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FDA Guidance Document Details Enforcement Policy for OTC Suncreens
May 22, 2018 |FDA

The Food and Drug Administration on May 22 issued a guidance document detailing its policy of enforcement discretion for over-the-counter sunscreen products marketed without approved new drug applications or abbreviated new drug applications. FDA will continue not pursuing enforcement action on such products in the absence of a long-awaited monograph for sunscreens, as long as the unapproved OTC sunscreen products meet certain labeling and testing requirements, including those outlined in a 2011 final rule, it said.

FDA Denies Additive Petition for Partially Hydrogenated Oils in Foods, Gives More Time for Compliance With Ban
May 21, 2018 |FDA

The Food and Drug Administration will not approve the use of partially hydrogenated oils as an additive in certain foods, but will give food companies additional time to comply with its recent ban on the ingredient, FDA said in a constituent update dated May 18. After finding in 2015 that partially hydrogenated oils are no longer generally recognized as safe (GRAS) and reclassifying them as a food additive (see 1506160024), FDA is now denying a petition from the Grocery Manufacturers Association to allow its use as an additive in some 60 categories of food. However, to allow for an “orderly transition,” FDA will give manufacturers of foods listed in the petition an additional year, until June 2019, before prohibiting the manufacture of such foods containing partially hydrogenated oils, and until June 2021 to sell such foods produced before June 2019. For foods not mentioned in the petition, FDA is not making any change to the June 2018 compliance date, but will allow distribution until June 2020 of foods containing partially hydrogenated oils that were produced before June 2018, FDA said.

FDA Adds New Supplier Evaluation Tool for Food Importer FSVP Compliance
May 18, 2018 |FDA

The Food and Drug Administration has updated the Supplier Evaluation Resources page of its online Data Dashboard to help importers and manufacturers meet the requirements of the Foreign Supplier Verification Program regulations and other rules issued under the Food Safety Modernization Act, it said in a constituent update. A new search function allows users to input their suppliers and get a report back that includes data on inspections; compliance actions taken by FDA, including injunctions and seizures; recalls; and import refusals, as well as any import alerts or warning letters that mention the firm. The new tool can be used by importers seeking to meet the FSVP requirement for evaluation of a supplier’s performance and the risk associated with the food, a process that includes evaluating a supplier’s compliance with FDA regulations "such as whether the supplier is subject to an FDA warning letter, import alert, or other FDA compliance action related to food safety,” FDA said. The new tool also may be useful to meet supply chain requirements of preventive controls regulations for human and animal food, it said.