FDA Releases Guidance on Use of Nanotechnology in Food and Cosmetic Industries

On April 20, 2012 the Food & Drug Administration (FDA) issued for comment two draft guidance documents concerning the use of nanotechnology in food, food packaging and cosmetics. These documents were analyzed in a recent Law360 article (subscription or free trial required) in addition to other legal blogs such as the the FDA Law Blog.

The first, entitled “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” (available here) “is intended to describe the factors you should consider when determining whether a significant change in manufacturing process for a food substance already in the market: 

  • Affects the identity of the food substance;
  • Affects the safety of the use of the food substance;
  • Affects the regulatory status of the use of the food substance; and
  • Warrants a regulatory submission to FDA.”

The food guidance gives an overview of current statutory and regulatory provisions and outlines the FDA’s process for assessing a food’s safety.  The guide strongly implies that formal pre-market approval will be necessary for all nanotechnology applications in food.

The second document, “Safety of Nanomaterials in Cosmetic Products” (available here) is meant to reflect the FDA’s “current thinking on the safety assessment of nanomaterials in cosmetic products.”  The use of nanotechnology in the cosmetics industry is rapidly growing and is particularly prevalent in moisturizers and high-end skin care products.  The Project on Emerging Nanotechnologies provides an inventory of all products which utilize nanotechnology divided by category and estimates that as of 2011 there were 143 nanotech-enabled cosmetic products on the market, a more than three-fold increase in the previous 5 years.  Traditionally these products have escaped intensive regulation however the FDA’s guidance specifically recommends that the use of nanotechnology requires “the development of new testing methods.”  Furthermore, the FDA recommends that cosmetic producers “meet with [the FDA] to discuss the test methods and data needed to substantiate the product’s safety, including short-term toxicity and other long-term toxicity data as appropriate.”   


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