Never mind that fly in your soup. Consider the bugs that may be in your juice, yogurt and eye shadow.
The Food and Drug Administration is deliberating a rule that would require food companies to state on their labels that the product contains an additive made out of bugs that, when crushed and processed, yields a rich red or a vivid orange color.
The additives, carmine and cochineal extract, have been used for centuries and come from a female beetle imported from Peru, the Canary Islands, Bolivia, Chile and South Africa.
The agency said the beetle-derived ingredient is used in some 815 cosmetic preparations most of which already are labeled. The additives produce the lovely pinks, purples and reds that perk up juices, popsicles, cosmetic face blush, the cherries in fruit cocktail that little kids love, port wine cheese, artificial crab meat, strawberry milk drinks, caviar, a fruit-based aperitif and other products.
Some Yoplait yogurt made by General Mills Inc., for example, uses carmine. It is listed on the ingredient label, and the company said it had no plans to discontinue its use.
In the 1960s, the FDA, based on company testing, declared the substances safe. And companies at that time said they had received no adverse reports from the substances' use.
It wasn't until about a decade ago that medical reports surfaced showing that the additives can cause allergic reactions in some people, including flushing, hives, eczema, sneezing and anaphylaxis, a severe, sudden allergic reaction that can result in death.
Though not widespread, the problem caught the eye of the Center for Science in the Public Interest. The watchdog group and several physicians petitioned the FDA in 1998 to ban the additives or to at least list them and their insect derivation.
"We're urging the FDA to get rid of it. Here is an opportunity to protect people from unnecessary reactions. When reactions are life-threatening, they the FDA should get it off the market," said Michael Jacobson, executive director of the CSPI.
Jacobson said the dyes can be replaced by other artificial or natural dyes that don't elicit the same reaction.
The FDA has taken a different tack. It proposed in January that foods containing carmine and cochineal extract list them on their labels. Retail cosmetics already must list them as ingredients, but the FDA proposal adds "professional-use" cosmetics and gifts or free samples that often come with promotions to buy cosmetics.
"FDA is proposing this action to protect the small number of consumers who are allergic to these color additives. By requiring label declaration of cochineal extract and carmine, these consumers will be able to avoid food and cosmetics containing these color additives. Cochineal extract and carmine are safe for the majority of the general population," the agency said in a statement last week. The comment period ended May 1.
Companies would have two years to change their labeling under the proposal, which could cost up to $3 million, the FDA said. The benefit for avoiding the consequences of allergic reactions was estimated at anywhere from $1 million to $26 million.
Because it comes from an insect, carmine is considered a natural additive and can be accounted for on a label as simply "artificial color" or "color added." There are many other natural color additives in that group, including annatto extract, beet powder and grape skin extract.
Under FDA rule, other colors used in food processing that are not derived from plants or animals must be listed by name, such as FD&C Red No. 40.
In its proposal, the FDA cited 35 cases of allergic reactions since 1994 from Ruby Red grapefruit juice, purple eye shadow and other products. Jacobson said the number is likely to be much higher because his group assumes that many cases are not reported.
Pediatric allergist Scott Sicherer at Mount Sinai Hospital in New York said he has not seen reactions in his patients. But he urged the FDA to list the additives as ingredients. "It's a rare allergen, but there's no reason not to label it," Sicherer said.
The Food Products Association, the country's largest trade group serving the food and beverage industry, doesn't object to putting the words on the label, said Robert Earl, senior director of nutrition policy. "Many of our companies have been listing it for years," he said.
But the group complained in its comment: "Numerous food ingredients and additives are derived from animals, including insects. FDA does not require a statement about insect derivation about any of those ingredients or additives, such as honey or shellac."
If the FDA doesn't ban the additive, the CSPI thinks the next best thing to is to tell consumers what carmine and cochineal extract are. The group suggested that people with dietary restrictions might be surprised to know the colors' origin.
In the proposal, however, the FDA said if people don't know what the words mean, they can look them up. "Information on the origin of these color additives is readily available to those consumers who want it. This information is provided in standard dictionaries for the words 'cochineal' and 'carmine.' "