Speakers at FDA Hearing Praise Success of Homeopathic Regulatory Framework

Silver Spring, Md., April 20, 2015—The American Association of Homeopathic Pharmacists (AAHP) today told the U.S. Food and Drug Administration that the agency’s regulatory policy for homeopathic medicines has worked effectively for the last 25 years to protect the public health and provide consumer access to safe homeopathic medicines. AAHP, the industry’s trade association, was joined by other industry leaders, practitioners and consumers of homeopathic medicines to engage in productive discussions with the regulator of homeopathic medicines.

AAHP president Mark Land said, “We are confident that the majority of homeopathic drug products in the market are manufactured and labeled in substantial compliance with the Compliance Policy Guide (CPG) and the Food, Drug and Cosmetic Act, ensuring consumers have access to safe and clearly identified homeopathic products to choose from for their healthcare needs.”

FDA called a two-day hearing to gather input on the appropriate regulatory policy for homeopathic medicines. Representing 90 percent of the homeopathic market in the United States, AAHP presented the following key facts:

Collectively the associations’ member reported industry’s sales near $800 million, which aligns with market intelligence source Mintel’s 2013 estimate of $1 billion.

• Growth of the category closely follows that of non-prescription drugs in general and is projected at under 5 percent per year.
• In the past 10 years, only nine monographs for new active homeopathic ingredients have been approved by the Homoeopathic Pharmacopoeia Convention of the United States, instead of the 500 reported in the Federal Register notice of the FDA meeting.

Safety is a hallmark characteristic of homeopathic medicines. As reported by the American Association of Poison Control Centers (AAPCC), the number of exposures to homeopathic medicines in any given year is less than 1 percent of all pharmaceutical reports to AAPCC, which is proportionally below the rate of the market share for homeopathic medicines.

FDA’s current policy has a 25-year record of successfully providing FDA with broad enforcement authority while appropriately guiding the industry. Under the authority of CPG, FDA has taken swift and comprehensive action to address manufacturing and labeling issue in the marketplace.

As an industry, AAHP welcomes this opportunity to open a dialog with FDA and recommends that the agency engages homeopathic medical and pharmacy experts in this area. Land adds, “These discussions contribute to the FDA’s and industry’s public health mission and recognize consumers’ desire for more natural health care options.”