June 2012

The U.S. Food and Drug Administration in April 2012 issued two draft guidance documents relating to the use of nanotechnology in food and food packaging and cosmetics.

"[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," covers the use of nanotechnology in the manufacture of food ingredients, including color additives, and food contact substances, e.g., packaging.

“[Draft] Guidance for Industry: Safety of Nanomaterials in Cosmetic Products,” covers the use of nanotechnology in cosmetics.

These draft guidance documents are the subject of a summary article by attorney Lynn Tyler (Barnes & Thornburg LLP), published in Product Liability Law360, on May 29, 2012, "Tightening FDA Nanotech Regs on Food, Cosmetics."

According to Tyler: "The message of the two guidance documents is similar: Manufacturers in these industries who incorporate nanoscale ingredients into their products should be prepared to prove that the resulting products are safe and that appropriate tests were used to validate their safety."

Excerpts of the article are provided below.