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6 Issues Raised By States, Consumers, and Industry
Pages 141-162

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From page 141...
... The first change is that Congress has mandated a comprehensive and undoubtedly costly revamping of food labels to provide improved nutrition and other information on food products for consumers. The second change, as part of this requirement for new information, is that Congress has decided that States should no longer continue to enforce certain local food labeling requirements that are different from those of other States and/or the Federal government.
From page 142...
... The concerns of States about FDA's implementation of the petition process of NLEA for exemption of a State requirement from preemption and State enforcement of Federal requirements, so that these processes will be uncomplicated and well managed. The importance of these issues was reiterated through a variety of communications from professional food and drug regulatory groups, food companies, trade associations, and national consumer organizations.
From page 143...
... 4~. In the May 1991 Final Report of the Advisory Committee on the Food and Drug Administration, that Committee's Food Subcommittee recognized the key role enforcement plays in the implementation of the law and a vigorous FDA is the most effective deterrent to the adoption of diverse and inconsistent State requirements.
From page 144...
... STATE ACTION UNDER NLEA In the administrative process established by NLEA, Federal preemption Is not intended to leave the States powerless, because they are provided with the opportunity to petition for exemption from preemption and enforce Federal requirements. State officials have raised some serious concerns, however, about how the procedure will wore NLEA Section 4, entitled estate Enforcement,n outlined the process the States and FDA must follow if a State action is to be undertaken.
From page 145...
... Correspondence from AFDO's Food Labeling Committee raised a question concerning whether NLEA requires a State to give FDA 30 days' notice before the State undertakes an enforcement action under FDCA (APDO, 1991~. This question suggests confusion on the part of some State officials.
From page 146...
... Thompson maintains that since NLEA gives the States total access to the Federal law and regulations, it is only logical "that the Congressional insistence on identical State requirements be understood to require the States to tie their implementation processes to the Federal processes including enforcement" (Thompson, 1991~. Because of the apparent confusion over how NLEA Section 4 is to be implemented, the Committee welcomed the proposed regulations on State enforcement under NLEA, which were published by FDA on November 27, 1991 (FDA, l991b)
From page 147...
... Concomitantly, although NLEA and the proposed regulations do not require FDA notification for a State to take action under its own statutes and regulations in a State court, it seems reasonable, in the interest of the goals of national uniformity and cooperation, that some mechanism should be established for States to apprise FDA and other States of actions taken in State courts. COOPERATIVE REI^TIONSHIPS BETWEEN FDA AND THE STATES It is also important that FDA and the States enhance the mechanisms available for cooperative working relationships.
From page 148...
... They express concern that State legislatures that are anxious to rend cost-saving measures may redirect the appropriations for food labeling regulation to other State programs, resulting in a decrease in consumer protection. Many State officials fear this elimination of State-funded programs and are skeptical about the future of enforcement, the subsequent implementation of the statute, and, ultimately, consumer protection (i.e., Corbin, 1991; Crawford, 1991; Harden, 1991; Lindan, 1991; Masso, 1991, McClellan, 1991; Niles, 1991; Rudd, 1991; Sevchik, 1991; Sowards, l991b)
From page 149...
... One result of such a drain would be that future marketing schemes that hurt consumers would be left largely unchallenged (Haas, 1991~. Using examples from different areas of regulation in support of their positions, especially food safety, the consumer groups emphasized the importance of vigorous State and local action in the national consumer protection regime.
From page 151...
... 12-13~. On November 27, 1991, FDA published a proposed regulation for the petition process concerned with preemption of State requirements.
From page 152...
... This type of importance and history of use could most certainly be supported by the State through citations to its published literature, annual sales figures, demographic data, and other similar sources. The Committee believes it is important for States to use this mechanism to deal with their particular local needs and unanticipated future issues that may be national in scope but yet have not been addressed by FDN The petition process or other mechanisms should also allow States to suggest those instances in which they believe some informational requirements may be considered candidates for Federal adoption.
From page 153...
... Each organization was asked to provide any information available on the costs of monitoring individual State legislative and regulatory activities, product negotiations with individual States having unique labeling requirements, legal confrontations over individual State requirements, and retrieval, relabeling, and scrapping of products and labels. The companies and trade associations contacted included: Borden Foods General Mills Grocery Manufacturers of America Kellogg Company Kraft General Foods, Inc.
From page 154...
... The Committee also recognized that nonuniform State requirements could result in significant savings for consumers in such aspect; as reduced health costs, while at the same time, resulting in higher food costs. There was no information available to the Committee for evaluation of the costs and benefits to consumers of nonuniform food label requirements.
From page 155...
... . If one assumes that, among these firms, only 1,000 of them have an average of one professional person on staff or serving them as outside counsel to monitor State activities, and each of these people is paid a salary plus benefits averaging $80,000, the cost of monitoring for nonuniformity of Federal and State requirements would total approximately $80 million per year.
From page 156...
... . Legal Confrontations Over Individual State Requirements Over the years, legal confrontations have generally resulted when manufacturers are confronted with a State's unique requirements for food product names and labeling claims.
From page 157...
... To avoid this expense, firms often find it more expeditious to scrap the retrieved food in a landfill or give it to appropriate charities. There is no way to estimate the total cost of these actions to the industry, but individual companies have reported on occasion up to as much as $100,000 in product retrieval and scrapping costs and $100,000 in label scrapping costs alone.
From page 159...
... The Committee believes that the implementation of NLEA should not adversely affect the established cooperative efforts of FDA and the States. The importance of accessible administrative procedures for the exemption petition process and State enforcement of Federal requirements cannot be overemphasized, and FDA must respond to such requests from States in a timely manner.
From page 160...
... 1991. Statement of Sharon Lindan, Assistant Director for Legal Affaim, CSPI, on behalf of CSPVCNVCFA/NCL at the Public Meeting of the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.= May 30.
From page 161...
... Written comments submitted to the Committee on State Food Labeling, Food and Nutrition Board, Institute of Medicine, Washington, D.C.


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