In an August 8 open letter to the dietary supplements industry about the FDA Safety & Landmark Advancements Act (FDASLA) and mandatory product listing proposals, the Council for Responsible Nutrition’s President and CEO Steve Mister reports that “negotiations for dietary supplement product listing continue with progress made each day toward getting a final bill that CRN can support.”
An open letter from Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), to the dietary supplement industry addresses what Mister says is “disinformation” circulating in discussions and media reporting about the FDA Safety & Landmark Advancements Act (FDASLA). Specifically, Mister addresses discussions over the mandatory product listing proposals for dietary supplements included in the bill’s language. (The Senate version of the bill includes the mandatory product listing language while a House version of the bill does not.) CRN has been a proponent of creating a federal mandatory product listing for dietary supplements.
In his letter, Mister states, “I want to reassure you that we continue to advocate for advancing this legislation and honor the guiding principles for this initiative directed by CRN’s Board of Directors. On the other hand, I am distressed to see so much disinformation being promoted that reflects lack of understanding of the complicated Congressional process, intentional misdirection and false information about what is in the bill, and intentional efforts to deceive the industry about the consequences of this legislation.”
Mister reports that negotiations with lawmakers are ongoing over any mandatory product listing language for dietary supplements that would be included in FDASLA, whose primary purpose is to reauthorize FDA user fees for pharmaceutical drugs. In June, the Senate HELP Committee passed a version of FDASLA that did not include some requests made by supplement industry groups, including CRN, to amend language related to the bill’s mandatory product listing provisions for dietary supplements. Then in July, Senator Richard Burr (R-NC) introduced his own FDA user fee bill that does not include a mandatory product listing provision for dietary supplements at all.
CRN’s negotiations with lawmakers over the original FDASLA bill continue—and Mister states that if changes that CRN feels are critical ultimately aren’t made to the FDASLA, that the association would support Senator Burr’s bill without mandatory product listing requirements.
But there is still ongoing work to revise the current FDASLA bill. Writes Mister: “Contrary to what you may have heard, the negotiations for dietary supplement product listing continue with progress made each day toward getting a final bill that CRN can support. The press reports you may have read about a ‘stripped-down, user fee only bill’ are still a possibility, and in fact, if CRN is not able to reach agreement on the ‘must have’ changes to the Senate Committee–passed bill, CRN would even support that bare bones reauthorization of the user fees without any mention of dietary supplements. But we are not at that juncture yet, and for now, we continue our discussions with the Hill.”
Mister’s letter then address what he says is inaccurate information being floated in discussions about FDASLA’s mandatory product listing language.
First, he says, arguments that FDASLA should restrict its contents only to drug-related issues are not well founded, as historically drug user fee bill proposals, which happen every five years, have addressed other issues such as bioterrorism. “So the notion that FDASLA must remain ‘pure’ to drugs and devices only is an effort to deflect attention from the real issues,” Mister writes. He continues, “These ‘must-pass’ omnibus bills are one of the few ways to get anything done…For people who know how to get things done in Washington, it’s the manner of doing business…We are fortunate to have FDASLA advancing with an opportunity to hitch a ride.” He also notes that supplements and the mandatory product listing language do not threaten the bill’s overall passage; rather, he states, “If the legislation does not pass, it will be over an impasse on drug issues,” and not because of any supplement provisions, which are viewed as less important than the bill’s drug provisions.
Mister also notes that while Senator Burr’s own version of a reauthorization bill does not include a mandatory product listing component for supplements, it is not because the Senator expressed objection to any supplement proposals in FDASLA. Rather, he says, objections Senator Burr expressed to the original FDASLA bill “are all related to drugs and devices, not supplements.”
“But to be clear,” Mister wrote, “[Senator Burr’s] statement explaining his bill doesn’t even mention supplements (or cosmetics—another provision of FDASLA). It is inaccurate to suggest that he is conceding to the will of the supplement industry with this alternative legislation.”
Mister says CRN has made progress in getting some critical changes made to the Senate committee–approved version of FDASLA, and one change in particular that would reassure industry that the bill does not give FDA premarket approval over dietary supplements. Mister writes that “when some industry stakeholders falsely alleged that the legislation ‘would require premarket approval,’ we approached the HELP committee for further assurances. The committee-approved version of FDASLA now contains the provision that ‘Nothing in this section shall be construed to grant the Secretary authority to require the approval of a dietary supplement prior to marketing.’ The committee bill also includes some protections for confidential business information (although we are asking for more).”
“Our most recent discussions suggest that there is opportunity for dialogue on our remaining issues,” Mister writes.
Mister also addresses those who believe that any movement toward a mandatory product listing for dietary supplements should wait until there is a greater effort to reform supplement regulations altogether and to enact other large changes, like allowing third parties to conduct facility inspections on behalf of FDA. Mister expresses doubt that more comprehensive changes to supplement regulations could happen in a timely manner especially in the current political climate. Whereas, he says, by focusing on the FDASLA bill that’s already in progress, “mandatory listing is achievable in this Congress.”
At the conclusion of his letter, Mister urges industry stakeholders, “I encourage you over the next few months to be scrupulous consumers of information and maintain a healthy skepticism when you read or hear that the product listing can’t be achieved or would doom the industry.”