December 19, 2017
In response to the U.S. Food and Drug Administration’s (FDA) draft guidance on homeopathic drug products released on Monday, December 18, 2017, the American Association of Homeopathic Pharmacists offers the following statement:
The American Association of Homeopathic Pharmacists (AAHP) shares the FDA’s commitment to protecting public health and applauds the Agency’s plan to take quick action against illegal or unsafe homeopathic medicines. In fact, the Association encouraged FDA to do just that in its comments at the regulatory body’s April 2015 workshop on the topic. The AAHP is confident that the current Compliance Policy Guide provides FDA with ample opportunity to take such action right now.
AAHP also notes that the draft guidance would not materially affect the vast majority of homeopathic drug products available in the United States, given these products’ wide margin of safety and manufacturing according to current Good Manufacturing Practices (cGMPs). The Association further underscores that the current Compliance Policy Guide 400.400 remains in effect.
AAHP looks forward to providing extensive comments to FDA on the new draft guidance during the open comment period. As always, AAHP is committed to ensuring that consumers have access to natural, safe, homeopathic medicines in the United States and throughout the world.
AAHP Communications Committee