FCC Expert Viewpoint Why Are "Standards" So Important...Do They Really Relate to Safety?

From FCC e-Newsletter (Spring 2008, Vol. 1, Issue 1)

By Jim Griffiths, Ph.D.
USP–Vice President, Food & Dietary Supplement Standards

Food standards have been around a long time...in fact, if one reads Title 21 of the U.S. Code of Federal Regulations (21 CFR), section 130, you will see that in many cases, "something" can only be named as truly "something" if it meets a certain standard. Standards of identity (SOIs) for foods were promulgated by the U.S. Food and Drug Administration (FDA) to provide a measuring stick (and "club") for adulteration and misbranding. These regulatory SOIs resemble recipes, describing the composition of foods in exquisite detail.

The FDA's thinking in providing such detailed mandatory composition was (1) to preclude modifications of basic, staple food formulas that would deceive consumers, and (2) to address the concern that synthetic food additives of questionable safety would insidiously find their way into foods.

There are more than 300 standards for food in the CFR covering everything from cheeses, to flours, to milks, to peanut butter and jam. By its SOI, jam must contain no less than 45% fruit.1 The SOI strictly controls the combination of fruits in the jam and specifies how jams of multiple fruits are to be named. As another example, the standards for canned cherries specify that

"not more than 15 percent by count of the cherries in the container are blemished with scab, hail injury, discoloration, scar tissue or other abnormality. A cherry showing skin discoloration (other than scald) having an aggregate area exceeding that of a circle of 9/32 inch in diameter is considered to be blemished.2"

The same kinds of SOIs exist for dairy products. Evaporated milk must "contain not less than 6.5 percent by weight of milkfat, not less than 16.5 percent by weight of milk solids not fat, and not less than 23 percent by weight of total milk solids."3

So in short, regulatory SOIs for foods define what a food must or may contain and, in many cases, how much of an ingredient the food must contain. They also specify which optional ingredients, if any, manufacturers can put into a standardized food. Food standards serve to protect the consumer against unscrupulous food manufacturers who would adulterate their products by substituting inexpensive, low-quality ingredients for more expensive ones. It's a problem as old as the hills—laws were passed in ancient Rome to prevent the watering of wine—and modern-day equivalents of this type of economic-based adulteration abound, both in the United States and abroad.

As expected, the public has been the primary beneficiary of the improved and dependable quality of many standardized food staples. Manufacturers have also benefited from the level playing field, because companies cannot undercut their competitors by selling inferior products. The broadest and most visible gains have been shown by the improved public health of all Americans. In the period after World War II, the standards for enriched food products helped eliminate once-widespread nutritional deficiency diseases such as pellagra.

Foods and basic food recipes are thus regulated through regulatory standards of identity, but what about the vast portfolio of added food ingredients? Peanut butter has a regulatory SOI of at least 90% peanuts.4 What are the standards for peanut butter's optional ingredients, such as salt and nutritive sweeteners like sucrose? Shouldn't these ingredients also be standardized? If there is no standard, isn't there a chance manufacturers will engage in economic adulteration of these ingredients—especially since the end product is governed by FDA's SOIs?

The Food Chemicals Codex (FCC) is a collection of standards for food ingredients. Through a science-based and transparent process that encompasses manufacturers, regulators, citizens, and consumer watchdog groups, monographs for food chemicals that have been proven to be safe (via a history of use, a food additive petition, or a GRAS determination) are added to the FCC, along with analytical methods and acceptance criteria. Just as the use of the regulatory standards of identity were embraced by a citizenry and industry that wanted higher-quality, safer foods, and protection from shady manufacturing practices, so the promise of food ingredients that have a minimum quality and purity can be fulfilled through the use of FCC standards.

Food ingredient specifications in the current FCC are comprised of information related to identification, purity, and quality of food ingredients. They include detailed analytical methods, acceptance criteria, and ancillary information related to chemical structure, ingredient functionality, optimum storage conditions, and more. If an ingredient "toes the line" and meets the quality (purity) specifications in the FCC, then users can be assured that the FCC ingredient is actually the one on the market and in our food supply. Seems like a "no-brainer" to cater to public health and the higher-road marketing opportunities.

Dr. Griffiths has more than 20 years' experience in toxicology risk assessment, project management, regulatory affairs, and international communications. Prior to joining USP, he was the director of toxicology and director of business development for the Burdock Group, a consulting company specializing in safety and regulatory issues facing the food and beverage, dietary supplement, and cosmetics and personal care industries. Dr. Griffiths has also worked for the Center for Food Safety and Applied Nutrition in the Food and Drug Administration, International Specialty Products, Flavor and Extract Manufacturers Association, Distilled Spirits Council, and Avon Products, Inc.

Dr. Griffiths holds a bachelor's degree in biology from Columbia Union College and a Ph.D. in toxicology from Rutgers University and Robert Wood Johnson Medical School. He was a post-doctoral fellow in physiological chemistry at Heinrich Heine University in Düsseldorf, Germany. He is board certified as a Diplomate of the American Board of Toxicology and is a fellow of the Institute of Biology.

Don't miss the next FCC Expert Viewpoint—"How Do 'Standards' and the FCC Accommodate Innovation?"—in the summer 2008 FCC e-Newsletter.

1 Title 21, Part 150, §150.160 (d).
2 Title 21, Part 145, §145.125 (b).
3 Title 21, Part 131, §131.130 (a).
4 Title 21, Part 164, §164.150 (a).