FCC Expert Viewpoint How Do 'Standards' and FCC Accommodate Innovation?

From FCC e-Newsletter (Spring 2008, Vol. 1, Issue 2)

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

In the previous issue of the FCC e-Newsletter, the importance of "food standards" as a means to ensure "safety" and a level playing field among purveyors of seemingly identical products—from peanut butter and jam to evaporated milk—was presented. To summarize, federal standards of identity (SOI) for foods are promulgated to promote honesty and fair dealing in the interest of consumers, to ensure fair competition between the manufacturers and distributors of different products, and to prevent confusion and deception in the sale of all such products.

One example is the prevention of economic substitution, which would occur if one could not distinguish between vanilla produced from vanilla beans, which is allowed to be labeled as "vanilla extract," versus synthetic vanilla manufactured from wood pulp, which must be labeled as "artificial vanilla."  1

However, these "standards of identity" would appear to prohibit or at least greatly curtail opportunities for the creation and innovation of new food products. As any marketer will tell you, "innovate or perish"...the public must constantly be presented with new food products, line-extensions, flavors, colors, and, nowadays, even overt functionality. This season's "new and improved" sport beverage must be dressed with new colors, flavors, packaging, and hopefully a pinch of something claiming functionality to rise above the background noise apparent on late-night infomercials.

If peanut butter is standardized, how can one make peanut butter that is new and improved, low-fat, low-salt, low-calorie, natural, or organic? Amazingly, there are peanut butter products on the market with these very attributes. The first option would be to change the name of the food. That is being done with "peanut butter spreads," "cheese products," and "mayonnaise substitutes." The consumer is likely to understand the reference to the original SOI holder and yet also not be misled into assuming it is identical to the referenced food product. Unfortunately, changing the name of the food product can also be a disincentive, as "ice milk" manufacturers probably have realized.

Another option is to make what change you can to still meet the SOI. To maintain the peanut butter SOI of no less than 90% peanuts, "low-fat peanut butter" can be made with some peanuts and some peanut flour to decrease fat and yet retain the 90% level. 2  A manufacturer wanting to offer lower-fat beef chili (beef chili has a SOI requiring 40% meat), could use leaner beef or reduce other fat-containing ingredients, but cannot reduce the amount of meat in the chili. 3

Finally, there is wholesale change under way to either modify the existing SOI to allow for these innovative ingredient options or to expand the number of SOI to provide more permutations. For example, the U.S. Department of Agriculture (USDA) lists nine "bacons" ranging from good old "bacon" to "Arkansas style bacon" to "bacon products" to "bacon-like products"...each with their own SOI. 4

The Nutrition Labeling and Education Act (NLEA) of 1990 streamlined the cumbersome regulatory process for establishing and amending Food and Drug Administration (FDA) SOI for almost all FDA-regulated products. 5  Trade and consumer groups, such as the International Ice Cream Association and the Public Voice for Food and Health Policy, have petitioned the FDA to amend the SOI for "ice milk" to change the name of the product to "reduced-fat ice cream" and to establish SOI for "low-fat ice cream" and "nonfat ice cream." 6  The National Yogurt Association is petitioning the FDA to (1) require a minimum level of the live and active cultures at the time of yogurt manufacture; (2) resolve labeling issues by ensuring that product claims, such as "low-fat" and "nonfat," are consistent with the provisions of the NLEA; and (3) provide flexibility in the ingredients that may be included in yogurt without compromising the integrity of yogurt as a dairy product. 7  The National Frozen Pizza Institute's citizen's petition took more than four years to win the argument that the traditional "pizza with meat" SOI, which required a minimum of 15% meat, was a disservice to the consumer—who by the late 1990s was seeking more exotic taste experiences (and less fat). 8  The restaurants not bound by the "pizza with meat" federal SOI were free to offer countless variations and permutations of toppings.

The Food Safety and Inspection Service (FSIS) and the FDA are proposing to establish a set of general principles for food standards that would maintain the traditional consumer protection from dishonesty, yet allow for technological advances in food production. 9

The Food Chemicals Codex (FCC) relies upon standardized "monographs" to apply an SOI-type consistency to food ingredients. But unlike the FDA, the FCC is open for interactive input from industry, consumer, trade, and advocacy groups. A standardized monograph may be revised with updated analytical methodology and specifications, depending upon the state of the industry and the state of knowledge. The Food Ingredients Expert Committee reviews any proposed changes and makes a decision on food standards based on all the facts. New legitimate food ingredients that may have come through the food additive petition process or the GRAS Notification process are strong candidates for monograph development and inclusion in the FCC. The FCC is hardly static; it is reflective of what the industry and public desire in their "new and improved" food options. No new colors have been developed, but a multitude of new flavors, non-nutritive sweeteners, concentrated food extracts, and functional ingredients are indicative of what John Q. Public wants to buy.

Standards of identity are important for consistency, but can be adapted for innovation. Food ingredients, which make up the majority of the changes or modifications to standard food items, can relate back to monograph standards, i.e., specifications that attest to purity and quality. It only makes common sense, marketing sense, brand-protective sense, public health sense, and economic sense to move from the previous generation's peanut butter and jam sandwiches to innovative and entrepreneurial food ingredients that will maintain the quality that the manufacturer and the customer expect.

1 Title 21, Part 169, § 169.175 and Part 101, § 101.22(i)(2).
2 Title 21, Part 164, § 164.50(a). Under the SOI for peanut butter, the fat content of the finished food must not exceed 55%.
3 Title 9, Part 319, § 319.300 Chili con carne. "Chili con carne" shall contain not less than 40 percent of meat computed on the weight of the fresh meat. Mechanically Separated (Species) may be used in accordance with Section 319.6. Head meat, cheek meat, and heart meat exclusive of the heart cap may be used to the extent of 25 percent of the meat ingredients under specific declaration on the label. The mixture may contain binders and extenders as provided in Section 318.7(c)(4) of this subchapter.
4 Food Standards and Labeling Policy Book, Food Safety and Inspection Service, USDA (August 2005).
5 Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353 (1990). See also http://findarticles.com/p/articles/mi_m3778/is_1991_Oct/ai_12013791/pg_3.
6 See http://findarticles.com/p/articles/mi_m3778/is_1991_Oct/ai_12013791/pg_3.
7 See www.fda.gov/ohrms/dockets/98fr/00p-0685-cp00001.pdf.
8 See www.fsis.usda.gov/oppde/rdad/frpubs/01-018F.htm. 
9 See www.fda.gov/bbs/topics/news/2005/usda_hhs051705.html.