Magazine article Drug Topics

Tooth Whiteners White Hot despite Heat from FDA; Tooth Whitener Sales Bring Smiles to Retailers

Magazine article Drug Topics

Tooth Whiteners White Hot despite Heat from FDA; Tooth Whitener Sales Bring Smiles to Retailers

Article excerpt

Tooth whiteners and other antistain dentifrices have shown explosive growth in the past two years. Sales vaulted to $63 million in 1991, up 72% from $36.6 million in 1990, said New York market researcher Towne-Oller & Associates.

The influx of tooth whiteners onto the market has caught the attention of the Food & Drug Administration. Last October, the agency sent out warning letters to manufacturers pointing out that it considers products that depend on bleaching to be new drugs. As a result, it said, they cannot be marketed legally without agency approval.

Marketers were given 15 days to notify FDA of the steps they have taken to comply with the law. Those that failed to comply would face possible regulatory action, including seizure or injunction, said FDA spokeswoman Sharon Snider.

To comply, manufacturers would have to submit their scientific data to FDA for review. Usually, when a new drug is being approved, long-term clinical studies that take two to three years are involved, noted Snider. "I don't know if any of the manufacturers have done that kind of study," she said.

Despite the FDA's warnings, several manufacturers are coming out with new products--and they have at least one support group. The National Tooth Whitener Coalition has declared that tooth whiteners sold in retail stores, using 3% hydrogen peroxide, do not alter tooth structure and have proved to be as safe as most toothpastes.

The coalition, organized by two marketers--CCA Industries (Plus + White) and Dental Concepts (Doctor's Teeth Whitener)--said the FDA's 1988 Tentative Final Monograph for Oral Health Care Products for Over-the-Counter Human Use concluded that a 3% hydrogen peroxide solution was safe for oral use as a wound cleanser and debriding agent.

A check around by Drug Topics found that CCA Industries in East Rutherford, N.J., has not received a letter from the FDA and doesn't expect one. Its Plus + White contains 3% hydrogen peroxide, "so we have been complying with the FDA monograph from the beginning," said Dunnan Edell, executive v.p.-marketing. "We have also done very thorough tests...(that) show our Plus + White is totally safe and effective."

CCA Industries offers a one-step product--Plus + White One Step Teeth Whitener Gel in 2-and 1/2-oz. sizes--and a three-step Plus + White Program, both with 3% hydrogen peroxide. In addition, the company recently expanded its Plus + White brand to include an Anti-Stain Fluoride toothpaste and an Anti-Stain oral rinse. Both started shipping in January.

The two new products will be backed by TV advertising, according to Edell. "We are presently running prime-time network TV for our Plus + White Teeth Whitener," he said. "We'll add advertising in May for the Anti-Stain products."

Out West, in Rancho Dominguez, Calif., Dep Corp. reported it has launched Topol Mega White, a three-step tooth whitening system. Senior marketing manager Randy Hart, who said shipping for that product began in January, noted that "we have never received any communication from the FDA." At any rate, the impact "hasn't been reduced sales" so much as some retail accounts' reluctance to add any more whiteners to their shelves until the FDA makes a decision.

Dep believes consumers are waiting for a familiar name, especially one associated with whiter teeth. "That's what Topol has been for more than 20 years," Hart noted. …

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