FDA Issues Draft Guidances on Assessment Of Nanotechnology Risks for Food, Cosmetics

FDA Draft Guidances on Assessing the Effects of Nanotechnology on Food and Cosmetics Safety

Key Provisions: FDA drafts recommend steps to take in assessing changes in the nature of food and cosmetics that could have safety implications.

Potential Impacts: The guidances could provide greater clarity on calculating the risks of emerging technologies.

By Alan Kovski  

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The draft guidance on food safety describes factors manufacturers should consider when determining whether emerging technologies such as nanotechnology may affect the nature and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The draft guidance to the cosmetics industry describes FDA's current thinking on the safety of nanomaterials in cosmetics.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 the Federal Register.

Steps Urged for Food Safety.

The document on food safety is titled Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives.

It recommends steps to take whenever there has been a significant change in the manufacturing process for a food or food contact substance that is the subject of a food additive or color additive regulation.

The draft recommends determination of changes made to the identity of the food or contact substance, taking into account physico-chemical structure and properties, purity, and impurities.

It recommends a safety assessment taking into account those changes and the bioavailability and toxicity of the food or contact substance.

The manufacturer should consider whether the altered food or contact substance is authorized under a food additive or color additive regulation. The manufacturer also should determine whether the altered food or contact substance warrants a regulatory submission to the FDA.

New Tests Foreseen for Cosmetics.

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).

By Alan Kovski  


A draft guidance from the FDA on assessing the effects of nanotechnology and other emerging technologies on food safety is available at http://1.usa.gov/IWKCYQ.

A draft guidance from the FDA on assessing the effects of nanotechnology on the safety of cosmetics is available at http://1.usa.gov/IcH34H.