You don’t have to cover the supplement industry for very long before you hear some variation of the conspiracy theory describing the Food and Drug Administration as out to take to down the supplement industry. As one longtime observer has told me, on numerous occasions, the FDA is a “wholly owned subsidiary of Big Pharma.”
Given what FDA Commissioner Scott Gottlieb said about the supplement industry in his Feb. 11 statement, Big Pharma may be rethinking that ownership. Gottlieb laid out some positives about supplements, not the least of which was his revelation that he has “benefitted” from taking them. He also opened the door to engagement with the supplement industry on matters even supplement makers agree are problems.
So where does that leave the conspiracy theorists?
With plenty to conspire about, I imagine.
For starters, Gottlieb brought up discussion of whether it’s time to “modernize DSHEA.” He also suggests a “mandatory listing” for supplements. A plan to “update our compliance policy regarding NDIs (New Dietary Ingredients)” is also mentioned as well as public-private “Botanical Safety Consortium.”
These will undoubtedly set off alarm bells across the industry. A mandatory listing has long been dreaded. The portents of doom that greeted the NDI guidance that was announced in 2016 and then widely ignored will be reignited by this statement.
People looking for bad news in Gottlieb’s announcement will find all of that and more.
I hope they aren’t looking too hard.
People willing to examine the pedestal on which they have placed DSHEA might see the wobbles and the spots where a little support could make it more stable, and perhaps more profitable. Gottlieb’s comments could make that examination more palatable than it has been for a long time.
Sure, there are things to worry about here. The statement was accompanied by news of new warning letters and scandals past were invoked, both lending a confrontational tone to the affairs. A clearer picture of what we can expect from the supplement working group announced last year and referenced again in Gottlieb’s statement would be helpful. I know of at least one respected industry name on the Botanical Safety Consortium revealed in the statement, but I’d like to know more. A coming public meeting about responsible innovation Gottlieb announced could be better described.
There are changes proposed in Gottlieb’s statements that the industry is already asking for, such as “dietary supplement exclusivity” that would reward companies that invest in branded ingredients.
I would suggest that the industry also embrace changes in the statement that the conspiracy theorists will wave their red flags at.
In an industry where the barrier to entry barely scrapes the floor, more enforcement and more requirements like the mandatory listing should be welcomed by the established players. People who play by the rules can benefit from those rules when they are enforced and as beneficial as DSHEA has been for the industry it could use a few new rules.
The industry is far larger than it was in 1994, as Gottlieb notes. If changes are coming, that size may provide gravitas, even bargaining power.
The commissioner just opened the door to the industry’s best intention. I’d suggest leaving the conspiracy theories outside.