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CSPI URGES HHS SECRETARY SHALALA NOT TO DELAY DIETARY SUPPLEMENT REGS

This article was originally published in The Tan Sheet

Executive Summary

CSPI URGES HHS SECRETARY SHALALA NOT TO DELAY DIETARY SUPPLEMENT REGS in a Dec. 8 letter. Referring to a Nov. 23 request from Sen. Orrin Hatch (R-Utah) and Reps. Bill Richardson (D-N.M.) and Elton Gallegly (R-Calif.) asking HHS Secretary Donna Shalala to prevent FDA from issuing final dietary supplement regulations until supplement legislation is passed ("The Tan Sheet" Nov. 29, p. 3), the Center for Science in the Public Interest asked that Shalala "not grant this request." The letter from Hatch, Richardson and Gallegly was sent after the House failed to pass an extension of the moratorium on Nutrition Labeling, & Education Act regulations for dietary supplements before going into recess; the Senate passed a four- month moratorium on supplement regs on Nov. 20 ("The Tan Sheet" Nov. 29, p. 1). The current moratorium, introduced by Hatch last year, expires on Dec. 15. CSPI pointed out that, by law, "FDA must issue final regulations" implementing NLEA for dietary supplements by Dec. 31 or "its proposed rules automatically become final." Thus, CSPI asserted, HHS "has no authority to honor the lawmakers' request." FDA published proposed dietary supplement regs in June ("The Tan Sheet" June 21, pp. 1-11). "The primary reason provided by the lawmakers for their extraordinary request," CSPI claimed, "is that they presume that new legislation on dietary supplements will be passed by Congress." However, CSPI asserted that dietary supplement regulation "has been debated in Congress since October 1990 and there is no guarantee that new legislation will be passed within the next six months." CSPI said it believes "supplements have a role to play in promoting health and preventing disease and opposes any unreasonable restrictions on their use." However, the group added, "we believe strongly that manufacturers should not be given the freedom to deceive and mislead consumers about the health benefits of their products." The three lawmakers are awaiting word on their request from the HHS secretary. In the meantime, members of the Senate Labor & Human Resources Committee are understood to be continuing discussions on compromise dietary supplement legislation ("The Tan Sheet" Dec. 6, p. 9).

CSPI URGES HHS SECRETARY SHALALA NOT TO DELAY DIETARY SUPPLEMENT REGS in a Dec. 8 letter. Referring to a Nov. 23 request from Sen. Orrin Hatch (R-Utah) and Reps. Bill Richardson (D-N.M.) and Elton Gallegly (R-Calif.) asking HHS Secretary Donna Shalala to prevent FDA from issuing final dietary supplement regulations until supplement legislation is passed ("The Tan Sheet" Nov. 29, p. 3), the Center for Science in the Public Interest asked that Shalala "not grant this request."

The letter from Hatch, Richardson and Gallegly was sent after the House failed to pass an extension of the moratorium on Nutrition Labeling, & Education Act regulations for dietary supplements before going into recess; the Senate passed a four- month moratorium on supplement regs on Nov. 20 ("The Tan Sheet" Nov. 29, p. 1). The current moratorium, introduced by Hatch last year, expires on Dec. 15.

CSPI pointed out that, by law, "FDA must issue final regulations" implementing NLEA for dietary supplements by Dec. 31 or "its proposed rules automatically become final." Thus, CSPI asserted, HHS "has no authority to honor the lawmakers' request." FDA published proposed dietary supplement regs in June ("The Tan Sheet" June 21, pp. 1-11).

"The primary reason provided by the lawmakers for their extraordinary request," CSPI claimed, "is that they presume that new legislation on dietary supplements will be passed by Congress." However, CSPI asserted that dietary supplement regulation "has been debated in Congress since October 1990 and there is no guarantee that new legislation will be passed within the next six months."

CSPI said it believes "supplements have a role to play in promoting health and preventing disease and opposes any unreasonable restrictions on their use." However, the group added, "we believe strongly that manufacturers should not be given the freedom to deceive and mislead consumers about the health benefits of their products."

The three lawmakers are awaiting word on their request from the HHS secretary. In the meantime, members of the Senate Labor & Human Resources Committee are understood to be continuing discussions on compromise dietary supplement legislation ("The Tan Sheet" Dec. 6, p. 9).

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