The bottled water industry is regulated on four levels: federal, state, industry association and individual company. Federal regulations by the U.S. Food and Drug Administration (FDA) coupled with state and industry standards, offer consumers assurance that the bottled water they purchase is stringently regulated, tested, and of the highest quality. The International Bottled Water Association (IBWA) has been a long-standing proponent of additional federal regulations for bottled water and has been very active at all levels of local, state and federal government assisting in the development of such regulations.
Bottled water is regulated as a food product by the FDA. Bottled water companies must adhere to the FDA’s Good Manufacturing Practices, Quality Standards, and Standards of Identity.
All bottled water products must comply with the FDA’s Quality Standards in Section 103.35(d)(2) of Title 21 of the Code of Federal Regulations (CFR). These standards, along with the FDA’s Good Manufacturing Practices, ensure the safety of all bottled water products from production to packaging to consumption.
FDA’s labeling rules for bottled water establish standards of identity and standardized definitions for terms found on bottled water labels such as “spring,” “artesian,” “well,” “mineral,” “purified,” and “distilled.” Seltzer, soda water, and tonic water are considered soft drinks; they are excluded from these regulations.
Good Manufacturing Practices:
Bottled water is subject to both General Food Good manufacturing practices (GMPs) and GMPs specific to bottled water processing and bottling. General food GMPs govern such areas as plant and ground maintenance, sanitary maintenance of buildings and fixtures, and sanitary facilities, including water supply, plumbing and sewage disposal. Bottled water GMPs provide detailed regulations governing plant construction and design, sanitary facilities and operations, equipment design and construction, production and process controls specific to the production and processing of bottled drinking water, and record keeping.
All European exporters must meet the federal and state standards as applicable. They must also meet strict standards set by the European Union. International bottler members that sell products in the U.S must submit a certificate of inspection to IBWA.
In addition to FDA’s extensive regulatory requirements, the bottled water industry is subject to state regulatory requirements. A significant responsibility of the state is inspecting, sampling, analyzing and approving sources of water. Under the federal GMP’s, only approved sources of water can be used to supply a bottling plant. Another area in which some states have important responsibilities that complement federal regulation is the certification of testing laboratories. As with any food establishment, the states perform unannounced spot inspections, and some states perform annual inspections.
IBWA Standards & Third-Party Inspections:
In addition to the state and federal standards for bottled water, IBWA bottler members are subject to another level of oversight. As a condition of membership, bottlers must submit to an annual, unannounced plant inspection administered by an independent, internationally recognized third-party inspection organization. This inspection audits quality and testing records, reviews all areas of plant operation from source through finished product, and checks compliance with FDA Quality Standards and Good Manufacturing Practices and any state regulations.
IBWA Model Code:
IBWA has established a quality assurance program: a strict set of standards called the Model Code. The Model Code establishes tougher requirements than federal and state authorities.