ELIZABETH SUSSKIND SURROUNDED BY TWO NEW LAUDER CLIENTS AT THE SPA’S OPENING.
Byline: Jennifer Owens
WASHINGTON — Edward Kavanaugh predicts 1997 will bring reform to the Food and Drug Administration — although the changes may be slower in coming than he would like.
“I think if the FDA reform bill is going to happen at all, it’s going to have to happen this year,” said Kavanaugh, president of the Cosmetic, Toiletry and Fragrance Association, during a recent interview in his Washington office.
“But what mixes this up a bit is that you’re going to have a new FDA commissioner. And who is that going to be?”
Answering that question will be Vice President Al Gore, who is leading the search to replace outgoing Commissioner David Kessler.
“I think having the choice being made by [Gore] may not be the best in terms of who we get in there,” Kavanaugh said. “It would be nice to get someone in there with a reasonable attitude to regulate, but to regulate in a way that makes sense.”
What should help is Senate confirmation, which for the first time is required before a new FDA Commissioner can be named, Kavanaugh said. He added, however, he’d like to see more than a new commissioner and a new reform bill at the FDA this year.
“I’d like to see an attitude change at the federal level,” he said. “You need cops, but good cops. They don’t need to come down with a hammer.”
Instead, Kavanaugh said the FDA’s top priority should be uniform, national guidelines for safety and labeling issues.
“For states to get into the act, it interferes with interstate commerce,” he said.
It also has CTFA fighting an increasing number of localized battles to protect the beauty industry, as well as monitoring ongoing national and international issues, such as alpha-hydroxy acid testing in the U.S. and animal testing bans in Europe.
At the local level, the association continues to fight local laws that would ban fragrances in public buildings on the request of people who claim they suffer from multiple chemical sensitivity, a condition that apparently makes some consumers highly sensitive to fragrances.
“Everybody has opened up a magazine and been overwhelmed by too many inserts, or they’re leaking,” Kavanaugh said. “And everyone can identify with the old-lady-in-the-elevator syndrome where they just get whacked over.”
But, Kavanaugh said, that shouldn’t be enough for Berkley and Oakland, Calif., and Pinellas County, Fla., which are currently studying the issue, to ban all fragrances. “There is something wrong with these people, but it’s psychological,” he said. “The medical community is adamant that this is not a physical ailment.”
Another hot issue among state governments is how to limit volatile organic compounds (VOC’s), such as alcohol, which are used in a wide array of products, including hair spray and deodorants.
The most contentious battle is in California, where the state’s Air Resources Board has set a 55 percent VOC limit for hair sprays by Jan. 1, 1998.
Although the board expressed willingness to push the deadline back to July 1, 1999, Kavanaugh said one supplier has been fighting the delay because it built a factory to produce an alcohol substitute.
Kavanaugh said, though, that the delay is needed industry-wide.
“These products that would reduce VOCs, at least to date, are not as good as the products that are on the market today,” he said. “Our approach out there is not to stonewall, but to work for reasonable dates.
“The amazing thing about it is that for our product category, VOC’s are actually already below the level they set,” since sales in aerosol categories have decreased, Kavanaugh said. “So even though they’ve met the goal for cosmetics, they are still going to go forward with these regulations. It’s mind-boggling.”
Other states, Kavanaugh said, have been much easier on the industry. For example, New York has set its date for a 55 percent VOC limit on hair sprays at 2001.
“That would be very reasonable,” he said. “We feel we could accommodate it by that date. But 1999 is going to be very tough, especially for the small and mid-sized companies.”
At the federal level, CTFA continues to fight for repeal of the Delaney Clause. The clause, which has been on the books for decades, prevents the use of any substance that has been shown to cause cancer in laboratory animals from being used in health and beauty aids, even if there is consensus in the scientific community that the product is not dangerous to humans.
As a result, U.S. cosmetics manufacturers have only about 30 colors to choose from in devising new shades, while foreign companies have about 100, Kavanaugh said. Repeal of the Delaney Clause has remained a hot CTFA priority for years, but change has been hard to come by.
“It’s difficult,” he said. “These members of Congress don’t want to be perceived by anybody as pro-cancer. So when you enact something like this, it’s difficult to change.” Also at the federal level, the FDA decided late last year to conduct its own investigation of alpha-hydroxy acids, even though CTFA’s Cosmetic Ingredient Review gave tentative approval to them in December.
CIR’s preliminary conclusion found alpha-hydroxy acids — in concentrations up to 10 percent for mass-marketed cosmetics and 30 percent for use by professionals, like salon operators — are safe if used with a sunscreen.
A final CIR report is due in June, while the FDA study is due within the year.
Kavanaugh said the FDA’s decision to conduct its own tests — to study issues including whether alpha-hydroxy acid-based products make skin more susceptible to sun damage — is particularly aggravating for CTFA considering that an FDA official always sits on the CIR panel as a nonvoting member.
He said a handful of complaints about the products has the entire industry playing a waiting game.
“The government can’t take care of everybody,” he said. “These products are safe…If you have fair skin, you should wear sunscreen anyway.”
Meanwhile, the FDA also has proposed eliminating part of its 20-year-old requirement that companies report adverse product reactions by consumers. The agency has said after 20 years, most data on minor complaints such as skin irritation have become duplicative.
Instead, FDA plans to publish the last 10 years’ data as a baseline, asking companies to compare it to their own complaint data for any product category.
Kavanaugh said CTFA has waited about a year for the baseline book. In the meantime, the association has suggested that the FDA expand its four-year-old MedWatch program, which allows health officials to report problems caused by products by phone, computer or mail.
MedWatch now focuses on prescription drugs and medical devices, but CTFA hopes FDA will expand it to include contributions on cosmetics from dermatologists.
“We told them we’d be very willing to work on it and spend a lot of our own money on educating dermatologists to send in that information to FDA,” he said.
CTFA also volunteered to develop a brochure for FDA field offices listing toll-free numbers for all cosmetics companies.
And finally, on the overseas front, CTFA has welcomed a new, two-year delay of the European Cosmetics Directive, which would prevent the sale of products tested on animals unless the manufacturer can prove no feasible alternative method was available.
Kavanaugh said he was recently told that the directive’s start date had been pushed back to Jan. 1, 2000.
“Eventually, I’m sure for most tests there will be a reasonable substitute, and there are some today that are used by some companies,” he said. “But those are for their products or for isolated tests. There’s no one deal you can use as a substitute.”
He added, however, that the ban should have little impact on most CTFA members. “I think that except for one or two of our companies, it’s a nonissue for the rest of the industry,” he said.