Bottled Water is Safe Under FDA's Comprehensive Regulatory System

August 28, 2006

Enforcement Actions Demonstrate FDA Effectiveness

Statement of the International Bottled Water Association (IBWA)

Bottled water is comprehensively regulated as a packaged food product by the U.S. Food and Drug Administration (FDA) and state regulatory agencies. The current system of bottled water regulation provides consumers with outstanding bottled water safety, quality and public health protection.

The recent recall of a few bottled water brands in New York State due to elevated bromate levels demonstrates the protective nature of FDA bottled water regulation. In this case, product that was not in compliance with FDA's 10 part-per-billion standard for bromate was removed from the marketplace and, through a variety of communication channels, consumers were notified of specific actions that they could take to return recalled products.

IBWA supports the implementation of appropriate enforcement action for food products that do not meet federal or state standards. IBWA understands that the producer and retailers of the recalled bottled water have been working closely with FDA at the national and regional levels to ensure appropriate measures are taken to remove noncompliant product from the marketplace.

Under federal law, FDA standards for bottled water must be as protective of public health as the tap water regulations set by the United States Environmental Protection Agency (EPA). As a result, both the FDA and EPA mandate a 10 ppb bromate standard of quality for bottled water and tap water, respectively. These standards are based on rigorous scientific analysis and the underlying risk assessment is very conservative and highly protective of consumer health, which means that the true risk is likely to be lower than predicted.

FDA regulations and the food production system enable tracking of specific product lot codes. As with all food in the United States, specific product lots that are not in compliance with myriad FDA standards can be identified, removed from the marketplace and thus made unavailable to consumers. An activist group is using this recall event as an opportunity to disparage the comprehensive nature of FDA bottled water oversight by comparing the EPA tap water alert system to the FDA food recall system. On this point, IBWA notes that, unlike tap water systems, which can distribute drinking water to consumers as long as the annual average level of bromate meets the EPA standard, noncompliance with FDA standards results in timely withdrawal of bottled water products from the consumer marketplace.

Consumers can remain confident in making bottled water their beverage of choice. The bottled water industry will continue to work closely with FDA and state agencies to help ensure that consumers have access to safe, high-quality bottled water.