Cosmetics-Drug Labeling Exemption Proposed At TABD By CTFA

A proposal to allow labeling exemptions for cosmetics-drug products to help align the U.S. with the European cosmetics definition was put on the table at the Transatlantic Business Dialogue conference, held in Charlotte, N.C. Nov. 5-7.

As suggested by the Cosmetic, Toiletry and Fragrance Association, the proposal asks FDA to treat products such as sunscreens, antiperspirants and antidandruff shampoos as cosmetics for labeling purposes, CTFA VP-International Louis Santucci announced at the trade group's Nov. 1-4 scientific meeting in Montreal.

CTFA chose to go the route of labeling exemption rather than asking for a "hard, specific change" to the U.S. cosmetics definition, Santucci said, because it acknowledged the latter would require an even greater "long-term, uphill effort" to convince FDA. The trade group decided there are "other ways to accomplish something similar" to a definition change.

In addition to the labeling derogation, the U.S. and EU cosmetics industries have "identified a number of changes that ought to be made in both markets that we think will help business," Santucci said. TABD provides a forum to allow business leaders from the U.S. and EU in a variety of industries, from health care to automotive, discuss ways to improve trade between the two markets with an eye toward harmonization.

CTFA is also asking for uniform labeling requirements both between the U.S. and EU and within the Union, due to problems with 6th Amendment compliance in the member states, Santucci continued. Domestically, CTFA is proposing use of the +/- symbol in place of "may contain" and EU color index numbers, instead of U.S. color additive designations.

Finally, the trade group proposes FDA "speed up the approval in either market" of ingredients such as UV filters and colors additives, Santucci added. To that end, CTFA recommends "a mutual recognition agreement be entered into between the U.S. and EU whereby once an ingredient is approved in either market, you get some kind of expedited review in the other market."

He continued: "Hopefully, this will eliminate the problems like having Parsol 1789 sit around for 10 years waiting for approval in the U.S."

In 1990, Parsol 1789 supplier Givaudan-Roure petitioned FDA to reopen the OTC sunscreen review and approve use of the UVA absorber. The agency approved marketing of Parsol 1789 in 1997.

None of the proposals is new to the cosmetics industry; the international harmonization issues have been at or near the front of CTFA's priority list for a number of years. The trade group has been involved in ongoing discussions with FDA since about 1995.

Asked to respond to the idea of mutual recognition, FDA Office of Cosmetics & Colors Director John Bailey, PhD, said while "there are advantages to having a system which is very fluid from one market to another," the "difficulty comes in just those sovereignty issues, and that is, we operate under...laws [that] give us our basic responsibility for the products that are marketed in the U.S."

"Certainly we have a degree of latitude within these laws, but I think ultimately we run up against the limitations and latitude that we have," Bailey continued. At that point, "it becomes a question of whether or not for the U.S. and for the other countries is the sufficient course for Congress maybe to move things to a more harmonized approach."

While noting it will take time to sort out, the FDAer said that "the fact that harmonization showed up in FDAMA is a pretty good indicator of the relative importance to our lawmakers."

Bailey noted one issue "that has not surfaced, but I think surely will during the discussions, is the basic difference between the regulation of cosmetics and drugs in the U.S." He continued: "By my measure, FDA's oversight for cosmetics is far less than those in place or proposed for other countries, and this will certainly become an issue [to] approach [in] discussions about equivalency or negotiations relative to mutual recognition."

European Commission Directorate General III-Pharmaceuticals and Cosmetics Unit Administrator Lee Bansil said he basically agreed with Bailey, but added that, unlike the U.S., harmonization is a "major factor of [the Commission's] work program in the coming years."

From a standpoint of limited resources to regulate cosmetics in the EU - which is the case of the Office of Cosmetics & Colors - "it makes very good sense," Bansil said, explaining that otherwise, "we end up duplicating the work that's already been done under another administration."