FDA regulation of homeopathic medicines called effective

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SILVER SPRING, Md. — The Food and Drug Administration’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, according to the American Association of Homeopathic Pharmacists (AAHP).

AAHP, which represents 90% of the U.S. homeopathic market, made its observations Tuesday as part of a hearing called by the FDA to gather input on regulatory policy for homeopathic medicines. The association’s members include homeopathic manufacturers, distributors and pharmacists.

“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 health care needs,” AAHP president Mark Land stated.

At the two-day hearing, AAHP was joined by other industry leaders, practitioners and consumers of homeopathic medicines to engage in discussions with the FDA, which has regulatory oversight for homeopathic medicines.

As part of its presentation, AAHP reported that collectively its members reported sales of nearly $800 million, and growth of the category closely follows that of nonprescription drugs in general and is projected at less than 5% per year.

In the past 10 years, only nine monographs for new active homeopathic ingredients have been approved by the Homeopathic Pharmacopoeia Convention of the United States, instead of the 500 reported in the Federal Register notice of the FDA meeting, AAHP said.

AAHP also attested to the safety 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% of all pharmaceutical reports to AAPCC, which is proportionally below the rate of the market share for homeopathic medicines, the association said.

Under the authority of CPG, the FDA has taken swift and comprehensive action to address manufacturing and labeling issues in the marketplace, AAHP said, and the industry welcomes the opportunity to open a dialogue with FDA and recommends that the agency engage with homeopathic medical and pharmacy experts in this area.

“These discussions contribute to the FDA’s and industry’s public health mission and recognize consumers’ desire for more natural health care options,” Land added.



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