FDA Should Grant Labeling Leeway For Cosmetics With SPF, Council Says

FDA’s recently released final sunscreen rule does not adequately take into account the unique nature of cosmetic products with built-in sunscreen, according to the Personal Care Products Council.

“The final rule is very clear that a sunscreen is a sunscreen is a sunscreen, and FDA does not treat beach product sunscreens any differently from cosmetic sunscreens,” said Farah Ahmed, associate general counsel for the Council and head of the trade group’s sunscreen task force, in a Sept. 7 interview.

From a labeling perspective, the final rule would now require “drug facts” boxes on cosmetic sunscreens (Also see "FDA Strengthens Sunscreen Testing And Label Requirements" - HBW Insight, 20 Jun, 2011.).

Inclusion of that information could be cumbersome as most cosmetic products with SPF come in small packages, the Council says.

Previously, FDA offered some slack to marketers of small packaged products, not requiring full drug facts labeling out of concern that the burden would persuade manufacturers to drop sunscreen ingredients altogether rather than make the label change.

However, in the 2011 rule, the agency holds that manufacturers do indeed have the ability to include all pertinent information on small packages.

Ahmed maintains that the extensive labeling requirements are “arduous from a business standpoint” and may not be feasible for many companies. The change could end up discouraging cosmetic manufacturers from including SPF in their products as FDA initially feared, she said.

In the event that manufacturers simply eliminate the sunscreen component from their cosmetic items, Ahmed said, many consumers will be less protected against sun exposure as they are not likely to switch brands just because the SPF element is suddenly missing from their favorite products.

“When you go to choose your lipstick or foundation, your priority is likely on the color and on the shade, and you’ll likely buy the same lipstick if it didn’t have the SPF in it,” she said.

Furthermore, the attorney pointed out that many firms are scaling down product packaging to reduce their environmental impact. The new labeling requirements, compliance with which could necessitate additional packaging to create space for text, run contrary to green trends, she suggested.

The Council also disagrees with a provision in the final rule that requires labeling on all products with SPF to recommend that users reapply every two hours.

Instructing consumers to reapply bihourly “is somewhat arbitrary; there’s really no solid science to support that,” Ahmed said.

Individuals who are swimming may need to reapply sunscreen more frequently than every two hours, the attorney pointed out. At the same time, it is impractical for consumers to reapply some cosmetic sunscreens. “If you’re putting on a daily moisturizer with SPF and you’re going into your office and you’re sitting in your office and working, you wouldn’t need to reapply every two hours. Likely just once a day would suffice,” Ahmed said.

The Council recommends wording suggesting that consumers apply as often as needed.

Not all labeling provisions in the new rule are problematic. The Council is pleased that the final rule allows anti-aging and skin-cancer-prevention claims on product packaging. “That’s a big deal,” Ahmed said. “We hope it’s going to encourage sunscreen use, especially in populations that don’t burn that readily.”

The Council and the Consumer Healthcare Products Association filed joint comments with FDA regarding the final rule Aug. 16 (Also see "Industry Needs More Time To Comply With Sunscreen Testing, Labeling Rule" - HBW Insight, 29 Aug, 2011.).

Comments On Delivery Forms Extended

At the same time it released the final rule, FDA also put out an advanced notice of proposed rulemaking asking for information and data on sunscreen products sold in certain delivery forms and marketed without approved applications, with comments due Sept. 15.

In a Sept. 14 Federal Register notice, FDA announced it was extending the comment period for another month, until Oct. 17.

The Council, along with the Consumer Healthcare Products Association, filed comments with FDA in August asking for the extension.

In the ANPR, FDA says it intends to pursue the elimination of several sunscreen delivery formats from its final OTC sunscreen monograph, namely sunscreen wipes, towelettes, powders, body washes and shampoos (Also see "FDA Seeks To Nix Some Forms From Sunscreen Monograph" - HBW Insight, 27 Jun, 2011.). The forms are not included, the agency says, because they were not marketed as OTC before the drug review began.

Ahmed likened the ANPR to an FDA “thumbs-up list” and “thumbs-down list” for sunscreen formats. Spray sunscreens “are more in the thumbs-up category,” as FDA is asking for more data and could potentially include them in the monograph. The Council plans to file comments in support of spray sunscreens, according to the attorney.

The association also will file comments supporting powder sunscreens, such as face powders with SPF. “We believe that powders should absolutely be allowed in the market,” Ahmed said.

By Lauren Nardella