In June 2018, during an industry conference in Manhattan, food and drug lawyer Scott Bass made a pitch that drew a strong rebuke, according to his recollection. The dietary supplement industry, Bass asserted at the time in a PowerPoint presentation, must “embrace mandatory product registration.”
“And everybody said, ‘What, are you out of your mind?’” Bass recalled in an interview. “And I said, ‘No,’ because we now have a $50 billion industry I want to see go to $100 billion, and the only way we’re going to do that is to assure governments and the public that we have products that are being looked after.”
Today, as members of Congress continue to hammer out the details of a legislative package reauthorizing FDA’s user-fee agreements for such commodities as prescription drugs and medical devices, Bass’s proposal is closer than ever to becoming embedded in U.S. law. The discussion draft of a user-fee authorization bill in the U.S. Senate, the FDA Safety and Landmark Advancements (FDASLA) Act, includes a requirement for mandatory listing of dietary supplement products with FDA.
Mandatory product listing (MPL) has garnered the support of multiple trade associations, FDA and outside groups, including The Pew Charitable Trusts and American Medical Association (AMA). One of its strongest proponents is Sen. Majority Whip Dick Durbin, D-Ill., who introduced a standalone bill in April called the Dietary Supplement Listing Act of 2022.
A subsequent version of MPL in the FDASLA Act discussion draft incorporates requirements proposed by Durbin, as well as other provisions that would affect dietary supplements.
Reflecting on his remarks in 2018 that he said still hold true today, Bass said, “Why would any responsible company not want the government to know what it’s selling? It just strikes me as so odd.”
MPL has become a divisive issue in the industry, perhaps highlighting philosophical differences over the best ways to evolve the law in an age of smartphones and social media while supporting the twin pillars of the Dietary Supplement Health and Education Act of 1994 (DSHEA): giving FDA authority to adequately protect the public from potentially harmful products while preserving open access to natural products consumed by the majority of Americans.
FDA cannot effectively regulate what it cannot see, and there is no centralized database today containing all the dietary supplement products in the U.S. market, MPL proponents say.
“I think the conversation … the different parts of the industry are having really turns on whether you think transparency is good because it builds confidence in the industry,” said Stuart Pape, a lawyer in Washington, D.C., who advises clients on FDA regulations and previously worked in the agency’s Office of Chief Counsel.
On one hand, proponents of Durbin’s bill believe MPL “facilitates appropriate regulatory intervention and scrutiny,” Pape said in an interview in April after the Dietary Supplement Listing Act was introduced in the Senate. “If you think that’s not a good thing, then the bill is terrible.”
Opponents of MPL have argued “bad actors” or firms already in violation of the law selling, for example, undeclared pharmaceutical ingredients won’t list their “dietary supplement" products with FDA. Some counterarguments are MPL legislation in the Senate would render such products “misbranded” for failure to list and more clearly distinguish—for the benefit of regulators, consumers and retailers—compliant products from non-compliant ones.
Pape said he agrees firms selling products with affirmative knowledge that they contain unlawful ingredients are unlikely to list them with FDA.
But, “So what?” he continued. “There are people who don’t file tax returns. Is that an argument that you shouldn’t be required to file a tax return? We have a tendency to overstate what something might do and then a critic comes along and says, ‘Well, it’s not possibly going to do all the things you claim it’s going to do. Therefore, it’s a bad idea.’ I think that’s part of what’s going on here.”
Asked whether he agreed MPL would let FDA know when new dietary supplement products are introduced to the market, Pape responded, “Mostly true most of the time, not necessarily all of the time.”
Pape also addressed criticism by MPL cynics that FDA under Durbin’s proposal would have discretion to reject products, which essentially amounts to a regulatory regime that cannot be reconciled with DSHEA: premarket approval.
“I think that’s a red herring of world-record size,” he said.
Pape, who serves as chair of the FDA practice at Polsinelli PC and whose law practice has involved such varied commodities as dietary supplements, medical devices and pharmaceuticals, described a listing requirement as “ministerial.”
“You’re required to list. You submit the listing information. You’re listed,” he said.
Pape was interviewed before the Senate released a discussion draft of the FDASLA Act, which includes a provision that would make it a “new prohibited act” to introduce into interstate commerce “any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under Section 201(ff)” of the Federal Food, Drug & Cosmetic Act (FDCA). Durbin's standalone bill did not include the language above.
The language “clarifies what’s driving these provisions goes well beyond the desire for transparency, a collection of labels or mandatory product listing (MPL),” according to a recent column authored by Natural Products Association (NPA) President and CEO Dan Fabricant. “Instead, it seems driven by a desire to allow FDA to ‘bar the door’ from listing anything it wishes to keep out of dietary supplements….”
Fabricant, who oversaw FDA’s Division of Dietary Supplement Programs from 2011 to 2014, warned the “prohibited act” language is not related to MPL and would give FDA an opportunity to reject ingredients like CBD administratively. Dietary supplement firms found to have committed such a prohibited act also would face potential criminal prosecution from the U.S. Department of Justice for running afoul of the FDCA, which carries civil and criminal penalties.
The “prohibited act” language “could encompass differences of opinion with FDA that shouldn’t rise to a criminal offense,” according to Bass, who is a founder of his law firm’s Global Life Sciences and Food and Drug Law practices in China, Europe and the U.S. “The intent of this section, which is to catch tainted products, [is] overbroad and using a shotgun for something that needs a rifle.”
The language, Bass explained, reflects FDA’s position that its authority isn’t explicit enough under the FDCA to target for enforcement products marketed as dietary supplements yet spiked with undeclared pharmaceutical ingredients.
“What’s really significant here is that [the provision] can apply to any technical argument about whether something’s a supplement or not,” cautioned the lawyer.
Bass believes the provision “can” and must be “fixed.” However, as far as MPL is concerned, he described a listing requirement as “a sine qua non of dietary supplement enforcement and of the future of the dietary supplement industry.”
“Without mandatory listing, there would be no credibility,” he said. “Responsible industry has to welcome mandatory listing.”
The legislation in the Senate, he added, can be tweaked “so that it doesn’t ever become akin to prior approval or to a registration system as opposed to a listing system.”
In an interview three years ago with Natural Products Insider, the late Sen. Orrin Hatch (R-Utah) was asked about a mandatory product listing or registry for dietary supplement products. He was one of the chief architects and champions of DSHEA during his long tenure in the Senate.
“The concept makes sense to me,” Hatch responded. “If this industry wants to be regarded as the mainstream regulated industry that it is, it seems logical that the FDA be able to know what products are out there as they do with other regulated products.”
Hatch warned, “If Congress is to consider a new requirement, that requirement has to be fair and not overly regulatory with too much reporting of information that FDA does not have the resources to use.”
He concluded, “In other words, we should not regulate the dietary supplement industry into the ground, which some people will try to do acting like they’re the sole protectors of our health and strength in this country.”
MPL, some industry critics maintain, is simply a path to imposing additional burdens on responsible industry. Bass, who was one of the industry lawyers who helped to negotiate DSHEA nearly 30 years ago, has been down this road before.
In the recent interview, he recalled strong opposition to a proposal several years ago that manufacturers of dietary supplements report to FDA serious adverse events associated with their products. The Dietary Supplement and Nonprescription Drug Consumer Protection Act was signed into law by President George W. Bush in late 2006 and took effect a year later.
“It’s just been a responsible law that has not killed innovation or killed the industry,” Bass said.
He described opposition from industry as “huge” before the bill was enacted by Congress and signed into law by Bush.
“I’ll never forget that [Sen.] Hatch’s office set up a conference call, and without mentioning the company, a very smart general counsel at one of the companies in Utah got on and hit me in front of 30 people on the phone with … 25 very intelligent objections,” he reflected. “I even had dinner at one point with some of them in Washington. They [said], ‘Oh, this is the end and this is giving FDA all the regulation. We’re going to become food additives.’ None of that happened.”
Editor's note: This article was amended to clarify a user-fee authorization bill being considered in the U.S.Senate was a discussion draft.