Homeopathy Update from the AANP
"A recent flurry of action alerts circulated last week, warning that the FDA is about to pull certain homeopathic products from the market, maybe as early as January. At issue is new draft guidelines that the FDA has proposed which would make some changes to the way the agency approaches enforcement of homeopathic medications.
While the FDA’s draft guidelines do have some significant problems, it is our opinion - after having consulted with homeopathic leaders in the naturopathic profession, the American Association of Homeopathic Pharmacists (AAHP), Boiron, and the AANP’s FDA attorney - that the new guidelines will have minimal impact on the vast majority of homeopathic substances and will not have a significant impact on the way most naturopathic doctors practice homeopathy.
An October 2019 statement released by the AAHP states “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,” and “the 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.”
There are many “homeopathic” products sold in the marketplace which do not adhere to good manufacturing processes, may be adulterated or combined with non-homeopathic substances, and may not in fact be homeopathic at all. The FDA is asking the homeopathic pharmaceutical industry to improve it’s compliance efforts in order to ensure that poor quality (or super-potent attenuations) products do not reach the market for public safety. Better enforcement to ensure that homeopathic products are properly manufactured and marketed is something that the AANP has previously supported.
However, the draft guidelines can definitely be improved, and the AANP, along with many others, is encouraging the FDA to provide more clarity to avoid confusion regarding the regulation of homeopathic substances and to prevent a biased system from overreaching it’s authority in the future.
The AANP continues to coordinate information with some of our homeopathic ND experts, including Drs. Amy Rothenberg and Paul Herscu, leading homeopathic companies, and the AAHP. We are following the lead of the AAHP’s legal team and our own attorney to develop focused messages to improve the guidelines to protect homeopathy as well as public safety.
The AANP will be sending action alerts when this messaging is ready, but the action alerts will ask for high quality, individually written comments on specific parts of the guidelines that we would like to see improved. Please understand that, unlike Congress which considers more form emails with the same message to be “the pulse” of public opinion on a topic, the FDA is only interested in the quality of the comments provided, relative to the content of the proposed guidance. The FDA makes it very clear that it considers the submission of multiple comments which are essentially the same (especially those that are verbatim copies) as one single comment, no matter how many times it is submitted. More is not better, quality is important!
Please stay tuned for more information from the AANP!"