April 23, 2012
Last year we told you about about glimmers of nanotechnology policy in the US. Sure enough, this month the Food and Drug Administration (FDA) is issuing new draft guidelines on the use of nanomaterials in the manufacture of substances added to food. Guidance is open for comment. Of note is Section II A, which burrows into Industry’s responsibility regarding the safe and lawful use of food substances.
It is the responsibility of both the manufacturer and the end user of a food substance to ensure that the use of the food substance is safe and lawful. And pursuant to sections 402 and 301 of the Federal Food, Drug, and Cosmetic Act (the Act), retribution for violations of the Act include seizure, injunction, and criminal prosecution.
Nanotech: yummy in the tummy? Under section 402 of the Act, food shall be deemed to be adulterated if (among other things):
- The food bears or contains an added poisonous or deleterious substance which may render it injurious to health
- The food bears or contains any food additive that is unsafe within the meaning of section 409 of the Act or
- The food bears or contains a color additive that is unsafe within the meaning of section 721(a) of the Act (section 402(c)).
Under section 301 of the Act, the following acts (among others) and the causing thereof are prohibited:
- The introduction or delivery for introduction into interstate commerce of any food that is adulterated
- The adulteration of any food in interstate commerce and
- The receipt in interstate commerce of any food that is adulterated, and the delivery or proffered delivery thereof for pay or otherwise .
About the new documents Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes describes factors industry should consider when determining whether a significant change in the manufacturing of a food substance affects its identity, safety or regulatory status (such as whether a substance is covered by an existing food additive regulation). A food substance is one that is added to food or to food packaging for purposes that include improving taste, texture, or shelf life.
This guidance covers “any manufacturing process change that might affect a food substance’s identity, intended uses, or the way it behaves in the body after it is eaten,” says Dennis Keefe, Ph.D., director of the Office of Food Additive Safety.
The draft guidance suggests the FDA will require food companies to prove the safety of any packaging using nanotechnology. Under longstanding regulations, companies aren’t required to seek regulatory approval before launching products containing established ingredients and materials, such as caffeine, spices and various preservatives. - Matthew Perrone / Associated Press
FDA Commissioner Margaret A. Hamburg, M.D. says the guidelines provide a starting point for the nanotechnology discussion. “Our goal is to regulate these products using the best possible science,” Hamburg says. “Understanding nanotechnology remains a top priority within the agency’s regulatory science initiative and, in doing so, we will be prepared to usher science, public health, and FDA into a new, more innovative era.”