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FDA Grapples with Nanotechnology

On June 24, 2014, the Food and Drug Administration (FDA) released three final guidance documents addressing the agency’s general approach to nanotechnology and its use by the food and cosmetics industries, as well as a draft guidance on the use of nanomaterials in food for animals.

These guidance documents reflect FDA’s understanding of nanomaterials as an emerging technology of major importance with the potential to be used in novel ways across the entire spectrum of FDA- regulated products.

The documents suggest that FDA plans to approach nanotechnology-related issues cautiously, through an evolving regulatory structure that adapts to manufacturers’ changing uses of this technology. FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or other related terms. The guidance documents provide a framework for factors FDA will consider in evaluating a product’s safety.

Rather than categorizing all products involving the use of nanotechnology as intrinsically either benign or harmful, FDA will consider on a case-by-case basis the characteristics of the finished product and the potential safety concerns for its intended use. FDA cautions manufacturers against assuming that a product containing nanomaterials is safe simply because larger particles of the same material have been established as safe. The agency encourages manufacturers to establish the safety of nanomaterials based on data relevant to the nanoscale version of the material and to consult the agency early and regularly with questions related to proper substantiation of product safety.

The FDA guidance documents are incredibly complex.  This is not surprising in view of the complexity of the issues involved.  Emerging nanotechnologies are being used in numerous industry sectors, including food and cosmetics.  Companies utilizing them are urged to study carefully the FDA guidance documents.

© 2018 Covington & Burling LLP

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About this Author

Jeannie Perron, food and drug lawyer, Covington
Partner

Jeannie Perron is a member of the firm’s Food and Drug Practice Group, resident in the Washington, DC Office.

In addition to being an attorney, Dr. Perron also holds a degree in veterinary medicine and has practiced as a veterinarian.  She specializes in food and drug law, with a sub-specialty in animal food and drug law.  In this capacity, she represents companies that manufacture feed, feed ingredients, drugs, biologics and medical devices for animals, as well as clients in related industries.

202-662-5687
Miriam Guggenheim, Covington, Food regulation attorney
Partner

Miriam Guggenheim, co-chair of Covington’s Food, Drug & Device Practice Group, assists a broad range of major food and dietary supplement companies in achieving their marketing goals while minimizing regulatory and litigation risks. She also helps clients successfully navigate crises such as recalls and unwanted Congressional or regulatory attention. In addition to her work for individual clients, Ms. Guggenheim serves as outside counsel to a number of key trade associations, helping them accomplish broad industry objectives by engaging with the FDA, FTC, and Congress.

202-662-5235
Allan Topol, Covington, Environmental attorney
Senior Counsel

Allan Topol is a resident in the firm’s Washington office.  While practicing law with Covington, he has written ten novels of international intrigue and numerous articles dealing with foreign policy issues in The Huffington PostThe New York TimesThe Washington Post, and Military.com.

Mr. Topol’s law practice has involved extensive civil and criminal litigation, with an emphasis on water, air and major hazardous waste enforcement cases, as well as international environmental law and toxic torts.  He has also advised clients on many of...

202-662-5402