A "food additive" (direct or indirect) is defined in Section 201(s) of the Federal Food, Drug, and Cosmetic Acts (the Act) as a substance that is reasonably expected to become a component of food under the intended conditions of use. Conversely, if a substance is not reasonably expected to become a component of food under the intended conditions of use, it is not a food additive by definition, and may be used without any prior action by, or consultation with, FDA.

In the past, FDA has acknowledged the low risk of possible migration of materials in grocery bags to food. In response to a question about recycled plastics in grocery bags, the Agency did not objected to the use of recycle in such products, stating:

We would agree that grocery bags made from these [recyclable or degradable] polymers may contact food, and, when they do, food contact would be for short periods of time and usually at ambient temperatures. In addition, we are aware that most foods are already wrapped in approved food-contact packaging before being placed into these type of grocery bags. Because of this, we expect that there would be little likelihood that recyclable or degradable polymers used in grocery bags would significantly come into contact with food and/or become components of food. Therefore, while it is not true that FDA does not regard grocery bags as food additives, it is true that, given currently available information, we would consider the use of polymers to make grocery bags as a food additive situation that does not require regulation.

— June 6, 1990 letter from L. Robert Lake, Director, CFSAN Office of Compliance, to Ms. Marjorie E. Powell.