The Food Chemicals Codex (FCC) is a compendium of monographs for food ingredients from the United States Pharmacopeial Convention (USP). U.S. Food and Drug Administration (FDA) regulations specify that food and color additives must receive pre-market approval and that other food ingredients must be generally recognized as safe (GRAS). For clarity, we use the term food ingredients for both food and color additives and GRAS materials. FCC began in 1961 following passage of the 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act.1 FCC was developed by volunteer experts of the Committee on Food Chemicals Codex of the Institute of Medicine’s (IOM) Food and Nutrition Board. In many interesting ways, the committee’s procedures in developing FCC paralleled activities at USP.
In August 2006, the USP Board of Trustees arranged for the transfer of FCC from the IOM at the latter’s request. FCC joins USP’s United States Pharmacopeia (USP, for drugs and biologics), National Formulary (NF, for excipients), and a Web-based series of monographs describing standards for articles legally marketed outside the United States (SALMOUS). This brings the total number of USP-published compendia to four. In addition, USP publishes the Pharmacists’ Pharmacopeia, a guide for compounding pharmacists.
Going forward, elaboration of FCC is now the responsibility of USP’s newly formed Food Ingredients Expert Committee of the USP Council of Experts. USP intends to publish the 6th edition of FCC in early 2008 and biannually thereafter, with a supplement in intervening years. Public comment on draft FCC documentary standards will be obtained via a Web-based FCC Forum (www.usp.org/fcc/forum).
The mission statement of USP’s Board of Trustees is:
USP promotes the public health and benefits practitioners and patients by disseminating authoritative standards and information developed by its volunteers for medicines, other healthcare technologies, and related practices used to maintain and improve health and promote optimal healthcare delivery.
USP first became involved in setting food standards as a result of the 1994 Dietary Supplement Health and Education Act, which names USP, NF, and the Homeopathic Pharmacopoeia as official compendia for dietary supplements. The board’s decision to acquire FCC expanded this involvement, because ingredients for foods sometimes play a role similar to that of excipients for drugs. That is, ingredients may be added to foods for one or more purposes unrelated to nutrition, just as excipients are added to drug products (finished medicines) for reasons separate from the safety and efficacy of the drug substance. Under U.S. law, dietary supplements may contain one or more food ingredients beyond the dietary supplement itself.
The obvious distinction between USP and NF on the one hand and FCC on the other hand is the constituencies they address: USP and NF are chiefly of interest to practitioners and patients—users and consumers of medicines—and to the manufacturers and compounding professionals who provide these medicines. In contrast, the food ingredient standards in FCC speak to a different group, namely, to all consumers, manufacturers of food ingredients and foods, and food control officials. As we shall see, however, these distinctions are, in many ways, artificial. The objectives of these compendia are quite similar because they help producers/manufacturers to ensure good quality products for consumers, and they assist regulatory bodies in evaluating the consistency and quality of products in the marketplace.
USP, NF, and the Web-based monographs for non-U.S. articles contain essentially two kinds of standards. Documentary standards can take the form of monographs for drug substances and drug products and also general chapters that guide practitioners in the performance of rigorous analytical procedures such as dissolution testing, detecting contaminants such as heavy metals, and so on. Documentary monographs may refer to reference materials (RMs) that are used in the course of analytical testing of drug substances or products. For example, a high-performance liquid chromatographic procedure may call for a comparison between a USP RM and a tested sample to ensure the identity, strength, quality, and purity of the latter.