Update on the FDA Draft Guidance
February 1, 2018
Update on the FDA Draft Guidance, January 31, 2018
Dear NCH Members,
Many of you have contacted us to learn what is the latest on responding to the Food and Drug Administration (FDA) Draft Guidance issue. We have appreciated your patience as NCH worked along with the American Association of Homeopathic Pharmacists (AAHP) and other organizations to determine an effective response to this serious situation.
NCH has been following the guidance of the AAHP as they are familiar with the regulatory requirements for manufacturing and have a long history of working within the FDA regulations. AAHP also has an active expert Legislative and Regulatory Committee and a dedicated lobbyist in Congress.
AAHP has now shared its strategy with NCH and the Homeopathy Action Alliance (HAA) member organizations, and we will be following their recommendations. Not all of the strategy can be disclosed at this time, because of the need for discretion, but we want to assure you that your NCH Executive Director and Board Members are prepared to participate. The strategy will be executed in two phases, with the grassroots response coming in Phase 2 in a couple of weeks. At that time, we will inform you of the details of Phase 2 and the recommended actions.
As part of the overall response, NCH will be preparing written comments to submit to the FDA. It is not recommended that individuals post their comments to the FDA, although there are some groups who are promoting individual responses and letters. In 2015 when the FDA first initiated a review of homeopathy, over 9000 comments were logged into the FDA public comment site. These were disregarded by the FDA and had no influence on their decisions. There is no expectation that individual comments will make a difference now, and some believe that comments may be disadvantageous. As citizens you have the right to contact the FDA as you choose, however, we are encouraging you to put your efforts into the areas that are thought to be more influential. We will give you all the tools and information when Phase 2 is launched.
Until then, we encourage you to remain patient. Your organization and indeed all of the homeopathy organizations are working together to present our concerns and opinions with a coordinated harmonious message and powerful voice.
For additional details concerning the FDA draft guidance, please register for the Regulatory Update Webinar – Presented by Mark Land of the American Association of Homeopathic Pharmacists on Feb 12, 2018 8:00 PM EST