An FDA proposal that would require manufacturers of dietary supplements list their products with the agency has gained support among several consumer advocacy groups and industry associations.
FDA has floated the idea through two consecutive budget requests by the Trump administration and reiterated its support for a mandatory product listing during public events.
A mandatory listing would allow FDA “to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products, improve transparency and promote risk-based regulation,” an FDA spokesperson said by email. “We look forward to working with Congress and other stakeholders to advance this goal, as it would significantly enhance the agency’s ability to efficiently and effectively protect the public health.”
Three of five major trade groups in the supplement industry support the proposal: Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA) and United Natural Products Alliance (UNPA). Two trade associations are not in favor of it: the American Herbal Products Association (AHPA) and the Natural Products Association (NPA).
Congressional action likely required
For the proposal to take effect, FDA would likely need Congress to amend the law since the agency does not believe it has clear authority to require listing of dietary supplement products. The Nov. 3 election could help or hurt the chances of a bill being introduced in 2021 and ultimately landing on the desk of the next president.
“Under the current administration, [I] don’t believe Congress has an appetite for this,” UNPA President Loren Israelsen said in an interview.
He predicts FDA would “ramp up” its efforts on Capitol Hill if Joe Biden is elected the next president and Democrats take control of both chambers of Congress.
In the GOP-controlled Senate, it remains to be seen who will chair the Committee on Health, Education, Labor and Pensions (HELP), which has jurisdiction over FDA. Sen. Lamar Alexander, Republican from Tennessee, is retiring.
If the Republicans remain the majority in the Senate, possible chairs of the HELP Committee include Sens. Richard Burr of North Carolina, Rand Paul of Kentucky or Bill Cassidy of Louisiana, said David Spangler, senior vice president of legal, government affairs and policy with CHPA.
Sen. Patty Murray (D-Washington), ranking member of the HELP Committee, would be in line as its chair if the Democrats wrest control of the Senate from the GOP.
In the House, where Democrats are expected to retain a majority, Rep. Frank Pallone (D-New Jersey) chairs the Energy and Commerce Committee, which has jurisdiction over FDA.
Representatives for Murray and Pallone did not respond to requests for comment on a mandatory product listing.
Pallone is considered friendly to industry, but he is also sympathetic to the concerns of FDA, said a senior-level industry source, who was granted anonymity to speak frankly. To “kickstart” the negotiation process for a mandatory product listing, FDA should introduce a proposed version of a bill, according to the source, who added FDA officials “really need to make the next move.”
FDA did not respond to a request for comment on whether it’s drafted legislative language for a mandatory product listing. Several sources within industry said they haven’t seen specific details of the agency’s proposal.
Proposal would preserve ‘DSHEA’s original vision’
Industry leaders stressed their opposition to any listing regime that would either require pre-market approval or slow down the process for bringing new products to consumers, such as through the issuance of a registration number for a product label.
Steven Tave, who leads FDA’s Office of Dietary Supplement Programs (ODSP), suggested a mandatory product listing would not undermine the Dietary Supplement Health and Education Act of 1994 (DSHEA). Industry groups have credited DSHEA for providing consumers unfettered access to supplements while protecting consumers from dangerous products.
“We believe it’s possible to construct a narrowly tailored plan that respects and preserves DSHEA’s original vision, does not impose any significant burdens on responsible industry and still facilitates our ability to act swiftly to protect consumers, better allocate resources and remove illegal products from the market,” Tave said during a recent conference hosted by five dietary supplement trade associations.
FDA has ‘blind spot’
Several consumer and industry groups expressed support for a mandatory product listing.
“We appreciate that FDA feels that they have a blind spot and that mandatory registration would give them visibility on … what’s in the market,” Israelsen said. UNPA supports FDA’s proposal, he added, with a caveat: “Naturally, everything is in the details.”
Israelsen raised a number of questions about a mandatory product listing, including, for example, how often companies would be required to list their products with FDA, and under what circumstances changes to product labels and formulations would trigger a renotification.
'Picking up new steam'
FDA’s proposal seems to be “picking up some new steam” due to the large number of dietary supplement products in the market and support from some factions of industry, said Chuck Bell, program director for the advocacy division of Consumer Reports. According to FDA, the market contains upwards of 80,000 products or more.
“We continue to have a large number of products with illegal or unsafe ingredients, and the FDA and public health authorities do not have an adequate ability to track and trace products that have been recalled or have safety problems,” Bell said in an interview.
He described as a “huge step forward” a product listing, including a requirement that labels are submitted to FDA before products are sold. Bell suggested a product listing regime could be linked to a system of QR codes. Such a framework could enable emergency room doctors to swiftly identify the contents of a product and contact a manufacturer or help retailers like Amazon to quickly identify a product flagged by FDA because of some problem, he explained.
Lemrey “Al” Carter is executive director and secretary of the National Association of Boards of Pharmacy (NABP), and he previously served as the divisional vice president of pharmacy operations and professional affairs for Walgreens.
Though Carter cautioned he knows little about the details of FDA’s proposal, he identified benefits from a mandatory dietary supplement product listing. For example, he discussed consumers being able to identify all the ingredients in a product and consult with a pharmacist regarding the supplement’s interactions with medications.
“The opportunity to have more data has always, and will always be, beneficial when it comes to research, when it comes to tracking and when it comes to truly understanding,” Carter added, when asked if a mandatory listing could help FDA identify a problem with a specific ingredient on the supplement market.
Industry representatives have contemplated a system in which failure to list a dietary supplement product would be a “prohibited act” under the law, which would render a product misbranded, some industry sources said. None of the trade associations in support of a mandatory listing have made public a template of an industry-backed legislative proposal.
Thomas Gremillion, director of food policy at the Consumer Federation of America, an association of non-profit consumer organizations, said a mandatory listing could subject “bottom-feeders” in the dietary supplement industry to enforcement action for failure to list their products.
“That alleviates the need for the agency to assemble a bunch of evidence showing that a company’s products actually cause harm,” he said in an email. “Of course, the agency will still need to identify products that are not listed, but once it does, it can take action.”
FDA could gain 'complete picture' of supplement market
The Pew Charitable Trusts, an independent non-profit organization, also is in favor of a mandatory product listing. Liz Richardson, Pew’s project director of health care products, recently co-authored an article published in The Hill that supported mandatory product listing. The co-author was Julia Gustafson, vice president of government relations with CRN.
Mandatory product listing “would permit the FDA to obtain a complete picture of the growing supplement marketplace and allow the agency to prioritize its resources and expertise based on a risk assessment of the thousands of products being sold,” Gustafson and Richardson wrote.
The requirement “would also strengthen the FDA’s ability to respond effectively to emerging safety concerns and to exercise its authorities under DSHEA,” the authors added. “If, for example, the agency learned that a particular ingredient was dangerous, it could easily identify all listed supplements that contain that ingredient and take rapid action to warn consumers, mandate a recall, or both.”
In an interview for this story, Richardson observed “unscrupulous companies” have been marketing supplements to treat or prevent COVID-19.
Many of these firms are “clearly not interested in following the rules around marketing,” she said. “There’s a chance that they would also fail to list” their products, which would give FDA another opportunity to target them.
Failure to list is a “black and white issue,” Spangler of CHPA said. “You violated the [Federal Food, Drug & Cosmetic] Act (FD&C Act). This is a ‘prohibited act’ to not list. So they’ve automatically got low-hanging fruit to enforce against.”
However, Israelsen expressed concerns that such an enforcement tool could be used against responsible companies who may inadvertently run afoul of the listing requirements, such as if there is staff turnover at a supplement firm while a new product is developed and goes to market. An FDA warning letter—issued for what would be considered an “insignificant violation”—is public, could harm a firm’s reputation and be used by competitors against a company, he cautioned.
“There’s a school of thought that says, ‘Don’t give the government anything you don’t have to,’ whether that’s your tax lawyer or your FDA lawyer,” Israelsen said. On the other hand, countries outside the U.S. impose similar requirements as FDA’s proposal, he pointed out.
Helping to close the ‘regulatory gap’
Tave signaled a mandatory product listing could help close what he has described as a “regulatory gap”— the void between requirements in the law and what can be “realistically” achieved through enforcement.
“We can’t responsibly ignore the regulatory gap or pretend it isn’t there,” he said during the Dietary Supplements Regulatory Summit. “That’s not in anyone’s interest. Consumers, responsible industry or regulators—all of us who expect or demand a better regulated dietary supplement market—share a duty to identify and pursue ways to narrow the regulatory gap.
“In fact, when we talk about modernization, we’re really talking about closing the regulatory gap,” he added. “As I’ve said before, FDA stands behind the twin pillars of DSHEA. The task that we’re all faced with now is updating the regulatory framework to ensure that those twin pillars remain viable in today’s world. One of the centerpieces of that plan is our proposal for mandatory product listing.”
Listing offers great benefits, nominal burdens
John Troup is vice president of scientific affairs and dietary supplements with CHPA. According to Troup, the benefits of a mandatory product listing are “significant.”
The proposal would allow consumers and retailers to “easily check to see whether a product has been listed and know to avoid products that aren’t,” he explained in an email. Such a requirement would not only make it easier for FDA to detect and target for action illegal products that should be taken off the market, it would help the agency more efficiently use its resources, such as planning for inspections, Troup added.
He described as “minimal” the burdens of a product listing. For example, Troup suggested the information that would be collected for listing with FDA is already disclosed on product labeling, and he said it would not be time-consuming to list a product.
Firms already compliant with cGMPs (current Good Manufacturing Practices) and “other requirements will have the information readily available, and it will likely take less time to list a product with FDA than it would to offer it for sale on an internet retailer,” he said.
FDA proposal is ‘unnecessary’ and ‘redundant’
Industry trade groups are not unanimously in support of a mandatory product listing. Michael McGuffin, president of AHPA, said in an email that the “vast majority” of the dozens of members with whom he has consulted either oppose a mandatory product listing or do not support it.
“We think that a mandatory product listing is unnecessary, redundant, likely to produce inaccurate results and possibly would cause direct harm to the market and … ultimately supplement consumers,” he said in an interview.
According to McGuffin, FDA’s proposal is unnecessary because it would not address ODSP’s stated priorities of consumer safety, product quality and informed consumer access.
“Records available through product recalls and adverse event reporting data suggest that supplements may well be the safest class of goods regulated by FDA—certainly safer than romaine lettuce or spinach or shellfish, and nobody is calling for mandatory product listing for these foods or for foods generally,” he said. “Is this the one thing that would resolve concerns about dietary supplement enforcement? And we’re waiting to hear an answer on that.”
In support of his assertion that a mandatory product listing would be redundant, McGuffin observed FDA has the ability to obtain information about supplements through such tools as cGMP inspections and recordkeeping requirements in which the agency could demand access to labels, for example.
McGuffin raised concerns that, short of a premarket approval process unanimously opposed by industry, there is no mechanism to verify the accuracy of the information provided to FDA. Marketers of drug-spiked products that falsely claim to sell dietary supplements will either ignore the listing requirement or fail to disclose their products contain such drugs as sildenafil, he predicted.
“We’re concerned that any eventual list will be prone to inaccuracy,” he explained.
McGuffin noted his members have expressed concerns that FDA will “overreach in reinterpreting its authority,” which he stated occurred when the agency issued draft guidance twice pertaining to new dietary ingredients (NDIs).
“Those were not simply explanations of the regulation,” he said. “They were reinterpretations of the law. FDA has backed off twice, but it has raised significant concern in our membership that the agency will make mischief. We can’t predict exactly where.”
Finally, McGuffin raised concerns that a mandatory product listing could impose financial burdens on small companies, causing the market to shrink, and also lead to “extensive, frivolous private litigation” tied to state consumer protection laws.
“Any industry guards against creating a new mechanism for private plaintiffs to come after us,” he said.
FDA can’t ‘process a mountain of information’
Dan Fabricant, president and CEO of NPA, questioned how a mandatory listing would benefit consumers or FDA. In a series of articles reported by Natural Products Insider, he criticized the agency for failing to take enforcement action against NDIs produced overseas, whose identity and safety has not been reviewed by FDA.
In the series, Tave acknowledged receiving “mountains and mountains of information” from people close to a supplement maker, Natural Alternatives International Inc. (NAI), which requested FDA enforce against forms of beta-alanine manufactured in China. FDA, on the other hand, argued the materials shared with the agency didn’t prove the Chinese manufacturers were in violation of the law.
“It’s clear that he [Tave] can’t process a mountain of information,” Fabricant said in an interview. A mandatory product listing is “going to be a mountain of information.”
He added, “The agency doesn’t know what to do with a case when they get it in their lap, so what would be the point? You’re going to get labels from, let’s say, 80,000 products. That’s not a mountain of data?”
‘What are they hiding?’
At the Dietary Supplements Regulatory Summit, Tave seemed to address such criticism. He explained FDA is requesting authority for a mandatory product listing to help the agency more effectively enforce the law.
“Why would we go through the time and trouble proposing this change if we don’t intend to use it?” he asked. “The claim that FDA refuses to take action is frivolous and it shouldn’t be taken seriously.”
Scott Bass, an attorney in Washington, D.C. with Sidley Austin LLP, who has been advising dietary supplement companies for decades, is a proponent of a mandatory product listing.
Without FDA knowing what products are on the market, “there’s really no way for the law to operate properly,” Bass said in an interview. “People who oppose it are raising questions in my mind as [to] why they don’t want the government to know they’re selling products to consumers to help their health. What are they hiding?”
He also said whether FDA enforces the NDI notification requirement in DSHEA is a distinct issue from whether the public and government would benefit from knowing what dietary supplement products are on the market.
“How they enforce is a separate issue from being able to enforce, and the fact that they [FDA officials] have not taken action on one matter doesn’t mean that the public doesn’t benefit,” Bass proclaimed. “And that’s what’s at issue here—public safety.”
Mandatory listing is ‘essential’
Steve Mister, president and CEO of CRN, described a mandatory product listing as “essential,” considering the industry’s size today.
“FDA has limited authority over supplements, and that was by design, but they need to know what’s in the marketplace for those things that they are charged with enforcing,” he said in an interview. “Where there are problems—and we know there are players in the industry who do not abide by all the requirements and restrictions on our products—FDA needs to be able to find them quickly.”
He added, “That is what a mandatory listing would do, and it would create an administrative enforcement mechanism for companies who don’t play by those rules.”
'DSHEA 2.0 is coming'
The concept of a dietary supplement product listing was raised nearly 20 years ago in a report by the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS). In an April 2001 report on adverse event reporting for dietary supplements, OIG recommended requiring manufacturers of supplements to register their products with FDA.
“A complete product registry would allow FDA to instantly access a list of all the ingredients in a particular product and determine the product manufacturer’s name as soon as it receives an adverse event report,” OIG stated.
In the early years following passage of DSHEA, OIG was fairly busy generating reports at the request of certain members of Congress, including former Rep. Henry Waxman (D-California) and Sen. Dick Durbin (D-Illinois), Israelsen recalled.
“DSHEA 2.0 is coming—the question is which side [FDA or industry] goes first,” he added via email. “A change of management in the White House and/or Senate would be an opportunity for FDA to seek changes to DSHEA, which is very much on their minds. And 26 years post-DSHEA, there are issues of interest to the industry as well. The key question remains: Are amendments to DSHEA advisable?”
As underscored by the arguments for and against a mandatory product listing, the answer to that question remains up for debate.