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Bottled Water: FDA Safety and Consumer Protections Are Often Less Stringent Than Comparable EPA Protections for Tap Water

GAO-09-610 Published: Jun 22, 2009. Publicly Released: Jul 08, 2009.
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Over the past decade, per capita consumption of bottled water in the United States has more than doubled. With this increase have come several concerns in recent years about the safety, quality, and environmental impacts of bottled water. The Food and Drug Administration (FDA) regulates bottled water under the Federal Food, Drug, and Cosmetic Act as a food and is responsible for ensuring that domestic and imported bottled water is safe and truthfully labeled. Among other things, GAO (1) evaluated the extent to which FDA regulates and ensures the quality and safety of bottled water; (2) evaluated the extent to which federal and state authorities regulate the accuracy of labels and claims regarding the purity and source of bottled water; and (3) identified the environmental and other impacts of bottled water. GAO reviewed FDA data, reports, and requirements for bottled water; conducted a state survey of all 50 states and the District of Columbia; reviewed bottled water labels; and interviewed FDA officials and key experts.


Recommendations for Executive Action

Agency Affected Recommendation Status
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner of the FDA to issue a standard of quality regulation for DEHP, or publish in the Federal Register the agency's reasons for not doing so 1 year after the conclusion of its task force study on this matter.
Closed – Implemented
On October 19, 2011, FDA published a final rule (76 FR 64810) establishing an allowable level of 0.006 mg/L for DEHP in the quality standard for bottled water. According to FDA, this final rule became effective April 16, 2012 and is intended to ensure that FDA's standards for the minimum quality of bottled water, as affected by DEHP, will be no less protective of the public health than those set by EPA.
Department of Health and Human Services The Secretary of Health and Human Services should direct the Commissioner of the FDA to implement FDA's findings on methods that are feasible for conveying information about bottled water to customers, such as, at a minimum, requiring that companies provide on the label contact information directing customers on how to obtain comprehensive information. Should FDA determine that it lacks the necessary authority to implement its findings, it should seek legislation to obtain such authority.
Closed – Not Implemented
According to FDA, the agency has not been able to make significant progress in the development of this guidance due to limited resources and multiple higher priority assignments (e.g., development of final rules to implement relevant sections of the Patient Protection and Affordable Care Act, developing a final rule to define the term "gluten-free," and developing other proposed regulations to implement the FDA Food Safety and Modernization Act.

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