To require the Food and Drug Administration to issue a monograph with respect to over-the-counter sunscreen.
What it does: Inserts new text on page 173, line 24Inserts new text on page 173, line 24
InsertsPrinted pageInserted: Sec. 7 . (a) Congress makes the following findings:
Inserted: (1) Consumers need clear and consistent information about the risks associated with exposure to the sun, and the protection offered by over-the-counter sunscreen products.
Inserted: (2) The Food and Drug Administration (referred to in this section as the "FDA") began developing a monograph for over-the-counter sunscreen products in 1978.
Inserted: (3) In 2002, after 23 years, the FDA issued the final monograph for such sunscreen products.
Inserted: (4) One of the most critical aspects of sunscreen is how to measure protection against UVA rays, which cause skin cancer.
Inserted: (5) The final sunscreen monograph failed to address this critical aspect and, accordingly, the monograph was stayed shortly after being issued until issuance of a comprehensive monograph.
Inserted: (6) Skin cancer rates continue to rise, especially in younger adults and women.
Inserted: (7) Pursuant to section 751 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379r), a Federal rule on sunscreen labeling would preempt any related State labeling requirements.
Inserted: (8) The absence of a Federal rule could lead to a patchwork of State labeling requirements that would be confusing to consumers and unnecessarily burdensome to manufacturers.
Inserted: (b) Not later than one year after the date of enactment of this Act, the FDA shall issue a comprehensive final monograph for over-the-counter sunscreen products, which shall include UVA and UVB labeling requirements.
Original wording
On page 173, after line 24, insert the following:
Read automatically from the Congressional Record. Check the original before relying on it.
As printed
On page 173, after line 24, insert the following:
Sec. 7 . (a) Congress makes the following findings:
(1) Consumers need clear and consistent information about the risks associated with exposure to the sun, and the protection offered by over-the-counter sunscreen products.
(2) The Food and Drug Administration (referred to in this section as the “FDA”) began developing a monograph for over-the-counter sunscreen products in 1978.
(3) In 2002, after 23 years, the FDA issued the final monograph for such sunscreen products.
(4) One of the most critical aspects of sunscreen is how to measure protection against UVA rays, which cause skin cancer.
(5) The final sunscreen monograph failed to address this critical aspect and, accordingly, the monograph was stayed shortly after being issued until issuance of a comprehensive monograph.
(6) Skin cancer rates continue to rise, especially in younger adults and women.
(7) Pursuant to section 751 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379r), a Federal rule on sunscreen labeling would preempt any related State labeling requirements.
(8) The absence of a Federal rule could lead to a patchwork of State labeling requirements that would be confusing to consumers and unnecessarily burdensome to manufacturers.
(b) Not later than one year after the date of enactment of this Act, the FDA shall issue a comprehensive final monograph for over-the-counter sunscreen products, which shall include UVA and UVB labeling requirements.
Legislative Activity
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Senate amendment submitted
September 21, 2005
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Senate amendment submitted
September 21, 2005
Senate amendment proposed (on the floor): Amendment SA 1818 proposed by Senator Kohl for Senator Dodd.
September 21, 2005
Senate amendment agreed to: Amendment SA 1818 agreed to in Senate by Voice Vote.
September 21, 2005
Amendment SA 1818 proposed by Senator Kohl for Senator Dodd. (consideration: CR S10286; text: CR S10286) To require the Food and Drug Administration to issue a monograph with respect to over-the-counter sunscreen.
September 21, 2005
Amendment SA 1818 agreed to in Senate by Voice Vote.
September 21, 2005
Amendments
1 amendmentOffered to this amendment
Amendments
1 amendmentOffered to this amendment