Transcript FDA Regulation of Bottled Water

FDA Regulation of
Bottled Water
An Overview
Joseph A. Levitt
Hogan & Hartson
April 21, 2009
© 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,
– Federal
•
Enforcement, and Product Recall
Bioterrorism Laws
State Governments Play a Complementary Role
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2
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
– Good
labeling, including claims
Manufacturing Practices (GMPs)
•
Prohibitions on Adulteration and Misbranding
•
FDA review of food packaging materials
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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
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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.
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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.
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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.
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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
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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.
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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
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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
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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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