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What FDA Regulations Apply to Secondary Packaging of Reusable Spoons?

March 16, 2016
Question 

What FDA regulations, if any, apply to secondary packaging of food-contact articles (i.e., reusable spoons individually wrapped in plastic)?

Answer 

Only food-contact substances that are also food additives (i.e., are reasonably expected to become a component of the food) require U.S. Food and Drug Administration (FDA) premarket clearance. FDA defines a food additive as "…any substance the intended use of which results, or may reasonably be expected to result…in its becoming a component or otherwise affecting the characteristics of any food," unless it is exempted from the definition of a food additive (e.g., a color additive, generally recognized as safe (GRAS), prior sanctioned). Thus, if a component of a secondary package is reasonably expected to transfer from the package to food, it may be considered a food additive, regardless of the intervening packaging material, and requires premarket clearance by FDA.

Another consideration applies to the example that you provided: reusable spoons are considered housewares (finished articles sold without prepackaged food and used by consumers in the home to hold, prepare, or serve food). Significantly, housewares are excluded from the need for FDA premarket clearance requirements. However, housewares are not exempt from the general safety requirements of the Food, Drug, and Cosmetic Act and, therefore, must be suitable for use with food so as not to result in its adulteration.