Newly introduced FDA user fee reauthorization legislation excludes mandatory product listing requirement

Senator Richard Burr (R- NC), ranking member of the Senate Committee on Health, Education, Labor and Pensions (HELP), has introduced new FDA user fee reauthorization legislation titled “Food and Drug Administration Simple Reauthorization Act.”

Senator Richard Burr (R- NC), ranking member of the Senate Committee on Health, Education, Labor and Pensions (HELP), has introduced new FDA user fee reauthorization legislation titled “Food and Drug Administration Simple Reauthorization Act.” The legislation was introduced because of the Senator’s concerns about the Senate’s ability to pass the “Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act” on time, as well as policies attached to the bill that he believes threaten innovation. Notably, this version of the FDA user fee reauthorization excludes provisions that impose a mandatory product listing requirement on dietary supplement manufacturers. Since FDASLA has passed committee, industry has spoken out against the legislation citing concerns that the dietary supplement provision was overly burdensome and threatened innovation by not including protections for proprietary business information.

“Senator Burr is absolutely right that extraneous, unnecessary and costly dietary supplement provisions have no place in this legislation, and should be applauded for this principled stance. The dietary supplement provisions in the FDASLA would drive up the cost for consumers while preventing them from accessing certain products,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA; Washington, D.C.), in a press release. “As the nation faces record double-digit inflation Congress should not be making it more expensive for Americans to stay healthy. Additionally, Congress has never required the nutritional supplement industry to pay user fees, and supplements are not prescription drugs, generic drugs, medical devices, or biosimilars, so including dietary supplement provisions was not only controversial but unprecedented.”