TOXICS INFORMATION PROJECT (TIP)

Liberty Goodwin, Director

P.O. Box 40572, Providence, RI 02906

Tel. 401-351-9193, E-Mail: TIP@toxicsinfo.org

(Lighting the way to Less Toxic Living)

REGULATION OF FRAGRANCED PRODUCTS

http://www.fpinva.org/Summary/regulation.htm

FDA: CFSAN: Office of Cosmetics and Colors: Consumer Complaints About Cosmetic Products: http://www.cfsan.fda.gov/~dms/cos-comp.html During the period from January 1, 1999 through December 31, 2001 six hundred and ninety cosmetic complaints were filed with the FDA. Of these, 143 or over 20% were complaints about perfumes, colognes, and other fragrance preparations. The complaints to the FDA are filed according to the product type. Since most cosmetics contain fragrance, it is difficult to ascertain the actual number of complaints that are fragrance related. Of the complaints on fragrance preparations, 14 were reports of dermatitis, 83 were reports of neurological effects, and 67 were of reports of respiratory problems. In the previous 3 years (1996-1998) there were 17 complaints on perfumes, colognes, and other fragrance preparations. In addition there are hundreds of comments from people adversely impacted by others use of fragrance filed in response to FDA petition 99P-1340. These comments can be found by searching the FDA docket site using the search term "Eternity". http://www.fda.gov/ohrms/dockets/default.htm

The EPA's High Production Volume (HPV) data includes assessment of the availability of basic health and safety information. HPV chemicals are those that are imported or manufactured in the US at levels of 1 million pounds or more annually. The EPA has asked that industry volunteer to provide six areas of basic safety data on the chemicals. http://www.epa.gov/chemrtk/ushpvweb.pdf The HPV chemicals, sponsors and other information can be downloaded from: http://www.epa.gov/opptintr/chemrtk/volchall.htm There are 66 materials that have been sponsored by fragrance companies or consortiums. Of these materials 17 have no data, 3 have one set of data, 10 have two sets of data, 8 have three sets of data, 10 have four sets of data, 4 have five sets of data, 2 have six sets of data

Since fragrance materials do not have to be declared on the label, it is impossible to know which exactly what materials are in the product. This makes it extremely difficult to ascertain which material in a product is problematic. Patch testing to determine skin allergy to fragrance is available only for a few dozen materials.

21CFR720.1 http://vm.cfsan.fda.gov/~lrd/cfr720.html (d) Ingredients in the product should be listed as follows: (1) A list of each ingredient of the cosmetic product in descending order of predominance by weight (except that the fragrance and/or flavor may be designated as such without naming each individual ingredient when the manufacturer or supplier of the fragrance and/or flavor refuses to disclose ingredient data).

U. S. Food and Drug Administration: COSMETIC LABELING GUIDE

http://www.cfsan.fda.gov/~dms/cos-lab3.html#clgl4 The ingredient or mixture of ingredients acting as a masking agent, i.e., covering the undesirable off-odor of a product without adding a discernable odor to it, may be declared by their individual name(s) or as "fragrance" (in lieu of a better designation). A masking agent present in a product at an insignificant level may be considered an incidental ingredient under § 701.3(1)(2)(iii) in which case it need not be declared on the label.

Nitro musks in fragrance products: an update of FDA findings. (includes related article on self-regulation by the fragrances industry) Cosmetics and Toiletries June 1996; (v111 n6) Start Page: p73(4) ISSN: 0361-4387; Wisneski, Harris S., Havery, Donald C.

U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors Fact Sheet
February 3, 1995

FDA is only able to regulate cosmetics after products are released to the marketplace. Neither cosmetic products nor cosmetic ingredients are reviewed or approved by FDA before they are sold to the public. FDA cannot require companies to do safety testing of their cosmetic products before marketing. If, however, the safety of a cosmetic product has not been substantiated, the product's label must read "WARNING: The safety of this product has not been determined."

FDA does not have the authority to require manufacturers to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries. To keep abreast of such information, FDA maintains a voluntary data collection program. Cosmetic companies that wish to participate in the program forward data to FDA.

Recalls are voluntary actions taken by the cosmetic industry to call back products that present a hazard or that are somehow defective. FDA is not permitted to require recalls of cosmetics but does monitor companies that conduct a product recall. If FDA wishes to remove a cosmetic product from the market, it must first prove in a court of law that the product may be injurious to users, improperly labeled, or otherwise violates the law.

FDA collects cosmetic product samples as part of its plant inspections, import inspections, and follow-ups to complaints of adverse reactions. The agency does not, however, function as a private testing laboratory. FDA is prohibited from recommending private laboratories to consumers for sample analysis. Consumers may consult their local phone directory for testing laboratories.

FDA can inspect cosmetics manufacturing facilities, collect samples for examination, and take action through the Department of Justice to remove adulterated and misbranded cosmetics from the market. Domestic and foreign manufacturers must follow the same regulations. Foreign products that appear to be adulterated or misbranded may be refused entry into the United States.

FDA Petition 99P-1340 asks that the FDA enforce the requirement for a warning label on products in which the safety of the ingredients and the final product has not been substantiated. In spite of the fact the safety of many fragrance chemicals have not been substantiated, the FDA has not taken any action to enforce the law.

FDA Lists Perfume as Trigger for Asthma

Breathing Better: Action Plans Keep Asthma in Check
by Michelle Meadows
U.S. Food and Drug Administration
FDA Consumer Magazine
March-April 2003
http://www.fda.gov/fdac/features/2003/203_asthma.html

Common asthma triggers include dust, pollen, cockroaches, cold air, smoke, and other strong odors, such as paint, cleaning fluids, perfume, hair spray, and powder. For some people, the problem is animal dander, flakes of skin and dried saliva from furry or feathered animals. For others, asthma can be triggered by medication, such as aspirin, or sulfites, preservatives used in food.

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U. S. Food and Drug Administration Center for Food Safety and Applied Nutrition Office of Cosmetics and Colors Fact Sheet February 3, 1995

U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors Fact Sheet
February 3, 1995