The Lachman Blog has posted numerous writings on the issue of homeopathic drugs over the years that we have been publishing this blog. The most recent post on this topic was on June 17, 2020 (here). That post spoke about regulatory action taken against four manufacturers of homeopathic drugs in the form of Warning Letters. That post also cites back to a few other posts of ours that address homeopathic drugs and the new interest that FDA has taken in potentially further regulating the industry.
With this backdrop, I decided to take a look at the October 2019 revised FDA guidance titled Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry to gauge the public response to the issuance of this revised document and others that reside in FDA Docket-2017-D-6580. As of June 23, 2020, there were 34,341 comments submitted to the public docket (here) that include comments to the various iterations of the guidance and several Federal Register Notices.
Not having the stomach to sift through all of these comments, I can tell you that generally, fans of homeopathic drugs don’t want the FDA to mess with the current system and those who are dubious about the efficacy of homeopathic drugs think that the directions that the Agency is moving (i.e., increasing enforcement action on products that do not conform to current standards with a potential down the road for re-evaluation of the regulatory scheme for homeopathic drugs) is called for.
Keep your eye on FDA’s enforcement actions and other Federal Register notices to keep abreast of how and when we are likely to see movement towards regulations to govern homeopathic drugs, or if the Agency will find this road too difficult to navigate.
