FEATURED ISSUE
FDA now handling homeopathic remedies as drugs
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 larger doses of those same substances in healthy people. Practitioners of homeopathy explain that it works because the “substance” becomes so diluted that only its energy is left. For this reason, homeopathy has generally been viewed for centuries as one of the safest treatment options available. Some note, however, that it is important that patients requiring more aggressive and time-sensitive therapies should not be dissuaded from considering other therapies.

AHHA first alerted you in 2015 to the U.S. Food and Drug Administration’s (FDA’s) reevaluation of the homeopathic industry. This issue has now progressed to the FDA’s considering the potential risk of homeopathic remedies and requiring pharmaceutical drug-safety testing requirements.

On October 25, 2019, the FDA published a revised draft guidance titled “Drug Products Labeled as Homeopathic” and asked for public comments. This document, like the original 2017 version, prioritizes enforcement and regulatory action of homeopathic biological products that potentially pose higher risk to public health marketed in the United States without the required FDA approval. Further,homeopathic medicines are designated “new drugs” because they have not undergone the FDA’s required pre-market testing. Note that the comments period for this document ends on January 23, 2020.

Additionally,  as of October 25, 2019, the FDA withdrew their 1988 compliance policy guide (CPG) titled “Conditions Under Which Homeopathic Drugs May be Marketed.” This documenthad linked compliance to homeopathic industry standards rather than FDA approval. Therefore, according to the FDA, homeopathic remedies are drugs that are being marketed illegally  andare subject to FDA enforcement action, perhaps as soon as a few months after the draft guidance comments period ends in January.

There appear to be three groups taking positions on this issue. (1) One group supports the FDA viewpoint that homeopathic remedies are an untested danger and should be handled as drugs. (2) A second group disputes the possibility of patient and consumer risk and points to a long history of homeopathic safety, citing that the costs of pre-market compliance required for testing to meet FDA requirements are unrecoverable and burdensome for non-patentable homeopathic remedies, which likely prices them out of the U.S. marketplace. The third group feels they have compromise revisions to the 2019 draft guidance version that would allow for the continuance of the homeopathic industry in the U.S. This latter group feels more time is needed for these proposed compromises to be considered and is campaigning to extend the comments period beyond the current January 23, 2020, deadline.

ISSUE: How to handle homeopathic product safety in the U.S.?

AHHA strives to maintain a neutral position on issues and viewsknowledge as power. For those interested in this month’s issue and learning more about this topic the articles below were selected to offer you some resources to begin your research.

PRO FDA approach
Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products (10/24/19)
U.S. Food and Drug Administration

Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry (10/25/19)
Federal Register
[posted 10/25/19; comments due by 1/23/20]

The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of Compliance Policy Guide Sec. 400.400 (CPG 400.400) entitled “Conditions Under Which Homeopathic Drugs May be Marketed,” which was issued in 1988. (10/25/19)
Federal Register

FDA to Prioritize Enforcement Actions Against Unapproved Homeopathic Drugs (11/27/19)
JD Supra

AGAINST THE FDA approach
Access to Homeopathy Threatened by Latest FDA Action
American Institute of Homeopathy

Tell the FDA That We Will Not Tolerate the Abolition of Homeopathic Medicine in America!
National Health Federation

FDA Renews Attack on Homeopathy (11/21/19)
Alliance for Natural Health USA

Homeopathy Remains at Risk
Americans for Homeopathy Choice

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