FDA Approval on Bottled Water
It might be surprising, but in the U.S. bottled water is subject to a pretty intense set of federal and state requirements (being regulated more like alcohol than you might expect) and multi-state permitting and licensing regime. In order for a company to sell bottled water in the U.S., the water must meet FDA, EPA (by way of the Hammer provision of 1996), and individual state standards, and it must be tested periodically to demonstrate that these standards are maintained. The labels as well as the packaging and closure systems are scrutinized by state regulators prior to permitting the product on retail shelves.
“Bottle bills” have been instituted in several states which necessitates that additional information be added to the labels before the water can be sold. Manufacturers or first distributors of a product that offers a refund must first deposit the return amount in a state fund that is tapped when the consumer returns the bottles. Each label specifies the state by its abbreviation and the refund amount that will be received in that state when the bottle is returned.
Even congress has had lengthy hearings on the regulations of bottled water. After a few studies on bottled water purity were released an committee was formed that sent letters to 13 different manufacturers requesting that they divulge the source of their water and their testing procedures. Congress received a 32-page report from the Environmental Working Group that three details should be made public by every manufacturer of bottled water. Those would be the source of the water, the procedures by which it is purified, and the presence of any chemicals that may remain after the purification treatment. There are only two bottled water manufacturers that complied completely with the Environmental Working Groups suggestions.
FDA already regulates all three of these aspects, but with such political pressure we expect to see FDA emphasize them in a greater number and frequency of Warning Letters, and possibly even more labeling requirements in the future.
Many people drink bottled water every day in the U.S. which results in demand pushing the retail value to 3.5 times the average price of gasoline. This makes bottled water an attractive business opportunity because it is simple to purify and easily accessible. These compliance terms can seem like they are designed to hamper the entry of a new product into the market; but savvy marketers can still generate a profit once their item meets the criteria.
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.