In June 2018, at an industry conference in Manhattan, food and drug attorney Scott Bass gave a speech that earned him 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 everyone was like, ‘What, are you crazy? “”, Bass recalled in an interview. “And I said, ‘No,’ because now we have a $50 billion industry that I want to see grow to $100 billion, and the only way to do that is to assure governments and the public that we have products that are being neat.”
Today, as members of Congress continue to hammer out the details of a legislative package reauthorizing FDA user fee agreements for products such as prescription drugs and medical devices, Bass’s proposal is closer than ever to being incorporated into US law. A user fee authorization bill in the US Senate, the FDA Safety and Landmark Advancements Act (FDASLA), includes a requirement for mandatory registration of dietary supplements with the FDA.
The Mandatory Product List (MPL) has garnered support from several trade associations, the FDA, and outside groups, including The Pew Charitable Trusts and American Medical Association (AMA). One of its strongest supporters is Majority Whip Sen. Dick Durbin, D-Ill., who in April introduced a standalone bill called the Dietary Supplement Listing Act of 2022.
A later version of MPL in FDASLA incorporates Durbin’s proposed requirements, as well as other provisions that would affect dietary supplements.
Reflecting on his 2018 remarks which he says still hold true today, Bass said, “Why wouldn’t a responsible company want the government to know what they are selling? It seems so strange to me.
The MPL has become a divisive issue in the industry, perhaps underscoring philosophical differences on how best to move the law forward in the age of smartphones and social media while supporting both pillars of the law on the Dietary Supplement Health and Education Act of 1994 (DSHEA): Giving FDA Authority to Adequately Protect the Public from Potentially Harmful Products While Preserving Free Access to Natural Products Consumed by the Majority of Americans.
The FDA can’t effectively regulate what it can’t see, and there is no centralized database today of all dietary supplements on the US market, MPL proponents argue.
“I think the conversation…different parts of the industry really revolve around whether you think transparency is good because it builds trust in the industry,” said Stuart Pape, a lawyer. in Washington, DC, who advises clients on FDA regulations and previously worked in the agency’s Office of Chief Counsel.
On the one hand, proponents of Durbin’s bill believe the MPL “facilitates appropriate regulatory intervention and review,” Pape said in an April interview after the law introduced the Dietary Supplement List to the Senate. “If you think that’s not a good thing, then the bill is terrible.”
Opponents of the MPL have argued that “bad actors” or companies already in violation of the law selling, for example, undeclared pharmaceutical ingredients will not list their “dietary supplement” products with the FDA. Some counter-arguments are that MPL legislation in the Senate would make these products “mislabeled” for not more clearly listing and distinguishing – for the benefit of regulators, consumers and retailers – compliant from non-compliant products.
Pape said he agrees that companies selling products knowing affirmatively they contain illegal ingredients are unlikely to list them with the FDA.
But then what?” he continued. “There are people who don’t file taxes. Is that an argument that you shouldn’t be required to file a tax return? that something could do, and then a reviewer comes along and says, “Well, it’s probably not going to do everything you claim it’s going to do. So that’s a bad idea. I think that’s part of what’s going on here.
When asked if he was okay with MPL notifying the FDA when new dietary supplements were introduced to the market, Pape replied, “Most of the time true, not necessarily all the time.”
Pape also responded to criticism from MPL cynics that the FDA, under Durbin’s proposal, would have discretion to reject products, which essentially amounts to a regulatory regime that cannot be reconciled with the DSHEA. : pre-marketing approval.
“I think it’s a world-record-sized red herring,” he said.
Pape, who is chairman of the FDA practice at Polsinelli PC and whose law practice has involved products as varied as dietary supplements, medical devices and pharmaceuticals, described a listing requirement as “departmental.” .
“You are required to list. You submit registration information. You are registered,” he said.
Pape was questioned before the Senate released a draft discussion of the FDASLA, which includes a provision that would make it a “new prohibited act” to bring into interstate commerce “any product marketed as a dietary supplement that does not does not meet the definition of a dietary supplement under Section 201(ff)” of the Federal Food, Drug, and Cosmetic Act (FDCA). Durbin’s stand-alone bill did not include the language above.
The language “clarifies what drives these provisions goes far beyond the desire for transparency, a collection of labels, or a mandatory product list (MPL),” according to a recent column written by the president and chief executive. the leadership of the Natural Products Association (NPA), Dan Manufacturer. “Instead, he seems driven by a desire to allow the FDA to ‘bar the door’ from listing anything they want to keep out of dietary supplements….”
Manufacturer, who oversaw the FDA’s Dietary Supplement Programs Division from 2011 to 2014, warned that the “prohibited act” language is unrelated to MPL and would give the FDA the ability to administratively reject ingredients like CBD. Dietary supplement companies found guilty of such a prohibited act could also be subject to criminal prosecution by the US Department of Justice for violating the FDCA, which carries civil and criminal penalties.
The “prohibited act” language “could encompass differences of opinion with the FDA that should not constitute a criminal offense,” according to Bass, who is one of the founders of global life science and food law practices. and medicines from his law firm in China, Europe and the United States “The intention of this section, which is to catch contaminated products, [is] too wide and use a shotgun for something that needs a shotgun.
The language, Bass explained, reflects the FDA’s position that its authority is not explicit enough under the FDCA to target products marketed as dietary supplements but fortified with undeclared pharmaceutical ingredients.
“What is really important here is that [the provision] can apply to any technical argument about whether something is a supplement or not,” the attorney warned.
Bass thinks the provision “can” and should be “fixed”. However, regarding the MPL, he described a listing requirement as “a sine qua non of the application of dietary supplements and the future of the dietary supplement industry.”
“Without mandatory registration, there would be no credibility,” he said. “Responsible industry must agree to mandatory registration.”
Legislation in the Senate, he added, can be changed “so that it never resembles a pre-approval or a registration system as opposed to a list system.”
In an interview three years ago with Natural Products Insider, the late Sen. Orrin Hatch (R-Utah) was asked about a mandatory product list or registry for dietary supplements. He was one of the main architects and champions of the DSHEA during his long tenure in the Senate.
“The concept makes sense to me,” Hatch replied. “If this industry wants to be considered the dominant regulated industry that it is, it seems logical that the FDA would be able to know what products exist as it does with other regulated products.”
Hatch warned, “If Congress is to consider a new requirement, that requirement must be fair and not overly regulatory with too many reports of information that the FDA does not have the resources to use.”
He concluded: “In other words, we shouldn’t regulate the dietary supplement industry into the ground, which some people will try to do by acting as if they are the only protectors of our health and strength in this country.”
According to some industry critics, the MPL is just a way to impose additional burdens on responsible industry. Bass, who was one of the industry lawyers who helped negotiate the 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 dietary supplement makers report serious adverse events associated with their products to the FDA. The Dietary Supplements and Over-the-Counter 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 responsible legislation that didn’t kill innovation or kill the industry,” Bass said.
He described industry opposition as “huge” before the bill was passed by Congress and signed into law by Bush.
“I will never forget that [Sen.] Hatch’s office arranged a conference call, and without mentioning the company, a very smart general counsel from one of the Utah companies got down to talking and punched me in front of 30 people on the phone with… 25 very clever objections,” he explained. “I even had dinner at one point with some of them in Washington. They [said], ‘Oh, it’s the end and it gives the FDA all the regulations. We will become food additives. None of this happened.