USP and NF are official compendia of the United States, but this is not the case for FCC. This situation has arisen because FCC is not mentioned in FFDCA but rather in various implementing regulations of the 1958 Food Additives Amendments. USP’s view is that FCC should be an official United States compendium. If FCC became an official compendium, regulations alluding to FCC would no longer be needed. In addition, an official compendium can be frequently updated without a need for regulatory action when safety is not in question.4 Finally, if FCC were an official compendium, the adulteration and misbranding provisions of FFDCA would allow FDA to take immediate action if an article labeled with the letters FCC failed to comply.5,6 At present, however, inconsistent and incomplete legal references to FCC weaken its regulatory utility.
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Explore This IssueDecember/January 2008
An FCC monograph can be developed in a straightforward manner when a food ingredient manufacturer provides information in a request for revision template.7 Requests for revision—understood in the sense of revision to FCC—usually come from food ingredient manufacturers who have an interest in providing information to support a new or revised monograph and suitable candidate RMs when needed. USP can hold this information in confidence if the manufacturer requests. Upon receipt of a request for revision, USP staff work with the manufacturer to understand the information received—specifically the analytical validation for the tests, procedures, and acceptance criteria for the proposed monograph, i.e., the specification—and prepare the draft monograph or revision for publication in FCC Forum.
After public comments are received, the draft monograph is modified as needed and is presented to the USP Food Ingredients Expert Committee for consideration and then, as appropriate, balloting. A positive ballot promotes the standard to official status in FCC or its supplement. Here, too, a spirit of cooperative communication exists among manufacturers who provide information and donate materials to support a request for revision and capable volunteers and staff who evaluate this information independently and create official public standards for official articles.
In addition to the elaboration of the documentary standard, USP laboratory staff characterize candidate RMs for FCC procedures and, by means of collaborative testing, assign a level of purity. In a manner similar to that used for work with the documentary standard, USP laboratory staff execute their work—which may involve collaborative studies with other laboratories—and then present data to the USP Reference Standards Expert Committee of the USP Council of Experts. This committee evaluates the data and, if appropriate, endorses the candidate material as an official USP Reference Standard.
Putting FCC to Use
A compendium is of value to the extent that it is used, and all relevant parties must appreciate its value. Consumers must be educated to look for the mark of a compendium and to understand its value in ensuring the quality of a food ingredient. Thus, for FCC, the monograph and the FCC mark are very important. Suppliers of food ingredients must be willing to test to FCC specifications and to use official USP Reference Standards in this testing. Purchasers of food ingredients must be willing to conduct additional qualifying tests.
The display of the FCC mark to purchasers and consumers signals a commitment to quality that is critical to both groups. Unlike many other compendial bodies, USP does not receive government funding and relies on the sale of its documentary and physical standards to gain resources for its standards-setting activities. This allows independence from government and from influence by commercial and political interests. USP rigorously separates its standards-setting activities from such interests by the careful application of conflict-of-interest guidelines and other rules and procedures. This separation is and will continue to be important to the new Food Ingredients Expert Committee so that it sets its standards unfettered by any extraneous influence.