The Environmental Health Network of California
Files Petition With the FDA

MCS: HEALTH & ENVIRONMENT

                                                   a support group for the chemically sensitive

June 11, 1999

Dockets Management Branch
Food and Drug Administration
Department of Health and Human Services, Room 1-23
12420 Parklawn Drive
Rockville, MD 20852-1745

Re: DOCKET #99P-1340/CP1

Dear Sir or Madam:

I am write about a public health matter that affects not only the thousands of people who are chemically sensitive but those with asthma and chronic fatigue; the elderly and the very young; those undergoing chemotherapy; and many Gulf War Veterans. We are all affected by synthetic chemicals in fragrance products. "Dear Abby" has published several letters (probably representative of many more) from people who experienced headaches or respiratory difficulties from inadvertent exposures to fragranced products. In 1989 a New York woman sprayed with a perfume by a Bloomingdale's salesperson won her lawsuit against the store, after she spent eleven days in a hospital in critical condition.

The above petition asks for a much-needed warning to potential users of at least one fragrance. Though most of us know that cosmetics are the least regulated of those substances under the jurisdiction of the FDA, several of your regulations do apply: 21CFR Sec. 740.1, 21CFR Sec. 740.2, and 21CFR Sec. 740.10. The latter states:

Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing. Any such ingredient or product whose safety is not adequately substantiated prior to marketing is misbranded unless it contains the following conspicuous statement on the principal display panel: "Warning--The safety of this product has not been determined."

The petition shows that Eternity contains toxic ingredients and ingredients whose safety have not been substantiated, yet there is no warning label on its packaging. How are we to know which fragranced products may have adverse effects on our health if there are no warning labels?

The list of perfumes that have given me severe headaches when worn by other people (I cannot always find out what they are, of course) includes Eternity, Cartier, Georgio, Pablo D 30086, Country Polo (by Ralph Lauren), Fred Hayman 273, Amethyst, Paul Sebastian men's perfume, Xeryus cologne, and Nivea Balsam Shaving Cream. I doubt that any of them carry warnings. I shudder to think what encounters with such fragrances are doing to babies.

Please help prevent such reactions in the millions of people who are exposed to these untested, unlabeled substances every day, at home, at work, at school, at social gatherings. Thank you.

Sincerely,

Lynn Lawson, Chair, Public Relations