Combination Oral Health Care Products Safety Defended By Industry

Marketing of combination oral health care products should be permitted in the antigingivitis/antiplaque final monograph, according to the Joint Oral Care Task Group of the Consumer Healthcare Products Association and the Cosmetic, Toiletry and Fragrance Association. The group submitted comments to FDA on the subject Nov. 25.

The combination of an antigingivitis/antiplaque ingredient with an anticaries ingredient, a tooth desensitizer or anticaries and tooth desensitizer ingredients has been demonstrated to be a "safe, effective and rational oral health care combination" by FDA's Dental Plaque Subcommittee, the task force explains.

"There is no legal or regulatory constraint that prevents FDA from adopting this recommendation of the subcommittee," the industry group asserts, adding, "There is no scientific basis for rejecting the subcommittee's dental expertise."

FDA excluded the combination of antigingivitis/ antiplaque ingredients with other oral health care ingredients in the advance notice of proposed rulemaking published in May (¹ (Also see "Antigingivitis/Antiplaque Combination With Other Actives Excluded In ANPR" - Pink Sheet, 2 Jun, 2003.), p. 3). The agency cited a lack of marketing history for such combinations and noted no products were submitted to the committee for review.

The task group, however, argues that at least five oral care products were submitted for review to the FDA subcommittee, and four were for combination antigingivitis/antiplaque and anticaries use. Among the products reviewed with antigingivitis/antiplaque and anticaries ingredient combinations were Church & Dwight's Mentadent P Toothpaste, Arm & Hammer Dental Care Toothpaste, Arm & Hammer Dental Care Toothpowder and Colgate-Palmolive's Viadent Toothpaste.

In addition, there is no legal regulation prohibiting FDA from accepting new conditions of use, as long as the products are safe, effective and not misbranded, the task force adds.

No "FDA regulation, compliance policy guide, speech or an other official FDA document has ever taken the position that every condition of use set forth in an OTC drug monograph must be traced and documented to a product that was marketed prior to the OTC Drug Review," the CHPA/CTFA group says.

There are several cases when new combination ingredients have been declared safe even when they have never before been marketed, the task group states, pointing specifically to the cough/cold category.

The marketing of combination products is in the public's interest, as reducing plaque and gingivitis, tooth sensitivity and dental caries are all dental health priorities, the group adds.

"There is no possible medical, dental or public policy reason for forcing these products to be sold separately," the task force maintains. In support of combination products, FDA permits the combination of an anticaries ingredient with a tooth desensitizer ingredient on an expedited basis, the group points out.

Pfizer's Warner-Lambert consumer products group has been trying to gain FDA approval for a Listerine oral rinse that would carry both anticaries and antigingivitis/ antiplaque claims (² (Also see "FreshBurst Listerine Study Must Exhibit 20% Gingivitis Reduction – FDA" - Pink Sheet, 2 Sep, 2002.), p. 14).

Separately, the task force recommends products labeled with cosmetic-related plaque claims should be regulated as cosmetics, not drugs as mandated. The proposed rule requires an OTC drug making reference to plaque reduction or prevention "must demonstrate a clinically significant effect on gingivitis."

"Use of the term 'plaque' does not in and of itself cause the product to be a drug," the task force asserts. "In general, the plaque claim needs to be reviewed in the context of the product's full labeling to determine the intended use of the product."

A product making antiplaque claims can offer drug and/or cosmetic benefits, according to the group. For example, drug benefits would include treatment and/or prevention of gingivitis, while cosmetic benefits include cleaner teeth.

Classification should be determined by a product's "intended use" based on its claims. A product should be categorized as a cosmetic if it makes no claim to prevent or treat disease, the group says.

While the majority of the task group member companies support cosmetic plaque claims, Colgate-Palmolive holds a differing view, which it plans to address in separate comments to the agency.

The CHPA/CTFA task force also requested a number of labeling changes.