Sunscreen labeling that claims the product "helps prevent" premature skin aging, cancer and other damage does not suggest that sunscreen alone protects against these conditions, but in fact informs consumers that "complementary measures" are needed for adequate protection, trade groups say.

In their comments on FDA's proposal to amend the sunscreen final monograph, the Personal Care Products Council and the Consumer Healthcare Products Association also ask FDA to drop other proposed labeling changes they say are "unduly burdensome" or could "confuse and mislead" consumers.

According to their joint comments submitted Dec. 26, the groups disagree with FDA's tentative conclusion that the "helps prevent" claim "would be inherently misleading to consumers by suggesting that sunscreen use alone may help prevent such conditions."

They say the claim does not suggest sunscreen alone prevents or protects against these conditions, but in combination with label statements on the risks of sun exposure "alerts consumers that complementary measures are necessary to assure adequate sun protection."

In addition, the claim may encourage people who do not burn easily to use sunscreen for other protective qualities such as helping prevent premature aging and some skin cancers, said Farah Ahmed, assistant general counsel for the Council, formerly known as the Cosmetic, Toiletry and Fragrance Association.

The groups add that manufacturers have a First Amendment right to use truthful claims for commercial purposes and that scientific data supports the claim.

To validate the claim, the groups cite new long-term data that show subjects who used sunscreen daily for 12 and a half years had 40 percent fewer incidents of squamous cell carcinoma.

However, FDA-requested data covering longer periods of sunscreen use are not available, the groups say. Long-term studies are "extremely challenging to complete and may not even be fully instructive" because it is difficult to know if skin damage is due to sun exposure prior to or after the test. Further, it is unethical to expose subjects to carcinogens without protection, according to the comments.

The groups previously have asked FDA to allow the claim at least two other times, including in an August 2003 petition that cited additional studies that demonstrate cause and effect between UV rays and skin aging (Also see "Sunscreen Anti-Aging Claims: Scientific Support Increasing – Petition" - HBW Insight, 1 September, 2003., p. 7).

Proposed Labels Could Confuse Consumers

The trade groups take issue with several other proposed label changes, including FDA's UVA rating system.

The associations ask FDA to drop its proposed UVA four-star rating system for OTC sunscreens in favor of simple category descriptors - low, medium, high and highest - to indicate the level of UVA protection provided.

The trade groups say the proposed rating system for UVA protection would "confuse and mislead consumers" who might think the stars represent a sunscreen product's overall quality - similar to star systems for hotels, restaurants and movies - not merely the UVA protection level.

Some consumers could "simply ignore" a product's SPF value and instead "choose a sunscreen based on the UVA star rating, contrary to FDA's goal that the two values be given equal weight in purchasing decisions," the associations say.

Rather than using stars, the associations propose that manufacturers describe a product's UVA protection level on the primary display panel in the same size font and same location as the SPF rating.

The groups also suggest that FDA abandon a proposed requirement for manufacturers to include a "No UVA Protection" disclaimer on products with SPF 2 or lower and on products not specifically tested for UVA protection (Also see "Sunscreen Proposed Rule May Create UVA Protection Marketing Opportunity" - HBW Insight, 27 August, 2007., p. 3).

The proposed disclaimer is "false and misleading," and if included on labels could lead to "serious legal problems" for FDA because the products offer some UVA protection, the associations say.

They add that the proposed rule would violate Food, Drug and Cosmetic Act regulations that mandate "clear and truthful" OTC labels, because sunburn is caused by both UVA and UVB rays and a product's SPF is a measure of its overall sunburn protection from both types of ultraviolet rays.

The groups also urge FDA to drop its proposal that manufacturers label sunscreen with a "UVB SPF" factor, and instead require just an "SPF" factor.

"SPF values have always been tested using solar simulators emitting both UVA and UVB radiation, and therefore the SPF level derived from this test represents the product's protection against both types of rays," the groups say.

Other "unduly burdensome" proposed labeling requirements the associations oppose include directions for child use on products unlikely to be used on children, the addition of "skin" before "rash" in the warnings section and a redundant water-resistant indication statement.

The associations ask FDA to move a proposed "sun alert" - which warns that "UV exposure from sun increases the risk of skin cancer" - from the warning section on product labels to the "Other Information" section of Drug Facts labels because the statement is "educational," according to their comments.

"The warning panel of drug labeling is not the appropriate vehicle" for the sun alert because the alert does not "disclose any risks, side effects, adverse events, or contraindications specific to using sunscreen," like most warnings, the groups explain.

"Instead, it discusses the risks of sun damage from UV sources and the use of sunscreen as part of an overall sun protection plan" and is "by FDA's own terminology" an educational statement that should appear in the Other Information section, according to the comments.

The groups also suggest that FDA offer label relief to all small sunscreen packages - not only small packages of products applied to small areas of the face - or risk violating the Administrative Procedure Act. Under APA, FDA cannot send "similar products ... down two separate [regulatory] tracks, one more treacherous than the other, for no apparent reason," the Council and CHPA say.

Finally, the associations discourage FDA from asking manufacturers to include warnings if a sunscreen contains alpha hydroxy acid. Current evidence does not warrant a warning that AHAs may increase sun damage risks, the groups say.

Changes May Hit Industry Harder Than FDA Says

The proposed label and other monograph changes will cost manufacturers substantially more than FDA estimated, the groups contend.

Relabeling will cost manufacturers approximately $90 million ($15,000 per sunscreen SKU), nearly twice FDA's projected $47.5 million ($7,600 per SKU), the groups estimate.

The discrepancy may be due partly to FDA overlooking the number of facial and body moisturizers and cosmetics that include sunscreen and which have both primary and secondary graphics that must be redesigned, the groups explain.

The associations estimate that retesting products for UVA protection will cost manufacturers approximately $32.9 million ($12,000 per product); FDA projected costs of $5.4 million ($2,400 per product).

Relabeling and UVA testing make the one-time expense of the proposed rule $124.2 million, more than twice FDA's estimated $53 million, the groups say.

While FDA projected that 75 percent of products would have to be retested for UVA, the Council's figure is 90 percent, Ahmed said. The higher estimate "adds to the time because the labs that do testing would be backed up and it would cost more," she explained.

Due to the time and money needed for compliance, FDA should give manufacturers 36 months rather than the proposed 18 to 24 months, the groups say.

FDA should add avobenzone with ensulizole and avobenzone with zinc oxide to the final monograph, the associations say. Procter & Gamble was one of the firms that petitioned FDA in 1997 to include the combination products in the monograph.

Ahmed said the council supports those combinations as well as additional ingredients pending "because it allows companies to formulate and market a broader ranger of products and do more with respect for research and development."

FDA has not set a timetable for finalizing the proposed rule, which it issued in August 2007, because it wants to review all comments, which were due by Dec. 26. The agency issued the sunscreen final monograph in 1999, but has put off implementing the potentially sweeping changes due in part to industry pressure.

- Elizabeth Crawford (e.crawford@elsevier.com)

Industry Groups Burned About Proposed Sunscreen Labeling Requirements

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