WAHA's position before the FDA

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Samuel Hahnemann 1755-1843; originator of homeopathy

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A Statement by the
Washington State Homeopathy Association
in Support of a Petition by

Americans for Homeopathy Choice

The Washington State Homeopathy Association (WAHA) endorses without qualification a petition regarding the regulatory status of homeopathy that has been submitted to the Food and Drug Administration by Americans for Homeopathy Choice.

In July of 2018, Americans for Homeopathy Choice (AFHC) formally petitioned1 the Food and Drug Administration (FDA), stipulating that:

  • The Commissioner of the FDA will issue a declaratory order finding that the petitioners (AFHC) have standing.

  • The FDA, under the provisions of the Food and Drug Cosmetic Act, will establish an expert advisory committee on homeopathy.

  • The Commissioner and the FDA will adopt the longstanding and effective Compliance Policy Guidance 400.400 (CPG 400.400)2, with minor revisions, as a regulation.

  • The proposed Draft Guidance “Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry”3 will be withdrawn.

  • During the time the FDA considers whether to publish a regulation governing the production and marketing of homeopathic remedies – and until such a time that AFHC’s petition is resolved – the FDA will continue to use CPG 400.400 as its guiding policy document for homeopathy.

  • If the FDA fails to grant AFHC’s petition, it will hold a public hearing on this matter before enacting the December 2017 guidance

Clear, coherent, and compelling rationales for these proposed measures are provided in AFHC’s petition, which offers a comprehensive and practicable strategy for the FDA’s ongoing regulatory oversight of the bona fide homeopathic remedies that are used by lay consumers as well as professional homeopathic practitioners.

     AFHC’s initiative comes at a time that, by any objective measure, should be promising for homeopathy. Increasing numbers of American consumers use homeopathy for the care of themselves and their families.4 Scientific studies continue to validate the beneficial effects of ultra--‐dilute substances – in vitro and in vivo – as, for example, reported in a study recently published in Nature Scientific Reports.5 The findings of this study contribute to a large and growing body of scientific evidence that substantially supports the practice of homeopathy, as amply documented in AFHC’s petition and elsewhere.6,7,8,9

In endorsing the provisions of AFHC’s petition, WAHA emphasizes that:

  • CPG 400.400 has provided essential and sufficient authority to the FDA for oversight of homeopathic pharmacy and practice for the past 30 years, ensuring both the safety and efficacy of homeopathic remedies for lay consumers and homeopathic practitioners.

  • The minor modifications to CPG 400.400 that are recommended by AFHC in its petition to the FDA enhance the letter and the spirit of this mutually beneficial arrangement while preserving its proven value as a policy guide.

  • FDA’s draft guidance “Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry (which the FDA has proposed to replace CPG 400.400) substantially undermines this longstanding collaboration, effectively depriving consumers and practitioners of bona fide homeopathic remedies.

  • The FDA’s rationale for this misguided change in its direction vis-­à-­vis the regulatory status of homeopathy depends, in part (and speciously), upon the proposition that the methods used to evaluate the safety and efficacy of allopathic medications can and should be applied to homeopathic remedies. Those methods are patently inappropriate for the evaluation of homeopathic therapeutics in that they ignore the precept of individualized prescribing. This precept is central to homeopathic practice, including informed self--‐care by lay consumers of over--‐the--‐counter homeopathic remedies.

  • Placebo-­controlled, double-­blind studies need not (and should not) be the mandated method for evaluating the efficacy of homeopathic remedies. Alternative research methodologies that are consistent with homeopathic methods of diagnosis and prescribing have been proposed.10, 11 These study designs warrant unbiased consideration by the FDA.

  • The FDA’s proposal to substitute a ‘draft guidance’ for CPG 400.400 depends upon a legally dubious mechanism, bypassing the usual and customary process for issuing binding regulations that have been duly vetted beforehand in accessible public forums.

     What is to be done? There is reason for optimism in the broad and growing coalition of lay consumers, homeopathic practitioners, professional organizations, and pharmacists who have rallied in support of AFHC’s initiative. With the timely mobilization of this impressive array of allies, the following immediate objectives warrant determined commitment and focused effort:

  • It is imperative to pursue any and all administrative and legal measures that are necessary to ensure durable and binding regulatory support by the FDA for the continued availability of bona fide homeopathic remedies.

  • The codification of CPG 400.400 as a regulation (with the revisions that are recommended in AFHC’s petition) remains the most expeditious and sensible path to this crucial objective. The FDA’s apparent intention to retreat from this longstanding regulatory position must be opposed – with vigorous and sustained legal challenges.

  • In whatever final form they may be implemented, the FDA’s policies vis-­à-­vis homeopathy must be formulated and articulated so as to discourage the possibility of further baseless and biased challenges to the practice of homeopathy and the marketing of bona fide homeopathic remedies. Homeopathy must be acknowledged explicitly in the FDA’s regulatory policies as a valid and legally sanctioned option for consumers of health care products.

  • Accordingly, the legal status of the Homeopathic Pharmacopoeia of the United States (HPUS) must be reaffirmed. The FDA must develop guidelines that ensure the future utility of HPUS in its oversight of new as well as existing homeopathic remedies.

  • Research methods and standards that are appropriate for homeopathic diagnosis and prescribing must be promulgated by the FDA and used in the FDA’s evaluation of homeopathic remedies. Provings must continue to be recognized as a method of research that is valid for evaluating new homeopathic remedies.

     We are grateful for AFHC’s due diligence in elaborating these and other important objectives in their petition. In offering our unqualified endorsement, WAHA applauds AFHC’s courage in contesting the most recent challenge in a long, counterproductive, and increasingly byzantine series of bureaucratic maneuvers that pose existential threats to the practice of homeopathy.12,13

     Apart from addressing specific points of contention that have arisen in response to the FDA’s proposed program of selective, “risk based” enforcement, it remains to be reaffirmed by all concerned that the practice of homeopathy is valid and valued:

…[I]t is also undeniable that qualified and dedicated physicians have continued to follow the same [homeopathic] principles and to practice medicine in accordance with them for more than two hundred years, and now do so on every continent and in most countries of the world. In the face of determined opposition, general ridicule, and the sacrifice of more prominent and lucrative careers for their sake, the mere fact that homeopathic medicine has survived intact for so long and even continued to grow and develop under such adverse conditions is already more than sufficient answer to the militant conviction of the quackbusters that it is a delusion and nothing more, and indeed suggests precisely the opposite conclusion. For no matter what mode of treatment we prefer to use, every practicing physician knows and must live by the obvious truth that our reputations and livelihoods depend on the extent to which our patients are benefited by our efforts on their behalf.14

     Integrity should be the preeminent, guiding principle in the FDA’s oversight of homeopathic pharmacy, governing its internal and external deliberations and overriding misguided, scientistic claims that are spuriously based on ideology rather than experience. We call upon the FDA to act swiftly and fairly in response to AFHC’s petition by adopting permanent regulatory policies that guarantee the ongoing availability of authentic, proven homeopathic remedies for the foreseeable future.


1Citizen Petition from Americans for Homeopathic Choice. Dated July 25, 2018. Posted at: link to document.

2CPG Section 400.400 Conditions Under Which Homeopathic Drugs May be Marketed. Issued May 31, 1988; revised March 1995. Posted at: link to document.

3Center 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.” Posted at: link to document.

4Dossett M, Davis R, Kaptchuk, T, et al. Homeopathy use by U.S. adults: Results of a national survey. American Journal of Public Health. 2016;106;743--‐745. Posted at: link to document.

5Shital M, Nayak D, Mahajan U, et al. Ultra--‐diluted toxicodendron pubescens attenuates cytokines and ROS--‐ mediated neuropathic pain in rats. Nature Scientific Reports. 2018; 8;Article number: 13562 (201}. Posted at: link to document.  

6Bell IR, Koithan M. A model for homeopathic remedy effects: Low dose nanoparticles, allostatic cross--‐ adaptation, and time--‐dependent sensitization in a complex adaptive system. BMC Complementary and Alternative Medicine. 2012;12:191. Posted at:  link to document.

7Bell IR, Schwartz GE, Frye J, Sarter B, Standish LJ. Extending the Adaptive Network Nanomedicine Model for Homeopathic Medicines: Nanostructures as Salient Cell Danger Signals for Adaptation. Nanoscience and Technology. 2015;2(1):1--‐22. Posted at: link to document

8Bell IR, Muralidharan S, Schwartz GE. Nanoparticle Characterization of Traditional Homeopathically--‐ Manufactured Silver (Argentum Metallicum) Medicines and Placebo Controls. Journal of Nanomedicine and Nanotechnology. 2015;6:311. Posted at: link to document.

9Bell IR, Gold P, Sullivan ML (Compilers). Homeopathy Research Evidence Base: References 2017. Posted by the American Institute of Homeopathy at: link to document.

10Moskowitz R. Homeopathy lives! American Journal of Homeopathic Medicine. 2018;11(3):7--‐11.

11Bell IR. The evolution of homeopathic theory--‐driven research and the methodological toolbox. American Homeopath. 2008;14:56--‐74. Posted here: link to document.

12Whitmont, RD. President’s message. American Journal of Homeopathic Medicine. 2018;11(1):4--‐5. 13Saltzman, S. Homeopathy and the FDA. American Journal of Homeopathic Medicine. 2018;11(1):6--‐7. 14Moskowitz R. Homeopathy lives! American Journal of Homeopathic Medicine. 2018;11(3):8.

Last updated: November 15, 2018

 

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