The AAHP held the annual membership meeting in Mid-March. The largest number of people attended this meeting than any other in the association’s history. In his welcome, President Land noted this is the 100th anniversary year of the AAHP. Mr. Land reported the association is active on many fronts including: hosting an Annual Executive Conference; outreach to allied organizations in other countries; launching a revamped website; retailer regulatory briefings; AAHP Industry Reception and Award Presentation.
Our Congressional education campaign reactivated after COVID-19 had closed off Capitol Hill. With a Congressional position paper and list of key Congressional offices, AAHP met virtually with health staff in ten offices, providing staff with invaluable insights into key elements affecting access to the medicines of choice for many of their constituents.
The monthly newsletter and special alerts continued to provide needed information. Some of the four dozen articles covered: FDA’s Production Quantity Reporting requirements; the agency’s Consumer Update on Cough/Cold products; the publication of the finalized FDA Guidance on homeopathic products; AAHP Top Honor to Grocer H-E-B; spotlights on a number of specialty pharmacies.
The AAHP welcomed new members Aphena Pharma Solutions, the National Center for Homeopathy, and two individuals. Two more companies and a third individual are completing their membership submissions in the coming weeks.
The highlight feature of our 100th Anniversary Celebration will be a commemorative document entitled, “AAHP: 100 Years of Promoting Quality, Integrity, and Trust in Homeopathic Medicines.” It portrays the past, current, and future of homeopathy and AAHP. The document provides a history timeline of homeopathy in the U.S. and an overview of homeopathy’s growth and influence around the world. During the annual meeting, attendees were treated to the kick-off presentation of the companion slide presentation that accompanies this paper; this was well received.
AAHP Legal Counsel, Al Lorman’s talk focused on the impact of the finalized FDA guidance on homeopathy which asserts FDA's position that all homeopathic drugs are unapproved new drugs, which is similar to FDA's guidance on the continued marketing of prescription unapproved new drugs. But the change in tone is very noticeable and is, quite possibly, the most important change FDA made.
Mr. Lorman reported that, excepting one action taken against parenteral homeopathic products, FDA has not acted against any other priority in the new guidance. All regulatory activity has been focused on lapses in good manufacturing compliance on the part of recipient companies.
Another event to make note of was FDA’s denial of the Americans for Homeopathic Choice Citizen Petition. In doing so, the agency’s positions are: an HPUS monograph does not mean the active ingredient has been found to be safe and effective under the law; a determination that a homeopathic drug is GRAS and GRASE cannot be made solely by experts in homeopathy; it would not recognize all homeopathic drugs as grandfathered under the Act.
Further FDA actions to be aware of are FDA’s request to Congress for a variety of legislative changes, several of these requests could impact homeopathic manufacturers; a recent article int eh AAHP’s newsletter details these. FDA has also posted four Warning Letters involving homeopathic drugs in the last six months.
In December 2022, the Federal Trade Commission released a lengthy guidance document on the substantiation it expects for health claims, Health Products Compliance Guidance. Despite not specifically mentioning homeopathic products, this guidance applies to homeopathic products as well as most other health products. The new guidance notes it represents the FTC’s position on the law, not the law itself. Nonetheless, it is useful to take a quick look at the new guidance (available here). The new guidance provides an excellent review of how the FTC approaches both the analysis of what claims an ad makes as well as how to substantiate those claims. As to products which rely on “traditional use,” the prominence of the disclaimer will be key in any FTC review of its adequacy.
Pete Evich, AAHP’s lobbyist presence on Capitol Hill provided an update on the make-up of the committees of jurisdiction following the 2022 elections. With the new Committee rosters set, the AAHP has developed an engagement prioritization list including several members who serve on the Senate HELP and House Energy & Commerce committees, plus other strategically selected lawmakers who either have - or appear to show - a propensity to support homeopathic and consumer access and choice to integrative health products.
AAHP’s legislative efforts will focus on enhancing our visibility, building relationships, and developing greater support for homeopathy on Capitol Hill as well as discussing the impact of the FDA’s homeopathic guidance document While divided government and partisanship is likely define much of the next two years, there are opportunities for bipartisanship through the reauthorization of programs
FDA is seeking new legislative authority from Congress which could affect homeopathic Manufacturers. This includes a proposal to require manufactures of non-application drugs (finished dosage forms and active pharmaceutical ingredients (API)) to provide the agency time to use a risk-based approach to determine if an inspection of the manufacturing facilities is necessary before the drug can be distributed, and to conduct the inspection if it is necessary. FDA is also wants to require manufacturers to identify the suppliers they relied on. And the agency wants its mandatory recall authority to be expanded to encompass all human and animal drugs.
As a part of the Annual Meeting, elections for the Board were conducted. Mark Phillips, who is stepping down from the Board, was thanked for more than 20 years of tireless service, including 15 consecutive years as treasurer! In addition to the four other members whose terms ended, two other members were nominated for the five available Board seats. The result of the balloting brings to the association a new composition on the Board of: Travis Borchardt (of Nature’s Way / Schwabe), Mary Borneman (of Hylands Naturals), Tim Clarot (of Church and Dwaight), Eric Foxman (conulstant), Mark Land (of Boiron), Guillaume Lois (of Sevene), Robert Melo (of OHM Pharma), Dan Quail (of Similasan), Paul Sprankle (of Washington Homeopathic Products).
Please join with the Board in welcoming Paul as your newest Board member. The following is a brief introduction in Paul’s own words:
I have been working in the homeopathic industry for over 20 years. I started this path in 2000 working at Washington Homeopathic Products. I have worked in all areas of the business, from customer service, to manufacturing, and now in the quality unit as Facilities Operations Specialist.
My current duties include overseeing the maintenance program and developing and executing equipment, cleaning, and process validations.
I wanted to become a board member to represent a small homeopathic manufacturing company. I have experienced the challenges that a small company faces from regulatory agencies. I look forward to bringing this perspective to the board.