Hair-raising claims lead to shampoo ban

FDA Consumer, June, 1995 by Tamar Nordenberg

A federal judge recently ordered a Rhode Island hair-care products distributor to stop selling two products it claimed would stimulate hair growth and prevent hair loss.

On Sept. 26, 1994, Judge Raymond J. Pettine, of the U.S. District Court for the District of Rhode Island, permanently enjoined Kasz Enterprises, Inc., of Warwick, R.I., and its owner and president James Kaszyk from marketing "Solution 109 Herbal Shampoo" and "Solution 109 Herbal Cosmetic Scalp Cleanser." The court found the products were new drugs being marketed without FDA approval. In addition, the court found the products were misbranded because they lacked adequate directions for use.

Kasz argued that the shampoo and scalp cleanser were cosmetics, not drugs, and therefore not subject to the agency's drug application and labeling requirements.

FDA maintained that the products were drugs, however, because Kasz promoted them with drug claims, such as causing hair growth and preventing hair loss, rather than only with cosmetic claims, such as making hair appear fuller or thicker.

The judge agreed with FDA and accepted the agency's position that merely ordering a halt to the therapeutic claims would not be a sufficient remedy. In light of the substantial market that had already been created for the products based on the hair growth claims, the court believed that unless marketing were halted altogether, buyers would continue to associate the products with hair restoration, and Kasz would continue to profit from its past illegal activity.

FDA investigator John Biello, of the East Providence, R.I., resident post, and investigator Debra Cooper and public affairs specialist Joseph Raulinaitis, of the Boston district office, gathered the required evidence of Kasz's illegal promotional claims.

Biello first inspected Kasz Enterprises on Feb. 12, 1991, in response to reports from consumers and government health agencies that the firm was promoting its products for baldness and thinning hair. He found promotional materials for Solutions 109 that included testimonials from Kasz customers. Examples included:

* A booklet entitled Kasz Enterprises, Inc.: Solution 109, containing a testimonial stating, "With Solution 109, I've stopped losing my hair and it's actually growing back, even in places that were totally bald before," and a claim that, "Usually in one to three months, most customers report their hair is regrowing and their hair loss has stopped." * A newspaper article reprint entitled "Is this the Solution to hair loss problem?" containing testimonials from radio personalities regarding the products' hair growing effects. * A memorandum entitled "From the Office of the President," stating, "There are many products today claiming to help people with a hair loss problem. Only Kasz Enterprises gives you: 90% satisfaction rate [and] proven results with local celebrities ...."

Radio advertisements broadcast around the time of the inspection stated, "There's a proven effective product that people are claiming regrows their hair. It's called Solution 109 by Kasz Enterprises. Kasz only claims to make hair fuller and thicker; the results confirm that Solution 109 far exceeds its claims."

FDA sent a warning letter to Kasz on Aug. 12, 1991, alerting the company that its claims of therapeutic effect were drug claims and that the two products were misbranded and unapproved new drugs. The letter also stated that continuing to sell the products as baldness remedies might lead to FDA enforcement action.

On Sept. 5, 1991, FDA representatives met with Kasz's attorney, at his request, and reiterated FDA's position.

Despite FDA'S warnings, Kasz continued to sell the solutions. As a result of the continued sales and drug claims, on April 10, 1992, the government seized 30 bottles of the products from a Burlington, Mass., hair salon and subsequently destroyed them.

Cooper and Raulinaitis inspected the company on Sept. 9, 1992, and April 16, 1993, and found that Kasz was still making therapeutic claims for the products.

Cooper visited one of Kasz's hair salon distributors on April 27, 1993. The salon had a sign in the window stating, "Solutions 109 Available Here," and, at Kasz's request, dispensed promotional literature containing hair restoration claims.

Because of the company's continued violations, FDA sought an injunction to stop Kasz from selling the hair products unless the firm submitted new drug applications and the products received FDA approval.

In court, Kasz argued that it had made no claims of therapeutic effect for Solutions 109, and thus the products were not drugs. Kasz said that, while promotional literature did include statements from third parties crediting Solutions 109 with hair restoration, the company only claimed that the products made hair fuller and thicker.

In granting the injunction, the court referred to Kasz's using third-party statements rather than its own as "linguistic game-playing." The court said that, because Kasz clearly intended people to buy Solutions 109 to treat or prevent hair loss, the products were drugs, regardless of the claims being third-party "testimonials." Judge Pettine said Kasz should have simply removed all references to hair growth in its promotions. "They have not done so," the judge said, "doubtless because they know that consumers will not purchase normal shampoo for the $ 100 price. now being charged for Solutions 109 unless they believe that it will grow hair."