04.24.12
The Food and Drug Administration issued two draft guidances April 20 on the assessment of the effects of nanotechnology on food and cosmetics safety.
The document on cosmetics is titled Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.
The draft guidance on food safetydescribes factors manufacturers should consider when determining whether emerging technologies such as nanotechnology may affect the nature and the regulatory status of a food or a substance such as packaging that comes into contact with food.
The draft guidance to the cosmetics industry describes FDA's current thinking on the safety of nanomaterials in cosmetics. It cautions that standard safety tests may need to be modified, or new test methods may need to be developed.
Public comment is invited, although official publication of the drafts has not yet been scheduled. For the comments to be considered by FDA in developing the final guidances, the comments should be submitted within 90 days of publication of the notices of availability in theFederal Register.
The document on cosmetics is titled Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.
It recommends that safety assessments for cosmetic products using nanomaterials address such factors as physico-chemical characteristics, testing conditions that correspond to the distribution of nanomaterials in the final product, impurities, potential exposure levels, toxicological data, and clinical studies.
“FDA expects that the science surrounding nanomaterials will continue to evolve and be used in the development of new testing methods,” the draft said.
The draft encourages manufacturers to meet with FDA personnel to discuss the testing methods and data needed to substantiate a product's safety.
Cosmetics are not subject to premarket approval, as the draft notes. But the Obama administration, members of Congress, and industry have been concerned about how proper regulation of cosmetics can be achieved. Such steps as a mandatory registration program have been advocated (36 CRR 386, 4/2/12).
The draft guidance on food safetydescribes factors manufacturers should consider when determining whether emerging technologies such as nanotechnology may affect the nature and the regulatory status of a food or a substance such as packaging that comes into contact with food.