Surprisingly enough, in the United States bottled water is monitored through a strict set of state and federal requirements and permitting conditions which make its treatment closer to that of alcohol than most people know about. Every company who sells bottled water in this country must meet EPA (in keeping with the Hammer provision of 1996), FDA and state regulations; and be periodically tested to ensure that their products meet the established standards. State regulators examine the labels, packaging and closures in preparation for the products transportation to retail store shelves.

Several states have even introduced so-called bottle bills that cover recycling and require even more labeling standards. Each bottle must label the return worth of a given bottle at a recycling plant in each state that has such a program, the manufacturer of the product or the distributor for that state need to offer money in advance for a state fund that is then paid to consumers who return the bottles for recycling.

The U.S. Congress held recent hearings to review bottled water regulations. The oversight committee was briefed on 2 reports concerning water purity and then sent 13 letters to specific companies that requested additional information about their testing practices and water sources. A 32-page document was submitted to Congress by the “Environmental Working Group” suggesting that each water bottler make 3 items public knowledge; water source, method of purification and the levels of chemical pollutants that remain in the product after processing. There were only 2 bottlers who complied with the request to their satisfaction.

Given this political pressure, it is likely that the FDA will issue more warning letters concerning these issues that will result in more complex labeling requirements over time. The FDA already regulates these three aspects to some extent.

Bottled water can be an attractive and lucrative business in the U.S.: water is easily accessible and fairly simple to purify, and its average retail value is the equivalent of 3.5 times the price of gasoline today – oh, and it seems like everybody is drinking it every day. The regulatory requirements may seem like a high barrier to entry, but once a company finds “the way through” these compliance issues, it’s only a matter of great taste and good marketing.

FDAImports.com was founded by Benjamin L. England, Esq., a former FDA professional with 20 years of direct FDA experience, 17 years of which were obtained inside FDA. Mr. England is now a privately practicing FDA lawyer managing food, drug, medical device, cosmetic, and electronic product regulatory compliance, international trade and customs law. FDAImports.com specializes in making the complex understandable.