By Sean Moloughney, Editor05.18.22
The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee has released a discussion draft of the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, which includes language to mandate product listing of dietary supplements, similar to the Dietary Supplement Listing Act of 2022 (S. 4090) introduced in April by Sen. Dick Durbin (D-IL) and Sen. Mike Braun (R-IN).
The FDASLA bill would reauthorize the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements. These user fee programs must be reauthorized every 5 years so the bill is considered “must-pass” legislation to provide for timely review of new drug and biologic license applications. The current user fee programs are currently authorized through September 2022.
The discussion draft was released by HELP Committee Chair Senator Patty Murray (D-WA) and Ranking Member Senator Richard Burr (R-NC). The senators developed the discussion draft following hearings with FDA officials and stakeholders last month, and plan to introduce and mark up a final version of the legislation in the coming weeks.
The House Energy and Commerce Committee previously released its version to reauthorize user fees that did not contain language on mandatory listing of dietary supplements.
Specifics for Supplements
For dietary supplements, the draft bill requires “responsible persons to list with FDA the dietary supplements they manufacture, pack, or distribute,” including information primarily found on labels, “at the time of introduction into interstate commerce.” Failure to comply with the listing mandate would render products “misbranded.”
The bill would also require FDA to publish final guidance on new dietary ingredient notifications no later than 18 months after the date of enactment and directs resources for the agency to inspect facilities, suppliers, and “dietary supplement types that present a high risk to public health.”
Introduction into interstate commerce of a product that doesn’t meet the definition of a dietary supplement under the Federal Food, Drug, and Cosmetic Act would be considered “a new prohibited act.”
Additionally, introduction of a dietary supplement that has been manufactured “by or for a person who has been debarred” would also be considered “a new prohibited act.”
The FDASLA also includes new mandates for cosmetics, including good manufacturing practices (GMPs), which are already required for dietary supplements.
Commentary and Context
“Families want to know the products they entrust their health to are safe and effective—which is why this bipartisan legislation is so important,” Murray said in a press release. “This legislation will ensure FDA has the resources it needs to do its work—and will enable the agency to finally provide serious oversight of the cosmetics and dietary supplements people in Washington state use every day.”
In previous statements on dietary supplements, Murray said “people across the country are faced with a shelf full of products that make health claims—but lack oversight. FDA does not have the authority to collect basic information about these products—or even to know what’s on the market. People in Washington state buy, use, and entrust their health to these items every day. They deserve to know these products are safe, are vetted, and are subject to careful FDA oversight.”
Responding to the draft bill, Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA) said the association is “significantly concerned” with Murray and Burr “who failed to reject the radical and dangerous legislation from Senators Durbin and Braun that would require premarket approval for dietary supplements and weaken key privacy protections of the Bioterrorism Act, which protects the dietary supplement supply chain.”
“Last time I checked, dietary supplements are not drugs, biologics, or medical devices,” Fabricant added, “so why is Congress or anyone supporting nongermane legislation that will only add costs to consumers who are doing all they can to stay healthy.”
He further added: “Groups who have supported this legislation, have stated there are protections for technical disagreements with the FDA like those with hemp, CBD, NAC, and several other products. However, if this legislation were to pass, it is abundantly clear these products would be eliminated from the market. The war is far from over. We need America’s health and wellness advocates to continue writing their members of Congress through the NPA Action Center, here. Grassroots involvement over the coming weeks is absolutely critical to defeating this radical and dangerous proposal.”
The FDASLA bill would reauthorize the Food and Drug Administration’s (FDA) prescription drug, generic drug, biosimilar, and medical device user fee agreements. These user fee programs must be reauthorized every 5 years so the bill is considered “must-pass” legislation to provide for timely review of new drug and biologic license applications. The current user fee programs are currently authorized through September 2022.
The discussion draft was released by HELP Committee Chair Senator Patty Murray (D-WA) and Ranking Member Senator Richard Burr (R-NC). The senators developed the discussion draft following hearings with FDA officials and stakeholders last month, and plan to introduce and mark up a final version of the legislation in the coming weeks.
The House Energy and Commerce Committee previously released its version to reauthorize user fees that did not contain language on mandatory listing of dietary supplements.
Specifics for Supplements
For dietary supplements, the draft bill requires “responsible persons to list with FDA the dietary supplements they manufacture, pack, or distribute,” including information primarily found on labels, “at the time of introduction into interstate commerce.” Failure to comply with the listing mandate would render products “misbranded.”
The bill would also require FDA to publish final guidance on new dietary ingredient notifications no later than 18 months after the date of enactment and directs resources for the agency to inspect facilities, suppliers, and “dietary supplement types that present a high risk to public health.”
Introduction into interstate commerce of a product that doesn’t meet the definition of a dietary supplement under the Federal Food, Drug, and Cosmetic Act would be considered “a new prohibited act.”
Additionally, introduction of a dietary supplement that has been manufactured “by or for a person who has been debarred” would also be considered “a new prohibited act.”
The FDASLA also includes new mandates for cosmetics, including good manufacturing practices (GMPs), which are already required for dietary supplements.
Commentary and Context
“Families want to know the products they entrust their health to are safe and effective—which is why this bipartisan legislation is so important,” Murray said in a press release. “This legislation will ensure FDA has the resources it needs to do its work—and will enable the agency to finally provide serious oversight of the cosmetics and dietary supplements people in Washington state use every day.”
In previous statements on dietary supplements, Murray said “people across the country are faced with a shelf full of products that make health claims—but lack oversight. FDA does not have the authority to collect basic information about these products—or even to know what’s on the market. People in Washington state buy, use, and entrust their health to these items every day. They deserve to know these products are safe, are vetted, and are subject to careful FDA oversight.”
Responding to the draft bill, Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA) said the association is “significantly concerned” with Murray and Burr “who failed to reject the radical and dangerous legislation from Senators Durbin and Braun that would require premarket approval for dietary supplements and weaken key privacy protections of the Bioterrorism Act, which protects the dietary supplement supply chain.”
“Last time I checked, dietary supplements are not drugs, biologics, or medical devices,” Fabricant added, “so why is Congress or anyone supporting nongermane legislation that will only add costs to consumers who are doing all they can to stay healthy.”
He further added: “Groups who have supported this legislation, have stated there are protections for technical disagreements with the FDA like those with hemp, CBD, NAC, and several other products. However, if this legislation were to pass, it is abundantly clear these products would be eliminated from the market. The war is far from over. We need America’s health and wellness advocates to continue writing their members of Congress through the NPA Action Center, here. Grassroots involvement over the coming weeks is absolutely critical to defeating this radical and dangerous proposal.”
