CRN has been advocating for the concept for several years (see my article in RAPS in 2020; a byline in Whole Foods Magazine that same year; Julia Gustafson’s byline in 2021; my blog a few weeks ago; and even my byline in Nutraceuticals World this week). Like our reasons for promoting the listing, we have been steadfast and vocal about our quest for transparency from the start--FDA can’t regulate what it can’t see. So, it’s surprising to read this week some think CRN is cowering from a full debate on the issue. Far from it–we welcome any opportunity to discuss and defend our well-reasoned and logical arguments. Name the time and place and fair rules, and we’ll be there.
For instance, consider the argument that because mandatory listing won’t solve all the problems of spiked products, then we shouldn’t pursue it at all. It’s like not hiring the cook—even if he’s an incredible chef—because he won’t do windows or walk the dog too. Let’s look at what mandatory listing will do.
It will give the FDA much better visibility into the U.S. dietary supplement marketplace. Currently, none of the other available databases are comprehensive, current, and mandatory. Without accountability for the company that puts the product in the marketplace, any other registry is dependent upon the altruism of companies to participate. Mandatory listing will compel participation with easily enforced consequences for companies who do not.
It's hard to argue with FDA or the myriad consumer and healthcare organizations who support mandatory listing when they insist FDA should have an accurate collection of the products it is charged with regulating. Neither facility registration, NDI, nor structure/function claim notifications give FDA a complete snapshot of the market. By placing the responsibility for listing with the company whose name is on the label, this legislation will do just that.
Opponents argue it won’t deter illegal products. Actually, it will. First, mandatory listing comes with the threat of being “misbranded” if a product is not in the registry. That’s an easy violation for FDA to identify and enforce without obtaining samples of the product, maintaining chain of custody, sending samples out to various labs for verification of ingredients, etc. The potential for enforcement changes the risk calculation and incentivizes companies to participate. A few high-profile enforcement cases would send a severe message to comply.
Moreover, if mandatory listing is enacted, most retailers can be expected to require the products on their shelves to be in the listing. That kind of marketplace pressure will persuade most reputable firms to submit their labels, even if the threat of FDA enforcement doesn’t. “Not on the listing, not on my shelf” is a powerful incentive. If Amazon takes a similar stand for online sales, compliance skyrockets.
Third, if FDA has access to the labels, it can identify a host of problems in the industry. You would be astonished how many products unabashedly make illegal disease claims (e.g., “treats cancer,” “prevents Alzheimer’s”) right on the label. Likewise, illegal ingredients like Tianeptine and DMAA also show up on labels with surprising frequency despite their illegal status. Mandatory listing gives FDA an efficient way to find and address these products.
Of course, undisclosed illegal ingredients are another matter entirely. One could expect some of these companies will list their products and the label won’t divulge their dangerous contents. That’s to be expected, but at least FDA will be able to see the product labels, identify the company responsible for them and its location, and develop a roadmap for addressing these products. These are tools FDA does not have today.
As I wrote last week, consumers assume FDA already knows what is in the market; they are surprised to learn that FDA doesn’t even know how many products and ingredients are out there. Mandatory listing corrects that void in the current law. Of course, mandatory listing won’t immediately address all the willful bad actors; every industry has a few bottom feeders that operate in the dark corners. But mandatory listing will bring many firms that operate in the grey areas (through indifference, negligence, or ignorance of the law) into the sunshine for FDA’s evaluation.
Opponents of mandatory listing who simply want to call on FDA to do a better job might as well be throwing pennies in a wishing well. Real solutions take compromise and negotiation. They should come to the negotiations with constructive suggestions for refinement and clarity. Otherwise, their claims that it doesn’t work will get left behind.
