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Samuel Hahnemann 1755-1843; originator of homeopathy

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The FDAs Proposed Draft Guidance for Drug Products Labeled as Homeopathic: A Statement by the Washington State Homeopathy Association
written by William Rogers II

The Washington State Homeopathy Association (WaHA) endorses the FDAs vital role in ensuring the safety and efficacy of all medications that are marketed to the public. The well established tradition of collaboration between the FDA and the homeopathic community of practitioners, pharmacists, and consumers has enhanced the health of the American public through ready access to authentic homeopathic medications in non--‐prescription formulations. By enforcing the proper preparation and labeling of these medications, the FDA past efforts have expanded and improved the options for self--‐care that are available to lay consumers.

Clear policies and equitable enforcement guidelines have prevailed for 30 years under the provisions of Compliance Policy Guide (CPG) 400.400. As the FDA looks to the future, we hope that the letter and the spirit of this long established and constructive regulatory approach will continue.

The publication by the FDA of recently issued Draft Guidelines* raises concerns that warrant further discussion:

  • How valid are claims that homeopathic remedies pose a unique challenge to public safety, especially since those claims may not have been reliably substantiated?

  • **Indeed, the preponderance of risk to consumers from self--‐prescribing is hardly confined to homeopathic medications, especially in vulnerable populations.*** Do the proposed draft guidelines thus represent equitable enforcement of the FDAs regulatory oversight?

  • Will the proposed draft guidelines effectively protect the public from the marketing of products that are inaccurately described as homeopathic as well as products in which homeopathic and non--‐homeopathic components have been improperly combined?

It is WaHAs position that the FDAs Draft Guidelines, as published in December 2017, do not sufficiently address these issues.

As we move forward, homeopathic practitioners, pharmacists, and consumers will be seeking assurances from the FDA that it will fulfill its mandated responsibilities equitably. It is our expectation that this will be demonstrated through specific and detailed regulatory enactments as well as consistent, transparent, and clear articulations of FDA policy  vis--‐a--‐vis homeopathic pharmacy practice.  Issues that will be important to the homeopathic community in assessing the FDA policies and enforcement priorities include:

(1) Are labeling and enforcement guidelines sufficiently stringent to prevent non--‐homeopathic medications from being marketed and sold as non--‐prescription, homeopathic medications?

(2) Are labeling and enforcement guidelines sufficiently stringent to prevent combination products with non--‐homeopathic components from being marketed and sold as non--‐prescription homeopathic medications?

(3) Are the standards for safety and efficacy applied equitably to homeopathic and non--‐homeopathic medications?

(4) Are enforcement measures pursued with equal and unbiased vigilance for homeopathic and non--‐homeopathic medications?

We join our colleagues in the homeopathic pharmacy industry as well as our patients in encouraging further discussion of these issues with the goal of preserving the atmosphere of constructive engagement that has legitimately enhanced the practice standards of homeopathy and the health of the public.

*Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services, Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry, December 2017. Marked Draft Not for Implementation.

**Lennihan B. Food and Drug Administration action against homeopathic teething tablets lacked evidence base. Published by Mary Ann Liebert, Inc., Publishers. Open access PDF version available on the World Wide Web at: https://www.liebertpub.com/doi/pdf/10.1089/act.2017.29148.ble

***Rimza ME, Newberry S. Unexpected infant deaths associated with the use of cough and cold mediations. Pediatrics. 2008 Aug;122(2):e318--‐22. doi: 10.1542/peds.2007--‐3813. Abstract available through the NCBI on the World Wide Web at: https://www.ncbi.nlm.nih.gov/pubmed/18676517


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