Group files suit over federal inaction on food dyes
The fate of maraschino cherries’ brilliant red color hangs precariously by a thin stem. There are serious doubts about the safety of the food dye that transforms dull-yellow cherries into artificially bright scarlet garnishes for everything from cocktails to cakes.
This week the Public Citizen’s Health Research Group, a Washington-based consumer advocacy organization, filed a suit against the federal government to force a ban on the color additive known as FD&C; Red No. 3, a chemical found to produce thyroid tumors in laboratory animals.
The trouble surrounding Red No. 3 is yet another problem for artificial food colors, a collection of chemicals that has one of the worst safety records of any additives used in the modern food supply.
Over the years, 24 variously colored dyes have altered the appearances of processed foods. Seventeen of those have been either banned or voluntarily withdrawn from market, a 70% failure rate.
The Health Research Group wants three of the seven remaining artificial food dyes banned immediately and believes the others are potentially unsafe as well.
“We hear a lot of hoopla from companies as to why they need food colors, and it all turns out not to be true,” said Dr. Sidney M. Wolfe, Health Research Group director. “There are many national brand products with a significant shelf life that do not have dyes and colors and do perfectly well (in sales). That’s because (consumers) do not want food laced with this junk.”
The group first petitioned the Food and Drug Administration in mid-December to ban FD&C; Red No. 3, FD&C; Yellow No. 5, FD&C; Yellow No. 6 and several other dyes used primarily for cosmetics. Dissatisfied with the government’s continuing inaction on the matter, Health Research has now taken its case to the U.S. District Court to force a ban on the three color agents because all caused cancer in laboratory animals.
The suit seeks to have the agency enforce a federal statute, the Delaney clause, which requires that all additives and preservatives suspected of being carcinogens be removed from the food supply.
In addition to the cancer indictment, Yellow No. 5 and Yellow No. 6 both trigger allergic reactions, and all three additives have caused chromosomal damage in animals during lab tests.
The three food colors in question amount to about 50% of the 3.4 million pounds of dye consumed by Americans in 1984, according to Wolfe.
“By failing to immediately ban these dyes, the Reagan Administration is making a mockery out of its alleged cancer reduction goals . . .,” Wolfe wrote in the December petition to FDA Commissioner Frank E. Young.
Wolfe also cites a 1976 government study that states children are especially vulnerable to threats posed by food dyes. The report estimated that between 95% and 99% of all children eat some chemically colored foods such as candy, desserts or baked goods. The study also estimated that most American youths consume about one pound of the suspect dyes by the time they are 12 years old.
“In addition to the possibility that (children) are more susceptible to carcinogenic chemicals such as food dyes, (they) will have a longer history of ingestion and thus a greater likelihood of developing cancer because they eat these dyes,” Wolfe stated.
A food industry representative claims, however, that Red No. 3 is safe and should remain in foods. Harry C. Mussman, executive vice president of the National Food Processors Assn., said that the 1982 and 1981 tests that indicted Red No. 3 as a carcinogen contained a number of errors in the materials and dosages used. There were also problems with the interpretation of results, he said.
More recent animal and human feeding tests have shown that the red food color is not directly responsible for the thyroid tumors found in previous research. Instead, only at high dosage levels does the dye interfere with hormone metabolism and indirectly place a strain on the thyroid, ultimately leading to a cancerous growth, Mussman said.
“If you look at the situation objectively, then (Red No. 3) is safe for its intended use. Then why should you not be permitted to use it if it imparts an attractive color and helps people to identify products that are desirable to purchase?” Mussman said.
The Certified Color Manufacturers Assn., a trade group in favor of retaining the yellow dyes, would not comment on the suit by the Health Research Group. However, food industry representatives express confidence in the safety of both Yellow No. 5 and Yellow No. 6.
“If there was any evidence of a hazard to humans (from these two dyes), then the industry would stop using them forthwith,” said one knowledgeable food industry source who requested anonymity. “The data is clean and there isn’t a problem. I don’t understand the opposition (to the yellow food colors).”
The current controversy actually began in 1960 when Congress passed an amendment to the Food, Drug and Cosmetic Act that required industry, rather than federal health officials, to prove that artificial colors were safe before they could be approved for use.
The Congressional action thus required that privately funded research be conducted to determine the health consequences of 100 color dyes used in the food, drug and cosmetic industries, according to an FDA spokesman.
In order to provide time for the necessary research while the dyes were still in use, the legislation created a provisional list upon which a dye could be placed until its ultimate fate was determined by testing. After more than two decades, there are only 10 dyes remaining on this provisional list, including the three food dyes that Health Research claims should be outlawed.
In fact, the FDA has recommended to its parent agency, the Department of Health and Human Services, that five of the 10 provisionally listed dyes be banned. The five dyes FDA proposes outlawing are all used in cosmetics. A decision on the three suspect food colors’ fate is not forthcoming.
Nevertheless, Health and Human Services has not acted on the FDA recommendation, and this delay prompted the lawsuit by Health Research Group.
The seeming contradiction between two sections of government is explained by some as being the result of political pressure brought by various trade associations.
The split is made more glaring by some of the documents used to support the Health Research Group’s case. Its presentation in favor of a ban on the various dyes will be based upon Food and Drug Administration internal memos that support such a move.
One memo obtained by the Health Research Group was written by Sanford A. Miller, director of FDA’s Center for Food Safety and Applied Nutrition. In the memo discussing five dyes on the provisional list, Miller writes:
“In our (FDA’s) judgment we have already extended the provisional list so many times for such tenuous reasons that we are in danger of losing both a lawsuit and our credibility as a regulatory agency.”
Miller said the statements in the memo are his, but declined to make any further comment on the food dye situation.
The Miller memo, and others like it, indicate broad-based support within the FDA to ban most, if not all, of the dyes on the provisional list, Wolfe said.
“There is no dispute in the (FDA) on this,” Wolfe said. “They are being pushed by industry away from obeying the law. . . . When the FDA wanted to do what they should (they) were stopped in their tracks. FDA scientists know that these dyes should be banned.”
Short of a court order, the next opportunity for the government to make a decision on the dyes is when the provisional list is up for renewal again during the first week of February.
In the meantime, consumers concerned about identifying exactly which processed foods contain the food colors in question will find the task difficult. Most foods that are chemically colored do not list a particular dye and instead state simply on ingredient labels that they contain an “artificial color.”
