So, it was no surprise that last week the head of the Natural Products Association floated a byline on this site suggesting there was a secret smoking gun hidden in the proposal to create a mandatory registry of dietary supplements. The piece asserted the effort to establish a product registry in 2022 was a veiled effort by FDA to obtain pre-market approval over dietary supplements. For the record, this theory is patently false. Completely false.
The “secret smoking gun” was neither secret, nor smoking, nor even a gun. The byline argues that its author had uncovered through a FOIA request a “confidential” memo purporting to reveal FDA’s true intentions because in it, FDA wrote, “The Agency recommends requiring a unique identifier be printed or affixed to the label for each listed product.” The one thing the article gets correct is that, yes, early in the legislative process, FDA did indeed suggest creating a unique alpha-numeric code for each dietary supplement that would be listed with FDA in order to maintain a method of cataloging the nearly 100,000 supplement labels that are purportedly on the market.
So, was it secret? No, the document was a Technical Assistance Comment provided to Congress by FDA, routinely filed by a government agency reacting to a piece of legislation that would impact its authority. It was easily available from the House Energy & Commerce Committee staff, and CRN’s staff had a copy of the document at the time and shared its content with members of CRN’s Government Relations Committee. For anyone who was constructively engaged in the negotiations around the legislation, it was no surprise.
But was it a smoking gun—a veiled nod to premarket approval for supplements? Again, no. FDA’s objective was to create a method of tracking the tens of thousands of labels it would receive with a formal serial number assigned to each unique product. Without an identifier, how would FDA compile a database?
The issue was whether the identifier would have to appear on the label, and how to accomplish that without delaying new product launches or creating a backlog in the assignment of identifiers as new products come to market. Because CRN was at the negotiation table, we were able to raise these concerns and suggest alternatives that would not stymie innovation. We proposed that companies should be able to obtain groups of ID numbers in advance, so they could use them as new products are introduced, and then alert FDA of the corresponding product and the ID being used.
In fact, this is what the bill sponsors eventually agreed to and wrote into the bill. The introduced legislation called for the registry to include, along with the product information and a copy of the label:
“The dietary supplement product listing number for the product provided by the Secretary in accordance with subsection (c) for that product.”
And what does subsection (c) provide? Well, it states “The Secretary shall provide each dietary supplement listed in accordance with [the previous] subsection a dietary supplement product listing number, which may apply to multiple dietary supplements with identical formulations, or formulations that differ only with respect to color, additives, or flavorings, including dietary supplements offered in a single package size or in multiple package sizes. The Secretary shall provide a process for a responsible person to reserve dietary supplement listing numbers in advance of listing under subsection (b)(1).”
That’s exactly what the industry asked for: to satisfy FDA’s organizational need for tracking products with a unique identifier, but assigning those ID numbers in a manner that allows companies to get them in advance and use them as they introduce new products, without having to wait for FDA to assign them at the time. There would be no opportunity for FDA to delay a submission to the registry because the company had not received its ID number.
As for whether FDA could use the supplement registry to accomplish a pre-market review of dietary supplements, there is no “gun” here either. CRN was very conscious to pre-empt any effort by FDA to do this—or even for detractors of the legislation to claim that it did. The final, negotiated version of the legislation that NPA continued to oppose, would have contained TWO separate assurances that the registry could not be used for premarket approval. It would have provided that “A listing is deemed complete once all fields of required information have been completed by the responsible person who represents that the product will be marketed in the United States as a dietary supplement” (i.e., no opportunity for FDA to delay or reject a submission), and further, that “Nothing in this section shall be construed to grant the Secretary authority to require the approval of a dietary supplement prior to marketing.” These are pretty clear assurances that the registry could not be used to create mischief as premarket review.
NPA would have known this if it had engaged in a constructive dialogue around mandatory listing in the last Congress. But it’s not too late: as FDA is again seeking to establish a supplement registry in the next Congress, we invite NPA to join us to build something the industry can live with.
I won’t spend time and ink here reiterating the rational for a mandatory listing, or the numerous benefits to both industry and consumers from the increased transparency, or the reasons why FDA can’t effectively govern an industry that it can’t really see. CRN has done that over a series of articles that can be found here, here, here, here, here, and here.
But on top of those reasons, here’s another one: it’s also inevitable. And it makes a lot more sense to help sculpt what that system will look like than to stand in front of a speeding train and try to stop it.
In addition, the FDA and many other stakeholders—from medical organizations to consumer groups—are calling for some accountability in the supplement marketplace. Congress enacted significant reform of cosmetics regulation last year that requires product registration for all cosmetics marketed in the US. Oddly NPA did not oppose registration for its natural cosmetics members. It’s likely only a matter of time until supplements get treated similarly. It’s getting harder to maintain with any credibility that the industry does not need some accountability to its regulator. States are jumping in with their own legislative proposals to restrict dietary supplements precisely because they believe FDA is feckless and neutered by its inability to tell which products and ingredients are in the market. The age restrictions in the states are in part a result of the perception that FDA doesn’t know enough about the supplement marketplace. Other examples of tianeptine and galantamine illustrate that FDA doesn’t know what’s being sold under the banner of a “dietary supplement.” A registry would help fix that.
Being at the negotiation table, and making good faith contributions to the discussion, have afforded CRN the ability to shape the legislation and keep the onerous aspects out. If NPA has not been privy to these negotiations, it’s because it has chosen to stand in the corner and obstruct, obfuscate, mislead and create conspiracies against every proposal. Let’s have a constructive discussion instead.
There is an old expression “If you aren’t at the table, you may be on the menu.” In this case, it may be more descriptive to paraphrase it: “If you are not at the table, you may just be paranoid of being eaten.” Come to the table.
