacy before inclusion in the Homeopathic Pharmacopeia of the United States.
In short, the FDA cannot make new law through a guidance document. Only Congress can change the status of homeopathic drugs.
THE DRAFT GUIDANCE INCREASES RISK
Increased risk to consumers is a direct result of the threat posed by the Draft Guidance to all of homeopathy. By withdrawing properly manufactured and labeled generic name homeopathic medicines, the FDA will increase risks both to individual consumers and to public health in the following manner:
1. Many consumers will be denied access to the particular nontoxic, inherently safe homeopathic medicine which has helped them. These persons will increasingly be forced to seek higher-risk alternatives including OTC remedies that haven’t been tested for safety and efficacy and pharmaceuticals, many of which are known to create dangerous and even fatal side-effects.
2. Homeopathic medicines may no longer be available to help address infections without creating antibiotic resistance or to treat pain without causing opioid dependence and death. Learn more at HomeopathyChoice.org/Research.
3. The FDA’s risk-based approach makes no sense when applied to properly manufactured and labeled homeopathic medicines used as directed. These medicines are by definition nontoxic and inherently safe. They are not pharmacologically active and work by a different principle. To focus resources on policing them would divert resources from much riskier categories such as even properly manufactured and labeled pharmaceuticals which the agency recognizes have toxicity and interaction risks because of their much higher concentrations of active ingredients.
A proper focus for the risked-based approach would be products IMPROPERLY labeled as homeopathic as these may not be nontoxic or inherently safe.
I therefore request that the FDA revise this Draft Guidance to reflect 1) that generic name homeopathic medicines are nontoxic and inherently safe when properly manufactured and labeled and used as directed, 2) that homeopathic medicines are not “new drugs” and 3) that the agency’s risk-based approach will be applied only to products IMPROPERLY labeled as homeopathic.
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If we do not stop those rules, the FDA could start withdrawing homeopathic remedies from the market in the second half of 2020 beginning with popular ones such as Belladonna and Nux vomica. And, what the FDA does will be noticed by drug regulators around the world.
If you ask us for the logic behind these rules, we are at a loss. There is none so far as we can tell. But we are certain that if they are allowed to go into effect, those rules will begin a countdown to zero homeopathic remedies in America. To learn more, click here.
If You Are Ready to Comment
In order to respond properly to these deeply flawed rules, we must first ask for more time to do so. That’s why it is important to get a very large number of people to ask for an additional 60-day extension for us to provide a response beginning either June 1, 2020 (the current projected end of the Coronavirus emergency) or 60 days from the date that the FDA is back to normal operations. You can ask for this extension on our behalf while commenting on the guidance at the same time in one of two ways:
- You can use our ready-made comment (listed above).
- You can write a comment which you compose. You can use this background document to help you highlight the main points. Even more effective would be a personal story that illustrates one or more points listed in the background document.
Either way, your voice will be heard. When you are ready, click here to go back to the top of this page and follow the instructions for making a comment.