1. © 2009 Hogan & Hartson LLP. All rights reserved. Joseph A. Levitt Hogan & Hartson April 21, 2009 FDA Regulation of Bottled Water An Overview

2. 2 © 2009 Hogan & Hartson LLP. All rights reserved. Overview Bottled Water is Comprehensively Regulated by the U.S. Food and Drug Administration (FDA) – FDA Regulations Applicable to All Foods Apply to Bottled Water – FDA Regulations Specific to Bottled Water – Inspection, Enforcement, and Product Recall – Federal Bioterrorism Laws State Governments Play a Complementary Role

3. 3 © 2009 Hogan & Hartson LLP. All rights reserved. Federal Regulations Applicable to All Foods Bottled water is regulated as a “food” under the Federal Food, Drug, and Cosmetic Act (FDCA) Bottled water is subject to general requirements for: – Product labeling, including claims – Good Manufacturing Practices (GMPs) Prohibitions on Adulteration and Misbranding FDA review of food packaging materials.

4. 4 © 2009 Hogan & Hartson LLP. All rights reserved. Regulations Specific to Bottled Water Bottled Water is defined as “Water that is intended for human consumption and that is sealed in bottles or other containers with no added ingredients except that it may optionally contain safe and suitable antimicrobial agents.” Standard of Identity Standards of Quality Good Manufacturing Practices

5. 5 © 2009 Hogan & Hartson LLP. All rights reserved. Regulations Specific to Bottled Water: Standard of Identity Provides uniform definitions for bottled, drinking, artesian, groundwater, distilled, deionized, reverse osmosis, mineral, purified, sparking, spring, sterile, and well waters. Regulations are very specific: – “Mineral water” is “water containing not less than 250 parts per million (ppm) total dissolved solids (TDS), coming from a source tapped at one or more bore holes or springs, originating from a geologically and physically protected underground water source.” Products are deemed misbranded unless they meet the Standard of Identity and bear appropriate labeling with the required name.

6. 6 © 2009 Hogan & Hartson LLP. All rights reserved. Regulations Specific to Bottled Water: Standards of Quality Regulations establish quantifiable limits for microbiological, physical, chemical, and radiological substances. More than 90 substances have FDA-established standards in the bottled water Standard of Quality regulations. FDCA Section 410: FDA’s regulation of bottled water must be at least as stringent and protective of the public health as the regulation of public water systems by the EPA. Products are deemed adulterated or misbranded if they do not meet the Standards of Quality.

7. 7 © 2009 Hogan & Hartson LLP. All rights reserved. Regulations Specific to Bottled Water: Good Manufacturing Practices FDA has also established specific GMPs for bottled water. Regulations govern the processing and bottling of bottled water, ensuring that the product is produced under safe and sanitary conditions. Specify the: – Frequency of contaminant testing – Requirements for sanitary operations, equipment design and construction, and production and process controls. – Testing, inspection, sampling, analysis, and approval requirements for source water – Testing requirements for product water.

8. 8 © 2009 Hogan & Hartson LLP. All rights reserved. Inspections All food manufacturers are subject to on-site inspection to ensure compliance with FDA regulations FDA assigns the frequency of inspections based on product risk Firms with compliance problems are inspected more frequently than firms that are in compliance States often inspect food companies either on behalf of FDA or under their own authorities

9. 9 © 2009 Hogan & Hartson LLP. All rights reserved. Recalls and Enforcement Manufacturer or distributor will recall a product if found to be adulterated or misbranded. FDA oversees the conduct of recalls to ensure their effectiveness. FDA enforcement actions include product seizure or injunctions against the manufacturer. Criminal prosecution pursued when appropriate.

10. 10 © 2009 Hogan & Hartson LLP. All rights reserved. Bioterrorism Act The Bioterrorism Act of 2002 requires food manufacturers, including bottled water manufacturers, to: – (1) Provide prior notice of import arrival at the border within designated time frames. – (2) Register facilities with FDA and maintain current information for their registration. – (3) Maintain records of previous source and subsequent recipients of all products at their facility

11. 11 © 2009 Hogan & Hartson LLP. All rights reserved. FDA Jurisdiction Interstate Commerce – Virtually all bottled water products are in interstate and subject to FDA regulation -- Component jurisdiction -- Presumption of interstate commerce Federal Preemption – FDCA expressly preempts states laws or regulations that differ from FDA regulations on standard of identity and standard of quality

12. 12 © 2009 Hogan & Hartson LLP. All rights reserved. State Regulation States play important role in bottled water regulation States have primary jurisdiction over water sources and administer licensing programs FDA contracts with states to perform inspections of food facilities States also regulate bottled water and conduct inspections under their own authorities

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