09.09.13
Senator Richard Durbin (D-IL) and co-sponsor Sen. Richard Blumenthal (D-CT) have reintroduced the Dietary Supplement Labeling Act (S.1425), which would require dietary supplement companies to register all supplements with FDA and would amend certain supplement labeling requirements.
The bill would also direct the Department of Health and Human Services (HHS) to coordinate with the Institute of Medicine to compile a list of dietary supplement ingredients that could cause potentially serious adverse events, drug interactions, contraindications or potential risks to subgroups such as children and pregnant or breastfeeding women. Additionally, the bill would require the HHS Secretary to establish a definition for the term “conventional food” for purposes of the Federal Food, Drug, and Cosmetic Act; require FDA to establish mandatory warning label requirements for some dietary supplements; and mandate inclusion of a batch number on each supplement product label.
“Like the previous version of this bill, the legislation would impose a product registration requirement for dietary supplements even though conventional foods bear no such burden,” said Michael McGuffin, president, American Herbal Products Association (AHPA), Silver Spring, MD. “There is no reason that product registration is needed specifically for dietary supplements and AHPA opposes this provision.”
The Council for Responsible Nutrition (CRN), Washington, D.C, voiced similar concern. Steve Mister, president and CEO, said the organization opposes the legislation, “because it creates added burdens for both FDA and companies already following the law, but does not address the problem of those companies that are disregarding the law.” He continued, “Rather than creating new laws, our industry needs a renewed commitment from Congress to provide FDA with additional funding and resources so the agency can use the ample enforcement tools already at its disposal to take aim at companies that do not comply with the regulations currently in place to protect consumers.”
The United Natural Products Alliance (UNPA), Salt Lake City, UT, also expressed its opposition to S.1425, noting the legislation creates redundant regulatory burdens and does nothing to better equip FDA in enforcing the provisions of the Dietary Supplement Health and Education Act (DSHEA). Rather than create “additional paperwork and cost for both the agency and reputable dietary supplement companies,” UNPA president Loren Israelsen implored Congress to “continue to support the full implementation of DSHEA, including proactive, industry-supported provisions covering GMPs and NDIs, as well as greater funding for specific FDA compliance programs.”
The bill would also direct the Department of Health and Human Services (HHS) to coordinate with the Institute of Medicine to compile a list of dietary supplement ingredients that could cause potentially serious adverse events, drug interactions, contraindications or potential risks to subgroups such as children and pregnant or breastfeeding women. Additionally, the bill would require the HHS Secretary to establish a definition for the term “conventional food” for purposes of the Federal Food, Drug, and Cosmetic Act; require FDA to establish mandatory warning label requirements for some dietary supplements; and mandate inclusion of a batch number on each supplement product label.
“Like the previous version of this bill, the legislation would impose a product registration requirement for dietary supplements even though conventional foods bear no such burden,” said Michael McGuffin, president, American Herbal Products Association (AHPA), Silver Spring, MD. “There is no reason that product registration is needed specifically for dietary supplements and AHPA opposes this provision.”
The Council for Responsible Nutrition (CRN), Washington, D.C, voiced similar concern. Steve Mister, president and CEO, said the organization opposes the legislation, “because it creates added burdens for both FDA and companies already following the law, but does not address the problem of those companies that are disregarding the law.” He continued, “Rather than creating new laws, our industry needs a renewed commitment from Congress to provide FDA with additional funding and resources so the agency can use the ample enforcement tools already at its disposal to take aim at companies that do not comply with the regulations currently in place to protect consumers.”
The United Natural Products Alliance (UNPA), Salt Lake City, UT, also expressed its opposition to S.1425, noting the legislation creates redundant regulatory burdens and does nothing to better equip FDA in enforcing the provisions of the Dietary Supplement Health and Education Act (DSHEA). Rather than create “additional paperwork and cost for both the agency and reputable dietary supplement companies,” UNPA president Loren Israelsen implored Congress to “continue to support the full implementation of DSHEA, including proactive, industry-supported provisions covering GMPs and NDIs, as well as greater funding for specific FDA compliance programs.”