Is mandatory product listing for dietary supplements imminent?

Legislation could very well be in the works to propose mandatory product listing for dietary supplements in the U.S., said speakers at the Consumer Healthcare Products Association’s Regulatory, Scientific & Quality Conference last week.

The debate over whether FDA should require dietary supplement companies to submit product information to a federal database is intensifying as unconfirmed reports hint that Congress may already be drafting legislation for such a mandate. While many groups who criticize FDA’s oversight of dietary supplements in the U.S. as too lax or ineffective support the creation of a mandatory product listing for supplements, supplement industry stakeholders remain split on whether a listing would actually help FDA better identify or enforce against companies running afoul of supplement regulations.

The topic of mandatory product listing took center stage at last week’s Consumer Healthcare Products Association’s (CHPA; Washington, DC) virtual 2021 Regulatory, Scientific & Quality Conference. During a September 9 webcast panel titled “DSHEA 2.0”—referring to possible reforms to the Dietary Supplement Health and Education Act (DSHEA) regulating dietary supplements in the U.S.—speakers Liz Richardson, project director at Pew Charitable Trusts, and Diane McEnroe, JD, partner at Sidley Austin LLP, presented the merits of mandatory product listing.

A few of the speakers said it’s likely that in the near future, Congress will take formal action to propose mandatory listing.

“At the time of this recording, we understand there will be legislation introduced by Senator [Richard] Durbin [D-IL],” said Sidley Austin’s McEnroe, “and we know from prior drafts of similar legislation that the main area of focus will likely be mandatory product listing.”

Pew’s Richardson said that mandatory product listing has “been the focus of a lot of discussion in Congress recently and seems to be something that may be advancing.” Richardson said that while she had not seen any specific details about a potential bill, “I was hoping there would be a formal proposal on the table to react to by this time. We know that Congress is very interested in this issue. But we haven’t seen it yet.”

FDA itself has pushed for authority to mandate product listing for supplements. As recently as July 13, during the 2021 Dietary Supplements Regulatory Summit hosted by the Natural Products Association (NPA; Washington, DC), guest speaker Cara Welch, PhD, acting director of FDA’s Office of Dietary Supplement Programs (ODSP) said not only is the agency in favor of a mandatory product registry but that FDA believes “there is a way to successfully implement a mandatory listing requirement that does not impose significant burden on responsible industry, or even slow the introduction of products into the market.”

Those who support a mandatory product listing say that requiring companies to submit information in order to be allowed to sell dietary supplements in the U.S. would help FDA get a fuller accounting of all the supplement products on the market.

What would a listing requirement look like? Some of the webcast speakers speculated.

Pew Charitable Trusts has vocally pushed for dietary supplement regulation reform—and not just for mandatory product listing. For mandatory product listing specifically, Richardson said, “At a minimum, mandatory product listing should encompass…ingredients, including the composition of proprietary blends; a copy of the labels; the directions for use; any relevant warnings or precautions; an allergen statement where applicable; the dosage amount and serving size; and the product claims being made.”

She added: “There are also other components that we think would be useful to the agency—for example, including the path to market. Were the ingredients all pre-DSHEA? Were some GRAS [Generally Recognized as Safe]? Were some submitted through NDI [New Dietary Ingredient notification]?”

McEnroe, who has worked with CHPA on exploring potential supplement regulation reforms, talked about CHPA’s own preferences for a mandatory listing. “At a minimum, at baseline, we would want to see what’s available on the label—the product formulation, including ingredients; the responsible party’s name and contact information. All of that information would be essential. Whether some additional things would be added is questionable and would obviously be subject to much discussion. Claims would be one area. Whether an NDI had been filed might be another area.”

Maintaining the database is also key, she said. “Obviously, there would need to be updates and some changes that would trigger an update, so annual updates would make sense in this case so the listing is kept current.” The database should also be publicly available and searchable for the use of parties like retailers, who would use the database to cross-check whether supplement companies had listed themselves and complied with the law, McEnroe said. The database itself could be modeled after FDA’s current database for over-the-counter (OTC) drug, she added. “And you would put this onus [for listing] on the manufacturer/partner/distributor as a responsible party.”

Richardson suggested that some information could be kept confidential and for FDA’s eyes only. “We primarily think of this as a public resource, but there are certain elements we listed…that we think could be kept kind of a firewall, available to FDA only, such as the proprietary blend components.”

Both McEnroe and Richardson emphasized that FDA would need to be given more funding to create, operate, and maintain such a database.

Richardson said Pew would like to see FDA be able to enforce noncompliance with listing. “In terms of timing, we think manufacturers should be required to list before market entry and will need to update the database in a timely manner,” she said. “And, finally, we think failure to list should be actionable by FDA. That is, if the agency finds a product on the market that is not listed, that in itself could trigger enforcement action.”

Likely to Happen?

At a time when both FDA and Congressional resources are being taxed by the pandemic and other crises, how likely is it that any legislation to enact mandatory listing—or to reform supplement regulations—will move forward?

Angela Wiles, health policy director for Senator Richard Burr (R-NC), was one of the webcast guest speakers. Webcast moderator Marc Schloss, CHPA’s vice president of federal government affairs, asked Wiles about how Congress, including Senator Burr, who is a ranking member of the Senate Health, Education, Labor, and Pensions Committee (HELP), might be prioritizing potential supplement-related legislation at this time.

Wiles replied, “That’s a great question, and I think my answer may be one that’s disappointing to some folks on the line, but I think the appetite and the focus this fall will really be on the pandemic preparedness and, as you mentioned, some of the other larger items.” She continued: “As we get into the winter, I think it’s going to be very difficult to move major pieces of FDA legislation. I think any reforms to dietary supplements would be something that the [HELP] committee, if they decided to take it on, would be something that we would go through a normal HELP committee process on, which typically takes a decent amount of time.”

“Would you have any advice for us about how we might seek to move dietary supplement reform this Congress? Is there any sense of where the ranking member might be on some of these issues?” he asked, referring to Burr.

Wiles said that while Senator Burr’s focus will be on “lessons learned from the pandemic,” she noted that he “has traditionally been critical or had a lot of questions about the expansion of the FDA’s authority and really defining what that need may be.” She noted that the decision on whether there’s need or not to expand FDA authority in general would be “a longer conversation.”

On the Horizon

Still, if reports of developing legislation around mandatory listing are true, it’s possible that the proposal for mandatory listing, which has been debated both outside and within the supplements industry for years, could get a big boost. Leaders in the dietary supplements industry remain split on whether to support mandatory listing; some remain skeptical that a listing database alone would actually enable FDA to actively clean up the market—and, in the meantime, wonder whether such a database could be used to the industry’s disadvantage.

The concept of mandatory listing remains key in conversations around DSHEA 2.0 and modernizing dietary supplement regulations, and it is likely to remain so. Pew’s Richardson argued that, “With respect to mandatory listing, clarifying mandatory recall authority, that’s where there’s a real recognition there’s an urgent need there. Since a lot of the other reforms that have been proposed really are predicated on the FDA knowing what’s on the market, which currently it really has no mechanism to know, I think, from our perspective, start there.”

Is there any going back on mandatory product listing? For better or for worse, the signals are getting stronger that mandatory listing for dietary supplements could one day soon move past debate and become reality.