This month we will discuss policy outcomes from FDA’s policy and enforcement guidance documents past and present for homeopathic drug products. In our first article, The Regulation of Homeopathic Drug Products, we give historical background and context that led to the current regulatory environment for our products.
Our second article, A Retrospective Policy Analysis of FDA’s CPG 400.400 reveals that FDA’s 1988 compliance policy Conditions Under Which Homeopathic Medicines may be Marketed was remarkably successful. We theorized 4 potential policy objectives for the guidance and then evaluated their relative success rate individually. Our review found that in all four policy categories reviewed, CPG 400.400 was very successful, especially in its first 20 years.
In our third article Al Lorman delves into the term “Unapproved New Drug”. As Al mentions, the transition from the CPG to the current guidance for homeopathic drugs has not changed their status in the least. What has changed is the volume used by FDA when talking about the unapproved status of homeopathic drugs currently. The term is falling out of favor these days. Instead, the term “Non-Application Product is heard more frequently recently.
Let’s not let our guard down on either of these guidance documents, however. Certainly, there were many difficult enforcement actions under CPG 400.400 and many to come under the current guidance.
As always one’s best defense against enforcement action is a strong compliance program.