08.06.13
The United Natural Products Alliance (UNPA), Salt Lake City, UT, has expressed its opposition to S.1425, the Dietary Supplement Labeling Act, recently introduced in the U.S. Senate Senators Richard Durbin, D-IL, and Richard Blumenthal, D-CT.
UNPA noted that this legislation creates redundant regulatory burdens for both industry and the regulator, the Food and Drug Administration (FDA). Additionally, according to UNPA, S.1425 does nothing to better equip FDA to enforce the provisions of the Dietary Supplement Health and Education Act (DSHEA) against known problem product categories, specifically those sold as dietary supplements for weight loss, erectile dysfunction or sports performance sold primarily on the Internet.
“As UNPA has stated since the first introduction of this bill in 2011, we support the overall objectives of Sens. Durbin’s and Blumenthal’s legislation—to ensure the safety of lawfully sold dietary supplements and to remove from the market illegal products being sold as dietary supplements. Unfortunately, as drafted, S.1425 would not solve the problems it seeks to address. In fact, it would likely impede progress towards cracking down on unlawful actors by adding an unfunded set of mandates to an already underfunded FDA dietary supplement enforcement effort,” said UNPA president Loren Israelsen.
“Congress created DSHEA in 1994, which provides FDA with specific tools to regulate dietary supplements,” he added. “The answer is to not add additional paperwork and cost for both the agency and reputable dietary supplement companies, but for Congress to fully fund FDA to exercise the power it already has to speed up enforcement of key regulations, such as good manufacturing process (GMPs).”
UNPA said its take-away of the proposed legislation is that it represents an unnecessary diversion from and a dilution of the agency’s already strained ability to implement components of the 20-year-old DSHEA—including guidance on new dietary ingredients (NDIs)—and enforcing current GMP and serious adverse event reporting (SAER) requirements.
UNPA noted that FDA’s GMP inspections have been successful in increasing compliance with DSHEA and are being utilized to confirm proper filing of SAERs and increasingly, to assess NDI compliance.
“We urge 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,” Mr. Israelsen said.
UNPA noted that this legislation creates redundant regulatory burdens for both industry and the regulator, the Food and Drug Administration (FDA). Additionally, according to UNPA, S.1425 does nothing to better equip FDA to enforce the provisions of the Dietary Supplement Health and Education Act (DSHEA) against known problem product categories, specifically those sold as dietary supplements for weight loss, erectile dysfunction or sports performance sold primarily on the Internet.
“As UNPA has stated since the first introduction of this bill in 2011, we support the overall objectives of Sens. Durbin’s and Blumenthal’s legislation—to ensure the safety of lawfully sold dietary supplements and to remove from the market illegal products being sold as dietary supplements. Unfortunately, as drafted, S.1425 would not solve the problems it seeks to address. In fact, it would likely impede progress towards cracking down on unlawful actors by adding an unfunded set of mandates to an already underfunded FDA dietary supplement enforcement effort,” said UNPA president Loren Israelsen.
“Congress created DSHEA in 1994, which provides FDA with specific tools to regulate dietary supplements,” he added. “The answer is to not add additional paperwork and cost for both the agency and reputable dietary supplement companies, but for Congress to fully fund FDA to exercise the power it already has to speed up enforcement of key regulations, such as good manufacturing process (GMPs).”
UNPA said its take-away of the proposed legislation is that it represents an unnecessary diversion from and a dilution of the agency’s already strained ability to implement components of the 20-year-old DSHEA—including guidance on new dietary ingredients (NDIs)—and enforcing current GMP and serious adverse event reporting (SAER) requirements.
UNPA noted that FDA’s GMP inspections have been successful in increasing compliance with DSHEA and are being utilized to confirm proper filing of SAERs and increasingly, to assess NDI compliance.
“We urge 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,” Mr. Israelsen said.
