To petition the FDA is to make a formal request for the FDA to take action. The action can be pretty much anything ... a new law, approval of an food additive, and in this case action against specific product.

If Eternity is declared "misbranded" it would mean it is not properly labeled. This would mean a warning message would have to be added to the label. While this may seem trival, it would be a major embarrassment to the fragrance industry to have to admit their products have not been tested for safety.

However, we cannot assume this petition will prevail. The politics and money involved is too great ... UNLESS this catches media attention and becomes a very public issue.

Most of the time it takes repeated attempts before any changes are made. It is all part of a very long process to make people aware so they put pressure on the system to make changes. Slow, tedious, and frustrating.

There are faster ways ... high profile law suits, someone dying from an exposure (not volunteering for that), discovering the use of a chemical that is banned, or finding a chemical that is extremely toxic, etc. But these things either require a lot of money or a stroke of luck ... which we can't count on.

-- Betty Bridges, RN
bcb56@ix.netcom.com
http://www.fpinva.org

EHN's FDA petition asks that our government agency -- the FDA -- follow the regulations already in place on its books to require warning labels on fragrances released to market without adequate testing. Products that have not been adequately tested and released that don't carry the warning label or considered by the FDA "misbranded." And that, my friends, is the beauty AND importance of this petition. The reason we petitioned the FDA in the way we did is spelled out in the FDA's Authority Over Cosmetics (http://vm.cfsan.fda.gov/~dms/cos-206.html).

While the FDA has the requirement for warning labels, it does not enforce it. Products are released to market without the prescribed warning label. Those products should then be declared "misbranded." That has not happened.

The analyses of six scents discovered a tremendous number of individual chemicals about which toxicological data is not known. The analysis of one of those six has the chemicals discovered in a table format with a brief comment regarding the toxicological information discovered in MSDS (Material Safety Data Sheets), when available. What we have found is that some of the chemicals used in fragrances are known irritants and sensitizers, and others are known or suspected carcinogens, neurotoxins (affecting the central nervous system) and teratogens (adversely affecting embryonic and/or fetal development). See http://www.ehnca.org/www/FDApetition/analysis.htm

Tens to hundreds of these chemicals are combined to make any one scent. The industry has a repertoire of between 3,000 and 5,000 chemicals. Synthetic fragrances -- not just plastics -- also contain phthalates. I believe that FDA Petition 99P-1340 clearly shows that the safety of synthetic scents has not been substantiated.

Let's take a closer look at the FDA's "authority." What the FDA can do is to follow the regulation already on its books. While the "FDA cannot require companies to do safety testing of their cosmetic products before marketing," it can require a warning label; it simply does not. The FDA states: "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.'"

What the FDA cannot do benefits the fragrance industry, not public health. You've already learned the FDA cannot require safety testing before marketing. The FDA also states (emphasis added):

"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.

Source: http://vm.cfsan.fda.gov/~dms/cos-206.html

There's additional information about cosmetic labeling on "FDA's Food and Cosmetic Regulatory Responsibilities - A summary of the legal requirements affecting manufacture and distribution of food and cosmetic products within and imported into the United States at http://www.cfsan.fda.gov/~dms/regresp.html and COSMETIC LABELING MANUAL at http://www.cfsan.fda.gov/~dms/cos-lab1.html where it states, under the subhead -- ADULTERATED OR MISBRANDED COSMETICS -- "A cosmetic is misbranded if its labeling is false or misleading, if it does not bear the required labeling information, or if the container is made or filled in a deceptive manner."

So folks, check this out for yourselves. If you feel that you deserve scented products proved safe BEFORE marketing, or at the very least carry the FDA required warning label, "WARNING: The safety of this product has not been determined," then join us by writing to your Representative and Senators. And, by all means, write to the FDA, referencing Docket Number 99P-1340 (email: fdadockets@oc.fda.gov Mail and fax contact information available at FDA Petition (http://www.ehnca.org/www/FDApetition/bkgrinfo.htm).

It was private testing, paid for privately, which in turn led to the FDA Petition, Docket Number 99P-1340. And, this in turn led to SNIFF -- the Safe Notification and Information for Fragrances Act, HR 1947 (107th Congress). http://ehnca.org/www/ehnlinx/s.htm#SNIFF

SNIFF was introduced into the House, May 22, 2001, by Rep. Jan Schakowsky (D IL). SNIFF is co-sponsored by Rep. Shelley Berkley (D NV) on May 22,2001 and by Rep. Chaka Fattah (D-PA) on July 18, 2001. (Please write to your representative and ask that this bill be co-sponsored, or at least supported. Write to your state senators and ask them to introduce a similar bill in the Senate.)

The FDA hasn't acted upon Petition 99P 1340 despite the fact it has generated over 1200 letters by mid-December 2001, without attention from mainstream media. However, I'm pleased to report that on February 6, 2002, Francesca Lyman, MSNBC Contributor wrote, "Scents and sensitivities - What to know before buying a Valentinežs Day perfume" http://www.msnbc.com/news/702445.asp

As far as SNIFF is concerned, Congress has had its attention directed toward the events and aftermath of September 11 . . . so SNIFF hasn't moved forward. But that shouldn't stop us from contacting our representative, as well as our senators to request that they introduce or sponsor a similar bill in the senate.

IF history is any judge of the future, the people affected by the fumes and the debris of WTC and the Pentagon, will be suffering from MCS. Not because they'll be suffering "mass hysteria," or "panic attacks," or "anxiety disorder," but because they, too, have been chemically poisoned. Their bodies will begin to show the insidious symptoms that far too often mainstream medical doctors cannot properly diagnose. They will develop many chronic symptoms, which are "unexplained" ailments caused by chemical injury. These newly injured people will join the folks who were injured in the Valdez clean-up. They'll join our Gulf War vets, and those of us exposed to refinery releases, to chemical plant leaks, to diesel exhaust, to asbestos fibers, to tobacco smoke. They'll join those who were injured in lab spills, and those who were injured in the workplace by unrecognized hazards found in commonly used consumer products such as synthetic pesticides, synthetically scented personal care and household and janitorial cleaning and maintenance products. They'll join folks injured by the high-emitting VOCs from carpets, adhesives, paints, solvents, etc. They'll join those of us whose bodies can no longer handle the synthetic drugs -- over-the-counter or prescribed.

As I see it: As time goes by, the FDA Petition and SNIFF will become even more important, because time and again, right up their with substances like diesel exhaust and fresh paint that "take one's breath away" you'll see listed: FRAGRANCES.

by Barb Wilkie
(Barb's email is no longer valid, please contact EHN)