Here are some talking points you can use in support of the issues raised in the Citizen’s Petition:
1. FDA is requested to make the CPG 400.400 a regulation with suggested additions and to withdraw the Draft Guidance.
a. The CPG400.400 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b. The Draft Guidance would undo decades of safety procedures, place unfair monetary burdens, and arbitrarily question the established safety record of homeopathic medicines.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. 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.
a. 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.
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process, which homeopathic medicines should be required to undergo the New Drug Approval Process as outlined in the Draft Guidance.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. The FDA is requested to 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. The FDA is requested to 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 If the FDA refuses to grant this Petition, they are requested to conduct a public hearing before enacting the Draft Guidance.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.
7. SHARE YOUR COMMENTS WITH YOUR REPRESENTATIVES AND SENATORS!
THANK YOU FOR YOUR ACTION TO SUPPORT ACCESS TO HOMEOPATHY!