FDA Center for Food Safety & Applied Nutrition Director Joseph Levitt is seeking a "proactive" approach to international issues in place of the largely reactive actions of the past. In presenting the center's priorities at a Jan. 26 press briefing, Levitt said the center is looking to "set out more of a proactive agenda."

FDA international activities "are largely both very diverse and diffuse and very reactive," Levitt said. This attitude comes despite feedback from industry members that international harmonization was "really important" at the June CFSAN priorities meeting, he added.

International harmonization was also a topic of discussion at the stakeholders meeting on cosmetics Jan. 22. Office of Cosmetics & Colors Director John Bailey, PhD, reiterated Levitt's views, noting that international issues are "popping up" more frequently and are requiring greater demands on FDA's time. While noting international harmonization will be more of a focus than in the past, Bailey admitted "the agency is struggling with where to put this on the priority list."

"How do you meet some of the international harmonization issues in the context of a public health mission," Bailey asked. FDA has said it views international harmonization as a business issue, rather than a public health priority. The cosmetics director added, however, that ultimately there would be an intersection between international harmonization and the public health.

Resources for harmonization activities also need to be considered. The Cosmetic, Toiletry and Fragrance Association has suggested the cosmetics program dedicate one person from the Office of Cosmetics & Colors to international efforts who could attend meetings and field questions.

In addition to the resources required for international issues, FDA said it wants to ensure agency centers and headquarters collaborate on harmonization efforts as a way to remain knowledgeable about all FDA initiatives and not overlap responsibilities.

Industry representatives encouraged FDA to become more involved in the international arena. "CFSAN should direct significant resources to this effort," CTFA President Edward Kavanaugh stated.

"It's important that FDA become the leader in achieving as much harmonization as possible in product approval, product labeling and product formulation," the exec added. A strong FDA effort "will pay major dividends in promoting consumer safety and well-being by creating an efficient, worldwide system for the delivery of safe and beneficial products."

Independent Cosmetic Manufacturers & Distributors Executive Director Penni Jones agreed, stating: "More funds need to be allocated to allow FDA scientists to interact abroad in the decision-making process in order [for] American companies [to] compete globally." She said the restoration of $2.5 mil. to the Office of Cosmetics & Colors is not enough and called for an additional $2.5 mil. to $3 mil.

ICMAD VP Howard Baker noted harmonization is especially important in light of the unified European community, which puts in question FDA's place "as the undisputed leader" in the regulatory arena. EU "regulations currently being implemented and developed may offer a tempting alternative to our FDA regulations as a worldwide benchmark." Baker continued: "FDA must continue to keep its regulatory status in the worldwide marketplace" by working with the EU to harmonize both sets of regulations.

Kavanaugh maintained FDA should not "inadvertently pose requirements that will act as a barrier to international harmonization." He cited cosmetic-drugs as an example. "There is certainly a growing concern that labeling requirements that may be imposed by FDA in OTC labeling proposals may cause significant barriers to harmonization," the CTFA exec said.

Consumer Federation of America General Counsel Mary Ellen Fise also voiced concern over cosmetic-drugs, saying that through harmonization initiatives, such as with TransAtlantic Business Dialogue, there might be some "backdoor rulemaking" where there is a quicker approval process but not to the same quality as FDA review.

CTFA asked TABD to consider exempting cosmetic-drugs from OTC labeling requirements at its upcoming June and December meetings ("The Rose Sheet" Dec. 7, 1998, p. 4). Bailey stressed that direct communication with TABD should be kept between FDA and its counterparts, adding industry requests would be considered at the discretion of regulatory bodies.

CFSAN's Levitt Vows "Proactive" International Approach

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