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in July, 2018 by the Americans For Homeopathy Choice (AFHC) as a response to the FDA’s December, 2017 issuing of the Draft Guidance “Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry” to replace the CPG 400.400.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 site. Comments about the petition can be made until December 1, 2018 at https://www.regulations.gov/document?D=FDA-2018-P-2962-0001
The National Center for Homeopathy (NCH) Board of Directors is encouraging NCH members to post individual comments to the FDA docket in support of the Petition. NCH as an organization, will be submitting a letter of support. Most of the other homeopathy organizations are also encouraging their members to respond and are sending organizational letters. There are currently about 500 comments. With your help, the goal is to have 1000 comments before the December 1st deadline.
The 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 It halts any forward action by the FDA in applying the Draft Guidance until the issues in the Petition have been resolved.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support to the FDA before the Petition was filed, have received replies from the FDA that it is moving ahead with the Draft Guidance.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” approach to evaluating homeopathic medicines.
Please follow the instructions below to submit your comments in support of the citizen’s petition.
You can read the Citizens’ Petition and the AFHC rationale for filing the petition on the AFHC website at:
SUBMIT COMMENTS TO:
Please include the following docket number at the top of your comments:
- Include your name, state, email, and phone number (if desired).
- Select “Individual Consumer” as the Category. This is a required field.
- 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. If you have questions, please read the Citizens’ Petition and the documents on the AFHC website and if there is no answer there, then contact NCH.
Here are some talking points you can use in support of the issues raised in the Citizen’s Petition:
- FDA is requested to make the CPG 400.400 a regulation with suggested additions and to withdraw the Draft Guidance.
- The CPG400.400 has successfully protected consumer safety for 30 years by guiding and standardizing the manufacturing and marketing of homeopathic medicines.
- The Draft Guidance would undo decades of safety procedures, place unfair monetary burdens, and arbitrarily question the established safety record of homeopathic medicines.
- The FDA is requested to 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.
- Homeopathic medicines in the HPUS and non-HPUS are not classified “New Drugs” by the definitions of the Food Drug and Cosmetic Act of 1938.
- 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.
- The FDA is requested to establish a Homeopathy Expert Advisory Committee.
- This committee will provide information and guidance on all matters pertaining to homeopathic medicines.
- The committee will be composed of homeopathy practitioners, both licensed and certified, industry representatives, consumers, patient’s families, and other health practitioners.
- The FDA has established many other Expert Advisory Committees.
- The FDA is requested to continue the CPG 400.400 until this Petition is resolved.
- If the FDA refuses to grant this Petition, they are requested to conduct a public hearing before enacting the Draft Guidance.
- Thank the FDA for their consideration.
- SHARE YOUR COMMENTS WITH YOUR REPRESENTATIVES AND SENATORS!
THANK YOU FOR YOUR ACTION TO SUPPORT ACCESS TO HOMEOPATHY!