Byline: Alison Maxwell

WASHINGTON — Like a holiday hopeful on Christmas Eve, Cosmetic, Toiletry and Fragrance Association president E. Edward Kavanaugh has a wish list.
But gifts in shiny packages aren’t on this list. If Kavanaugh’s wishes come true, they’ll result in a cosmetics industry that’s regulated to the liking of the 106-year-old CTFA.
Topping Kavanaugh’s list is the outlawing of Proposition 65 “bounty hunters” in California. Prop 65, as the law is known, allows private citizens to sue companies on behalf of the state in cases of unsafe products. Under the law, plaintiffs can retain 25 percent of all fines levied by the state.
“Safety issues are going out of the hands of the state and into the hands of bounty hunters who are bringing companies to their knees,” said Kavanaugh.
Second on the list is modification of the Delaney Clause, which prevents any substance that has been shown to cause cancer in laboratory animals from being used in health and beauty aids.
As a result of the clause, U.S. cosmetics manufacturers have about only 30 colors to choose from when devising new shades, while foreign companies have about 100, Kavanaugh said. Repeal of the Delaney Clause has been a hot CTFA priority for years, but change has been hard to come by.
Kavanaugh also hopes to garner more financial and moral support for the cosmetics industry from the government.
“In most other countries, the government helps its industries to compete worldwide,” Kavanaugh said. “If we’re going to compete more successfully in the world, we can’t hinder our industries; we have to help them.”
Kavanaugh’s final wish is that the Food and Drug Administration’s Center for Drugs would “get off this kick that a drug is a drug is a drug.”
And those are just the association’s priorities. When it comes to the Food and Drug Administration, the CTFA has three major issues on the front burner.
“This year has been a particularly interesting year, to put it mildly, with the FDA,” said the seasoned and savvy Kavanaugh.
At the top of his “to-do” list is the resolution of two seemingly perpetual questions about alpha-hydroxy acid (AHA): Is it a drug or a cosmetic? Is it safe? During the past few years, these issues received so much attention that the FDA considered moving the Office of Cosmetics from its location at the Center for Foods to the Center for Drug Evaluation. No way, said CTFA.
“We wanted to keep [the office] where it was because the people at the Center for Drugs are most of all doctors, and they’re used to looking at clinical studies,” Kavanaugh said. “Everything to them is a drug. The last thing we needed was for cosmetics to be regulated by a drug mentality.”
CTFA lobbied Congress and received $2.5 million, which was used to secure the Office of Cosmetics’ place in the Center for Foods. CTFA’s next goal is to convince the FDA that alpha-hydroxy acid is not a drug and to get the appropriate labeling requirements finalized.
Kavanaugh said that CTFA’s Cosmetics Ingredient Review Board determined that AHAs are safe in concentrations of no higher than 10 percent. If a product does not contain a sunscreen, the panel said, consumers should be advised.
CTFA wants to initiate required labeling for products containing AHAs and to make an anti-aging claim. Packaging information would have to instruct consumers to use a sunscreen with products that don’t already contain one. For those that do contain such a block, labeling would suggest using a sunscreen for seven days after discontinuing use of the product.
“We’re hopeful that the FDA will see that labeling is the answer here and not getting into what would certainly be a war, because it goes to the heart and soul of the industry: What is a cosmetic and what is a drug?” Kavanaugh said. “The consumer doesn’t care whether AHAs are regulated as drugs or cosmetics. What they care about is if the product works and is safe.”
Kavanaugh’s fight against a final sunscreen regulation that was released by the FDA last year is also heating up. The regulation lists the active ingredients that can be used in sunscreen products, as well as labeling and testing requirements.
Primary among such regulations is a new clause that states that sunscreen products with SPF values of more than 30 must be labeled “SPF 30 plus” or “SPF 30+.” According to the rule, any product that lists a specific SPF value higher than 30 or uses similar language to indicate that a person can stay in the sun more than 30 times longer than he or she can without sunscreen will be misbranded.
It’s a first amendment issue, said Kavanaugh: “We have the right to say truthful things about our products.”
Gerald McEwen CTFA vice president for science agreed. He said the products, if not intended for beach use, should be able to make truthful statements and not be subjected to sunscreen regulations.
Meetings with the FDA on the issue proved unfruitful, so CTFA asked for a time extension.
In September the FDA extended the effective date of the new regulations by 19 months to Dec. 31, 2002, and agreed to discuss the SPF issue in more depth in the ensuing six months. Kavanaugh said if CTFA is not satisfied with the results, he will pursue “every legal course necessary.”
The final hurdle for CTFA is the over-the-counter labeling regulation. Some products — like sunscreens, antiperspirants, skin protectants, antimicrobial products and anti-dandruff shampoos — are both cosmetics and drugs. But CTFA said the extensive labeling required for OTC products such as painkillers and cold medications should not apply to lip balms and hand lotions.
“There are no dosage limitations on sunscreens and antiperspirants. If anything, people should use more of them,” Kavanaugh chuckled.
The issue is quickly coming to a head. In mid-February the FDA extended the effective enforcement date of the regulation to May 2002. In addition, Kavanaugh agreed to further explore the issue of reduced labeling for cosmetics. “This is a means to an end,” he said of the extension. “The FDA has finally agreed to put the substantive issues on the table.”
CTFA vice president and general counsel Tom Donegan hopes FDA will focus on the small packaging consideration. “FDA is asking for a lot of information to be placed on packages without any effort to compensate for the small packages that cosmetics are generally contained in,” he said.
The CTFA and Consumer Healthcare Products Association had previously filed a citizen petition requesting an additional two years within which to comply. The original deadline was May 2001.
On the lobbying front, in 2000 CTFA will be fighting an increasing number of localized battles to protect the beauty industry.
In California, where the food and cosmetics industries have enjoyed an exemption from the recycling packaging law, the legislature is considering a repeal. If the exemption is removed, food and cosmetics packaging would be required to contain at least 25 percent of materials that have been recycled in California.
“Because of health reasons we don’t support it,” Kavanaugh said. “Packaging can leach into the food or cosmetics product, and if that packaging is recycled, it could create contamination problems.”
Also on the table in California is a bill that would ban the use of animals in safety testing of household products, including cosmetics.
“Even though the cosmetics industry uses fewer animals than many other industries, we have always been a sexy target for the animal rights groups because we’re in the beauty business,” Kavanaugh said. “Our first obligation is to the consumer. If you have a new shampoo for children, you have to make sure it doesn’t cause problems in the eye, and the rabbit eye is closest to the human eye.”
Other lobbying targets include states considering a ban on the use of mercury and those considering requiring warning statements if particular ingredients cause reproductive problems or have carcinogenic effects.
Looking ahead, Kavanaugh said the fact that it’s an election year isn’t affecting CTFA’s agenda. In fact, the association might have a few changes to look forward to.
“If the whole administration were to change over, it would probably be in our best interest,” Kavanaugh said, referring to the possibility of the election of a Republican president. “And the whole House is up in the air, but I think the Democrats could very well take it back. We’d like it to stay Republican.”
Either way, Kavanaugh said he hopes different parties control the White House and Congress.
“That way nothing gets too extreme. You have a balance,” he said. “I would hate to see either party have control of the White House and Congress, because then you get a seesaw sort of government.”
Farther down the road, there’s one thing Kavanaugh doesn’t have much control over: consolidation within the industry. He said it just might catch up with CTFA.
“It may be good for the companies involved in all of the consolidating, but it’s not good for the association,” he said. “If one company buys another company, we lose the dues of the acquired company. And more importantly, you see drastic changes in the people side of the businesses.”
“It’s a challenge to adapt to a changing industry,” he continued, “and the consolidation is not going to stop.”
Maybe that could go on next year’s wish list.

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