The bottled water industry is regulated on three levels: federal, state and trade association. U.S. Food and Drug Administration (FDA) regulations, 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 is active at all levels of the local, state and federal government assisting in the development of such regulations.
Federal Regulations
Bottled water is fully regulated as a food by the United States Food and Drug Administration ("FDA") under the Federal Food, Drug, and Cosmetic Act ("FFDCA" or the "Act"), 21 U.S.C. § 301et seq. The FFDCA defines food as "articles used for food or drink for man or other animals. . . ." FFDCA § 201(f). This includes packaged water sold in smaller containers at retail outlets as well as larger containers distributed to the home and office market. In contrast, municipal water is regulated not as a food by FDA but as a commodity by the Environmental Protection Agency ("EPA") pursuant to the Safe Drinking Water Act, 42 U.S.C. § 300f et seq. Like all food except meat and poultry products, bottled water is subject to FDA`s extensive food safety and labeling requirements. In addition, bottled water is one of only several food product categories that are subject to additional specific FDA Good Manufacturing Practice ("GMP") requirements. Between the general food provisions and the provisions specific to bottled water, bottled water is one of the most extensively regulated food products under FDA`s jurisdiction. Indeed, the federal requirements applicable to bottled water include:
- Full application of far-reaching food adulteration and misbranding provisions of federal law;
- Full application of FDA`s general food GMP regulations;
- Full application of FDA`s specific bottled water GMP regulations;
- Full application of FDA`s standard of identity and quality for bottled water; and
- Full application of both civil and criminal penalties for non-compliance with the above-mentioned FDA requirements.
State Regulations
In addition to FDA`s extensive regulatory requirements, the bottled water industry is subject to state regulatory requirements as well. A significant responsibility of the states is inspecting, sampling, analyzing and approving sources of water. Under the federal GMPs, 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. Some states perform annual inspections as well.
Bottled water is fully regulated at the federal, state and industry levels. There are extensive and specific FDA requirements that must be met. Failure to comply will subject the manufacturer and/or product to regulatory action. Further, there are state requirements that must be met as well as self-imposed industry requirements. All of these combine to ensure that bottled water remains a high quality, safe product.
Industry Regulations - The IBWA Model Code
The bottled water industry routinely employs additional measures to further the protection of its product beginning with the source on through to the packaging. These requirements are laid out in the IBWA Model Code. One important measure is the annual facility inspection. International Bottled Water Association members are required to undergo an annual, unannounced plant inspection. These inspections are conducted by an outside third-party organization and assess compliance with all applicable regulations. IBWA currently contracts the services of the National Sanitation Foundation International, an independent, highly qualified technical auditing and compliance firm, to perform these comprehensive audits.
