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.

Prepared by Hogan & Hartson L.L.P.

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