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From: Food Quality & Safety magazine, December/January 2008

Crack the Food Chemicals Code

The Food Chemicals Codex strengthens public safety networks to protect consumers from dangerous foods

by Andrew Ebert, Phd; Darrell Abernethy, MD; Paul Kuznesof, Phd; Ruth K. Miller, JD; Catherine Sheehan; and Roger L. Williams, MD

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).

USP’s Mission

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.

Terminology

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.

Monographs provide additional important information, including official names, recognized synonyms, applicable registration numbers (e.g., Chemical Abstracts Service numbers), and a description of the substance. They also provide information on properties, tests, and procedures that enable scientists to qualitatively verify the ingredient’s identity, along with tests, procedures, and acceptance criteria intended to ensure safety and purity. Monographs also give packaging and storage requirements and, in some cases, labeling requirements.

USP terminology is closely linked to terms in the U.S. Federal Food, Drug, and Cosmetic Act (FFDCA). For this reason, USP frequently uses the word official. After its development, publication for public review, a comment period, and a final decision by USP’s Council of Experts, a USP documentary standard or monograph is finalized and becomes effective with an official date. If an RM is needed in order for analysts to conduct official monograph tests, the RM is stated to be an official USP Reference Standard. In its initial sections, FFDCA refers to official compendia and cites the existence of a USP monograph as one definition of a drug. If a USP Expert Committee publishes a monograph for a drug substance or product, then that substance or product is a drug and must comply with the standards in USP, or the label must clearly state how the substance or product differs from the monograph standards.

FFDCA’s reference to official compendia has ramifications for FCC: A food ingredient with an FCC monograph is termed an official article and may be labeled with the FCC mark in conjunction with the official title. Official food articles recognized in FCC must comply with standards set by USP if the articles are dietary supplements or dietary ingredients, or substances intended directly or indirectly for use in foods or food processing and are labeled as conforming to FCC.

When a food ingredient supplier (first party) puts the letters FCC on the certificate of analysis of the container of an ingredient, it signals to a food manufacturer (second party) that the ingredient is official, bears an official title (name), and complies with standards of purity and identity that should be maintained throughout the time the article is in commerce. These quality standards can be tested by third parties (government officials, independent testing laboratories, and others) according to the monograph published in FCC. The terms first, second, and third party are drawn from a nomenclature provided in guidance from the National Institute of Standards and Technology (NIST), as is other terminology useful to standards-setting bodies.

Careful use of terminology and related activities help food ingredient suppliers and USP leverage an FCC monograph as part of an important component of the communication process, not only to food manufacturers and government but also to the public at large. The communication establishes that a quality standard in FCC is publicly known and is being met. This ensures that all parties are able to know, understand, and utilize independently the documentary and physical standards of an article of commerce to preserve the safety and quality of foods and dietary supplements. Because of the linkages among USP, NF, and FCC, this communication can highlight the efforts of first-, second-, and third-party actors to ensure the safety not only of foods and dietary supplements but also of medicines.

Conformity Assessments

Any standard has little meaning unless it includes a conformity assessment, which for FCC involves testing by the food ingredient manufacturer to ensure that the monograph specifications have been met. The manufacturer should note the results of the testing on a certificate of analysis (CoA) and should provide the CoA to the purchaser. FCC achieves its purpose when second parties (e.g., food manufacturers) require CoAs and test food ingredients to them. Under good manufacturing practices for foods, a food manufacturer may, upon receipt of a food ingredient, qualify it by means of an audit and testing program, including testing to FCC standards.

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.

Monograph Development

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.

Advancing the science of a compendium is an exciting opportunity for USP, because it carries on the distinguished efforts of IOM’s Committee on Food Chemicals Codex. A compendium of quality standards is, necessarily, a living document. It must account for new ingredients, changes in the manufacturing process of ingredients, development of new analytical procedures, and new safety concerns that may arise. Measurement science has advanced remarkably in the past 50 years. This science evolves in many ways, including contributions by national metrology institutes such as NIST. USP is expanding applications of modern measurement science (metrology) to both its documentary standards and RMs, and this expansion will include applications to official articles in FCC and food ingredient RMs.8

USP is proud to become involved with FCC. USP has a longstanding public health mission, and inclusion of FCC in this mission extends USP beyond its primary focus on drugs into the realm of documentary and RM standards for foods. USP’s practitioner-based approaches for foods can address consumers’ interests not only in the United States but also in other countries. FCC is an official compendium of food ingredients for Australia, Canada, and New Zealand, and it may be used by other countries. In advancing FCC, USP thanks and congratulates IOM and its Committee on Food Chemicals Codex for their remarkable efforts. Manufacturing and measurement science and technology for foods and food ingredients are advancing rapidly. Yet, at the same time, so is the risk of contaminated and adulterated foods. Public safety networks need strengthening to protect consumers from dangerous foods. USP intends for FCC to be an important part of the approaches needed to ensure good quality foods and food ingredients.

Dr. Ebert is chair of the Food Ingredients Expert Committee, USP Council of Experts; Dr. Abernethy is chief scientific officer; Miller is counsel; Sheehan is director of excipients and FCC; and Dr. Williams is chief executive officer and executive vice president, all at the U.S. Pharmacopeia. To reach them, contact Dr. Williams at rlw@usp.org or at (301) 816-8300. Dr. Kuznesof is president of pmKuznesof, LLC; reach him at (301) 585-1253 or paul.kuznesof@pmkuznesof.com.

References

  1. U.S. Food and Drug Administration. 1958 Food Additive Amendments to the Federal Food, Drug, and Cosmetic Act. Washington, D.C.: U.S. Food and Drug Administration; 1958.
  2. U.S. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act: Sec. 501 [21 USC 351(b)]. Washington, D.C.: U.S. Food and Drug Administration; 1938.
  3. National Institute of Standards and Technology. Guidance on federal conformity assessment activities. NIST, Fed. Reg. 65: 48894-48902. Gaithersburg, Md.: National Institute of Standards and Technology; 2000.
  4. Bhattacharyya L, Cecil T, Dabbah R, et al. The value of USP public standards for therapeutic products. Pharm Res. 2004;21(10):1725-1731.
  5. U.S. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act: Sec 501 [21 USC 351(b)]. Washington, D.C.: U.S. Food and Drug Administration; 1938.
  6. U.S. Food and Drug Administration. Federal Food, Drug, and Cosmetic Act: Sec 502 [21 USC 352(e)(1)(B)(3)(C)]. Washington, D.C.: U.S. Food and Drug Administration; 1938.
  7. United States Pharmacopeial Convention. Guideline for submitting requests for revision to USP–NF. Available at: www.usp.org/pdf/EN/USPNF/ introduction.pdf. Last accessed November 22, 2007.
  8. Williams RL; 2000–2005 Reference Standards Committee of the USP Council of Experts and Its Advisory Panel; USP Staff and Consultant. Official USP Reference Standards: metrology concepts, overview, and scientific issues and opportunities. J Pharm Biomed Anal. 2006;40(1):3-15.

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