This alert is for those who prefer (or need) non-drug options for dealing with a health challenge. The future availability of homeopathic remedies in the United States appears to be threatened.

Homeopathy is a 200-year-old system of medicine based on the principle that highly diluted substances can be used to treat symptoms similar to symptoms that would be caused by large doses of those same substances in healthy people. Homeopathy works because the “substance” becomes so diluted that only the energy of it is left. For this reason, homeopathy has been viewed for centuries as one of the safest treatment options available.

With the U.S. Food and Drug Administration’s (FDA) new Draft Guidance, Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry (released in December of 2017), the FDA’s enforcement policy is changing entirely and the 1988 CPG Sec. 400.400 Conditions Under Which Homeopathic Drugs May be Marketed is being rescinded. The deadline for submitting comments to the FDA has been extended to May 21, 2018. If this change goes into effect, the reality is that requiring non-patentable homeopathic remedies to meet pharmaceutical drug testing requirements will be too expensive for costs to ever be recovered, so it would be expected that most homeopathic products will not qualify to be available for sale.

There are two dramatically opposing positions about the credibility and safety of homeopathy. AHHA’s review of the history, articles, and research has revealed conflicting interpretations of this healing modality.

ISSUE: Should the FDA change the homeopathy Guidelines?

AHHA strives to maintain a neutral position on issues and views knowledge as power. For those interested in learning more about this month’s issue, the following related articles were selected to serve as a foundation for learning more about this issue.

PRO
FDA proposes new, risk-based enforcement priorities to protect consumers from potentially harmful, unproven homeopathic drugs (12/18/17)
U.S. Food & Drug Administration

FDA to step up enforcement of homeopathic medicine (1/11/18)
by Diane Romza-Kutz, Fredric Roth
Thompson Coburn, LLP

FDA to crack down on “harmful, unproven homeopathic drugs” (12/18/17)
by Rich Haridy
New Atlas

FDA takes on homeopathic drugs with potential safety risks (12/19/17)
by Michael Nedelman
CNN

My Christmas Wish Came Early: FDA Cracks Down on Homeopathy (12/22/17)
by Julianna LeMieux
AmericanCouncil on Science and Health

FDA takes more aggressive stance toward homeopathic drugs (12/18/17)
by Laurie McGinley
The Washington Post

Homeopathic products and practices: assessing the evidence and ensuring consistency in regulating medical claims in the EU (September 2017)
European Academies Science Advisory Council

CON
The Case FOR Homeopathic Medicine: The Historical and Scientific Evidence (updated 12/6/17)
by Dana Ullman, MPH, CCH
Homeopathic Family Medicine

What You Need to Know About the FDA’s War on Homeopathy (2/1/18)
Living Whole

Letter to FDA (2/8/18)
American Institute of Homeopathy

Critique of Proposed Regulations of Homeopathic Medicines and Alternative Proposals (3/6/18)
by Dana Ullman, MPH, CCH
Mercola

Patricide by the FDA on Homeopathy (3/19/18)
by Scott C. Tips
Whole Foods Magazine

Is the FDA Trying to Ban Over-The-Counter Homeopathy? (2/2/18)
by Larry Malerba, DO
GreenMedInfo

Comments by: National Health Freedom Action (NHFA) [Link no longer available] (3/8/18)
on Docket ID. FDA-2017-D-6580 – FDA DRAFT GUIDANCE Comments Drug Products Labeled as Homeopathic; Guidance for FDA Staff and Industry

American Institute of Homeopathy Accuses European Academies Science Advisory Council of Deliberate Scientific Bias (October 2017)
American Institute of Homeopathy

We encourage you to go to post your comments. You are also invited to share additional resources you have found relating to this issue.

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