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U.S. consumers have a big thirst for bottled water, buying more than 8 billion gallons of it in 2007 alone, according to the International Bottled Water Association.
The U.S. Food and Drug Administration (FDA) regulates bottled water products, working to ensure that they're safe to drink.
FDA protects consumers of bottled water through the Federal Food, Drug, and Cosmetic Act (FD&C Act), which makes manufacturers responsible for producing safe, wholesome, and truthfully labeled food products.
There are regulations that focus specifically on bottled water, including
FDA describes bottled water as water that's intended for human consumption and sealed in bottles or other containers with no added ingredients, except that it may contain a safe and suitable antimicrobial agent. (Fluoride may also be added within the limits set by FDA.)
The agency classifies some bottled water by its origin. Here are four of those classifications:
Bottled water may be used as an ingredient in beverages, such as diluted juices or flavored bottled waters. However, beverages labeled as containing "sparkling water," "seltzer water," "soda water," "tonic water," or "club soda" aren't included as bottled water under FDA's regulations. These beverages are instead considered to be soft drinks.
Some bottled water also comes from municipal sources—in other words, the tap. Municipal water is usually treated before it is bottled. Examples of water treatments include
Bottled water that has been treated by distillation, reverse osmosis, or another suitable process may meet standards that allow it to be labeled as "purified water."
Federal quality standards for bottled water were first adopted in 1973. They were based on U.S. Public Health Service standards for drinking water set in 1962.
The 1974 Safe Drinking Water Act gave regulatory oversight of public drinking water (tap water) to the U.S. Environmental Protection Agency (EPA). FDA subsequently took responsibility, under the FD&C Act, for ensuring that the quality standards for bottled water are compatible with EPA standards for tap water.
Now each time the EPA establishes a standard for a contaminant, FDA either adopts it for bottled water or finds that the standard isn't necessary for bottled water.
In some cases, standards for bottled water and tap water differ. For example, because lead can leach from pipes as water travels from water utilities to home faucets, EPA has set its limit for lead in tap water at 15 parts per billion (ppb). For bottled water, for which lead pipes aren't used, the lead limit is set at 5 ppb.
For bottled water production, bottlers must follow the CGMP regulations put in place and enforced by FDA. Water must be sampled, analyzed, and found to be safe and sanitary. These regulations also require proper plant and equipment design, bottling procedures, and recordkeeping.
In addition, FDA oversees inspections of bottling plants. The agency inspects bottled water plants under its general food safety program and has states perform some plant inspections under contract. (Some states also require bottled water firms to be licensed annually.)
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
FDA Center for Food Safety and Applied Nutrition
Bottled Water Regulations
www.cfsan.fda.gov/~lrd/bot-h2o.html
Date Posted: August 25, 2008
