We may not yet have a final US sunscreen monograph, but we do at least now have FDA rules on sunscreen testing and labelling, says Julian Hewitt
The FDA Sunscreen Monograph has had a long and tortured history, dating back to the first Advance Notice of Proposed Rulemaking (ANPR) in 1978. In August 2007 the FDA published proposed UVA test methods and a new labelling system, involving a star rating system for UVA. The UVA test methods became the subject of much debate with many criticising them as impractical and expensive. Also, given the FDA’s restrictive list of permitted filters, it was impossible to achieve the highest (4-star) UVA rating in high SPF products.
Since 2007 the industry has been waiting for the full Final Monograph to be issued. This has still not happened, but on 14 June FDA did announce final rules on testing and labelling, together with notices concerning some other aspects of the monograph. These changes were published in the Federal Register on 17 June and include four key documents.
Final rule on labelling and effectiveness testing for sunscreen drug products
This requires action by manufacturers of all sunscreen products sold in the US. Manufacturers will have to revise their labelling and many existing products will need to be re-tested for SPF and broad spectrum performance. Products with annual sales of less than $25,000 must comply with the new rules by 17 June 2013. Products with sales greater than this figure must comply by 18 June 2012.
The two UVA tests and star rating system proposed in 2007 have been dropped and replaced with a single in-vitro test to measure the critical wavelength, with a simple pass/fail criterion (the critical wavelength must be greater than 370nm). Products which pass this test may include the claim ‘broad spectrum’ on the front of the pack, before the SPF.
The critical wavelength test is also part of EU and ISO performance requirements for UVA, but there are some differences in detail between the Colipa and ISO tests and the method laid down by the FDA. The Colipa and ISO methods specify an application rate of 1.3mg/cm2 on PMMA plates with a 6-micron surface roughness. The FDA specifies an application rate of 0.75mg/cm2, but the surface roughness can be anywhere from 2 to 7 microns. It is surprising that the FDA has not specified surface roughness more closely since it exerts significant influence on the absorption spectrum and hence on the critical wavelength – a higher surface roughness gives a higher critical wavelength value. Pre-irradiation protocols also differ from the Colipa/ISO tests.
How difficult will it be to pass this new test? I think many in the industry will be heaving a sigh of relief. As mentioned earlier, for high SPF products, achieving the highest star rating on the 2007 proposed tests was effectively impossible. Clearing the new critical wavelength hurdle will be much easier. Also, unlike in Europe, there is no requirement regarding the ratio between UVA protection and SPF. It is possible to create products that would fall well short of meeting European requirements but would still pass the FDA test. However, it is also possible that some products that pass Colipa’s critical wavelength test may fail on the FDA test. So the message is, don’t make any assumptions. Products meeting EU requirements should be retested for sale in the US.
There have also been changes to the FDA’s in-vivo test protocol, the most significant of which is a change in the required number of test subjects, from a minimum of 20 to a minimum of 10. This brings it more closely in line with the International Method, now used widely in many parts of the world.
Draft guidance for industry on FDA enforcement policy
This draft document, issued for comment, outlines FDA’s current thinking on its enforcement policy for the new sunscreen rules. The key point in this document is that for products that were already on the market before 17 June 2011 and which have been SPF tested according to the previous FDA test methods, the agency proposes to allow an extra year (until 17 June 2013) for these products to be retested according to the new SPF protocol.
Request for data on spray sunscreens
FDA feels that more data is needed to demonstrate the safety and efficacy of spray sunscreens to allow their inclusion in the final sunscreen monograph. The agency goes on to point out that if sufficient data is not received, these products “may not be included in the future sunscreen monograph”. In other words, spray sunscreens would be banned in the US, unless the manufacturer goes through the New Drug Application (NDA) process. Of course, given the high market share of spray sunscreens in the current US market, manufacturers will make sure that the necessary data is submitted. Sunscreens formulated as wipes, towelettes, powders, body washes or shampoos are not eligible for inclusion in the monograph, so will not be allowed for sunscreen products.
Proposed rule on revised effectiveness determination
This actually refers to a proposed rule limiting the maximum SPF claim to 50+, as is currently the case in Europe. The FDA is soliciting comments on this proposal. So, we still await the final sunscreen monograph, and we still don’t know if the FDA’s list of permitted UV filters will be extended. But at least sunscreen manufacturers now have clarity regarding testing and labelling. No doubt there will be a flurry of activity for test laboratories over the next few years, but the number of products that need to be reformulated to meet the new standard is likely to be small compared to Europe after the introduction of the EU guidelines in 2006.