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  1. Other documents specifically identified as advisory opinions, for example, advisory opinions on the performance standard for diagnostic x-ray systems, issued before July 1, 1975, and filed in a permanent public file for prior advisory opinions maintained by the Freedom of Information staff.

  2. Guidelines issued by FDA under 21 CFR 10.90(b), which establishes the procedure for the issuance of guidelines [21 CFR 10.85 (d)].

Since FDA has publicly agreed to bind itself by these materials, it seems fair to view them as the agency's official implementation of the statute. The Committee judged that this approach provided ample material with which to work and perform its task.

A second consideration for the Committee was the impact of the provisions of FDCA Sections 403(a)(1), 403(e), and 403(i)(2) on the adequacy of FDA implementation when coupled with the requirements of the six provisions that are the subject of this study. Because FDA can bring charges in cases of violation of FDCA under more than one section, the Committee concluded that this interrelationship could not be ignored. Indeed, when the Committee reviewed the enforcement history of regulatory actions taken by FDA, it invariably encountered charges under multiple sections of FDCA.

For example, FDCA Section 403(a)(1) states that a food will be deemed to be misbranded if its labeling is false or misleading in any particular. A food in package form is considered misbranded under FDCA Section 403(e) unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor, and (2) an accurate statement of quantity of contents. FDCA Section 403(i)(2) raises another misbranding issue: in cases in which a food is fabricated from two or more ingredients, the label must bear the common or usual name of each such ingredient (with limited exceptions), or the product will be considered misbranded. These three sections affected the Committee's review of the adequacy of implementation of FDCA Sections 403(b) [food offered for sale under the name of another food], and 403(i)(1) [common or usual name]. The Committee, however, was careful not to attribute greater significance to the requirements of FDCA Sections 403(a)(1), 403(e), and 403(i)(2) than was appropriate for the study. On the other hand, these three sections were not ignored when the Committee considered the overall ability of FDA to implement an adequate food labeling regulatory program.

Two other components of Federal regulations that could be considered in adequate implementation are compliance and enforcement. Compliance would address the issue of the extent to which manufacturers have met the provisions of the laws and regulations, i.e. the degree to which food labels

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