The FDA is attempting to repeal historic guidance documents (CPG 400.400) Conditions Under Which Homeopathic Drugs May Be Marketed, that has for decades acknowledged and protected the unique nature of homeopathic remedies and provided clear guidance to manufacturers regarding the marketing of these remedies.
Over the past few months our industry representatives and consumer activists have worked together to make our legislators aware of the need and urgency for their participation. Our multi-pronged approach targeted key influencers. Senator Orrin Hatch of Utah and Congressman Ryan Costello of Arizona agree with our position and have created letters asking the FDA to maintain the current CPG 400.400 supporting advice of the American Association of Homeopathic Pharmacists (AAHP). We need as many legislators as possible to sign onto those letters.
National Health Freedom Advocacy (NHFA) has reviewed the Draft Guidance and submitted a 20 page formal comment to the FDA opposing the Draft Guidance and recommending changes. This review is the most comprehensive statement that has been generated from the legal perspective. There are two key reasons why NHFA opposes the draft guidance:
- The FDA is attempting to repeal historic guidance documents (CPG 400.400) that has for decades acknowledged and protected the unique nature of homeopathic remedies and provided clear guidance to manufacturers regarding the marketing of these remedies.
- In addition, FDA is now attempting to establish enforcement priorities for homeopathic remedies similar to all other pharmaceutical drug unapproved drugs, based on a general “risk-based” approach, but with even added restrictions not imposed on pharmaceutical unapproved drugs.
Read FDA Draft Guidance Here. Read NHFA’s Comments Here.
Links to an Overview and templates of letters you can use.
Go to the FDA site to leave your comments.
Other Resources for Understanding the impact of the FDA Draft Guidance
Dana Ullman, MPH, CCH, RSHom(NA) has written a comprehensive article that was published in Mercola – Click here to read that article.
Diane Miller, JD discusses her legal viewpoint as the Director of Legal and Public Policy of the National Health Freedom Action in this short youtube. Click here to view that.
Paola Brown and attorney Jim Turner discuss their recent meeting with the FDA. Paola and Jim represent a group of citizens belonging to the Citizens for Homeopathy Choice which is an advocacy group. Click here to view that video.
The National Center for Homeopathy (NCH) has similar links to help submit your comments – click here to view their information.