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I Case Study: Requirements for Labeling Bottle Water
Pages 209-218

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From page 209...
... has been seen by some as an unfortunate paradigm of the effects of deregulation.) For its part, FDA has candidly stated that it does not believe that bottled water poses a risk to the public health and so has not devoted substantial resources to its regulation.
From page 210...
... If it is found that FDA is adequately implementing the common or usual name requirement of the statute under either circumstance, and thus preempting this area of State requirements, the question still remains as to whether a State can name a food by issuing a standard of identity. Another issue surrounds the peculiarities of the bottled water quality standard.
From page 211...
... FDA noted then that the recently created Environmental Protection Agency (EPA) had assumed the responsibility for establishing drinking water standards and that FDA intended to revise the bottled water standards to keep them compatible with EPA drinking water standards.
From page 212...
... In 1974, passage of the Safe Drinking Water Act codified the division of labor for regulating water between FDA and EPA In addition to directing EPA to promulgate national primary drinking water standards, the Safe Drinking Water Act also added Section 410 to FDCN Section 410 directs FDA to consult with EPA whenever the latter issues interim or revised national primely drinking water standards and, within 180 days of EPA's promulgation, either amend the bottled water standard or explain its rationale for not doing so in the Federal Register. From 1975 to 1979, FDA met or came close to meeting the 180-day time limit.
From page 213...
... filed a citizen petition with FDA seeking the amendment of the bottled water quality standards to define the various kinds of bottled water, including mineral water. IBWA also sought amendment of the bottled water GMPs to require source testing and mandatory annual testing by all producers.
From page 214...
... These products were sweetened, thus making them flavored soda waters rather than bottled waters. Although they were arguably misbranded for failing to state their common or usual name, they were not subject to the bottled water quality standard and should not have been counted as such.
From page 215...
... The GAO report also suggested that the bottled water industry is causing considerable potential health hazards to the public. However, FDA believes that the evidence supports its view that, by and large, the bottled water supply in this country is safe and adequately labeled and simply does not deserve a higher level of regulatory scrutiny.
From page 216...
... The subcommittee was told that the agency was reconsidering the coverage of the bottled water standards to include mineral water and the bottled water component in flavored beverage products fabricated from bottled water ingredients. It is also considering a new quality standard requiring the water component of seltzer, tonic water, colas, and similar products to meet quality standards based on EPA's primary drinking water standards.
From page 217...
... As mentioned above, the fact that nearly half the States have established definitions for the different types of bottled and mineral waters on the market is evidence that there is a perception that FDA's efforts here have not been adequate. Although the general misbranding provisions of FDCA could have been used by FDA to prosecute many of the perceived offenders, it is clear that the States believed that the existence of definitions in the form of standards or common or usual names would make their enforcement job easier.
From page 218...
... 1973b. Bottled Water, Quality Standards; Addition of Flouride and Current Good Manufacturing Practice Regulations; Final Rule.


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