Face-Off : Madeleine Verdon of Camarillo has created a skin cream that has ‘broken all the rules’ of cosmetics development. Industry insiders say the product may rub federal agencies the wrong way.

Of all the flowers on her one-acre estate, Madeleine Verdon loved her roses most: the imported French Josephines, white with dark pink centers, that grew beside full-blooming yellow ones; the small red buds, mixed among peach-colored petals, that seemed to burst open in a day.

To Verdon, who tended them with a meticulousness never afforded her azaleas, they were a symbol of grace and delicacy.

She never expected that, indirectly, they would damage her skin, prompt her to look into the inner workings of the cosmetics industry, or cause her to develop and market a face cream that, she asserts, has successfully “broken all the rules.”

“I never intended to do any of this,” said Verdon, seated on an antique divan inside her ornately decorated Camarillo home. “It’s just that every face cream I tried was like a chemistry set. I couldn’t use anything. I was only looking for a formula that would help me.”

Two years ago, Verdon began selling by direct mail the formula she eventually created. Since then, she says, things have gone smoothly. Jars of the $24 cream have sold well, and she is now shipping the product across the United States. But industry insiders paint another possible picture. By creating and marketing the all-natural formula for mass consumption--and making assertions about the efficacy of her face cream--Verdon, they say, could find herself in a face-off with both the federal Food and Drug Administration and the Federal Trade Commission. At present, neither agency has the product under review.

“There is a line between what the FDA considers is a cosmetic claim and what it considers is a drug claim,” said Wayne Stevenson, a chemist in the FDA’s division of colors and cosmetics in Washington, D.C. “Based on her claims, we would consider her product to be a drug.”

Verdon, a handsome woman with charcoal-colored hair pulled into a neat chignon, is a classically trained singer from Canada. She never, she said, aspired to form a cosmetics company. She only wanted relief.

Verdon set out to find a non-irritating moisturizer after she inadvertently was poisoned several years ago by pesticides she had spread over her rosebushes. Her arms and face were badly burned by the exposure, she said, and her skin became highly sensitized as a result.

Her doctor prescribed cortisone to help the dryness and inflammation, but it didn’t help. And every face cream she tried--even high-priced ones and those marked “hypoallergenic”--made the condition worse.

“I really suffered,” she said.

It was her son, a biochemist and researcher who had completed his doctoral thesis on natural Vitamin E at Tufts University, who came to the rescue. Dr. Carl Verdon presented his mother with what he said were Vitamin E’s clinically proven benefits: It speeds healing, smoothes wrinkles, helps prevent scarring, cleanses pores and helps guard against ultraviolet rays. Verdon purchased a bottle of the natural oil at a local health food store.

The oil soothed her skin, but it was tacky, greasy and impossible to wear under makeup. When she turned to Vitamin E creams already on the market, she found that most contained a synthetic form of the vitamin, usually in concentrations of less than 5%. According to her son, studies had shown that the synthetic form of the vitamin is less effective.

It was then that Verdon--with input from her biochemist son and more than $100,000 in financial backing from her husband, an investment executive--decided to develop her own formula.

To her surprise, she discovered that there wasn’t much to it.

“Anyone can do it. They don’t need any experience,” said John McConville, a biochemist and president of Cosmetic Products International, the Valencia laboratory where Verdon’s face cream was developed.

“It’s like baking a cake, except it’s chemistry,” McConville said. “I’ve been doing this for 20 years. You come in, you tell me what kind of cream you have in mind, and I can do anything you want.”

What Verdon wanted, she told him, was a cream high in natural Vitamin E. She also wanted it free of fillers, perfumes, mineral oil and stabilizers. And no matter what, it couldn’t contain wax or traditional preservatives.

McConville balked. “I can’t make a cream without a thickening agent,” he said. “There has to be some kind of wax. Otherwise it is a liquid.”

Verdon was adamant. There was an agent called squalene, made from olives. It would serve the same purpose.

And what about the FDA’s requirement that manufacturers put preservatives in creams? There was a way around that, too, she said.

“Most skin-care products available today are irradiated for a long shelf life,” Verdon said. “It kills bacteria and keeps it lifeless.” They also contain preservatives and chemicals, she said, “to keep them from turning and changing. But we found a way to use grapefruit seeds and ascorbic acid--Vitamin C--as a natural preservative. It’s much gentler.” The Vitamin E used in her product, she said, is derived from sunflower seeds.

According to a study conducted by the North American Contact Dermatitis Group, fragrances are the most common cause of allergic and irritant reactions in cosmetics. Preservatives, the study found, are second.

McConville finally relented. He conducted stability tests to make certain the formula would hold up under normal conditions.

And in 1989, Promess, French for “a promise” was born.

Verdon may not have known much about the competitive world of marketing cosmetics when she started out, but she learned the basics soon enough.

She hired a public relations firm--SDH Associates in Sherman Oaks--to help her with the packaging of her product, and immediately began discussing the best ways to position it.

Verdon says there never was any thought of selling the cream in stores. Direct mail, she said, was the only way to “ensure it is always fresh.”

“We never wanted to put it on shelves,” she said, “because it would need preservatives and waxes with the heavy light systems in the department stores.”

Although Verdon says the product was tested for stability in temperatures up to 110 degrees, the cream does become liquid if it gets too warm. She also said it has a tendency to change from its light yellow color to a “nutty color” if the lid is left off.

Those factors alone make some industry insiders uncomfortable.

“Why should it do that?” asked Jerome Michell, executive director of Independent Cosmetic Manufacturers Distributors, an Illinois-based trade association that provides advice on regulations, labeling and product liability issues to about 600 small cosmetic companies throughout the United States.

“There is something wrong,” he said, “with the formulation of any product that liquefies.”

Michell also expressed concern about what can happen to a face cream if proper preservatives aren’t used.

“It might be safe when you open the jar, but as soon as you put your finger in it . . . the next day there are 20 million bacteria in it,” he said. “Certain compounds, especially with things like sunflower seeds, can spoil as easily as something in your refrigerator.”

According to FDA data, cosmetic contamination is most frequently caused by manufacturers using ineffective preservatives and then not testing the stability of those perservatives for a product’s normal shelf life.

But Verdon, who said she is a member of Michell’s trade association, doesn’t seem worried. The liquefaction, she said, is easily remedied by “putting it in the refrigerator.” The nutty color disappears, she added, “if you just stir it up a little.”

She said the cream also has been tested by biochemists for its shelf life and has been shown to be bacteria-free after two years.

Verdon has product liability insurance for $1 million, the minimum amount for any small cosmetics company. No policy, however, could protect her from scrutiny by the FDA or Federal Trade Commission. And if either regulatory agency chose to take a closer look, it probably would be prompted by Verdon’s claims about her product.

In preparation for an advertising campaign, Verdon’s public relations agency printed background information on the cream and a brochure describing the “miraculous healing properties” of the sunflower.

Verdon also asked that a three-inch insert be placed inside each package of Promess, describing what it can do. According to that brochure, the cream “accelerates cellular renewal, promote(s) healing, guard(s) against UV rays” and “prevents the formation of lines.”

“I’m making those claims based on research done on natural Vitamin E,” Verdon said. “Vitamin E can do all those things.”

But Ann Guler, with the Federal Trade Commission’s Los Angeles office, is not impressed.

“There are a lot of cases we’ve brought against companies, where we have sued them for taking general research and appropriating it for their own product,” Guler said. The commission, she added, is responsible for ensuring that companies do not make claims that are “false or unsubstantiated.”

“Studies may have shown that Vitamin E has these properties,” Guler said, “but that doesn’t mean the product would necessarily have the same effect.”

Stevenson, with the FDA’s Washington office, was even more skeptical. Once Verdon made certain claims about the cream, he said, she crossed a line.

“The FDA has no jurisdiction over advertising, but we do get involved over any printed matter that accompanies the product, like an insert,” he said.

“And ‘promotes healing’ is a drug claim. ‘Accelerates cellular renewal’ is a drug claim. ‘Guards against UV rays’ is a drug claim. Anything that is promoted to prevent or take away wrinkles is a drug claim.”

To substantiate those claims, Stevenson said, Verdon would be required to “test the product herself through clinical studies. And to do that would cost her hundreds of thousands of dollars.”

But if Verdon is aware of the flutter around her, or the difficulties she may encounter, she shows no sign of it. Excitedly, she showed a visitor her newest product, a Vitamin E body lotion.

“I believe in this cream,” she said. “I know what it can do.” For a moment, she held it silently in her hand.

“I would never say these things about it if I didn’t.”