What guidance does FDA have for manufacturers of Bottled Waters?

The FDA has established standards of quality for bottled drinking water (21 CFR 165). Bottled water is defined as water that is intended for human consumption sealed in bottles or other containers with no added ingredients except that it may optionally contain safe and suitable antimicrobial agents. Fluoride may be optionally added within the limitations established in Sec. 165.110(b)(4)(ii). FDA has established maximum allowable levels for physical, chemical, microbiological, and radiological contaminants in the bottled water quality standard regulations. Therefore, all bottled water products that meet the bottled water definition must comply with the quality standard.

FDA has also established Current Good Manufacturing Practice (CGMP) Regulations for processing and bottling drinking water (21 CFR 129). The CGMP regulations for bottled water apply to all waters sealed in bottles, packages, or other containers and offered for sale for human consumption, including bottled mineral water. Under the CGMP regulations for bottled water, the source water to be bottled must be from an approved source that is in compliance at all times with the applicable laws and regulations of the government agency or agencies having jurisdiction. Moreover, the CGMP regulations require that bottled water be processed, packaged, transported, and stored under safe and sanitary conditions. Furthermore, the CGMP regulations require producers of bottled water to monitor their source waters and their finished products at specified time intervals for contaminants to ensure that their products comply with the quality standard regulations for bottled water.

Bottled water, because it is a food, must comply with the general requirements for food labeling contained in 21 CFR 101. Nutrition labeling must be provided on the label of any bottled water product that contains more than insignificant amounts of any of the nutrients or food components that are required to be listed under the nutrition labeling requirements, or whose label, labeling, or advertising contains a nutrient content claim or any other nutrition information in any context. Furthermore, any health claims made on bottled water products must comply with the requirements that FDA has established for the use of health claims that characterize the relationship of a food component to a disease or health related condition on the labels and in labeling of foods (21 CFR 101).

The Food and Drug Administration established standard definitions for various terms used on the labels of bottled water. They include the terms mineral, spring, artesian, well, distilled, and purified. You may contact the Food and Drug Administration, Office of Plant and Dairy Foods and Beverages (HFS-306), 200 C Street, S.W., Washington, D.C. 20204 (telephone number (202) 205-4681) for additional information.