FDA Closes in on Your Supplements

A few weeks ago, we reported that 2024 could be the year the FDA finally publishes the final version of its natural product-destroying “new dietary ingredient” (NDI) guidance that it has been working on since 2011. It appears that we might have been right. On January 17, the FDA published a notice in the Federal Register explaining that it intends to break this up into several guidance documents while also naming the issues it intends to prioritize. It is a tactic we’ve seen the agency deploy in its war against compounded medicine: rather than issue a policy outright and risk the backlash, the FDA takes a piecemeal approach to diffuse the negative reactions to what it is doing. Even more concerning, it shows the level of focus the FDA is committing to the various issues contained in the guidance. We need to keep hammering away at our elected representatives to take notice of what the FDA is doing.

The Federal Register notice states that the issues FDA is prioritizing are administrative procedures, identity, safety, and master files. The FDA’s webpage describing the guidance documents it plans to issue over the next year has been updated accordingly, with a “procedures and timeframes guidance” listed before a master files guidance.