Outstanding questions about Gottlieb’s supplements treatise

FDA Commissioner Scott Gottlieb — in his typical fashion — released a 2,000-plus-word statement Monday touting a number of potential changes to the way the FDA regulates supplements. Chief among them: reworking the seminal law that gave FDA oversight over supplements in the first place. There’s a lot to unpack in Gottlieb’s statement, but here are two questions I’ve been mulling since the announcement:

• Is there any interest in Congress to re-open the supplement law? The 1994 law that gave FDA some power to regulate supplements is head-scratch-inducing to say the least, but I’m struggling to imagine a scenario where Congress decides to reopen that can of worms. Remember, lawmakers have tried for years now to give FDA more power to regulate cosmetics and over-the-counter drugs. Neither of those efforts, as common sense as they seem, have been successful. My bet is those have to get over the finish line before we start talking about reworking the supplement law.
• Gottlieb says there’s interest from manufacturers in “establish[ing] avenues for dietary supplement exclusivity,” but how exactly would that work? This is a question I really don’t have an answer to, but it’s worth watching. Exclusivity could mean a huge windfall for certain supplement makers, and ultimately higher prices for consumers. While there might be merits to exclusivity in certain circumstances, I’m already having nightmares that one day in the near future I’ll be writing about the proper exclusivity for CBD oils.