[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3084 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 3084

To require the Food and Drug Administration to establish a standard for 
    broad-spectrum protection in sunscreen products, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 18, 2007

  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 establish a standard for 
    broad-spectrum protection in sunscreen products, and for other 
                               purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

SEC. 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 5 Americans and one in 3 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 5 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.

SEC. 3. BROAD-SPECTRUM SUNSCREEN STANDARD.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended--
            (1) in section 502, by adding at the end the following:
    ``(y) If it is a drug that is a sunscreen product and its labeling 
is in violation of section 566 .''; and
            (2) by inserting after section 565 the following:

``SEC. 566. BROAD-SPECTRUM SUNSCREEN STANDARD.

    ``(a) Labeling.--The labeling of a drug that is a sunscreen product 
and fails to meet the standard adopted under subsection (b)(1) shall 
not--
            ``(1) describe the product using the term `broad-spectrum' 
        (or any variant of such term); or
            ``(2) include the symbol described in subsection (b)(2).
    ``(b) Standard; Symbol.--The Secretary shall--
            ``(1) adopt a standard for broad-spectrum protection in 
        sunscreen products in order to better protect Americans from 
        skin cancer and premature aging; and
            ``(2) adopt an easily recognized symbol for inclusion in 
        the labeling of sunscreen products meeting such standard.
    ``(c) Minimum Requirements.--
            ``(1) Minimum requirements.--In establishing the standard 
        under subsection (b)(1), the Secretary shall require--
                    ``(A) a minimum ratio 1 to 3 of UVA protection 
                factor (UVA-PF) to sun protection factor (SPF);
                    ``(B) a critical wavelength of 370 nanometers, as 
                obtained in application of the critical wavelength 
                testing method;
                    ``(C) a minimum level of UVB radiation protection 
                of sun protection factor 6 as obtained in application 
                of the International Sun Protection Factor Test Methods 
                (2006) or an equivalent degree of protection obtained 
                with any in vitro method; and
                    ``(D) truth in labeling requirements such that--
                            ``(i) claims of broad-spectrum protection 
                        from ultraviolet radiation can only be made in 
                        cases where the product meets the requirements 
                        established under this section; and
                            ``(ii) labels claiming broad-spectrum 
                        protection include the symbol described in 
                        subsection (b)(2) only if the sunscreen product 
                        meets the standard adopted under subsection 
                        (b)(1).
            ``(2) Measurement of protection levels.--The protection 
        factors described in paragraph (1) shall be measured using 
        standardized, reproducible testing methods that take photo-
        degradation into account. In considering such methods, the 
        Secretary shall give preference to in vitro testing methods.
    ``(d) Regulations.--Not later than December 31, 2007, the Secretary 
shall issue comprehensive final regulations for carrying out this 
section with respect to sunscreen products.
    ``(e) Definitions.--
            ``(1) Broad-spectrum protection.--The term `broad-spectrum 
        protection' means protection from both UVA radiation and UVB 
        radiation.
            ``(2) Sun protection factor.--The term `sun protection 
        factor' is the ratio between the ultraviolet dose required to 
        produce minimal erythema reaction (redness) in protected skin 
        (skin with sunscreen) compared to unprotected skin (skin 
        without any sunscreen). The number indicates how many times 
        longer a person can stay in the sun before beginning to burn 
        while wearing sun protection than if he or she were not wearing 
        any sunscreen at all.
            ``(3) UVA protection factor.--The term `UVA protection 
        factor' means the ratio of the minimum UVA radiation dose 
        necessary to induce a persistent pigment darkening on the skin 
        protected by a sunscreen product to the minimal UVA radiation 
        dose necessary to induce the minimal darkening effect on the 
        same unprotected skin.
            ``(4) UVA radiation.--The term `UVA radiation' means sun 
        radiation in the spectrum of 320 to 400 nanometers.
            ``(5) UVB radiation.--The term `UVB radiation' means sun 
        radiation in the spectrum of 290 to 320 nanometers.''.
    (b) Effective Date.--The requirements of sections 502(y) and 566(a) 
of the Federal Food, Drug, and Cosmetic Act, as added by subsection 
(a), shall take effect on the earlier of--
            (1) the date determined appropriate by the Secretary of 
        Health and Human Services; or
            (2) the date that is 1 year after the date of the enactment 
        of this Act.

SEC. 4. EDUCATION.

    (a) Education.--Upon issuing the regulations required by subsection 
(d) of section 566 of the Federal Food, Drug, and Cosmetic Act, as 
added by section 3, 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 UVA radiation and UVB 
radiation (as defined in such section 566) in the development of skin 
cancer, the effective application of sunscreen, and the release of the 
standard requiring broad-spectrum protection (as defined in such 
section 566) in sunscreen products.
    (c) Duration.--The education campaign under this section shall be 
implemented for not less than one year.
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