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A regulatory status is a set of mandatory texts that define the procedure to follow in order to obtain the marketing of a health product. The regulatory status therefore determines the legal framework surrounding the specific characteristics of each category of health products.

The FDA may also grant a substance used in a food-contact article (for example, food-packaging or food-processing equipment) that migrates, or that may be expected to migrate, into food an exemption from regulation as a food additive.

The FDA does not regulate the practice of medicine, medical services, the price or availability of medical products and whether they are reimbursed by health insurance or Medicare.

The first route to compliance applies to the many established food contact materials, which have existing FDA regulations specific to them. These regulations are laid out in 21 CFR Parts 170-199. For new food contact substances, manufacturers must register the product with the FDA.

A substance intended for use as a component of materials used in manufacturing, packaging, transporting, or holding food (also known as food contact substance) is regulated as indirect food additive under the Food Drug and Cosmetic Act (FD&C Act) and Title 21 Code of Federal Regulations (21 CFR).

The agency regulates all foods and food ingredients introduced into or offered for sale in interstate commerce, except for meat, poultry, certain processed egg products, and catfish, which are regulated by the U.S. Department of Agriculture.

(1) Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use.