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Petition to the FDA to Have the Perfume "Eternity" Declared Misbranded


A petition was filed with the FDA in May of this year requesting that the FDA declare the perfume Eternity misbranded or mislabeled. The basis of the petition is that Eternity contains materials that have not been adequately tested for safety. Cosmetics do not have to be tested for safety before being marketed. But if the safety of the ingredients and the final product has not been substantiated, the law requires a warning label saying:

"Warning--The safety of this product has not been determined."

An analysis of Eternity was done by a lab specializing in analysis of fragrances. The chemical data available on most of the materials found in Eternity state: "The chemical, physical and toxicological properties have not been thoroughly investigated." The chemical at the highest level in the product had no available health and safety data. In addition materials used in the products had known and suspected health effects.

Two were listed as respiratory sensitizers meaning they can cause a person to become allergic to them and develop asthma. At least five had central nervous system effects, At least two were suspected carcinogens and one may cause fetal effects. Virtually all are general irritants

Eternity does not carry a warning label. The petition asks that existing labeling laws be enforced. The FDA has 180 days from the time the petition is filed to respond. That 180 days will be up on November the 10th, five days from now. In the event the FDA does not make a timely response, then we may have a little longer to respond.

Approximately 490 comments have already been filed with the FDA.

Whether the FDA takes any action on this petition or not, the fragrance industry can no longer say they are not aware of increased complaints regarding health effects of fragrances. The comments become part of public record and are being put up at the FDA website, though they are a couple of months behind getting actual comments up.

More information on the petition.

Be sure to put the docket number on your correspondence so that it will be attached to the right documents. Comments become a part of public record. Anonymous comments will not be accepted.

Docket Number: 99P-1340/CP 1

Comments are to be sent to:

Dockets Management Branch
The Food and Drug Administration
Department of Health and Human Services, Rm. 1-23
12420 Parklawn Dr.
Rockville, MD 20857

FAX: 301-827-6870

E-mail: fdadockets@oc.fda.gov

Thank you,
Betty Bridges, RN
Fragranced Products Information Network (FPIN)

More information on health effects of fragrances.

SUPPORT THE PETITION TO THE FDA
Docket # 99P-1340
Send comments to fdadockets@oc.fda.gov

For more information, click here and here.
 


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Most recent revision Saturday, November 24, 2001