MILWAUKIE, Ore., Oct. 25, 2019 — Yesterday, the U.S. Food and Drug Administration (FDA) released a revised draft of a proposed guidance on homeopathic drugs and officially withdrew the 1988 Compliance Policy Guide as expected. The American Association of Homeopathic Pharmacists (AAHP) is pleased that the proposed new guidance continues to recognize the same legal status of homeopathic drugs as established in 1962 and should have little impact on the majority of products which are manufactured and marketed properly.
“AAHP supports FDA protecting public health through enforcement efforts on any products that do not meet manufacturing standards, contain substances in harmful concentrations, or are offered over the counter for prescription indications,” says Mark Land, AAHP president. “However, for continued consumer safety, key elements of the former guide be incorporated into the guidance.”
Recent History of Regulatory Activities
The Compliance Policy Guide Sec. 400.400, “Conditions Under Which Homeopathic Drugs May Be Marketed,” governed the industry since 1988. In 2015, FDA held a public hearing on homeopathy due to the rising popularity and consumer demand for these beneficial medicines. After receiving more than 9,000 supportive comments, FDA released its first draft of a new guidance in December 2017, which was intended to replace CPG 400.000. Now after meetings with the industry and consumers, FDA released a revised draft for which the agency will accept comments until March 23, 2020.
CPG vs. Draft Guidance and Revision
Similar to the first draft, this revised draft outlines FDA’s priorities to exercise its enforcement discretion for homeopathic drugs based on risk. This is not much different from how the agency exercised its enforcement discretion in the past.
The revised draft, however, adopts AAHP’s recommendation to define homeopathic drugs in a way that minimizes the risk of rogue products entering the market. The Homeopathic Pharmacopeia of the United States (HPUS) is included as an official reference in this revised draft, per the compendium’s acceptance by Congress since 1938.
AAHP will continue to request other practical specifications from the 1988 guide be incorporated into the draft guidance. Such specifics will offer manufacturers, retailers and regulatory clarity and promote compliant products. AAHP members companies are urged to contact the association with comments to present a unified industry voice to FDA.
AAHP’s viewpoints are based on substantive talks with several FDA personnel, including the director of the Office of Manufacturing Quality, who served as the keynote speaker at the AAHP Summit in Baltimore in June 2019. The Summit led to engagement with FDA’s Office of Compendial Affairs to identify and solve technical gaps. During the past two years, AAHP educated Capitol Hill staff through 80 sit-down appointments. And in 2018, the association’s grassroots campaign flooded the Hill with 38,000 letters. As a result, AAHP’s request was amplified to FDA through one letter signed by five Senators and another letter signed by 10 Representatives.
“FDA’s revision and call for comments on a revised draft is a welcomed continuation of the dialogue on the marketing of homeopathic over-the-counter drugs,” says Land.
Founded in 1923, the American Association of Homeopathic Pharmacists (AAHP) is the leading industry association for the manufacturers, distributors and marketers of homeopathic drugs. AAHP promotes excellence in the practice of homeopathic pharmacy, manufacturing, marketing and distribution by supporting the requirements, criteria and published guidelines in the HPUS, relevant Federal statutes, as well as other industry regulations/compendia — all to help members provide safe, effective homeopathic medicines to consumers, retailers and healthcare practitioners.