It's a tiny company, basically two men and a fax machine. But every time you reach for something on a grocery shelf, you could be touching their work.
C. Graham Arnold and Edward W. Underriner are Label Check, Ltd., of Baltimore, and they help food-product companies stay out of the hands of the label police -- most notably the U.S. Food and Drug Administration, which regulates the information that appears on pretty much every jar, can, box, bottle, and bag that contains something edible.
The company is not yet a year old; the two entrepreneurs were in the label compliance and food technology fields when they saw this niche and broke out on their own. With food manufacturers spending $400 billion a year getting their products on grocery shelves, food labels can be an important component of that business.
Companies have had increased need for vigilance on labels because enactment of the Nutrition Labeling and Education Act of 1990, requiring a standardized Nutrition Facts panel on virtually all food labels, added reams to the regulations governing the information that has to appear on food products. (You'll find the amount of fat, cholesterol, sodium, calcium, fiber and other nutrients on the Nutrition Facts panel.) But every item on a label, from the claims that manufacturers can make to sell their products right down to the size of the numbers and letters in which the information is printed, is strictly regulated. And just to make things a bit more complicated, some of the "regulations" shift.
Label Check's basic tool is the Federal Register, published daily.
"It covers every regulation, every proposed regulation, in every agency within the United States," Mr. Arnold says.
Besides the food and drug administration, responsible for most of the rules that concern Label Check, there are regulations dealing with food products issued by the Bureau of Alcohol, Tobacco and Firearms (beer and wine labels), the U.S. Department of Agriculture (meats and poultry), and the Federal Trade Commission (advertising).
Label Check monitors dozens of details, all of which have to be correct and in keeping with federal rules if the product manufacturer is to avoid potentially costly label redesigns or product recalls. All ingredient listings, all weights and measures, and all claims (such as "light," "fresh," "fat-free" and "low cholesterol") must be documented according to the regulations.
In extreme cases, such as where the mislabeling might threaten health, the federal agencies can seize and destroy mislabeled products, and can even shut down a company whose product labels don't meet the regulations. Substances that cause severe allergic reactions in some people, such as yellow dye No. 5, nut meats, sulfites, egg whites, and egg albumen, among others, must be declared on the ingredients statement, or the FDA will demand the product be recalled. "They're very careful with these things," Mr. Arnold said, "because people can die."
Mr. Arnold and Mr. Underriner, who both once worked for McCormick & Co. and who between them have more than 60 years experience in food labeling, food ingredients and product marketing, get most of their clients by word of mouth. They attend food trade fairs, and routinely scan warning letters issued by the FDA to companies whose labels don't meet regulations to find out what sorts of problems are cropping up.
Typically, clients will submit a proposed label, and the two will go over it, then return a letter with suggestions and pages of documentation from the Federal Register that are pertinent.
As an example, the two pulled out a box that was the proposed packaging for a foreign company that hoped to sell its products in the United States.
Mr. Arnold said, "we changed every panel on the package. There were at least a dozen things we changed," such as correcting type sizes in the weight notation and moving the nutrition panel to the proper side.
"What [the FDA is] really concerned about now is the Nutrition Facts panel -- that is their top priority," Mr. Arnold said. "After all these regulations, you can see why. That's not just U.S. companies -- it's any product sold in the U.S." The nutrition labels, which are still relatively new and thus not as well understood as other labeling requirements, were adopted after some rancorous protest by food companies. The FDA is still concerned with making the labels meet the concerns of manufacturers as well as the needs of consumers.
After the nutrition labels, "the second priority is health claims that are not approved," Mr. Underriner said. "There are only a few health claims that can legally be made on a label," he said. To make health claims that cannot be substantiated is a violation. For instance, "some companies over-use the word 'fresh' " he said. To be labeled "fresh," foods must have continued in their raw state from origin to point of purchase, without being frozen or cooked.
Other pitfalls include the listing of preservatives, such as BHT or nitrites, without saying they're preservatives. And there are other types of regulations that come into play as well, such as the fact that all weight statements must be in metric as well as standard terms. Although that's not part of FDA regulations, the FDA warns companies that it is "covered by public law," Mr. Underriner said, and that means it must be on the labels. And then there are the bar codes that track inventory and carry pricing -- those must be on the label by industry regulation, he said.
Companies that have a labeling mistake get a warning letter from the FDA. If a "company whose violations are not health-threatening" contacts the FDA and says it's changing its labels to be in compliance, Mr. Underriner said, that "will probably be accepted by the FDA."
"And [the FDA is] terribly overworked," Mr. Arnold said, estimating that while there are 46,000 food firms in the United States, the FDA has only about 800 inspectors.
Label Check deals with companies of all types, from food producers to graphic designers to restaurants to contract package providers. And they deal with all sizes of companies, from the "little guy" with one product to major manufacturers who need an entire line of labels to conform to the law.
Sometimes they can provide enough information that the company is off and running on its own. Some clients say, "Don't give me all that stuff, just tell me what to do," Mr. Arnold says.
"Most clients don't expect to become an expert on labeling," Mr. Underriner says. "They want us there to check them -- that's the name of our company."
The two don't envision a time when all the labels in the world will be perfect and they can retire.
"We don't see the regulations getting simpler," Mr. Arnold says.