FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for December 2016

Posted on Friday, December 23 2016 at 5:12 pm by -

FDA Recommends Maximum Level of Lead in Cosmetic Products . . . But Finds that Most Products Surveyed are Already Well Below the Recommended Levels


By Carolina M. Wirth

As 2016 comes to an end, the Food and Drug Administration (FDA or agency) is turning its attention to cosmetics by issuing a draft guidance on December 21, 2016 recommending a limit of “no more than 10 parts per million (ppm) of lead as an impurity in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, compact powders, shampoos, and body lotions).[i]”  This is the first guidance since 2014,[ii] that the agency has published involving cosmetics.  The draft guidance is in part a response to a 2011 Citizen Petition by the Personal Care Products Council (PCPC) requesting that the FDA establish a limit of 10 ppm for lead in lipsticks and other types of externally applied cosmetics.  After completing its own testing of cosmetics products and conducting exposure analysis, the FDA decided to grant the PCPC’s Petition.  The draft guidance does not apply to “topically applied products that are classified as drugs or to hair dyes that contain lead acetate as an ingredient.[iii]

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Posted on Wednesday, December 14 2016 at 11:05 pm by -

FDA Makes Public the Scientific Data Evaluated and Provides Draft Guidance Regarding the Inclusion of Certain Fibers in the Definition of Dietary Fiber

By: Alyson L. Wooten, Pharm.D.

getty_rm_photo_of_whole_grain_breakfast_nutritionAs previously reported here, in May 2016, the Food and Drug Administration (FDA or agency) published new final regulations on Nutrition and Supplement Facts labeling.  As part of the final rules, FDA defined “dietary fiber,” in relevant part, as “non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units), and lignin that are intrinsic and intact in plants; isolated or synthetic non-digestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health.”[i]  The final rule identified only 7 isolated or synthetic fibers that met this definition.[ii]  Under the prior method of identifying “dietary fibers” for labeling (which involved analytical methods for measuring levels of fiber present), there were many other types of isolated or synthetic non-digestible carbohydrates that manufacturers routinely declared as dietary fiber on Nutrition Facts labels.  In drafting the final regulations, FDA indicated that there was insufficient evidence of a beneficial physiologic effect for other previously considered dietary fibers to be included in the definition, but indicated that anyone could provide evidence to support the addition of other dietary fibers through the Citizen Petition process.  This immediately led to questions about what data had been reviewed and the standard the agency would apply to determine beneficial physiological effects.

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