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As the number of people using homeopathic medicines has increased, the FDA has appropriately paid more attention to its regulations for "Good Manufacturing Practices" and their enforcement. Internationally accepted guidelines for the manufacture of all drugs have always required that all manufacturers have adequate quality systems. Such systems are expensive and require rigorous ongoing documentation.

FDA’s regulatory standards have evolved with changes in pharmaceutical science and technology. Those standards are appropriate for conventional drug products. However, they can be problematic when applied to certain unique aspects of homeopathic drug manufacturing. In response, the Convention has expanded its efforts to harmonize with those standards of FDA which are appropriate, while continuing to preserve the uniqueness of homeopathy.

The Convention’s volunteers all have expertise in aspects related to homeopathic drug product manufacture and use. The above challenges have created a need for hiring outside consultants with other expertise to address our ongoing work with the FDA. However, this need coincides with a decrease in outside funding that previously supported such efforts.

The overall homeopathic industry has seen remarkable shifts in the makeup of firms actively engaged in producing homeopathic drug products, with a more than 50% change in companies during the last 5-7 years. More companies are marketing and fewer are manufacturing. One hidden result has been a loss of capacity in the manufacturing sector which impacts the consumer's access directly because it creates a lack of availability of some products. It affects the Convention due to a loss of firms subscribing to the HPUS. In addition, it results in a smaller pool of expertise within the industry that can provide meaningful information and ideas for issues affecting the Convention.

The Center for Inquiry (https://centerforinquiry.org/) is a very well-funded, self-styled consumer advocacy group that publicly opposes homeopathic medicine. Among other efforts, they file a variety of lawsuits whose goal is to deny millions of Americans the right to choose homeopathic medicines. Defending these suits drains significant time, energy, and money from manufacturers and the HPCUS that could be better used to promote health through homeopathy. Other lawsuits, as well as FDA actions against manufacturers, target the quality of homeopathic products. The HPCUS publishes guidelines for quality manufacturing. We work in good faith with the FDA to create science-based rational guidelines that are achievable for manufacturers and enable the FDA to fulfill its duty to the American people to ensure that our medicines are safe.