Friends Newsletter

Dear Friends, 

It has been nearly a year since the fourth Friends Newsletter was sent to you. Time passes so quickly, even though it may sometimes seem glaringly slow.  This edition will include highlights from the April 2026 meeting of the Board of Directors, an update on the White Paper Project, notification of a Strategic Planning initiative, and, lastly the effort to set ANSI-compliant voluntary Consensus Standards for Homeopathic Products.

Changes at the HPCUS  Board of Directors 

The Board of Directors met in mid-April. I stepped down as President of the HPCS after six years in office.  I will remain on the Board and devote more time to the activities of the Community Relations Committee (recruitment for future leadership and clinical subject matter expertise, managing the Friends program, and, importantly, participating in the NSF Joint Committee on setting ANSI-compliant standards for Finished Homeopathic Drug Products (more on that below).   

 The Convention accomplished a lot during that time, which required a team effort from many members.  For a review, click here. 

Todd Hoover, MD, D.A.B.H.M will replace me.  His experience and skills make him well-positioned to continue developing and publishing the HPUS, and to meet the various challenges that we continue to face. 

Sandra M. Chase, M.D., D.A.B.H.M. has left the Board of Directors after 40 years of service to the Convention.  She has made many other important contributions to Homeopathy.  Please read the Tribute to Sandra Chase M. Chase, D.A.B.H.M  to learn more. 

We added Richard Lostritto, Ph.D., to the Board of Directors.  He is a pharmacist by training, did post-graduate research in nanoparticle chemistry, and worked at the FDA in the product quality division until he retired in 2022.  His participation as a consultant in our White Paper project was invaluable.   

A complete list of the Board of Directors can be found by scrolling down the page at https://www.hpus.com/document/hpcus-and-hpus-basics/  
 

White Paper Project Update – Around mid-October 2024, we sent the final draft of three White Papers to the FDA along with a request for a meeting with their technical staff.  They immediately acknowledged receipt and referred the matter for internal review.  The Presidential election happened 2-3 weeks later, and we have since been unable to schedule a meeting. 

Accordingly, the HPCUS Board of Directors has instructed the Convention’s Council on Pharmacy to begin drafting language operationalizing the principles embedded in the White Papers within our Guidelines for manufacturing Homeopathic Drug Products.  We expect this to take about a year.   

A relatively non-technical introduction to the White Papers can be found here. 

A summary of each of the papers can be found here. 

Strategic Planning —  While “planning” is a problematic concept in the currently volatile and uncertain climate (including economic, political, social, and existential risks of climate change), it remains necessary to understand the present and how the Convention will maintain its leadership and technical expertise to continue as one of the “anchors” of the availability of homeopathic medicines in the United States.   

We have begun a formal process and will continue to report in future newsletters. 

NSF Joint Committee – the following contains many acronyms and a complicated web of organizations with many links.  I will try to summarize the story: 

Originally known as the National Sanitation Foundation, NSF has become an ANSI-accredited “American Standards Developer “ASD, and supplies its expertise around the globe.NSF’s areas of standards include dietary supplements and also include standards related to many sectors of the commercial, technical, and other aspects of life today. 

ANSI is the American National Standards Institute.  In turn, ANSI is the American arm of ISO, the International Standards Organization. 

From the ISO website: “International standards ensure that the products and services you use daily are safe, reliable, and of high quality. They also guide businesses in adopting sustainable and ethical practices, helping to create a future where your purchases not only perform excellently but also safeguard our planet. In essence, standards seamlessly blend quality with conscience, enhancing your everyday experiences and choices.” Bold type emphasis is mine. 

NSF was contacted by the National Homeopathic Products Certification Board (NHPCB, operating as a semi-autonomous part of the American Institute of Homeopathy), for the purpose of creating “voluntary consensus standards” for Finished Homeopathic Drug Products.”  The original idea was to create a “seal of approval” certifying that a given manufacturer’s final product was made with appropriate methodology and quality controls. The NHPCB met with the Food and Drug Administration in the summer of 2022 and proposed to set such standards.  The FDA was supportive of this effort, if it was done in an ANSI-compliant way.   

To understand what this means, please see https://www.ansi.org/american-national-standards/ans-introduction/essential-requirements.  In brief, the requirements are met if all stakeholders have a say in the creation of such standards, no one interest group (manufacturers, consumers, regulators, and public health / regulatory representatives) should have dominance, the interest groups are similar in size, and there needs to be an appropriate appeals process.   The committee must arrive at a consensus (at least a 2/3rds majority) for the final approval of standards.  JC members not in agreement can submit comments for NSF’s upper-level review. 

As an ANSI-certified American Standards Developer, NSF is one of several organizations that can create and conduct Joint Committees, composed of individuals with expertise and interest in the standards under consideration. 

The NSF’s description of the Purpose, Scope, Rationale, and Limitations of the Joint Committee is critical to understanding the project.  

The draft standards NHPCB presented to the Joint Committee can be found here. 

In a process expected to take approximately two years and many meetings, a successful result will be the creation of “Voluntary Consensus Standards.” Those standards are then evaluated by the Council of Public Health Consultants, which also appoints the chairperson of the Joint Committee.  The Council reviews the proposed standards for their impact on public health and reports directly to NSF, whether approving or not. In the latter case, the reasons for disapproval must be specified. 

Final approval rests with NSF itself, and if approved, the Standards are published by NSF. Any manufacturer can apply to any 3^rd party certifier for an audit and inspection of their facility for a product-specific seal of quality.  NSF is one of several 3^rd party certifiers. 

The US Government encourages its agencies, including the FDA, wherever possible and practical, to adopt such created voluntary standards.  While it is not mandatory for an agency to do so, if it so chooses, it must submit its rationale to the Office of Management and Budget.  The FDA’s process can be found here.  The document sets out specific reasons that the agency may use to decide against adoption. 

All members of a Joint Committee must apply for membership and be approved by the Chairperson.  Many of the members have either technical experience, regulatory experience, or are users (practitioners and consumers).  They may be affiliated with various organizations and businesses, but members serve as individuals, and not as representatives of the groups with which they are affiliated and have thereby gained experience and expertise.   

The Joint Committee currently has 55 members, 24 of whom are voting members, and 31 are “observers.”  Other than the privilege of voting, observers have full participation in all meetings. 

There are nine (out of fifty-five total members) with affiliations with the Convention, although some are listed with other affiliations and interest groups.  Out of 24 voting members, five Convention members serve on the committee.  In meetings and discussions so far, we have taken an active role in sharing our knowledge and expertise. 

The Homeopathic Products Purpose, Rationale, Scope, and Limitations, as detailed by NSF can be found here and are used with Permission of NSF. 

One note regarding point 1 in that document – as an “Official Compendium” listed in the Food, Drug, and Cosmetic Act of 1938 (and all subsequent amended versions), the HPUS has the legal authority to establish and publish standards for a medicine’s identity, strength, quality, and safety.  The HPUS’s standards are not, however, ANSI compliant, as set forth here.   

In its present form, the 1938 FD&C Act names two Official Compendia – the HPUS and the USP.  In and of themselves, neither compendium’s Good Manufacturing Practices (GMPs) were derived from an ANSI-compliant process.   

An AI-generated response gives a sense of how many USP GMPs became formal regulations with statutory authority: 

[Begin AI-generated section] 

The FDA’s adoption of formal Good Manufacturing Practice (GMP) regulations was catalyzed by tragic public health crises rather than a direct translation of United States Pharmacopeia (USP) guidelines. Today, USP and FDA standards work in tandem, but their historical development is distinct. [1, 2, 3] 

The Path to Formal GMP Regulation 

The transition from voluntary standards to strict, government-enforced regulations occurred in several stages: 

• 1938 Federal Food, Drug, and Cosmetic (FD&C) Act: Spurred by the 1937 Elixir Sulfanilamide disaster (which killed over 100 people), Congress required manufacturers to prove drug safety before marketing. It also authorized factory inspections, but did not define detailed manufacturing methods. [1, 2, 3, 4, 5] 

• The 1941 Sulfathiazole Crisis: Nearly 300 people died or were injured due to contaminated tablets from Winthrop Chemical Company. Investigations revealed massive manufacturing and quality-control deficiencies. This incident pushed the FDA to begin actively defining minimum manufacturing controls. [1] 

• 1962 Kefauver-Harris Amendments: Traced directly to the global Thalidomide tragedy. Congress amended the FD&C Act to require proof of both safety and efficacy. Crucially, these amendments formally authorized the FDA to establish and enforce mandatory Current Good Manufacturing Practice (cGMP) regulations and conduct regular facility inspections. [1, 2] 

• Formalization: In 1963, the FDA published the first formal, codified GMP regulations in the Code of Federal Regulations. These regulations evolved over time, resulting in the comprehensive cGMP rules found today in 21 CFR Part 211. [1, 2, 3, 4, 5] 

• The USP vs. FDA Relationship 

• The USP and the FDA historically serve complementary, not identical, roles in drug quality: 

• USP’s Role: Established in 1820, the USP is a private, non-profit organization. It sets the official public standards (monographs) for drug identity, strength, quality, and purity. [1, 2, 3, 4, 5] 

• Legal Integration: Since the 1906 Pure Food and Drugs Act and the 1938 FD&C Act, Congress has designated the USP as an official compendium of the United States. If a drug is listed in the USP, it must comply with USP standards; otherwise, it is considered legally adulterated or misbranded. [1, 2] 

• Regulatory Compliance: While the FDA enforces USP testing and quality standards, the FDA’s cGMP regulations dictate the processes, facility conditions, and systems used to manufacture the drug. [1, 2] 

• Ultimately, rather than directly adopting USP guidelines as formal GMP regulations, the FDA absorbed the broader principles of industrial quality control in response to early 20th-century tragedies. The agency used its newly granted 1962 regulatory authority to build its own cGMP regulations, which work alongside the USP’s chemical and testing standards. [1, 2, 3] 

[End of AI-generated section] 

A 2025 Brookings Institution research paper on rethinking manufacturing quality oversight for prescription drugs compares the European and American regulatory systems and identifies inherent problems. 

The Friends newsletters will continue to report on the Joint Committee’s progress.  We consider this effort especially worthy of close attention from the larger homeopathic community. Please encourage your friends and colleagues to join us.  They can find out more about the program by clicking here, and joining at the registration page.