I 111th CONGRESS 1st Session H. R. 2088 IN THE HOUSE OF REPRESENTATIVES April 23, 2009 Mrs. Lowey introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require the Food and Drug Administration to finalize a standard for broad-spectrum protection in sunscreen products, and for other purposes.

1.

Short title

This Act may be cited as the Skin Cancer Prevention, Education, and Consumer Right-To-Know Act.

2.

Findings

The Congress finds as follows: (1)Skin cancer is a growing epidemic in the United States with more than 1,000,000 new cases diagnosed each year. (2)About 10,000 Americans die each year from skin cancer. (3)The most deadly form of skin cancer, melanoma, has tripled among Caucasians since 1980. (4)One in five Americans and one in three Caucasians will develop skin cancer in the course of a lifetime. (5)A person’s risk for skin cancer doubles if he or she has had five or more sunburns. (6)More than 90 percent of all skin cancers are caused by sun exposure, yet fewer than 33 percent of adults, adolescents, and children routinely use sun protection. (7)Most skin cancer is caused by prolonged exposure to the ultraviolet rays from the sun. This invisible radiation is classified as UVA radiation and UVB radiation. (8)UVB radiation is the chief cause of sunburn and skin cancer. (9)UVA radiation is more constant, year-round, and penetrates the skin more deeply, causing both premature aging and skin cancer. (10)Current United States sunscreen standards set by the Food and Drug Administration (FDA) require protection from UVB radiation but not UVA radiation. (11)The current United States sunscreen standards provide a false sense of security to Americans, since their sunscreen is protecting successfully against sunburn, but not adequately against other forms of skin damage, including skin cancers. Consumers may wrongly believe that their sunscreen is sufficiently protecting them and therefore stay in the sun longer.

3.

Effective date for rule relating to sunscreen drug products for over-the-counter human use

Notwithstanding subchapter II of chapter 5, and chapter 7, of title 5, United States Code (commonly known as the Administrative Procedure Act) and any other provision of law, the proposed rule issued by the Commissioner of Food and Drugs entitled Sunscreen Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph, 72 Fed. Reg. 49070 (August 27, 2007), shall take effect on the date that is 180 days after the date of enactment of this Act, unless such Commissioner issues the final rule, which includes formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection, before such effective date.

4.

Education

(a)

Education

The Secretary of Health and Human Services shall implement a general, nationwide education campaign identifying the risks posed by sun exposure without the use of a sunscreen providing broad-spectrum protection. (b)

Contents

The education campaign under this section shall be designed to increase the level of knowledge and awareness among the general public of the causes of skin cancer, the risks posed by unprotected sun exposure, the respective roles of ultraviolet B (UVB) and ultraviolet A (UVA) radiation in the development of skin cancer, the effective application of sunscreen, and the promulgation under section 3 of the standard requiring broad-spectrum protection in sunscreen products. (c)

Duration

The education campaign under this section shall be implemented for not less than one year.