REGULATORY NEWS

	U.S. FDA RELEASE OF NEW SUNSCREEN LABELING REGULATIONS AND THE IMPACT ON YOUR PACKAGING The long awaited Proposed Amendment of the Final Monograph for the labeling of all sunscreen products in the USA has been released. The ruling is in the Federal Register, Docket No. 1978N-0038, also available on-line HERE. Our preliminary evaluation of this ruling indicates MANY significant changes to ALL your sunscreen packaging: - First and most important to all of us...The FDA has allowed no significant alleviation of the standard Drug Facts Panel for sunscreen make-ups, skin moisturizers and the like except as already outlined for "products labeled for use only on specific small areas of the face (e.g., lips, nose, ears, and/or around the eyes)" and meeting all other criteria for small packages as stated in the original monograph. - For the Drug Facts Panel itself there are changes and additions in the verbiage to the Uses, Warnings and Directions sections. - Additionally there are significant NEW items required for the PDP (Principal Display Panel) for UVA designations and even changes to the existing UVB SPF designations. - The SPF values can go as high as 50+, which is changed from the original limit of 30+. - The date for implementation is 18 months based on the date of issuance of the final rule. The final rule date will take into consideration the time needed for the comment period of this proposed rule, all of which is part of the process required by law for all FDA regulations. Stay tuned to the H+Y Regulatory News Flash for more details as this regulation progresses and the impact this ruling will have on your packaging is determined in detail.
	U.S. FDA PROPOSES ALTERNATIVE LABELING REQUIREMENTS FOR CONVENIENCE-SIZE OTC PRODUCTS On December 12th, in response to a citizen petition, the FDA issued the long-awaited (it's been delayed since 2002) proposed rule on convenience-size OTCs. The proposed rule includes a definition of "convenience-size" products and amended Drug Facts Labeling content and format requirements. The words "See information inside before using," in at least 7-point bold italic type, will now have to be added to many of these labels. Look for H+Y's detailed summary of these labeling regulations in our next newsletter.