Effective Date of FDA’s 2011 Sunscreen Rule

August 31, 2011: On June 14, 2011 FDA released a Final Sunscreen Labeling Rule that outlines permitted and required claims, testing procedures required to substantiate those claims, and claims that are not permitted. The Final Rule also now requires Drug Facts labeling for all sunscreen products.  This includes combination cosmetic—sunscreen products such as lipsticks, foundations, and daily moisturizers that are labeled as containing an SPF. 
Effective Date:  The Final Rule effective date is June 18, 2012, except for products with annual sales less than $25,000 for which the effective date is June 17, 2013. All products labeled on or after the effective date must meet all final rule requirements (see below for additional time/enforcement discretion for SPF testing). This means, FDA will not require the removal of products already in interstate commerce, which includes those on retail shelves. 
  • FDA will not require non-compliant products introduced or delivered for introduction into interstate commerce prior to the compliance date, June 18, 2012, to be removed from the market. 
  • Product delivered to customers, even if in their warehouses, ready to be shipped from manufacturers’ warehouses, or imported prior to June 18, 2012 can continue to be shipped and sold. 
  • Product imported prior to the compliance date would be protected, as would any product delivered to customers, even if still in customers’ warehouses on the effective date. Under the general interpretation of “delivered for introduction into interstate commerce,” other warehoused product might also be protected, but would have to be evaluated on a case-by-case basis.[1]
More Time for SPF Testing:  In the Draft Guidance, FDA stated it does not intend to initiate enforcement action before June 17, 2013, for OTC sunscreen products that: i) are subject to the 2011 Final Rule; ii) were on the market prior to June 17, 2011, the date of publication of the final rule; and iii) are labeled with an SPF value determined prior to June 17, 2011, using the SPF test method described in the 1999 final rule[2] or the SPF test method described in the 2007 proposed rule.[3] However, it is important to note that all other labeling and testing requirements must be met prior to June 18, 2012.

[1]           This document is not intended to provide specific legal advice. Individual companies should consult their own council for further advice.
[2]           64 FR 27666 at 27689-693.
[3]           72 FR 49070 at 49114-119.