March 11, 2008

Experts and Bottled Water Industry Confident that Technical and Safety Measures Used to Produce and Process Bottled Water are Effective in Protecting From Pharmaceutical Contamination

US Food and Drug Administration (FDA) Standards Provide Tough Protection

Bottled Water is NOT Simply Tap Water in a Bottle International

A recent Associated Press article reports that trace amounts of pharmaceuticals have been found in some U.S. municipal drinking water systems. The International Bottled Water Association (IBWA) would like to remind consumers that bottled water is not simply tap water in a bottle and that the safety and quality of bottled water produced in accordance with US Food and Drug Administration (FDA) standards do not pose a health risk due to pharmaceuticals or other substances. Bottled water is comprehensively regulated as a packaged food product by FDA. Bottled water companies use a multi-barrier approach to bottled water safety, which includes source protection, source monitoring, reverse osmosis, distillation, filtration and other purification techniques, ozonation or ultraviolet (UV) light. The combination of FDA and state regulations, along with a multi-barrier approach and other protective measures, means that consumers can remain confident in choosing bottled water.

Stephen C. Edberg, Ph.D., ABMM, Yale University School of Medicine (, stated that consumers should be confident in bottled water as a safe beverage choice. Dr. Edberg stated, “The technical and safety measures used to produce and process bottled water are extremely effective in protecting the product from these and other substances that were reported in the article, should they be present in source water to begin with. This report raises no concern for the safety of bottled water.”

Consumers should also consider these additional measures, which help ensure the safety and quality of bottled water:


  • Bottled water is fully regulated as a packaged food product by the U.S. Food and Drug Administration (FDA) and bound by FDA’s quality, safety, inspection, and labeling requirements.
  • Bottled water is not simply tap water in a bottle. FDA and state governments recognize both groundwater and municipal water systems as legitimate and valid sources for bottled water production. There are specific labeling and other standards to help ensure that consumers are aware of the type of bottled water they choose.
  • Bottled water companies that use municipal source water treat and purify the water by employing processes such as reverse osmosis and distillation before it is bottled and delivered to consumers as a packaged food product. The product will be labeled as “purified water,” or alternatively, “reverse osmosis water” if it is treated by reverse osmosis or “distilled water” if it treated by distillation. These processes are effective in removing pharmaceuticals and other substances, if they are present in the source water to begin with.
  • If bottled water is sourced from a municipal water system and has not been further treated, FDA requires the label to state that it is from a municipal or community water system.
  • Bottled water products, such as mineral water, spring water or artesian water, come from well-protected, underground water sources that are not under the direct influence of surface water such as rivers or lakes, which are the source for many community water systems.
  • Bottled water products are required to comply at all times with FDA Standards of Quality. As with other food products, bottled water is subject to the food adulteration requirements of the Federal Food, Drug, and Cosmetic Act and is also subject recall and the full array of FDA enforcement actions, including warning letters, civil (seizure and/or injunction) and criminal penalties.
  • In addition to federal and state regulations, members of the International Bottled Water Association (IBWA) are required to adhere to standards in the IBWA Bottled Water Code of Practice that, in several cases, are stricter than FDA and state bottled water regulations. The IBWA Bottled Water Code of Practice is enforced through a mandatory, annual, unannounced plant inspection by an independent, third-party organization.

    The following measures are employed by IBWA member bottlers to help ensure the safety of the bottled water brands they produce:


  • A MULTI-BARRIER APPROACH – Bottled water products are produced utilizing a multi-barrier approach, from source to finished product, that helps prevent possible harmful microorganisms or chemicals, such as pharmaceuticals, from contaminating the finished product as well as storage, production, and transportation equipment. Measures in a multi-barrier approach may include source protection, source monitoring, reverse osmosis, distillation, filtration, ozonation or ultraviolet (UV) light. Many of the steps in a multi-barrier system may be effective in safeguarding bottled water from microbiological, chemical, and other contamination. Piping in and out of plants, as well as storage silos and water tankers are also maintained through daily sanitation procedures. In addition, bottled water products are bottled in a controlled, sanitary environment to prevent contamination during the filling operation.


  • HAACP CONTROLS –IBWA members are required to employ a HACCP (Hazard Analysis Critical Control Point) approach to quality assurance. This practice scrutinizes every step of the production process – from source to finished product – that are critically important to the safety of the product and puts in place systems to help ensure that all safety and quality control processes are functioning effectively. Identification of risk and severity of health effects and control measures for specific biological, chemical and physical agents are included. FDA considers HACCP a comprehensive method for assuring product safety.


  • SOURCES AND FACILITIES ARE SECURE AND MONITORED –Bottled water products from groundwater sources, such as spring water or artesian water, come from well-protected, underground water sources that are required by FDA regulations to be free of direct influence of surface water contamination. The water is collected at sites and bottled at facilities with security systems that may include controlled access to the plant and critical production areas, gating, motion sensors, electronic contact security alarms, and tamper-proof locks. Water intake systems are sanitary and sealed. For brands that utilize community water systems as their source, bottlers work in concert with community water authorities to ensure the security and safety of the system’s source and the community’s water and employ equivalent security measures at the bottling plant.