Survey of Members Concerns Reviewed at Annual Membership Meeting

By Mark Land, M.S., RAC-US, AAHP President

The turbulent nature of the legal and regulatory environment in general over the past several years and, more pointedly, with the arrival of the second Trump Administration motivated AAHP’s board of directors to ask the question: What are the most pressing legal and regulatory issues facing AAHP members today? Prior to our March 21 Annual Membership Meeting, a survey of members was conducted for this purpose.

Survey Questions

The survey of 11 questions broadly asked about the ease or difficulty navigating current regulatory environment, before asking specifically for the top two most pressing legal and regulatory issues. Most of the questions were open-ended and asked for AAHP manufacturing members to briefly explain problems (if any) and propose solutions about:

• FDA facility/remote inspections
• FDA’s use of the term: “unapproved new drug”
• Existing/potential class action and/or lawsuit activity
• Other legal or regulatory issues

Some Findings Voiced by Manufacturing Members

The top reason homeopathic manufacturers receive FDA Warning Letters is due to current Good Manufacturing Practice (GMP) issues. As such, the membership continues to support the multi-year development of GMP requirements specific to homeopathic manufacturing in instances where existing allopathic GMPs cause confusion among manufacturers and FDA inspectors. The Homoeopathic Pharmacopoeia Convention of the United States, the standard setting organization, has been building a positive relationship with FDA by soliciting and reviewing the agency’s comments on the draft GMP White Papers. Clarity here would reduce warning letters and help ensure drug quality.

When asked if guidance, regulation or legislation would be best to effect a change in the regulatory framework, it was noted that guidance would be the most practical solution — specially as stated above, to address unique aspects of testing and manufacturing of homeopathic products.

Another theme was that the change in how FDA refers to the legal status of homeopathic drugs despite the status remaining the same for decades. This language change destabilizes the retail setting and attracts frivolous but costly lawsuits. A solution is for homeopathic drugs to be referred to as “non-application” products rather than “unapproved” or “illegal” drugs. FDA itself is the origin of the non-application nomenclature.

2025 Priorities

AAHP will continue supporting HPUS’s GMP White Papers and investigate a campaign to make a language change. These solutions would be scientifically defensible and affordable for FDA to implement, and therefore the best use of AAHP’s resources to ensure public safety and access to quality products; safeguard the reputation of homeopathy; and maintain a level playing field among competitors.