UVA CLAIMS WILL BE ALLOWED FOR SOME CATEGORY I INGREDIENTS

UVA CLAIMS WILL BE ALLOWED FOR SOME CATEGORY I INGREDIENTS while FDA develops testing methods and labeling for protection against ultraviolet A radiation, the agency noted in the OTC sunscreen tentative final monograph published in the May 12 Federal Register. Acknowledging that the the sunscreen panel focused largely on regulating screens for ultraviolet B radiation, FDA concluded "that protection against [ultraviolet A] radiation may be as important to consumers' well-being as protection against UVB radiation. The agency wants to ensure that a sunscreen ingredient claiming to protect consumers against UVA radiation truly offers such protection." The TFM states that "at this time, OTC sunscreen drug products may bear UVA claims provided that they . . . contain sunscreen active ingredients that absorb UVA radiation (e.g. dioxybenzone, lawsone with dihyroxyacetone, octocrylene, octyl methoxycinnamate, red petrolatum, sulisobenzone, and titanium dioxide)." In addition, sunscreen products making UVA claims must also "meet the agency's enforcement policy, which allows claims that were available in labeling prior to the beginning of the OTC drug review to appear in the labeling of currently marketed products" until an OTC sunscreen final rule is effective, the TFM states. However, in supporting documents to the TFM, FDA indicated that the major hurdle preventing the agency from incorporating UVA claims into the sunscreen rulemaking is the absence of appropriate testing methods to determine UVA protection. Citing an 1989 National Institutes of Health consensus conference statement, FDA noted that "recent evidence suggests that the longer UVA wavelengths (340 to 400 nm) are less damaging than shorter UVA wavelengths (320 to 340 nm) but that long wave lengths can induce connective tissue damage and produce tumors." FDA said "sunscreen ingredients whose spectra extend only into the lower UVA range (i.e. oxybenzone and possibly lawsone with dihydroxyacetone) may not absorb sufficient UVA radiation to provide an adequate level of protection against that radiation." FDA added: "UVA protection claims in the labeling of products containing such ingredients would be partially false and . . . misleading." FDA acknowledged that it "does not have enough information or data to propose a method for determining UVA protection in this tentative final monograph" and asked for comments and data regarding an appropriate testing methodology. "It should include the use of a control sunscreen preparation that absorbs UVA radiation" and "though it may not result in a meaningful PPF [phototoxic protection factor] or UVA protection factor, a standardized UVA testing method should demonstrate that a sunscreen ingredient either does or does not protect against UVA radiation," FDA stated. The agency added that it does not believe "at this time" that PPF values are appropriate, since such values are determined using chemically photosensitized skin and, therefore, may not be relevant to normal skin. The TFM supporting documents include proposed criteria from FDA on UVA protection claims and labeling. Under FDA's proposal, sunscreen ingredients could claim to protect against UVA rays (320-400 nanometer range) if the active "ingredient has an absorption spectrum extending to 360 nanometers or above in the UVA range . . . and . . . demonstrates UVA protection using appropriate testing procedures that the agency is proposing be developed." Proposed labeling for sunscreen products meeting these two criteria would read: "('Protects against,' 'Absorbs,' 'Screens out' or 'Shields from') UVA (select one of the following: 'rays' or 'radiation')," according to the TFM. Also, products offering protection from both UVA and ultraviolet B rays may claim "broad spectrum sunscreen: provides protection against UVB and UVA radiation" on their labeling. However, FDA added the caveat that "although these [UVA] indications are discussed in this document for public comment, they are not currently included in the TFM." The agency said it may propose an amendment to the TFM at a later date dealing with UVA claims. FDA also emphasized that products wishing to make UVA claims but containing "ingredients not included in the monograph, and new chemical entities that protect against UVA exposure, are considered to be new drugs." FDA explained that the sunscreen panel did not look closely at UVA radiation because the dangers were not well understood at that time and because "the majority of OTC sunscreen ingredients . . . primarily protect the skin from UVB radiation." However, because UVA radiation reportedly "penetrates the skin more efficiently than UVB," FDA said it "is concerned that sunscreens with higher SPF values allow consumers to stay out in the sun for long periods of time without burning, thus increasing UVA exposure." FDA also pointed to "the growing popularity of high-intensity UVA sources for 'cosmetic tanning' [which] has raised serious concerns among dermatologists." In light of recent scientific evidence, FDA said it now believes that UVA radiation contributes to "both acute and chronic skin damage such as erythema, melanogenesis, carcinogenesis, drug-induced photosensitivity, photoaging, and morphological alterations of Langerhans cells." The agency said it would not extend UVA claims on OTCs to include protection from certain types of "drug-induced photosensitivity reactions, which are usually caused by UVA radiation." FDA explained that "if a sunscreen ingredient does not protect against the appropriate wavelength for a specific ingredient, it will not protect against against a photosensitivity reaction." FDA instead concluded that "claims for protection against drug-induced photosensitization reactions induced by UVA radiation should only be made in professional labeling." The agency said it would "consider professional labeling for claims of protection against photosensitization reactions in the final monograph . . . if adequate data are submitted" in response to the TFM.