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Pages 1-26

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From page 1...
... This report is the culmination of that study, the purpose of which was to review and determine whether current Federal requirements were adequately implementing the intent of the six provisions of FDCA Section 403. NLEA directed the Secretary of the U.S.
From page 2...
... . The IOM established the Committee on State Food Labeling under the auspices of the Food and Nutrition Board to advise the agency on whether those six provisions of the law were being adequately implemented and recommend any State requirements that should be considered for Federal adoption.
From page 3...
... Department of Agriculture, and the Federal Trade Commission reviewed existing U.S. food labeling requirements to
From page 4...
... The food industry was particularly concerned about national uniformity in food regulation. All of these efforts culminated in the passage of NEED CRITERIA FOR DETERMINING ADEQUATE IMPLEMENTATION OF THE FEDERAL STATUTE In carrying out its charge, the Committee evaluated the adequacy of FDA's implementation of the six provisions of FDCA Section 403 by first applying principles developed during its deliberative process.
From page 5...
... An evaluation of enforcement would address the extent to which FDA has pursued manufacturers that market products with labels that do not meet Federal requirements. With regard to compliance as a measure of adequate implementation, this criterion was considered to be important because it represents the effectiveness of existing requirements to fulfill the Congressional mandate on the six FDCA misbranding provisions under study.
From page 6...
... Third, the Committee categorized the State requirements according to the following criteria: 1. An adequate Federal requirement exists on the issue.
From page 7...
... State requirements provide an avenue for new and innovative regulatory approaches to labeling to be developed and tested prior to Federal adoption, and (2) in the absence of Federal leadership, States have often found it necessary to regulate to ensure that consumers are protected.
From page 8...
... Where State requirements were established in response to an absence of Federal regulations to ensure consumer protection, the Committee suggested actions to be taken by FDA and State requirements be exempted from preemption until FDA acts. Where State requirements regulate commodities important to a State economically but do not provide consumer protection, the Committee suggested that States petition FDA either for exemption from preemption or to establish a unifying Federal requirement.
From page 9...
... (1) · Related State requirements are candidates for preemption · Exempt related · Consider using requirements from FPLA definition of preemption until nonfimctional slacl: adequate FDA policy fill for Federal in place · Related State requirements are candidates for preemption · Related State requirements are candidates for preemption · Related State requirements are candidates for preemption For commodities and food categories examined: requirements Bottled watt · Exempt State · Establish common requirements until adequate FDA policy Is in p ace Cider, cider vulgar, and 0~ vulegarprodl4c~ · Related State requirements are candidates for preemption r or usual name or standards of identity for names (sours)
From page 10...
... ~1) - Continued requirements are candidates for preemption petition FDA to amend citrus standards of identity
From page 11...
... -Artificial Colors, Adequate Flavors, and Chemical Preservatives requirements until FDA considem need for Federal requirement · Related State requirements are candidates for preemption ~ Issue advisory .
From page 12...
... has been adequately implemented. The Committee further concludes that State requirements related to H)
From page 13...
... Seven states were found to have differing statutes related to deceptive packaging and slack fill. California in particular has determined that there is a need to implement additional requirements to further consumer protection in this area and adopted the language of F~PLA for nonfunctional slack fill as a basis for its statute.
From page 14...
... . The majority of these State requirements related to the prominence of information to describe specific commodities, such as names and other qualifying statements for substitute daily products, or production characteristics, such as "paddy-grown wild nce." State requirements frequently included specific requirements for size, style, and color of type to be used on food labels.
From page 15...
... The C:ommittee's review of State labeling requirements in the area of standards of qualipr and fill of container raised an important question of interpretation of NLEA The Act seems clear in regard to the preemption of State requirements for food labeling "of the type" for which Federal standards of identity exist. If the law also calls for automatic preemption of State requirements for labeling of products for which Federal standards of quality and fill of container exist, the question of whether there are State substandard labeling requirements related to FDCA Section 403(h)
From page 16...
... The Committee grappled with problems associated with differentiating between State requirements that were common or usual names, or definitions and standards of identity. Viewing its jurisdiction broadly, the Committee embraced for analysis a set of State requirements that included provisions for establishing common or usual names and many requirements related to the naming of specific foods that could be subject to either FDCA Section 403(i)
From page 17...
... ~1) is adequately implemented and all differing State requirements should be preempted.
From page 18...
... The Committee suggests that the Association of Food and Drug Officials' model bill be examined as a unifying basis for Federal regulation of bottled water. Cider, Cider Vinegar, and Other Vinegar Products In applying its critena, the Committee concluded that none of the State requirements it had identified met the threshold for consideration for adoption as a Federal requirement, nor did there appear to be a compelling reason for additional Federal regulation of cider products.
From page 19...
... . Therefore, the Committee suggests that Florida and/or other citrus-producing States consider petitioning FDA to amend the Federal standards of Identity for citrus products, and existing State requirements be exempt from preemption until the petition process is complete.
From page 20...
... Oriental Noodles Because of national marketing and acceptance of oriental-type noodles, the Committee suggests that the existing FDA compliance policy guide serve as the national standard for oriental-type noodles and concludes that individual State requirements are candidates for preemption. Pine Nuts The Committee concludes that although this unique State provision meets a local need, it appears to serve only the economic interest of a limited commodity industry.
From page 21...
... ated into Federal regulations. because FDA policies for labeling surimi-based products appear to provide adequate regulation, State requirements are candidates for preemption.
From page 22...
... are adequately implemented, noting that a lack of perceived problems over the years provides the rationale for preemption of State requirements for food labeling "of the types provided by this provision. Consumer groups, however, stated that Federal implementation has been inadequate, citing State requirements as offering a significantly higher level of consumer protection than that afforded by FDA requirements.
From page 23...
... When the groups named above were asked if there were issues other than the six provisions under study that the Committee should consider as it deliberated on recommendations for preemption of State/local requirements, the following concerns were raised: The adequacy of the fiscal and personnel resources applied by FDA in enforcing its food labeling requirements as a dimension of implementation. The importance of the enforcement activities of the States to ensure consumer protection in the area of food labeling.
From page 24...
... The petition process affords the States a mechanism to deal with their particular needs and the opportunity to suggest to FDA those instances in which some informational requirements may be considered candidates for Federal adoption. The Committee believes that the petition process must take into account genuine local concerns basing judgments on evidence to justify exemption of State requirements from preemption.
From page 25...
... The Committee requested information from a number of food companies and trade associations on the costs to industry of monitoring individual State legislative and regulatory activities; product negotiations with individual States having unique requirements; legal confrontations over individual State requirements; and retrieval, relabeling, and scrapping of products and labels. The Committee was advised that industry considered the economic impact of nonuniformity between State and Federal requirements for food labeling to be significant, although the cost figures it provided were principally anecdotal.


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