UVA testing for sunscreens with avobenzone required -- FDA interim marketing notice.

UVA TESTING FOR AVOBENZONE SUNSCREENS REQUIRED, FDA said in an April 30 Federal Register notice allowing immediate use of the ingredient prior to publication of a final rule on sunscreens. The agency will allow the marketing of products containing the broad-spectrum sunscreen ingredient avobenzone (Parsol 1789) in concentrations of up to 3% alone and in concentrations of 2%-3% in combination with specific Category I sunscreen ingredients.

Products containing avobenzone require both UVA radiation protection testing and SPF testing of the finished product, FDA said. Until a UVA radiation testing method is proposed in the monograph, FDA said it considers testing procedures "similar to those described by R.W. Gange et al. and N.J. Lowe et al. as adequate for determining the UVA radiation protection potential of a finished sunscreen." The Gange and Lowe studies were published in the Journal of the American Academy of Dermatology in 1986 and 1987.

The Cosmetic, Toiletry and Fragrance Association had argued in October comments to the agency that UVA testing is unnecessary for avobenzone-containing sunscreens since FDA has already determined that 2%-3% avobenzone alone and in combination with proposed monograph sunscreen ingredients provides "broad spectrum" protection ("The Rose Sheet" Oct. 28, 1996, p. 3). The association had also urged that FDA consider the "modified Diffey" method of assessing UVA protection as an alternative to the method reported by Gange and Lowe.

The ingredients that may be combined with avobenzone include: cinoxate, diethanolamine methoxycinnamate, dioxybenzone, homosalate, octocrylene, octyl methoxycinnamate, octyl salicylate, oxybenzone, sulisobenzone and/or trolamine salicylate. CTFA had requested that the agency also allow combinations with titanium dioxide and phenylbenzimidazole sulfonic acid. However, FDA said it does not consider the available data adequate to allow combinations with titanium dioxide, phenylbenzimidazole sulfonic acid and/or zinc oxide.

Issued as an "enforcement policy," FDA's notice follows publication of a proposed amendment to the sunscreen monograph on Sept. 16 ("The Rose Sheet" Sept. 23, 1996, p. 10). The amendment would confer Category I status on avobenzone. However, FDA had to publish a separate notice to allow for use of the ingredient prior to a final rule.

Current evidence does not support label warnings against the use of avobenzone-containing sunscreens in children ages one to 12, FDA said. Comments submitted to the agency had recommended such warnings based on the irritation potential of avobenzone. The agency said that "at this time the data do not support the contention that children one to 12 years of age `may be at a greater risk than adults with respect to contact irritation reaction and photoallergenic potential' of avobenzone."

FDA also noted that "overall, medical literature reports of allergic reactions to avobenzone appear to be few in comparison to the scope of its usage." The notice adds that avobenzone-containing products will be required to carry the direction specified in the proposed monograph for all sunscreens, which include the statements: "Children under 2 years of age should use sunscreen products with a minimum SPF of 4" and "Children under 6 months of age: consult a doctor."

The agency decided to maintain a 2% concentration minimum for avobenzone in combination sunscreens to "ensure that each ingredient contributes to the overall effectiveness." The agency also noted that "to require no minimum contribution at all could allow the use of amounts so small as to be misleading and deceptive to the consumer and could permit the inclusion of ingredients solely for promotional purposes."

This "could result in the consumer's exposure to an additional ingredient or ingredients with minimal additional benefit being provided," the agency continued. Banana Boat distributor Sun Pharma was among the marketers that objected to the 2% minimum ("The Rose Sheet" Oct. 28, 1996, p. 14).

Some comments expressed the concern that claims for avobenzone may lead consumers to think the ingredient is the only UVA protector available. In response, FDA pointed out that until it proposes a method for determining UVA radiation protection, sunscreen products may carry UVA claims provided they: 1) contain sunscreen active ingredients that absorb UVA radiation and 2) "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 labeling of currently marketed products until the rulemaking" for OTC sunscreens is completed.

FDA said it is "aware that some currently marketed sunscreens that contain titanium dioxide are promoted with claims pertaining to UVA radiation and/or broad spectrum protection," adding it "does not believe that consumers have been misled into believing that only avobenzone-containing sunscreen products can provide broad-spectrum protection."

FDA addressed concerns over the implications of its decision regarding avobenzone on its upcoming rule regarding the definition of what it means for an ingredient to be marketed for a "material time" and to a "material extent" before it can be considered for inclusion in a monograph.

The notice states that "the agency's reliance on information other than the available foreign marketing data in the [avobenzone] amendment to the proposed rule is not intended to reflect an ultimate agency conclusion about the potential usefulness of foreign marketing data." An advanced notice of proposed rulemaking on the "material time/material extent" policy that would allow acceptance of foreign marketing data was published Oct. 3 ("The Rose Sheet" Oct. 7, 1996, p. 2).

The decision to allow interim marketing of avobenzone-containing sunscreens responded to a request from Roche, which has assumed marketing responsibility for the ingredient from its affiliate company, Givaudan-Roure. The proposed amendment grants the company's request that avobenzone be included in the sunscreen monograph. Givaudan-Roure submitted the petition for monograph status in March 1993.