Cover Image

PAPERBACK
$27.00



View/Hide Left Panel

403(i)(1)], and the requirement that a food meet any applicable standard of quality or disclose on its label that it does not [FDCA Section 403(h)(1)].

In examining FDA's regulation of bottled water, several ambiguities arose. State standards of identity are preempted if they are not identical to corresponding Federal standards. Similarly, State common or usual name regulations are preempted if it is determined that FDA is adequately implementing the common or usual name requirement of FDCA. But does NLEA permit a State to adopt a standard of identity for a product for which no Federal standard exists? The superficial answer would appear to be yes, since NLEA and the regulations proposed to date do not specifically prohibit a State from doing so. Yet the preemption provision applicable to the common or usual name requirement prohibits ''any requirement for the labeling of a food of the type required'' by FDCA Section 403(i)(1). It is unclear, however, whether (1) FDA must have established a specific common or usual name for bottled water, or (2) the general provisions of FDCA Section 403(i)(1) and its implementing regulations are sufficient for preemption of any such State requirements. 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. Bottled water is the only food for which FDA has adopted a standard of quality in the absence of a standard of identity. Quality standards usually do not deal with issues of food safety, and State regulation of food safety is not preempted by NLEA. Therefore, ambiguity also surrounds the question of whether States can regulate the safety of bottled water in a regulation that is called a quality standard, or whether they can regulate bottled water by calling the regulation one of food safety when in fact it covers the same ground as the FDA quality standard.

Although these problems ultimately must be faced and resolved by FDA, their resolution is viewed as beyond the scope of this case study. As discussed in Chapter 4, the Committee has decided to leave to FDA the decision of whether a State law or regulation is a standard of identity or a common or usual name regulation, and determination of the consequences that flow from that decision.

FDA ADOPTION OF STANDARD OF QUALITY AND GOOD MANUFACTURING PRACTICE REGULATIONS

FDCA Section 401 (a) [21 USC §341(a)] authorizes FDA to establish for any food definitions and standards of identity, reasonable standards of



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement