Housewares (finished articles sold without prepackaged food and used by consumers in the home to hold, prepare, or serve food) are generally considered excluded from the premarket clearance requirements of the Federal Food, Drug, and Cosmetic Act (the Act). However, housewares are not exempt from the general safety requirements of the Act, which prohibits adulteration of food by materials used to hold, serve, or store food.

Paper and plastic cups and utensils and takeout containers are generally considered housewares and as such are exempt from the premarket clearance requirements. Although, the adulteration provisions of the Act (see Title 21 of the Code of Federal Regulations, Part 174.5) do apply to housewares, and FDA will take action against houseware products that are found to adulterate food. Therefore, it remains the responsibility of producers of housewares to take every reasonable precaution to ensure that their products are suitable for use with food and will not create a health hazard under the intended conditions of use.

Please consult with a qualified attorney to assure that your products comply with the requirement of the Act in all respects.