REGULATION: Death of a Dye

REGULATION: Death of a Dye

Without it, instant chocolate pudding
would be greenish, artificially flavored grape soda would look blue,
and cake mixes would have a lemony-green tinge. The substance is Red
Dye No. 2, which has been used for decades to brighten up innumerable
products, including frankfurter casings, pet foods, ice cream, gravies,
makeup and myriad red pills. About 1 million pounds of the
coal-tar-based stuff—a $5 million industry in itself—have ended up
annually in more than $10 billion worth of foods, drugs and cosmetics. Now all that is ending. Last week the Food and Drug Administration
rescinded its provisional approval of Red No. 2 because its safety
could not be established. The FDA's most recent tests showed a
significant increase in cancer among aged female rats that had been fed
large doses of the dye. Commissioner Alexander Schmidt stressed that
the FDA found “no evidence of a public health hazard” from
products made with the dye; according to one manufacturer, a human
would have to drink 7,500 12-oz. cans of soda pop containing Red No.
2 every day to reach the rats' level of consumption. Accordingly, the
FDA will let companies sell completed products made with Red No. 2, but
forbids them to use the dye any longer. The ruling was more than 15 years in the making. In 1960 the FDA got
jurisdiction over color additives and gave provisional approval to
substances already in use, making the approval permanent when safety
had been proved.
The agency extended Red No. 2's provisional status 14 times as tests
continued. In 1971, however, a Russian study linked cancer to Red No.
2, and consumerists in the U.S. stepped up pressure on the FDA to ban
the dye. Some now feel that the agency should have ordered the recall
of goods containing it.
Says Lawyer Anita Johnson of the Public Citizen's Health Research Group:
“It is a charade to say it's safe to eat it now, but not a year from now.” Anyway, the dye is cast out, and manufacturers are shifting to a
substitute: Red Dye No. 40, which the FDA considers safe. Several
manufacturers, including Armour, General Mills, Nabisco and Revlon, say
that they stopped using Red No. 2 long ago; others, such as Borden and
Ralston Purina, are in the last stages of the changeover. General
Foods, which used Red No. 2 in some flavors of JellO, Kool-Aid and
Gaines pet foods, says it stopped a week before the FDA ruling. The ruling may push up the price of many consumer products. Red No.
40 costs $8.50 per lb., v. $5.50 for No. 2, and manufacturers have to
use 30% to 50% more of it to get the same color intensity as with Red
No. 2. Even then, the colors do not come out quite the same, so
chocolate pudding may look a bit greener. Some potential losers from
the FDA ruling: New York's Crompton & Knowles, Chicago's Stange
Co., Cincinnati's Hilton-Davis Chemical Co.
They relied on Red No. 2 for up to 25% of sales, and lack—for now—a
license to make No. 40. The big winner: Allied Chemical, which owns the
patent on No. 40 and licenses other companies to make it under the name Allura.

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