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 and should have little impact on most products that 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,” said Mark Land, AAHP president. “However, AAHP still feels its proposed additions to FDA’s first draft guidance also apply to the revised draft guidance and gives manufacturers, retailers, and regulators clarity to ensure consumer safety.”
A 2015 analysis of the inherent safety of homeopathic medicines showed that the number of exposures to homeopathic medicines in any given year is less than 1 percent of all pharmaceutical reports to American Association of Poison Control Centers, which is proportionally below the rate of the market share for homeopathic medicines.
The Compliance Policy Guide Sec. 400.400, “Conditions Under Which Homeopathic Drugs May Be Marketed,” has 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.
After meetings with the industry and consumers, FDA has released this revised draft for which it will be accepting comments for a 90-day period. Similar to the first draft, this revised draft outlines FDA’s priorities to exercise its enforcement discretion for homeopathic drugs based on risk, which is not much different from how the agency has exercised its enforcement discretion in the past.
The new 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 new revised draft, per the compendium’s acceptance by Congress since 1938.
For the revised proposed draft guidance, AAHP will prepare and submit comments to further clarify labeling and manufacturing quality guidelines by the deadline (possibly Jan. 22). Similar to comments for the first draft, AAHP will continue to ask FDA to incorporate key elements of the 1988 guidance regulating homeopathic products into the newly proposed guidance, such as:
Definition of What Constitutes a Homeopathic Product
- A product that contains active ingredients listed in the Homeopathic Pharmacopeia of the United States
- A product that is supported by references that describe appropriate homeopathic uses
- A product with documentation to support active ingredients that are not recognized in the HPUS as being homeopathic
- Products that contain a combination of a homeopathic and non-homeopathic active ingredients are not considered homeopathic
Last year for the first draft guidance, AAHP blasted email alerts to nearly 2.3 million consumers or health care providers through AAHP member companies’ databases, as well as through partners including the Alliance for Natural Health USA, American Institute of Homeopathy, the National Center for Homeopathy, the Organic Consumers Association, and other organizations—resulting in 38,000 letters flooding Capitol Hill. AAHP leaders and members also conducted approximately 80 in-sit appointments on Capitol Hill in the past two years to encourage Congressional members to amplify the homeopathic community’s message to FDA. As a result, one letter signed by five Senators and another letter signed by 10 Representatives were sent to FDA.
In general, AAHP views FDA’s revision and call for comments on a revised draft a welcomed continuation of the dialogue on the marketing of homeopathic over-the-counter drugs.
For more information about AAHP, visit aahp.info.
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.