Q: Should dietary supplements be subject to Mandatory Product Listing?
You’ve probably been distracted by the headlines about Ukraine, the Supreme Court, and Johnny Depp and Amber Heard. But if you care about dietary supplements, including sports nutrition products, you need to know what’s going on with a new bipartisan bill introduced in the U.S. Senate. The Dietary Supplement Listing Act of 2022,1 S.4090, would require dietary supplement marketers to list their products with the U.S. Food and Drug Administration (FDA), including an electronic copy of the label.
The bill’s sponsors claim that Mandatory Product Listing (“MPL”) will give the FDA the information it needs to protect Americans from dangerous products masquerading as supplements, and cited tianeptine, an unapproved drug sold illegally as a dietary supplement, as an example of the problem. Through MPL, the government, at least in theory, would have on record every supplement product on the market.
MPL has ignited a fierce debate among the industry trade associations.2 Some industry groups applaud the bill3 and the “transparency” it provides,4 maintaining that the FDA wouldn’t get to “approve” or “reject” the product – rather, the FDA’s acceptance of the label would be followed by a public posting of it for regulators, retailers, and consumers.5
The bill says that while marketers of existing products have a grace period in which to submit their product listing submissions, all products would eventually need to be listed and new products would have to be submitted before the product could go to market. When the FDA receives a company’s listing submission, the bill requires the agency to “confirm” a “complete listing” and issue an identification number. The process raises important questions. Can the FDA refuse to confirm a product? If so, can a marketer still launch the product? If it can’t, doesn’t MPL effectively amount to pre-market approval – the type of authority the FDA has over prescription drugs but was specifically not supposed to have over dietary supplements?
That’s exactly what some industry groups are complaining about. The Natural Products Association (NPA) has denounced the MPL bill, submitting a six-page letter to the congressional sponsors citing all the reasons the bill is a disaster.6 NPA President and CEO Dan Fabricant, Ph.D., maintains that the bill requires information that is already easily available from public sources and it simply adds unnecessary complexity without improving public safety. Doug Kalman, Ph.D., RD, NPA Senior Vice President of Scientific and Regulatory Affairs, decries the bill as practically worthless: “FDA has failed to use its existing regulatory authority to remove unsafe or adulterated supplements from the market. This bill does nothing to protect consumers.” Drs. Fabricant and Kalman recently participated in this excellent deep dive into the MPL bill’s problems in PricePlow’s video podcast at https://blog.priceplow.com/podcast/npa-vs-dick-durbin-s4090
Even Harvard’s Pieter Cohen, MD, a long-standing supplement industry critic whom you would assume to be a supporter of the bill, has instead called it a “waste of taxpayer money” that will limit, not expand, the FDA’s enforcement abilities by diverting their resources.7
What’s my take, especially looking at the sports nutrition market? The overwhelming bulk of the market consists of safe, compliant products made by responsible companies. But the reality is that there is a certain population of fitness consumers who want edgy muscle-building and fat-burning substances, such as SARMs, DMAA-related ingredients and steroidal variations, whether they are labeled as “dietary supplements,” “research chemicals” or anything else. Demand generates supply, and the marketers who choose to meet this demand will be highly unlikely to submit their labels to the FDA. Which means that even if MPL is passed, the illegal products will still be out there, just like they are now, except more “underground.” So, what is the bill really accomplishing in this regard?
The real solution doesn’t require changing laws. If the FDA wants to take illegal products off the market, it needs to stop dragging its feet and enforce the existing laws in a much more consistent and methodical fashion. The laws as currently written give the FDA all the tools needed to get products that don’t comply with the law off the market. MPL would only expand government’s power over lawful supplements and add unnecessary burdens on law-abiding companies. What can you do, as a supplement consumer? You can voice your opposition to the MPL bill by signing an online petition here: http://www.votervoice.net/Shares/BzN7dAj1ACeAXA_Zj-Z7FAA
4. https://www.crnusa.org/MPL; https://www.raps.org/news-and-articles/news-articles/2020/6/a-mandatory-dietary-supplement-registry-transparen