It's really nothing more than red dirt in a pretty bottle that sells for $12.50 at Bloomingdale's, Hecht's, and Lord & Taylor.
Still, the facial blush Indian Earth is stirring up a dust storm at the Food and Drug Administration and muddying the agency's role in judging whether some cosmetics have met regulatory requirements before going to market.
The story of Indian Earth is a tale of how federal regulation can play quite differently for different companies, how regulation can be used as a weapon in competition, and how members of Congress put themselves in the middle of the process.
It began in 1978 when two former employes of the Hollywood film industry started selling a cosmetic whose basic ingredient is hematite, an iron oxide powder found naturally in a "secret" location in the Southwest.
After the Indian Earth Co. sent a copy of its product's label to the FDA and heard nothing, the cosmetic was placed on the market. Its sales grew rapidly, from $1 million to $10 million in less than three years, and so did the company.
About 10 percent of the FDA's time is devoted to cosmetic regulation -- primarily through testing or seizing products found to be unsafe. By law, the FDA does not clear cosmetics before they are sold, only the color additives they may contain.
Indian Earth claims that although its product imparts color, it contains no additives and is therefore exempt from FDA's regulatory overview --unless it is subsequently proven unsafe. The FDA insists that a product imparting color, even if sold as a finished cosmetic, is subject to regulation.
Late last year, two years after Indian Earth was placed on the market, the FDA responded to a consumer inquiry, tested samples of Indian Earth and declared it safe.
In February, Private Label Cosmetics Inc., a Fair Lawn, N.J., manufacturer, charged that Indian Earth was on the market illegally and asked the FDA to state whether it prohibited the use of hematite in cosmetics since hematite is not on the list of approved color additives for cosmetics. Synthetically produced iron oxide is approved.
John M. Taylor, director of the FDA's division of regulatory guidance, wrote Richard Faun, president of Indian Earth, that his product appeared to violate the cosmetic provisions of the Food, Drug and Cosmetic Act, "in that it is or it bears or contains a nonapproved color additive."
That letter was followed by one from Joseph P. Hile, associate commissioner of the FDA for regulatory affairs, who said Indian Earth is "an adulterated cosmetic . . . since it is or bears or contains a color additive which is unsafe within the meaning" of the law. The fact that FDA tests had already found Indian Earth to be safe is not germane, FDA officials claim, because it had not submitted the cosmetic for preclearance.
So far the FDA has just written letters; it has taken no legal action against Indian Earth. That stance miffed Rubigo Cosmetics Inc., which produced with Private Label Cosmetics a synthetic iron oxide cosmetic similar to Indian Earth. Rubigo, unlike Indian Earth, had specifically asked the FDA if it could use hematite in its product, and had specifically been told no, because hematite had not been tested for safety as a color additive. Meanwhile, Indian Earth is still on the shelf, making money.
Rubigo president Jules Schlesinger wrote his congresswoman, Rep. Marge Roukema (R-N.J.). In a press release later, she said: "The FDA wrote me that the Indian Earth is indeed unapproved and unsafe, but we were also told that they probably wouldn't have time to do anything further."
"In light of this disparity," she added, "it would seem counterproductive for a company to act in good faith to contact the FDA with regard to the use of a product, especially when the FDA seems to be failing to carry out its enforcement possibilities."
Indian Earth's Faun wrote his congressman, Rep. Henry A. Waxman (D-Calif.), who happens to be chairman of the House Commerce subcommittee on health and the environment, which oversees the FDA.
Waxman fired off a letter to FDA Commissioner Arthur Hull Hayes Jr.: "I am concerned because the president of Indian Earth Co. is my constituent and I would not want an injustice to be done." Waxman added he would be happy to work with the agency to clear up any "ambiguities in the law." The FDA answered again that it "feels compelled to conclude that the ingredients that constitute Indian Earth is sic a color additive."
"The issue is now a paper war," said the FDA's general counsel Thomas Scarlett. "We're writing, they're writing, but no one is taking 'critical' action."
Hyman, Indian Earth's attorney, charges that the FDA is trying to extend its regulatory control without authorization. Hyman said that if the red dirt were combined with other ingredients, it should be considered a color additive and the company would petition to have it approved.
Scarlett disagrees: "If they won't file a color additive petition, they're marketing their product illegally. To put this in the most clear-cut terms: If somebody took Red Dye No. 2 --which has been banned -- and sold it as a face-coloring substance, that would be illegal. This is the same thing." Still, Scarlett says he is unaware of any substantive danger of using Indian Earth.
"The bottom line is this," said an agency official familiar with the case. "We have better things to do than to be a shuttlecock referee between these two competing companies. What Rubigo should have done is put their product on the market illegally while filing for a color additive petition, having the best of both worlds." CAPTION: Picture, Red dirt, selling for $12.50 as Indian Earth, is case study in problems of regulation. By Gerald Martineau -- The Washington Post