FEATURED ISSUE
Is homeopathy doomed in the U.S.?
Are you one of the nearly seven million U.S. residents who use homeopathic remedies in your personal health care? If so, this is to alert you to upcoming anticipated changes in the accessibility of these products.

Homeopathic medicines were intended to be grandfathered into the Food, Drug, and Cosmetic Act of 1938, a federal law, but with an exemption from the usual new drug approval process. Instead homeopathic medicines are required to undergo pre-market approval with a monograph from the Homeopathic Pharmacopoeia of the United States, which involves some clinical verification of the efficacy of the substance. In 1988, the U.S. Food and Drug Administration (FDA) issued a Compliance Policy Guide titled “Conditions Under Which Homeopathic Drugs May be Marketed.” This was withdrawn in 2019 and replaced with a draft guidance titled “Drug Products Labeled as Homeopathic.” While this guidance, which was finalized 12/6/22, labels the text as “Contains Nonbinding Recommendations,” in practice, a guidance is in fact binding and must be followed, it is more difficult for the public to challenge it legally.

The new 2022 FDA guidance states:

• Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug;
• FDA has not determined that any homeopathic drugs are GRAS/E;
• A new drug cannot be marketed unless it goes through the FDA’s approval process;
• No homeopathic drugs have gone through FDA approval.

One omission of concern to the homeopathic industry is that the new guidance document does not provide manufactures with clear direction and standards for marketing homeopathic products, which were in the 1988 guide. Might this be contributing to the headlines that every homeopathic medicine on the market is now illegal? Are we to believe those that predict that it is just a matter of time until homeopathic products will not be available in the U.S., but we just don’t know how quickly this will happen? Might there still be time to slow down or stop this latest FDA action? What we do know for sure is that the FDA now holds the rights to take enforcement action against any homeopathic product it chooses.

Issue: What is the future of homeopathic medicines in the U.S.?

AHHA strives to maintain a neutral position on issues and views knowledge as power. For those interested in this month’s issue, we are providing you with articles to help you understand that there are two divergent views of an ancient healing option and its safety for the American public.

PRO Homeopathy
General Homeopathy FAQs
American Association of Homeopathic Pharmacists

CON Homeopathy
Homeopathy: What You Need To Know
National Institutes of Health – National Center for Complementary and Integrative Health

FDA’s latest position on regulating homeopathy
FDA News Release: FDA Roundup (12/6/22)
U.S. Food & Drug Administration

Homeopathic Products (12/7/22)
U.S. Food & Drug Administration

Homeopathic Drug Products Guidance for FDA Staff and Industry (December, 2022)
U.S. Food & Drug administration

Industry concerns about FDA’s position on regulating homeopathy
FDA Finalizes Homeopathic Guidance (12/12/22)
by Alissa Gould
American Association of Homeopathic Pharmacists

Explaining the FDA’s New Homeopathy Policy (12/15/22)
Alliance for Natural Health USA

Urgent Action: FDA Plans to Ban Homeopathic Medicines (12/2/22)
by Michelle Edwards
UndercoverDC

You are also encouraged to go to our blog at ahha.org/blog and post your comments.

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