Regulation of Bottled Water: An Overview
Bottled water is comprehensively regulated by federal, state and, occasionally, local governments. At the federal level, bottled water is regulated as a packaged food product, governed by the U.S. Food and Drug Administration (FDA) through the Food, Drug, and Cosmetic Act. At the state level, bottled water is regulated in myriad ways, typically through state environmental, food or agricultural agencies.
Bottled water is fully regulated as a food product by the FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA or the Act) and several sections of Title 21 of the Code of Federal Regulations (CFR).
Standard of Identity: 21 CFR, Part 165, provides uniform definitions for the following bottled water classifications: bottled, drinking, artesian, ground, distilled, deionized, reverse osmosis, mineral, purified, sparkling, spring, sterile and well. A bottled water product must bear the appropriate name on its label as reflected in the applicable Standard of Identity definition or it may be deemed misbranded under the Federal Food, Drug, and Cosmetic Act.
Standard of Quality: 21 CFR § 165 also contains the Standard of Quality for bottled water. This regulation establishes limits for microbiological, physical, chemical, and radiological substances for both source water and finished bottled water products. Federal testing frequency and parameters are specified in 21 CFR, Part 129, as part of the Good Manufacturing Practices (GMP) for bottled water. Bottled water is one of few food products with its own specific GMPs. FDA has established standards for more than 75 substances pursuant to the Standard of Quality for bottled water. Substandard bottled water must be clearly labeled with the appropriate statements regarding non-compliance (e.g., “This product contains excessive amounts of iron.”). The product will otherwise be considered misbranded and possibly adulterated.
The Hammer Provision of 1996, 21 USC § 349: The Hammer Provision of the Federal Food, Drug, and Cosmetic Act provides that the Secretary of Health and Human Services shall consult with the Administrator of the Environmental Protection Agency (EPA) in regard to any EPA-proposed changes to the national primary drinking water regulations for public water supplies. Within 180 days of the effective date of such regulations, the Secretary must either promulgate amendments to the regulations applicable to bottled drinking water or publish in the Federal Register reasons for not making such amendments. The standards of quality issued for bottled water by FDA must be as stringent as those adopted by EPA for tap water.
Amendments to the FFDCA Made by the Nutrition Labeling and Education Act (NLEA): Enacted in 1990 and resulting in FDA’s promulgation of final regulations in 1993, the NLEA amended the Federal Food, Drug, and Cosmetic Act by requiring packaged food products to disclose the exact nutritional content of the product by way of a uniform “nutrition facts” panel. For bottled water, the obligation to provide nutrition information arises when an express or implied nutritional claim is made [21 USC § 343 (g)]. Nutritional labeling is also required when nutritional ingredients are added. The essential nutrients and the order in which they must appear are: total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron.
Misbranding: Food misbranding is regulated under Section 403 of the Act. The Act requires a bottled water product to include on its label the correct standard of identity (i.e., bottled water, mineral water, spring water, etc.), the name and place of business of the manufacturer, and a statement of the net quantity of contents. Additional misbranding (labeling) regulations specific to bottled water include:
- If it is represented as bottled water for which a Standard of Identity has been prescribed and it fails to conform to the definition, statement of identity or other specific requirements. For example, the Standard of Identity for “mineral water” (21 CFR § 165.110) requires that the final product contain not less than 250 ppm total dissolved solids, come from a source tapped at one of more bore holes or springs, originate from a hydrogeologically protected source, and contain no added minerals. If these requirements are not met, and the product is labeled “mineral water,” the product is misbranded.
- If it is represented as bottled water and its quality falls below the Standard of Quality for Bottled Water, unless specifically disclosed in its labeling. For example, under the Standard of Quality for Bottled Water (21 CFR § 165.110), the maximum contaminant level for iron is 0.3 mg/L. A bottled water containing in excess of this amount would be misbranded unless its label disclosed the substandard nature of the product by stating “contains excessive chemical substances” or “contains excessive iron” (21 CFR § 165.110 (c))
- If it does not bear ingredient labeling, and is required to do so. A bottled water must include ingredient labeling if it contains more than one ingredient.
- If it does not bear nutritional labeling, and is required to do so. Some bottled waters must bear nutritional labeling, depending on statements made for the product or nutrients added to the product.
- If it does not conform to FDA regulations regarding nutrient and/or health claims. For example, if a bottled water label states the water is “sodium free” and the product does not meet FDA requirements to be so designated, the product would be misbranded.
- If its labeling is false or misleading.
- If it is an imitation of another bottled water and it is not so labeled.
- If information required to be on the label is not sufficiently prominent.
Adulteration: Section 402 of the Act (21 USC § 342) deems a food to be adulterated under any of the following conditions:
- If it contains a “poisonous or deleterious substance which may render it injurious to health.”
- If it bears an added poisonous or deleterious substance that is unsafe within the meaning of Section 406 of the Act. For example, bottled water may be deemed adulterated if it contains industrial contaminants, pesticides, or other substances harmful to health.
- If it contains “any filthy, putrid or decomposed substance, or if it is otherwise unfit for food.” Bottled water may be deemed adulterated under this provision if it becomes contaminated with dirt or other debris during processing.
- If it has been “prepared, packaged, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” Bottled water may be deemed adulterated under this provision if it was not manufactured in compliance with Good Manufacturing Practices.
- If a bottled water container “is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.”
- If any valuable constituent has been removed from the product. For example, bottled water may be deemed adulterated if its label claims a certain amount of Vitamin A and that nutrient has been removed during processing.
- If any substance has been wholly or partially substituted.
- If damage or inferiority has been concealed in any manner.
- If any substance has been added to the product or its packaging to increase the product’s bulk or weight, reduce its quality or strength, or make it appear of greater value than it is.
FDA Enforcement: The following tools are available to FDA in its enforcement of bottled water regulations:
Pursuant to section 704 of the Act (21 USC § 374), FDA may inspect any food manufacturing facility, including a bottled water plant.
In the event a product is deemed misbranded or adulterated, FDA generally seeks voluntary compliance through the use of warning letters and requests for voluntary recalls.
If the company declines to comply with applicable requirements or declines to take action to correct the violation, FDA may take either civil and/or criminal action. FDA may seek action from the U.S. Department of Justice in the form of a civil seizure or an injunction against the products and/or company involved. Depending on the circumstances, a criminal prosecution may also be warranted.
FDA may also use its authority to warn the public (e.g., press releases).
Good Manufacturing Practices (GMPs): 21 CFR, Part 110, contains FDA regulations relating to GMPs for all food production facilities. These regulations address:
- Chemical, physical and bacteriological contamination during the packaging and handling process, and govern plant and grounds maintenance.
- Plant construction and design.
- Sanitary maintenance of buildings and fixtures.
- Sanitary facilities.
- Design and maintenance of equipment.
- Production and process controls of raw materials and manufacturing operations (including sanitation and quality control of receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging and storage).
- Defect action levels.
In addition, 21 CFR, Part 129, contains GMPs specific to bottled water. The section entitled “Processing and Bottling of Bottled Drinking Water” sets guidelines for:
- Bottled Water Plant Construction and Design (including separation of the bottling room, protection of processing operations, adequate ventilation and enclosure of washing and sanitizing operations).
- Sanitary Facilities.
- Source water must be obtained from an approved source and conform to applicable state and local laws and regulations.
- Operations water, if different from source water, must also be obtained from an approved source and conform to applicable state and local laws and regulations.
- Required analysis of source water includes testing for chemical parameters once a year; radiological once every four years; and microbiological once a week.
- Sampling and analytical methods used must be those recognized and approved by the government agency of jurisdiction.
- Sanitary Operations.
- Equipment Design and Construction.
- Production and Process Controls (including water analysis, sampling and analytical methods, sampling and inspection of containers and closures, and record keeping).
State governments use one of the following approaches in their regulation of bottled water:
Federal/FDA Model: Under the Federal/FDA Model, used in the majority of states, bottled water is treated solely as a food product and subject to the FDA’s extensive food safety and labeling requirements. Bottled water is treated in the same manner as all other packaged food products by the state and, therefore, is subject to the same requirements. Bottled water may also be required to meet certain state-specific labeling and/or quality standards.
Environmental Model: Under the Environmental Model, bottled water is regulated by a particular state’s environmental protection or natural resources department, comparable to that of the EPA. This regulation, used to some degree in six states, begins at the source of withdrawal and usually includes inspection, sampling, analysis and approval of water sources. Withdrawals are generally treated in the same manner as municipal water sources, thus subject to state regulations similar to the Safe Drinking Water Act, 42 USC 300(f).
Combination: In a majority of jurisdictions, bottled water is regulated in a manner combining the Federal/FDA and Environmental Models. The withdrawal of water at the source is regulated by an EPA-type agency, while bottled water, once packaged, is treated like a traditional food product and regulated accordingly. Some states also take responsibility in the certification of testing laboratories. Unannounced inspections are among the steps that some states take to ensure quality in the testing process.
The bottled water industry also employs additional measures to help ensure the safety and quality of its product beginning with the source on through to packaging. Bottler members of the International Bottled Water Association (IBWA) must adhere to the IBWA Model Code, which requires members to undergo an annual, unannounced plant inspection. These inspections are conducted by an independent third-party organization and assess compliance with all applicable regulations. The major areas covered by the IBWA annual inspections are: plant construction and design, sanitary facilities and controls, sanitary operations, equipment and procedures, process and controls, and personnel. IBWA bottler members must also develop a Hazard Analysis and Critical Control Points (HACCP) program for each of their facilities to be in compliance with the IBWA Model Code. The HACCP program requirement further ensures food safety and security within the production facility.
The IBWA Model Code (available at www.bottledwater.org ) is, in several cases, more stringent than state and federal regulations and has been adopted by more than a dozen states as their standard for regulation of bottled water.
Bottled water’s consistent safety and quality is due in part to the extensive FDA requirements, individual state regulations and industry standards which bottled water must meet. All of these combine to make bottled water one of the safest food products available for human consumption.