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Regulatory Rundown

The regulatory landscape of the personal care and cosmetic industry is ever changing, as it is a global network of legislation, certifications and standards, and more. To help the industry understand and navigate through the regulatory world, Inside Cosmeceuticals' blog—Regulatory Rundown—will feature monthly insights from industry insiders on all matters legal.

FDA's Draft Guidance on Nanomaterials in Cosmetics


by Linda M. Dougherty, Esq.

In late April, FDA issued a draft guidance document—Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products. Although FDA has not adopted a formal definition of “nanotechnology," it references the common definition of “the intentional manipulation, manufacture or selection of materials that have at least one dimension in the size range of approximately 1 to 100 nonometers." Materials at the nanoscale may have different chemical, physical, or biological properties than materials at a larger scale, and therefore the incorporation of nanomaterials into cosmetic products may have important safety implications.  While cosmetics are not subject to premarket approval by FDA, the manufacturer of a cosmetic product is responsible for ensuring that the product is safe prior to going to market.  Because materials at the nanoscale may behave differently than their larger counterparts, FDA notes that “standard safety tests may need to be modified or new methods developed… [D]ata needs and testing methods should be evaluated accordingly to address the unique properties and function of the nanomaterials used in the cosmetic products as well as the questions that continue to remain about the applicability of traditional safety testing methods to products that involve nanotechnology." 

FDA concludes by encouraging any manufacturer who wishes to use a nanomaterial in a cosmetic product to meet with FDA to discuss the test methods and data needed to substantiate the product’s safety. In addition, FDA will be considering public comments that are submitted by July 24, 2012, in preparing a finalized guidance document on this topic. Although guidance documents, even once finalized, are not legally enforceable and do not carry the force of law, they are closely examined by industry because they provide important insight as to how FDA will act in terms of enforcement. 

Linda M. Dougherty, Esq. (ld[at] is an associate at the law firm of Ullman, Shapiro & Ullman, LLP, which concentrates in legal issues affecting marketers of food, cosmetic, and dietary supplement products and the natural products industry.

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