Docket Number 99P-1340 . . . Safe and wholesome fragraFrom: Barbara Wilkie [wilworks@lmi.net] Sent: Tuesday, June 29, 2004 7:34 PM To: fdadockets@oc.fda.gov Subject: Docket Number 99P-1340 . . . Safe and wholesome fragrances and fragrance ingredients? Note, this just found lurking in my outbox. Date: March 26, 2004 Dockets Management Branch The Food and Drug Administration Department of Health and Human Services, Rm. 1-23 12420 Parklawn Dr. Rockville, MD 20857 Re: Docket Number: 99P-1340 Petition the FDA Have Calvin Klein's Eternity eau de parfum declared "misbranded" VIA e-mail Dear FDA Staff: I've a question, based upon the findings of analyses that accompany FDA Citizens' Petition, Docket Number: 99P-1340, currently open: How can the fragrance industry claim that their products are safe and wholesome? The exact quote is "Providing the public with safe and wholesome fragrances and fragrance ingredients". The above from the branch of the multibillion dollar fragrance industry, whose mission it is to, and I quote [emphasis added]: Represent the collective interests of the U.S. fragrance industry. To this end, the Board has adopted the following objectives: Ensure the safety of fragrance materials; Proactively engage in the development of international, federal and state laws; Reduce barriers to international trade; Preserve our ability to self-regulate; Assist members with regulatory compliance; and Protect proprietary information. Ensure the safety of fragrance materials Endorse the Research Institute for Fragrance Materials (RIFM) research program; adhere to the International Fragrance Association's (IFRA) safety guidelines. Enforce FMA's self-monitoring program. Proactively engage in the development of international, federal and state laws Take action to advance the interests of our industry through legislative and regulatory initiatives and related actions. Cooperate with international, national, trade organizations and associations to promote the interests of the fragrance industry. Reduce the barriers to international trade Support legislation and regulations that advance global commerce. Cooperate with national and international trade and standards organizations and associations. Promote harmonized global tariffs, safety assessment methods and standards/specifications. Serve as the industry spokesperson on questions about fragrance materials. Preserve our ability to self-regulate Endorse the RIFM research program; adhere to the IFRA's safety guidelines. Cooperate with our customers' trade associations in promoting the safety of our products. Take action to preserve self-regulation in the face of legislative and regulatory initiatives. Enforce FMA's self-monitoring program. Serve as the industry spokesperson on questions about fragrance ingredients. Provide advice to members on how to comply with applicable laws and regulations. Assist members with regulatory compliance Provide advice to members on how to comply with applicable laws and regulations. Seek legislative and regulatory relief from burdensome laws and regulations. Protect proprietary information Ensure the safety of our products by supporting RIFM and IFRA. Take action to protect proprietary information from legislative, regulatory and related initiatives. Educate FMA members on the importance of protecting proprietary information. Serve as the industry spokesperson on questions regarding ingredients used in fragrances. Source pages: HomePage: http://www.fmafragrance.org/ Mission Statement: http://www.fmafragrance.org/sub_pages/gi_missionstatement.html Those "burdensome laws and regulations" don't yet exist to save public health. Right now, we the consumer, have to deal with the industry as a faith-based operation . . . I pray that their products don't kill me while someone else is using or wearing them AND the user better pray that he/she will not be developing cancer, Alzheimer's, Parkinson's, or even eczema, asthma, migraines, or need a lung plant for reasons the doctors can't fathom, et al., because of the chemical soup benignly called fragrance. According to the Dept. of the Interior's page, "Guidance and Training on Greening Your Janitorial Business CHAPTER 2: Traditional Versus "Green" Cleaning Products" at http://www.doi.gov/greening/sustain/trad.html . . . and its section: "A Sampling of Environmental Attributes for Cleaning Products" . . . Must not contain any carcinogens, mutagens, or teratogens designated by federal law. On this page and in this section you will also find: "Must not contain petrochemical-derived fragrances." It is a good thing DOI has that information, for our modern, petrochemical derived fragrances contain not just the chemicals listed on the first line, but those that are also, hormone disrupters, irritants, neurotoxins and sensitizers. Remember, these chemicals are in addition to the three categories listed on the first line of DOI's document. I am very much interested in learning what the FDA suggests will be the next and very important step, in informing the public. EHN has asked that you require your warning label on all fragrances released to market without substantiation of safety. That is the very minimum. The FDA should make public service announcements. Let the public decide if it wants to look for safer, fragrance-free products. The industry only tells us its products are safe and thoroughly tested. Yet, we don't have data on tests for effects upon inhalation, effects upon our brains and nervous systems, nor do we know the effects of these products over time, systemically or the effects on developing embryos and fetuses. Will the new law passed -- harming of a fetus is a federal crime -- do anything to curb the brunt of the chemical fragrance industry? Maybe that is one way to at least remove the teratogens. We ALL are stakeholders when it comes to breathing. Sincerely, Barb Wilkie 1241 Carlotta Ave. Berkeley, CA 94707 -- EWG petitions FDA, June 2004 Support Cosmetic labeling petition, Docket Number 2004P-0266 http://www.ewg.org/reports/skindeep/ EHN's fragrance petition, 99P-1340, remains open http://www.ehnca.org/FDApetition/bkgrinfo.htm