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Questions and Answers on the 2007 Sunscreen Proposed Rule
1. What is ultraviolet light and why should I be concerned about it? The sun produces not only the visible light that we can see but also ultraviolet (UV) light that we can’t see. There are two types of UV light that can be harmful to us: UVA and UVB. UVB light is primarily responsible for causing sunburn. Both UVB and UVA light contribute to skin cancer, premature skin aging, and other types of skin damage. It is important to protect ourselves from both UVB and UVA light. FDA has been concerned about exposure to ultraviolet (UV) light from the sun since the OTC drug review process began over 30 years ago. Until now most of the focus of FDA’s attention has been on reducing exposure to UVB light. Nonetheless, the issue of protecting against exposure to UVA light has been addressed broadly in all previous rulemakings. Currently, there are no internationally accepted standards for evaluating the effectiveness of a sunscreen in protecting against UVA light. In fact, only a few countries have even addressed UVA protection at all. FDA is aware of ten different tests designed to measure UVA protection. Over the last several years, FDA has conducted detailed analyses of data and information related to all of these UVA tests and, in this rule, is proposing a standard testing protocol. The new protocol requires clinical and non-clinical tests to give an accurate and reproducible assessment of UVA protection. Comparable to the SPF test which measures how well a sunscreen reduces burning, the clinical test for UVA effectiveness measures how well a sunscreen reduces darkening of the skin. Based on this test, sunscreens are classified as low, medium, high, or highest UVA protection. The non-clinical test measures the ability of a sunscreen to reduce the amount of UVA light passing through the sunscreen. Based on the non-clinical test, sunscreens are also classified as providing low, medium, high, or highest UVA protection. The results of both tests are combined to produce a single UVA protection level (i.e., low, medium, high, or highest) with a corresponding star rating. The UVA protection level represents the lowest level of protection determined by the two tests. For example, if one test indicates a low level of UVA protection and the other test indicates a medium level of protection, the sunscreen is labeled as having a low level of UVA protection. The level of UVB sunscreen protection is indicated by a numerical value (e.g., SPF 30). In contrast, the level of UVA protection is indicated by a descriptor with an accompanying star rating (e.g., medium 3. Is the 1999 rule currently in effect? How does this proposed rule relate to the 1999 final rule? The 1999 final rule addressed UVB testing and labeling requirements for sunscreen products. That final rule was stayed and is not currently in effect so that the agency could also address UVA testing and labeling requirements for sunscreen products. This proposed rule amends the conditions of the final rule to incorporate these UVA testing and labeling requirements. After consideration of the comments submitted in response to this proposed rule, FDA will then issue a final rule that addresses both the UVA and UVB issues for sunscreen products. 4. What’s being proposed in this new rule? FDA is proposing to:
5. What does the proposed labeling look like? For a three-ingredient, very water resistant sunscreen, the principal display panel will look something like this:
6. Why are sunscreens limited to Sun Protection Factors ( SPF) of “50+?” FDA limits SPF values based on data demonstrating that the SPF test provides accurate and reproducible results. When FDA published the sunscreen final monograph in 1999, FDA had only received data demonstrating that the SPF test produces accurate and reproducible data for sunscreens with SPF values as high as 30. Since publication of the final monograph, FDA has received data indicating that sunscreens with SPF values as high as 50 can be measured accurately and reproducibly using the SPF test. Further, FDA believes that, although we have not yet seen such data, some sunscreens may produce SPF values greater than 50. For such sunscreens, we are allowing an SPF of “50+.” If FDA receives data that support accurate testing of sunscreens higher than 50, we will consider revising the upper limit of SPF permitted in labeling. 7. How will consumers know how much UVA protection a sunscreen provides? FDA is proposing to use symbols (stars) along with descriptors (low, medium, high, or highest) to indicate how much UVA protection a sunscreen provides. Sunscreens providing UVA protection will bear one of the following configurations:
So a sunscreen providing medium UVA protection may be labeled like this:
If a sunscreen hasn’t been shown to provide any UVA protection, FDA proposes that the sunscreen contain the statement “No UVA Protection” near the SPF value. Because SPF values have been used in the United States for more than three decades, consumers are familiar with SPF numbers and know how to select the appropriate sunscreen based on the SPF value. Therefore, FDA does not believe the SPF numerical values should be changed. However, FDA believes consumers might be confused if UVB and UVA protection levels were both identified by numbers. Having distinct ways of identifying UVB and UVA protection levels should make it less likely that consumers will confuse the two ratings. Although the symbol and descriptor rating of UVA protection is new, FDA expects consumers will learn how to use this information to select the appropriate sunscreen, as they have done with SPF values. FDA believes consumers are familiar with star rating because they are used to rate the quality of a variety of topics (e.g., movies, hotels, and restaurants). 9. Have star ratings for UVA protection been used before? Yes. In January 1992, the Boots Co. in the United Kingdom developed a star rating system to characterize UVA protection. Protection ratings range from “minimum” (one star) to “ultra” (five stars). In addition, although star ratings have not previously been used in the Unites States to rate UVA protection levels, they have been used extensively to rate many industries (e.g., movies, hotels, and restaurants). 10. What type of testing is required to demonstrate UVA protection? Two separate tests must be conducted to demonstrate that a sunscreen helps provide protection against UVA light. One of these is an in vitro test (performed on a quartz plate) and the other is an in vivo test (performed on humans). The results of both tests are combined to produce a single UVA protection level (i.e., low, medium, high, or highest). The UVA protection level represents the lowest level of protection determined by the two tests. For example, if one test indicates a low level of UVA protection and the other test indicates a medium level of protection, the sunscreen is labeled as having a low level of UVA protection. The in vitro test is a non-clinical test, meaning it is performed in a laboratory and not on humans. This test measures the ability of a sunscreen to reduce the amount of UVA radiation passing through the sunscreen. The in vivo test is performed on humans and is similar to the SPF test. The major difference between this test and the SPF test is that sunburn is measured in the SPF test and skin darkening is measured in this test. 11. How long is the comment period and where should I send comments? Before finalizing any monograph, FDA allows the public to share its views (comments) on the proposed regulations. For most of the issues in this proposed rule, FDA is accepting comments for 90 days from the date the proposed rule published. Comments must be identified with “Docket No. 1978N-0038” and can be submitted electronically or in written form: Electronic submissions
Written submissions
12. Can sunscreens prevent skin cancer? FDA doesn’t have any data directly linking the use of sunscreens to a reduction in the risk of developing skin cancer. Research has shown that UV exposure increases skin cancer, premature skin aging (e.g., wrinkles), and other skin damage (e.g., sunburn). Although studies have shown that limiting time in the sun, wearing protective clothing, and using sunscreens decrease UV exposure, studies have not specifically linked the use of sunscreen by itself to reduced risk of skin cancer or skin aging. To the contrary, studies have shown that some consumers increase time in the sun when wearing sunscreens, thereby increasing UV exposure. Thus, in this proposed rule, FDA proposes that the following statement be required in the Warnings section of the Drug Facts box:
13. What has changed about the sun alert statement and why did we change it? The sun alert statement used to be optional and, if included, appeared in the Other information section of the Drug Facts box or outside the Drug Facts box altogether. The statement read, “Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.” FDA now proposes to require a modified version of the sun alert statement be included as the first statement under Warnings in the Drug Facts box. The new statement reads:
14. Why is it important to reapply sunscreens frequently? There are three reasons why sunscreens should be reapplied frequently. First, sunscreens can be physically rubbed off. For example, drying off with a towel can remove sunscreen from the skin. Second, sunscreens can be washed off when swimming or with heavy sweating. No sunscreens are truly “waterproof” or “sweatproof.” Third, some of the active ingredients in sunscreens start to break down over time. This break down can be accelerated by sun exposure. These three factors can prevent sunscreens from providing the level of protection indicated by the SPF and or UVA values. Thus, to ensure that sunscreens provide effective prevention, FDA proposes that sunscreens include the following directions:
15. Are sunscreens really “waterproof?” No. FDA has determined that sunscreens are neither sweatproof nor waterproof. Most sunscreen formulations don’t dissolve in water (or sweat), but can be washed off during swimming and as a consequence of sweating. Thus, FDA does allow claims that sunscreens are water resistant or water/sweat resistant if the sunscreens retain the label SPF and /or UVA protection values following 40 minutes of water immersion. Sunscreens that retain the label SPF and/or UVA protection values after 80 minutes of water immersion can be identified as “very water resistant” or “very water/sweat resistant.” You may see sunscreen products marketed as “waterproof” or “sweatproof.” FDA does not believe that these are accurate statements and explained this position in both the tentative final monograph published in 1993 and the final monograph published in 1999. When FDA publishes a sunscreen final rule that includes both UVB and UVA testing and labeling requirements, manufacturers will be required to amend these claims. 16. Are sunscreens and “sunblocks” the same thing? FDA does not believe the term “sunblock” is accurate. No sunscreen completely blocks UV rays. FDA believes the term “sunscreen” more accurately describes the action of this type of drug product. 17. Have any changes been made to the SPF (UVB) test method? Yes. FDA is proposing changes to the SPF test method. FDA believes these changes will decrease the health risk to persons enrolled in the SPF test. The changes also should lead to more accurate and reproducible results. The changes will not alter how consumers compare sunscreens with different SPF values to select the appropriate product. The changes will only alter how manufacturers determine the SPF values of these products. 18. Do manufacturers have to comply with the regulations in this proposed rule? When the final rule is published, manufacturers will be required to comply with sunscreen regulations. Until then, FDA strongly encourages manufacturers to comply with this proposed rule. We believe that compliance with this proposed rule is in the best interests of public health. Nonetheless, manufacturers are not required to comply with the proposed regulations until FDA publishes a final rule 19. When will FDA publish a final rule based on this proposed rule? Following publication of this proposed rule in the Federal Register, there is a 90-day comment period allowing any interested parties to recommend changes to the proposed rule. After the comment period ends, FDA will review all of the submitted data and information. FDA will then issue a final rule for OTC sunscreens, which will take effect on a date specified in the final rule. After that date all OTC sunscreen manufacturers must comply with the final rule. FDA will work as quickly as possible to draft the final rule. 20. Sunscreens are considered cosmetics in Europe. Why are sunscreens regulated as drugs in this country? This issue was addressed in the 1999 sunscreen final rule (Federal Register, vol. 64, pages 27668 – 27669). In that document, we noted that because sunscreen active ingredients “affect the structure and function of the body by absorbing, reflecting, or scattering the harmful, burning rays of the sun,” sunscreen products intended for such use are regulated as drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 USC 321(g)(1)). Although the European Commission classifies sunscreens as cosmetics, sunscreens in Europe must meet standards for safety and effectiveness comparable to the sunscreen (drug) standards that exist in the United States. 21. Where can I get more information about sunscreens? Visit FDA’s website for nonprescription drug products: http://www.fda.gov/cder/Offices/OTC/consumer.htm
Date created: August 23, 2007
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). FDA believes the different ways of labeling UVB and UVA protection will minimize potential confusion about the ratings.
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