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 posts to come...
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 initiated new sunscreen labeling claim
guidelines that companies must abide with this year in order to be in
compliance. Here are the major 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...
References:
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
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