Stakeholders Meeting
Washington, DC
January 22, 1999
MEETING SUMMARY
BACKGROUND
On January 22, 1999, the Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN), Office of Cosmetics and Colors, convened a public meeting to solicit input on priorities and strategies for its cosmetics program. This meeting gave the public an opportunity to provide comments on the priority-setting process, in view of funds specifically provided by Congress for the Agency’s cosmetics program, which had been significantly reduced in Fiscal Year 1998. It was also one of the many activities undertaken by the Agency to solicit input in accordance with Section 406(b) of the FDA Modernization Act (FDAMA) of 1997.
INTRODUCTION
Dr. John E. Bailey, Director of CFSAN's Office of Cosmetics and Colors (OCAC), welcomed the attendees to the Cosmetics Program Stakeholders meeting. He said that OCAC staff would describe various activities conducted by the office and this would be followed by presentations from industry and consumer representatives. The purpose of the meeting was to provide the public with an opportunity for input and for FDA to listen to stakeholder concerns and suggestions about future program strategies.
Mr. Joseph A. Levitt, Director of CFSAN, said 1998 was a difficult year because FDA needed to reduce funding for the cosmetics program (e.g., program activities were reduced and a number of OCAC staffers were reassigned to food safety initiative activities). For Fiscal Year 1999, Congress has added an additional $2.5 million for cosmetic activities. Of this amount, $1.5 million would be allocated to CFSAN and $1.0 million would be used for field enforcement activities. Mr. Levitt acknowledged the efforts of the cosmetic industry in obtaining the funding increase for the FDA cosmetics program and indicated that these additional funds would allow CFSAN to re-shape and re-direct the cosmetic programs. The attendees were asked where they thought FDA should focus its direction. Mr. Levitt said a CFSAN priorities document would soon be issued and evaluated quarterly. One of the priority activities for OCAC is to work with stakeholders to solicit input on priorities and strategies for their programs.
OVERVIEW OF OCAC ACTIVITIES
Division of Science and Applied Technology (DSAT) - Dr. D. Adele Dennis, Director, DSAT, described the role of her office and activities carried out by her staff. These included: providing chemical and toxicological support to the program through laboratory studies and the development of analytical methods for cosmetic products, ingredients and color additives, conducting scientific reviews on cosmetic policy issues, and responding to consumer complaints or injuries reported to the Center.
Division of Programs and Enforcement Policy (DPEP) - Mr. Raymond L. Decker, Director, DPEP, described major activities in his division. These included: administration of the Agency’s color certification program, Certificates of Free Sale, the Voluntary Cosmetics Registration Program (VCRP), the Cosmetics Adverse Reaction Monitoring Program, and the Cosmetics web page. Mr. Decker said the resources for his Division was cut drastically last year and he is glad that resources will be restored. The Cosmetic, Toiletry, and Fragrance Association (CTFA) will be notified soon about reactivating the VCRP, which he hopes, will be fully operational by March 1999.
Special Projects - Dr. Stanley R. Milstein, Special Assistant to the Director, OCAC, described his role as a special assistant. He said one of his most important projects is working with CTFA on the International Cosmetic Ingredient Dictionary. FDA has been involved in the dictionary process for many years and reviews each monograph. The unique naming of ingredients is important for consumers to identify the products they are buying. This is a resource intensive process and FDA welcomes suggestions to improve the review process.
Compliance / Field Programs - Mr. Allen R. Halper, Senior Compliance Officer, discussed FTEs, projected inspections and samples planned for the domestic and import cosmetic compliance programs from 1995 - 1999. In 1998, field program activities were canceled. In FY 1999, however, $1.0 million has been directed back to the cosmetic program and will be used to provide 2.7 FTEs for domestic field activities and 2.9 FTEs for import field activities. Proposed activities include microbial contamination of products, illegal colors, and bovine-derived ingredients. Mr. Halper asked for input on where priorities should be for the program.
Dr. Bailey discussed highlights from the June 1998 CFSAN stakeholders meeting. Major themes that emerged for non-Food Safety Initiative programs included:
PRESENTATIONS
Cosmetic, Toiletry, and Fragrance Association (CTFA) - Mr. Edward Kavanaugh, President, CTFA, presented five issues of concern:
(1) CFSAN Resources and Enforcement - CTFA supports the restoration of resources by Congress and feels a strong FDA enforcement presence is needed. CTFA will continue to support additional funding for FDA but only if the cosmetic program remains in CFSAN. In 1997, there was a proposal to move the cosmetics program to FDA’s Center for Drug Evaluation and Research and CTFA was opposed to that plan.
(2) Cosmetic Ingredient Review (CIR) - The CIR was founded at the suggestion of FDA to evaluate the safety of cosmetic ingredients. The activities of the CIR are carried out under the same rules as FDA Advisory Committees. Mr. Kavanaugh feels the work of the CIR has saved FDA millions of dollars. In 1999, three significant changes are planned:
(3) International Harmonization - CTFA feels CFSAN should expend significant resources in this area and feels this is an important role for OCAC. Resources are needed, for example, to participate in international meetings and work to harmonize labeling.
(4) Voluntary Cosmetics Registration Program (VCRP) - CTFA has sent a letter requesting this program be made more efficient for both FDA and industry and suggests streamlining the process. Industry has been criticized for not fully participating in this program. Additional information on use levels would be beneficial to the CIR. CTFA offered to work with FDA to modernize Parts 1 and 2 and asked that FDA defer the VCRP until the program is modernized. Mr. Kavanaugh asked if Dr. Bailey would consider announcing this at the CTFA meeting on February 2, 1999.
(5) Agency Communication - CTFA thinks this meeting is positive but hopes that FDA will communicate more frequently and informally. CTFA feels the confusion about the voluntary program could have been eliminated if there was better communication.
Cosmetic Ingredient Review (CIR) - Dr. Alan Andersen, Scientific Director of the CIR, reviewed the current team members of the expert panel and described procedures of the CIR for the scientific assessment of cosmetic ingredients. The panel includes three physicians and four scientists as voting members and three non-voting members; one from FDA, one from the Consumer Federation of America, and one from CTFA. Dr. Andersen said that of the 798 ingredients that have been reviewed, 55% are considered "safe as currently used" and 45% are considered "not safe as currently used." (Note: of the 45% considered "not safe as currently used," 32% are classified as "safe with qualifications," 12% have "insufficient data," and less than 1% are considered "unsafe"). The "not safe as currently used" ingredients are of most interest to FDA.
Dr. Andersen noted that the FDA can rely on CIR decisions and recommends the appointment of a formal FDA liaison to the CIR to interact with the expert panel. This would give FDA the opportunity to present its concerns to the panel early and often. When FDA can rely on CIR conclusions, this is work that FDA will not have to do and will be able to maximize use of its scientific resources for other issues.
Independent Cosmetic Manufacturers and Distributors, Inc. (ICMAD) - Ms. Penni Jones, Executive Director, ICMAD, described her organization as the "voice of small cosmetic businesses" and presented background information about her organization. ICMAD believes that FDA is needed to "keep a level playing field" and relies on FDA to provide regulatory information to its members. ICMAD co-sponsors education workshops on labeling and other regulatory matters, and has printed and distributed the "Cosmetic Handbook" because FDA lacked the funds. She is pleased that $2.5 million has been restored but feels $5 - 6 million are needed for the program. While cosmetics are among the safest products in the world, she feels that when concerns do arise, FDA is needed to address safety and labeling issues. Ms. Jones said that consumers rely on FDA to assure that cosmetic products are safe.
ICMAD supports resumption of the VCRP without delay and endorses the changes suggested by CTFA that the forms for the VCRP be streamlined. ICMAD also feels that the CIR process should be strengthened. Ms. Jones suggested that OCAC should: reactivate its in-house research and testing program; be available to answer questions from industry and consumers and maintain leadership in the international community (e.g., provide more funds for FDA scientists to interact abroad).
Mr. Howard Baker, ICMAD member, discussed how he answers questions from members on compliance with FDA regulations. Many ICMAD companies are small businesses that hope to grow into the new Revlon or Estee Lauder companies. Mr. Baker said FDA regulations not only provide the framework for doing credible business but for providing a level playing field for all competition. ICMAD looks to FDA to provide a credible structure - e.g., what ingredients can be used, proper labeling requirements, and how products are produced and sold. Mr. Baker believes that if FDA were not strong, there would be more consumer complaints. A weakened FDA presence would also be felt outside the U.S. FDA needs to continue to work with the European Union to harmonize regulations. ICMAD encourages a strong FDA presence, and encourages FDA to answer regulatory questions to provide sound advice to industry.
Consumer Federation of America (CFA) - Ms. Mary Ellen Fise, General Counsel for CFA, a non-profit consumer advisory organization, is also the consumer liaison on the CIR. She applauded FDA for holding this meeting and for protecting the American public. CFA wants FDA to have a strong enforcement program and had comments in the following five areas:
(1) Enforce existing CIR conclusions - CFA feels the most important priority is for FDA to review the existing CIR conclusions and enforce those conclusions. The CIR has determined that 45% of the ingredients reviewed are "safe with qualifications" and CFA maintains that these ingredients are unsafe because the CIR can’t say they are being used according to their recommendations. She asked FDA to look at these ingredients.
(2) Cosmetic Ingredient Review (CIR) - CFA supports the CTFA changes to open up meetings to the public, limit terms served by members and add an EU liaison. Because the concentration of use data is important for the panel, the resumption of the VCRP is good even though changes are needed in the way information is reported. CFA disagrees with CTFA’s suggestion to delay the voluntary reporting program because changes could take up to one year to complete and FDA should continue to collect information during this time.
(3) Adverse Reaction Monitoring - CFA supports mandatory reporting by cosmetic companies of consumer complaints. Severe adverse reactions should be reported immediately and non-severe reactions should be reported semi-annually.
(4) Consumer Information and Education - CFA believes that FDA should require more mandatory information on labels and invoke CIR conclusions. While Agency communication is needed, the burden should be on industry to provide information to the public.
(5) International Issues - CFA is concerned about CTFA wanting to redefine sunscreen and over-the-counter cosmetics products. CTFA has said it doesn’t want to lower the level of safety for U.S. consumers and she is glad to hear about CTFAs dialogue with the EU. A strong FDA presence is needed on international discussions on health safety.
National Coalition of the Chemically Injured (NCCI) - Dr. Lawrence Plumlee, a physician and member of NCCI, said his organization is working with people with increased sensitivity to chemicals, including cosmetics and fragrances. NCCI believes chemicals are causing sensitivity to the nervous system and asked FDA and industry to look at these chemicals. Dr. Plumlee mentioned several studies and books that have been written on this subject and referred to organizations that are looking at this problem. In one study, 10% of a random sample of over 1000 rural North Carolina residents complained that they developed symptoms of illness when exposed to perfumes. He said he appreciated FDA’s work on collecting adverse effects and injuries, and urged OCAC to strengthen this program by making the brand names of the responsible products available on the CFSAN web page.
Dr. Plumlee said he believes FDA’s major role is to "protect public health" and not to "encourage consumer confidence." This can be done in part by keeping the public aware of injurious cosmetic brand names. Chemical sensitivity, according to Dr. Plumlee, is studied much less than natural allergens. He said that FDA needs to understand why approximately 10% of the U.S. population is complaining about chemical sensitivity. Dr. Plumlee noted that many chemically sensitive patients experience disruptions of their endocrine system and said traditional toxicological studies do not identify neurotoxins and endocrine disruptors. Dr. Plumlee said that most physicians would not come forward with information on this topic unless approached by FDA.
Betty Bridges, RN (Individual) - Ms. Betty Bridges is an individual with allergy sensitivities. In 1988, she developed a sensitivity to fragrances used in a cleaning product. Asthma medications had limited benefit or she did not tolerate the side effects. Avoidance became her primary means of preventing illness but this is difficult because of the widespread use of fragrance products. Ms. Bridges has had products analyzed and has undergone "challenge tests" trying to pinpoint the specific material that caused her problem in hope that allergy shots would be available. When she found a specific fragrance that caused a severe reaction, she found out there are no allergy shots for chemical sensitivities. In October 1997, Ms. Bridges put up a web site of information on fragrances that can cause health problems and to gather available information.
Gathering data on the actual incidence of fragrance-induced health problems is difficult. While the Research Institute for Fragrance Materials (RIFM) tests skin effects, fragrance materials are not required to be disclosed on labels because they have trade secret status and no pre-market approval or safety testing is required. Ms. Bridges stated that asthma rates have increased recently and suggested there is a connection to fragrances. She said that studies need to be done to determine if fragrances are the cause of some respiratory problems. Ms. Bridges would like industry to: collect and report complaints; establish a program to identify materials that cause adverse reactions while protecting trade secrets; test fragrance material both individually and in common combinations; establish the safety of products targeted toward children; and study the effects of fragrances on health.
CONCLUSIONS/WRAP-UP
Dr. Bailey provided comments on the following topics:
(1) Enforcement/Compliance - Dr. Bailey said enforcement and compliance activities usually mean an FDA presence in the industrial setting. While cosmetic inspections have been a low priority for the Agency in recent years, with the resumption of funding, the FDA might be able to restore activities in this area and/or consider alternative approaches. The range of options could include the use of the traditional inspection, the initiation of a "HACCP-type" program, the development of Good Manufacturing Practice (GMP) regulations or the use of third party inspections.
Dr. Bailey noted that this topic could be considered at a later meeting. He stated that when considering options, Stakeholders need to remember the cosmetics industry generally has less significant health or safety concerns then other regulated commodities and might be amenable to alternative approaches.
(2) Cosmetic Ingredient Review (CIR) - Dr. Bailey complemented the presentations on what the CIR does and how it works. He is encouraged by steps taken to get greater FDA involvement and he will respond by letter to CTFA’s proposal to strengthen the program. Dr. Bailey addressed the following topics:
(4) Communication - This is an important but under-utilized part of the program. Meetings like this are good to find out what is important, but FDA needs to keep in touch with industry and consumers on a regular basis to determine what is relevant to them. Industry needs to remember that FDA’s mission and primary responsibility is as a public health agency.
(5) International Harmonization - This is a problematic area since other countries have an impact on FDA-regulated products that may present public health issues.
Dr. Bailey reminded the attendees that written comments may be submitted to Mr. Charles Haynes through February 19, 1999. A summary of this meeting would be prepared and put on the CFSAN's OCAC web page for the record.
Subsequent to the Stakeholders meeting, the Agency received written comments from the following groups listed below:
National Coalition of the Chemically Injured (NCCI): Dr. Lawrence Plumlee's supplemental submission included an article entitled "Prevalence and Nature of Allergy and Chemical Sensitivity in a General Population" by Meggs et al (1996), Archives of Environmental Health, 51, 275-282 which concluded, in part, "... 4.1% of the general population suffered from daily or almost daily occurrences of symptoms from.... chemical sensitivity...".
Cosmetic, Toiletry, and Fragrance Association (CTFA): The trade association's supplemental comments included: 1. A desire that FDA becomes a leader on harmonization issues affecting cosmetics in the international community. 2. An urging that CFSAN/OCAC become an educator within the Agency, to those responsible for the regulatory requirements of OTC drugs, in an effort to make it clear that product safety will not be compromised and consumer health will benefit by granting exemptions to cosmetic-drugs from certain OTC drug labeling requirements. 3. A reserved welcome of the reinstitution of the Voluntary Cosmetics Registration Program (VCRP). CTFA urged the Agency to defer the resumption of the program until a joint industry/government program to modernize Parts I and II of the VCRP could be completed and suggested that FDA explore the feasibility of developing an electronic filing information system as part of the modernization. 4. A belief that additional expenditures on the safety testing of alpha hydroxy acids are not necessary, since the industry-funded CIR Expert Panel performed a thorough review of the ingredients and found them safe with recommendations.
The Agency also received written comments from thirty-seven (37) individuals concerning fragrance sensitivity, the adverse effects exposure to fragrances has created and how such chemicals should be regulated. Summaries of the texts for these comments follows:
CFSAN Priority-Setting Meeting Summary and Transcripts, June 1998