To: FDADockets@OHRM-MAIL@FDAOC From: Certify: N Subject: Comments on Docket no. 98-N-0339 Date: Monday, September 14, 1998 at 12:17:10 pm EDT Attached: PUBLIC~2.DOC Dear Sirs: Attached are the comments of the Independent Cosmetic Manufacturers & Distributors (ICMAD) regarding question 6 on the agenda for the Puclic Meeting September 14, 1998 on Section 406(b) of the FDA Modernization Act of 1997. Hard copy of these comments will arrive on Wed., Sept. 16th. Penni Jones Executive Director. Public Meeting on Section 406(b) of the FDA Modernization Act of 1997, September 14, 1998, 9 A.M. to 5 P.M. [Docket no. 98-N-0339] e mail address: FDADockets@bangate.fda.gov Question 6: Would it be appropriate for the agency to sanction the use of an FDA seal or mark on products that meet the 'gold' standard as a way of encouraging more widely behavior that meets the standard? Should FDA charge user fees to third parties and others who use the seal as a way of financing agency operations? Comments from the Independent Cosmetic Manufacturers & Distributors, Inc. (ICMAD): Representing 660 small entrepreneurial cosmetic companies, ICMAD opposes the award of an FDA seal or mark that meets the "gold"standard. Putting an FDA seal or mark would discriminate against small businesses that lack the resources of larger companies. It would be deceptive in implying that products without the seal are somehow unworthy of FDA approval. Moreover, a program of this nature would give the agency too much discretion to make awards on what will inevitably be highly subjective criteria. ICMAD also opposes charging user fees to those who use the seal. Such fees would discriminate in favor of large, wealthier companies. It would discourage meritorious companies from applying for the seal. In considering any user fees, it is imperative that the agency assess the impact on small business before any proposed implementation. Adequate funding for FDA Offices within CFSAN (such as the Office of Cosmetics & Colors) should be funded by Congress, not user fees. Protecting the U.S. consumer with adequate funding should be a top priority for the 105th Congress. Since its inception 25 years ago, ICMAD has worked diligently to provide information and assistance to help our members follow and comply with FDA regulations. Since 1983, we have co-sponsored with the agency cosmetic education workshops all over the United States. These workshops have informed and educated our members and non-members alike on what they should and should not be doing regarding labeling, packaging, claims and overall cosmetic industry regulations. The cosmetics and personal care product industry has always been characterized by vigorous entrepreneurial activity. This vibrant segment of the economy has done a remarkable job over the years in working with the FDA to achieve a high level of self-regulation so that the consumer is offered a wide array of safe, useful, and constantly evolving products. The overall benefits from this atmosphere of self-regulation with FDA oversight are reduced regulatory burdens and reasonable freedom to create new and innovative products for the benefit of the consumers. Page 2 Establishment of any FDA seal program would depart drastically from this path and devastate the small, creative entrepreneurial companies that lead the way in pleasing the consumer. User fees would have to be coupled with some amount of product registrations. This could lead to a defacto system of premarket approval for cosmetic products and all the increased costs that such a system would involve. New cosmetic products are introduced in large numbers all the time. If the rate of new product introductions remains the same, the administrative burden on FDA to review products would be huge. If the product registration and user fee program results in a significant decline in new product introductions, then both the consumer and the industry would suffer. The FDA in the meantime would not have achieved any significant benefit for either themselves or the consumer. Competition in the industry would also suffer. Aside from a current funding situation, there are at present no problems that point to a need for a gold standard program or imposition of a user fee .The funding problem should be addressed by Congress - not by a gold standard program filled with costs and unfairness. The consequences of further costs and regulatory requirements for compliance with FDA regulations will erode the cooperative efforts that have been built over decades between the industry and the FDA. A user fee program is in essence a tax imposed on small companies disproportionately. The effect would be to give large companies an unfair and unneeded advantage in the marketplace. Again, this would dampen the creativity and viability of the industry as a whole. Successful small companies either grow into large companies, or they are acquired by the larger companies. In either case, they contribute to the growth of the U.S. economy and the workforce. The relationship between the FDA and the cosmetics and personal care industry has been a long and fruitful one for everyone concerned. The industry continues to grow while the consumer has a vast array of clearly labeled safe products from which to choose. The FDA in the meantime benefits from the substantial level of self-regulation the industry imposes on itself by not needing a massive staff to enforce onerous regulations on this part of the economy. A seal program and user fees will most likely damage this relationship, eroding the FDA's credibility as well as the credibility of the industry both nationally and internationally. Submitted by The Independent Cosmetic Manufacturers & Distributors, Inc. (ICMAD), 1220 West Northwest Highway, Palatine, IL 60067. E mail: PICMAD@aol.com; Phone 1-800-334-2623.