When it comes to sunscreen, standards and regulation around the globe, there is no global harmonization. However, sunscreen is highly regulated in each country. Sunscreens are considered cosmetics, but fall under their own regulation categories. Each country has their own approved methods for testing efficacy; this includes approved UV filters, SPF ratings, and any label claims or warnings. Part 1 will provide an overview of the US regulations, presented by Anne-Gael Glaevic, a group leader in Global Regulatory Affairs in Personal Care. I’ll review the differences in EU and Asia regulations in following posts.
Bringing a Sunscreen to Market in the United States
In the US, sunscreens are considered OTC (over the counter) drugs that are regulated by the FDA. Any products with a sunscreen claim must be registered prior to use to be in compliance. There are 2 ways to bring a new sunscreen to the market in the US:
1. Ingredients must be in compliance with the OTC sunscreen monograph which was released in 1999. This includes following the regulatory standards set up by the FDA; active ingredients, labeling and marketing claims must comply. Only registered UV filters are allowed through this method. There are 16 approved filters at a given maximum concentration listed in the 1999 OTC monograph. Companies may use a combination of these approved filters in their products, but the combos must be registered as well. There are also specific regulations on how these filters can be combined, and in what percentage the various combinations are allowed.
2. New Drug Application (NDA) is for finished products with new UV filters, or a new combination of filters that are outside of the already approved percentages in the OTC monograph. NDA is a year and a half process to get reviewed and approved for the finished product. There is one other option, TEA (time and extended application) that falls under NDA for sunscreens that already have 5 years of safe sales in another country. This is a slightly longer process to get approved by the FDA with a 2 year registration process with no pending issues.
Anne pointed out that both processes are very time consuming and expensive. It’s important to also acknowledge that when compared to other areas of the world, the USA is not as strict in the area of bringing new sunscreens to market!
In 2011, the US passed new sunscreen labeling claim guidelines that companies must abide with this year in order to be in compliance. Here are the main changes:
- The verbiage used in claims “waterproof” “100% protection” “sweatproof” “sunblock” are no longer allowed on product packaging or marketing claims. “Water Resistant” must be used instead, and specifically designated as 40 or 80 minutes in the water.
- Limit SPF to 50+
- Broad spectrum claims for SPF 15+: The US is the only country that has approved this verbiage for broad spectrum claims on UVA and UVB protection that must be listed under the “drug facts” on the back of the label “If used as directed with other sun protection measures this product reduces the risk of skin cancer and early skin aging as well as helps prevent sunburn”
- Any sunscreen under SPF 15 may only make this claim “This product has been shown only to prevent sunburn, not skin cancer and early skin aging
Apparently there will be a future publication of the US Final Sunscreen Monograph to come…
Anne-Gael Glaevic – presentation on EU and US regulatory status for sunscreen at In-Cosmetics 2012 Barcelona
Final Ruling on Labeling and Testing: http://www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14766.pdf
Understanding Over-the-Counter Medicines > Sunscreen: http://1.usa.gov/IJmFUK
Labeling and Effectiveness Testing http://www.regulations.gov/#!documentdetail;D=FDA-1978-N-0018-0698
Rulemaking History for OTC Sunscreen Drug Products http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-counterOTCDrugs/StatusofOTCRulemakings/ucm072134.htm