The U.S. Food and Drug Administration (FDA) has posted long awaited regulations regarding over-the-counter (OTC) sunscreen products. The updated rules provide new labelling requirements as well compulsory testing for effectiveness by extending compulsory testing to the measure of ultraviolet A (UVA) protection. Under the current regulation, manufacturers were only required to test for ultraviolet B rays (UVB) that are the major cause of sunburn.

“Broad Spectrum”

The final regulation allows sunscreen products that pass the FDA’s test for protection against both UVA and UVB rays to be labelled as “Broad Spectrum.”

Furthermore, as both UVB and UVA radiation contribute to sunburn, skin cancer, and premature skin aging, while sunburn is primarily caused by UVB radiation, sunscreens labelled as both Broad Spectrum and SPF 15 (or higher), if used regularly, as directed, and in combination with other sun protection measures can claim they “help prevent sunburn, reduce the risk of skin cancer, and reduce the risk of early skin aging.”

Any product that is not “Broad Spectrum”, or that is “Broad Spectrum” but has an SPF between 2 to 14, will be required to have a warning stating that it has not been shown to help prevent skin cancer or early skin aging. The FDA clear wants to push these products out of the market.

The new regulations will become effective for most manufacturers in one year. However, manufacturers with annual sales less than USD 25,000 have two years to comply.

“We are concerned about manufacturers’ ability to make the required testing and labelling changes in only 12 months given the thousands of products on the market, the limited number of testing facilities, and the time needed to redesign product labelling. It is unusual for FDA to require such a short implementation period for a rule making of this scope. Manufacturers typically require at least two years to design and implement broad-scale, product-wide labelling changes,” said Farah Ahmed, Chair of the Personal Care Products Council Sunscreen Task Force, in a statement.

50+ SPF limit proposed

In addition to the final rule for sunscreen labelling, the FDA also released a Proposed Rule that would limit the maximum SPF value on sunscreen labels to “50+”.

According to the FDA, there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50. However, the proposal creates the opportunity for the submission of data to support including higher SPF values in the final rule. FDA looks forward to receiving stakeholders’ comments on this document.

Major companies, such as Johnson & Johnson or Energizer, have already said they would oppose this proposal and that data is available to support the usefulness of sunscreen with SPF higher than 50.

“In its Proposed Rule, FDA acknowledged that SPFs higher than 50 have been substantiated by independent clinical testing labs, and the results are validated and repeatable. We look forward to working further with the agency on this issue. Individual companies may also provide their own additional data supporting SPFs higher than 50,” added Farah Ahmed.

Safety of sunscreen sprays

In an Advance Notice of Proposed Rulemaking (ANPR) for Dosage Forms, the FDA announced its intention to investigate several issues regarding dosage forms for sunscreens, in particular the safety of sunscreen sprays.

The federal agency said the ANPR will allow the public a period of time to submit requested data addressing the effectiveness and the safety of sunscreen sprays and to comment on possible directions and warnings for sprays that the FDA may pursue in the future, among other issues!