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in July, 2018 by the Americans For Homeopathy Choice (AFHC) as a response to the FDA’s December, 2017 issuing of the Draft Guidance, “Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry,” to replace the CPG 400.400.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 It halts any forward action by the FDA in applying the Draft Guidance until the issues in the Petition have been resolved.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of support to the FDA before the Petition was filed, have received replies from the FDA that it is going ahead with the Draft Guidance.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
SUBMIT COMMENTS TO:
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.
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!
*Nourishing Plot is written by Becky Plotner, ND, traditional naturopath, CGP, D.PSc. who sees clients in Rossville, Georgia. She is a Board Certified Naturopathic Doctor, through The American Naturopathic Medical Association and works as a Certified GAPS Practitioner who sees clients in her office, Skype and phone. She has been published in Wise Traditions, spoken at two Weston A. Price Conferences, Certified GAPS Practitioner Trainings, has been on many radio shows, television shows and writes for Nourishing Plot. Since her son was delivered from the effects of autism (Asperger’s syndrome), ADHD, bipolar disorder/manic depression, hypoglycemia and dyslexia, through food, she continued her education specializing in Leaky Gut and parasitology through Duke University, finishing with distinction. She is a Chapter Leader for The Weston A. Price Foundation. firstname.lastname@example.org
“GAPS™ and Gut and Psychology Syndrome™ are the trademark and copyright of Dr. Natasha Campbell-McBride. The right of Dr. Natasha Campbell-McBride to be identified as the author of this work has been asserted by her in accordance with the Copyright, Patent and Designs Act 1988.
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