Regulated & Controlled
Bottled water sold in the U.S. is regulated at both the federal and state levels, and the U.S. Food and Drug Administration (FDA) has regulated bottled water as a packaged food product since 1938. In addition to federal requirements, all U.S. state governments regulate bottled water produced within their state.
Federal regulations can be found in the FDA Code of Federal Regulations (CFR), which include requirements regarding the naming, production and labeling of food products and the quality they must meet. The FDA enforces these regulations and has the jurisdiction to recall products it finds to be misbranded or adulterated.
In 1996, the FDA established regulations in Title 21 CFR 129 and 165, which are specific to bottled water. The sections cover items such as: what bottled water can be called; how it can be produced; what can and cannot be on the label; and contaminants for which bottled water must be tested.
Title 21 CFR, Part 165.110(a) includes specific standards of identity for different types of bottled water based on type of source, treatment processes and mineral composition. Some identities include: artesian water or artesian well water; spring water; mineral water; and purified water.
The FDA establishes the list of contaminants and safe levels for which bottled water must be tested, based on those established by the U.S. Environmental Protection Agency (EPA) National Primary Drinking Water Regulations (NPDWRs) for public water supplies. They are categorized into four major groups: microbiological; physical characteristics; chemical; and radiological.
The chemical quality covers inorganic and organic chemicals including: volatile organic chemicals; synthetic organic chemicals; disinfectants; and disinfection byproducts.
The guidelines that bottled water must meet are the Standards of Quality (SOQ)—Title 21 CFR, Part 165.110(b). Bottled water SOQ must be no less stringent than EPA standards for public water supplies. By law, all bottled water in the U.S. must be in compliance with the FDA SOQ, ensuring that it is safe to drink.
Title 21 CFR, Parts 110 and 129—Current Good Manufacturing Practices (GMPs) provide guidelines to assure compliance with FDA SOQ for bottled water. GMPs cover practices for operation of a sanitary facility including: production; process controls; equipment maintenance; housekeeping; grounds upkeep; design; construction; and recordkeeping.
The FDA regulations governing bottled water stipulate that the full scope of testing is to be performed on each type of finished product water produced and on nonmunicipal sources. If the same type of finished product water is produced on multiple production lines, using separate equipment, the product from each line should be tested as a separate product.
If a bottler produces purified drinking water as one product type and then adds fluoride to the water to sell as a separate fluoridated product, the bottler must have the full scope of testing performed on both the purified and fluoridated finished products.
Finished product water that is sold as purified water must meet U.S. Pharmacopeia (USP) standards. This includes water sold as RO, DI or distilled. A separate group of tests are performed to verify USP compliance, which specifies more stringent limits on parameters such as heavy metals, chloride, pH and total solids.
The FDA monitors and inspects bottled water products and processing points under its general food safety program. They collect and analyze samples to verify compliance as part of performing routine plant inspections and follow up on consumer or trade complaints and customs inspections of foreign bottled water products imported into the U.S.
The FDA has also established regulations to protect the food supply as required by the Bioterrorism Act of 2002. These requirements include provisions for facility registration, prior notice and record keeping.
Enforcement of FDA regulations is primarily managed at the state level. Each state’s regulations pertaining to bottled water testing may refer to the FDA Federal Register requirements, or the state may have their own legislation dictating testing requirements.
Bottled water products sold in the U.S. must meet FDA and state requirements and apply for license to the states in which they plan to sell the finished product water. The amount of documentation that must accompany the application also varies by state, from simply providing a copy of the analytical report to submitting an array of information, including copies of product labels, hydrogeological survey reports and plant engineering reports.
The FDA relies on the states to approve bottled water sources specified by the FDA in 21 CFR 129.3(a). This section outlines requirements for source approval and includes the minimum sampling and testing required of source water, product water, containers and closures and final bottled water product for microbiological chemical and radiological contaminants. The section also establishes the period of time that bottlers are required to maintain and make available to government inspectors records demonstrating compliance with 129 and 165.
In addition to testing requirements mandated by U.S. government regulations, bottled water industry associations and other agencies worldwide have established guidelines to ensure bottled water producers adhere to a high standard of quality.
These guidelines can be more stringent than FDA regulations and may cover a different scope of analytes, making global bottled water sales a bit complicated. Bottlers should provide their testing lab with as much information as possible about their distribution plans in order to design the most efficient testing program to meet all applicable regulations.
There is constant regulatory activity surrounding federal and state requirements for bottled water production, labeling and water quality. The future will likely continue to bring new testing requirements as the EPA adds parameters to the NPDWRs, leading to FDA promulgation of new bottled water regulations. Bottlers who do not have the internal resources devoted to tracking these complex regulations should align themselves with consultants or industry associations that can provide them with access to current updates, interpretation and advise them on compliance procedures.