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WHAT: Submit Your Comments to Save Homeopathy
A Citizens’ Petition was filed in July, 2018 by the Americans For Homeopathy Choice (AFHC) as a response to the FDA’s December, 2017 issuing of the Draft Guidance, “Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry,” to replace the CPG 400.400. The FDA has posted the Petition and opened a comments docket. Comments about the petition can be made until January 28, 2019. at https://www.regulations.gov/document?D=FDA-2018-P-2962-0001.
The Weston A. Price Foundation is encouraging members to post individual comments to the FDA docket in support of the Petition. Most of the homeopathy organizations, such as the National Center for Homeopathy (NCH) are also encouraging their members to respond and are sending organizational letters. There are currently about 4131 comments; the goal is to have 5000 comments before the deadline but the more we get, the greater the impact – 10,000 would be ideal.
A Citizens’ Petition is a stop-action maneuver to protect consumer access to homeopathy. It halts any forward action by the FDA in applying the Draft Guidance until the issues in the Petition have been resolved. This Petition is the work of AFHC and their attorney, Jim Turner, with input from many members of the homeopathy community, including NCH. It is a timely action, since Senators Hatch and Connolly, who wrote letters of support to the FDA before the Petition was filed, have received replies from the FDA that it is going ahead with the Draft Guidance. The FDA made this decision despite several thousand submitted public comments, three in-person meetings from AFHC homeopathy consumers, and direct contact from congressional representatives urging the FDA not to discard the CPG 400.400 by substituting a “risk-based” assessment.
Read the Petition here: https://www.regulations.gov/document?D=FDA-2018-P-2962-0001
TAKE ACTION:
SUBMIT COMMENTS TO:
https://www.regulations.gov/document?D=FDA-2018-P-2962-0001
Please include the docket number at the top of your comments:
1. Include your name, state, email, and phone number (if desired).
2. Select “Individual Consumer” as the Category; this is a required field.
3. State your support for the Petition put forth by Americans for Homeopathy Choice.
You are encouraged to be polite. If you are a consumer, be sure to state that. Consumer comments are very important to the FDA.
TALKING POINTS:
Please use your own words, but for clarification, here are some talking points in support of the issues raised in the Citizens’ Petition:
1. It is requested that the FDA make the CPG 400.400 as regulation with suggested additions and withdraw the Draft Guidance.
a. The CPG 400.400 has successfully protected consumer safety for 30 years by guiding and standardizing the manufacturing and marketing of homeopathic medicines.
b. The Draft Guidance would undo decades of safety procedures, place unfair monetary burdens, and arbitrarily question the established safety record of homeopathic medicines.
2. It is requested that the FDA adhere to the Food Drug and Cosmetic Act of 1938, which exempts all homeopathic medicines in the HPUS and any new non-HPUS homeopathic medicines with documentation from undergoing New Drug Approval Process.
a. Homeopathic medicines in the HPUS and non-HPUS are not classified as “New Drugs” by the definitions of the Food Drug and Cosmetic Act of 1938.
b. It is not within the purview of the FDA to arbitrarily decide, based on their unsubstantiated and ill-defined “risk assessment” process, which homeopathic medicines should be required to undergo the New Drug Approval Process as outlined in the Draft Guidance.
3. It is requested that the FDA establish a Homeopathy Expert Advisory Committee.
a. This committee will provide information and guidance on all matters pertaining to homeopathic medicines.
b. The committee will be composed of homeopathy practitioners, both licensed and certified, industry representatives, consumers, patient’s families, and other health practitioners.
c. The FDA has established many other Expert Advisory Committees.
4. It is requested that the FDA continue the CPG 400.400 until this Petition is resolved.
5. If the FDA refuses to grant this Petition, they are requested to conduct a public hearing before enacting the Draft Guidance.
6. Thank the FDA for their consideration.
SHARE YOUR COMMENTS WITH YOUR REPRESENTATIVES AND SENATORS!
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A retired FDA employee: Frank Russell wrote in a Wise Traditions Journal letter: “I now believe the FDA is a corrupt organization.”[1] If this corruption is truly the case (and I am certainly convinced that it is) then this situation needs to be responded to. It just might possibly be grounds to essentially revoke whatever Congressional “charter” this “corrupt organization” is operating under. Would one of the attorneys who is WAPF friendly be willing to have an apprentice research this? If so we could possibly pull this thing out at the root rather than hacking at the branches.[2]
[1] https://www.westonaprice.org/letters-winter-2018/
[2] “There are a thousand hacking at the branches of evil to one who is striking at the root.”
Henry David Thoreau (1817-1862)
With the Spanish Flu (pandemic of 1918) the allopathic hospitals had a 30% death rate, while the homeopathic hospitals had about a 1% dead rate. We need to have unreduced access to all homeopathic remedies. Any action to require recertification will cause more deaths!
What I know is true is that all the govt. agencies were created to BLOCK citizen’s right to protect themselves from corporate HARM. “The Revolving Door” from corporations into govt. jobs, lobbyist jobs and political office is a REAL THING. It assures that the rich few will always have a way to deny the citizenry the right to protect themselves or their environment from harm to capitalism’s goal of wealth creation.
Yes, I wrote my letter to protect 400.400 but I am under NO ILLUSION that the FDA will choose my rights over the right of capitalism to THRIVE. 🙁 Nothing short of replacing our corrupt political/judicial/economic systems will change the trajectory we are on.
I want access to other forms of medicines than poisonous pharmacuedicals. End the war on natural cures! Corrupt shills are attempting to keep the masses sick & it’s disgusting!
Homeopathy works. I treated a dog with it and she got better. I don’t think she got better because she expected to. Stopping treatment too soon allowed the problem to come back, and continuing treatment longer completely took care of the matter. It needs to remain a choice!
Docket # FDA-2018-p-2962-000
Individual consumer.
We need access to all homeopathic remedies; we should have a choice in how we are treated. It is requested that the FDA continue with the CPG 400.400 until the petition is resolved.
The plants that are used in homeopathy had been created by God Almighty. Homeopathy had been used for over 100 years and is well known to be safe and most effective when nothing else will help. Also many kings, queens, princess and princesses had use them. Let this remedies be use by anyone that chose too. Thank you.
I recently bought a homeopathic spray, that I spray under my tongue, to relieve headaches. It is the the best thing I have ever tried for headaches. It works quick and effective. Beats any pharmaceuticals
This is the real medicine with no side effects
These plants, roots, seeds, stems, ect used in homeopathic medicine come from Mother Nature, Mother Nature is NEVER wrong!
This is not about protecting mankind, this is greed.
Anyone thinking the FDA and big pharmaceutical are not in bed together need to open their eyes.
We need to demand that our right to choose alternative, natural treatments are protected.
The FDA and big pharmaceutical are the threat, not homeopathic medicine.