FDA "cosmeceutical" regulatory class with premarket approval advocated by J&J researcher.

FDA "COSMECEUTICAL" REGULATORY SCHEME WITH PREMARKET APPROVAL ADVOCATED by Johnson & Johnson Consumer Products Worldwide VP-Research & Development Geert Cauwenbergh at a 1996 HBA Global Expo symposium on the future of skin care in New York City June 3. Predicting that FDA will address the regulatory issue of "cosmeceuticals" in the next five years, Cauwenbergh suggested that three "key" requirements be established as part of a cosmeceutical approval process.

The requirements are essentially the same as those for drugs. In addition to needing "approval of specific claims prior to marketing," Cauwenbergh suggested that cosmeceutical manufacturers demonstrate claimed effect and submit a "solid safety profile" for approval. The development and approval time for a cosmeceutical, however, would be considerably less than for drugs, he said: 1-3 years compared to the 6-10 year timeline for NDA approvals.

Cauwenbergh defined cosmeceutical as a product "not intended to treat or prevent diseases, but with an effect aimed at improving function and appearance of the skin."

He explained that there are four categories of cosmeceuticals: "known natural substances," such as vitamins A, C and E and alpha hydroxy acids; drugs used at lower-than-monograph levels to affect cosmetic conditions (i.e. ketoconozole for dandruff); new synthetic molecules designed for use as cosmetic drugs; and "close cousins of registered drugs."

Addressing the need for a cosmeceutical regulatory class, Cauwenbergh pointed out that "recent events," such as the approval of J&J's Renova as an antiwrinkling agent "have increased awareness that the current [regulatory] situation is unrealistic." FDA needs to either create this new regulatory class, called cosmeceuticals or medicocosmetics, he said, or "change...the definition of drugs and cosmetics."

FDA's approval of Renova has "created a shock wave in the cosmetics industry," largely because wrinkling and photoaging are not diseases, Cauwenbergh explained. He also cited AHAs, retinoic acid and sunscreen actives as ingredients that fit into the same category on this issue.

With regard to the cosmetics/pharmaceutical industries' acceptance of a cosmeceutical regulatory class, Cauwenbergh stated that views vary depending on the structure of a company, a company's size, its testing capabilities and the size of a company's skin care business.

He noted that in general, companies that focus on pharmaceuticals would favor some regulation whereas consumer products companies would prefer less regulatory activity.

In addition to a lack of industry consensus, Cauwenbergh noted that other factors might create resistance to a new regulatory scheme that recognizes cosmeceuticals. The need for toxicological testing, the role of the dermatologist, and a possible "lack of interest" from the regulatory agency are potential stumbling blocks.

Cauwenbergh also assessed the status of cosmeceuticals in Europe and Japan. The cosmeceutical category in Europe is not recognized by health authorities, he said. However, he noted that the concept was legalized to an extent by the EU in the 1994 directive. He predicted that Europe will either continue under its current regulatory status or adopt a quasi-drug category like that found in Japan.

The Japanese regulatory system includes three categories: drugs, cosmetics and quasi-drugs, which have "well-defined" approval requirements, Cauwenbergh stated. The approval time for quasi-drugs in Japan is half that of the drug approval process, including registration, he said. Noting that Japan's system may serve as a regional regulatory example, Cauwenbergh indicated that there is a "potential risk for overregulation" in that country with little chance for change.