You may be surprised to learn that in the United States bottled water is required to follow a strict set of guidelines, both on the state and federal levels, and is regulated with nearly the same strictness as alcoholic beverages. For a business to be able to sell bottled water in the U.S.A they must first meet the standards of both the FDA and EPA, after that they also need to meet the standards of individual states and they must prove on a regular basis that their product is keeping with these standards. Even the packaging of bottled water and the labels need to be approved by state regulators before the product can even hit 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.
Congress recently held hearings on bottled water regulation in the U.S. After being briefed on two studies about water purity, the oversight committee sent letters to 13 companies requesting more information about the source of their water and how it is tested. The “Environmental Working Group” submitted to Congress a 32-page document opining that 3 facts should be made public by every water bottler: source, purification methods, and chemical pollutants remaining after treatment. Only 2 water bottlers did so to the satisfaction of the Working Group.
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.