Adverse Fragrance Reaction? Inform the FDA!

Revised 11/8/98, Health & Environment Resource Center 

A person injured or made ill by a fragrance can file a formal complaint with the FDA. By documenting injury and illness, the FDA will be able to recognize patterns of cause and effect. This is the first step toward requesting that the FDA take action with regard to fragrances that cause injury/illness. 

In addition, we ask that Health & Environment Resource Center be sent a carbon copy of the injury report so that we can tabulate the data (names will be kept confidential). Copies of the reports can be submitted via mail to: Health & Environment Resource Center, P.O. Box 7277, Pueblo West, CO 81007; or e-mailed to me at enviroknow@aol.com. I will also be happy to answer any questions. 

Health & Environment Resource Center is a non-profit 501(c)(3) organization whose goal is to educate the general public about the health hazards of consumer products in order to effectuate a reduction in the toxins used by industry in consumer products. 

Save the following form text as a document in your word processing program and mail a certified letter to the FDA every time you have an adverse reaction to a fragrance product. Be sure to include all relevant information [see brackets]. Keep any opened or unopened containers/packages of the product. Save all your documentation. Be prepared if the FDA contacts you to follow-up on the complaint. 

Let’s educate the FDA about the severity of the problems caused by fragrances! 
-------------------------------------- 
VIA U.S. CERTIFIED MAIL # 
TO: Mr. Lark Lambert HFS FDA - Office of Cosmetics and Colors 
Cosmetic Adverse Reaction Monitoring Program 
200C St. S.W. Washington, DC 20204 

phone:202/205-4706 
fax: 202/205-5098 

FROM: [Your Name] [Your Address] [Your Phone] 
RE: Adverse reaction to fragrance [specify if known] on [date] 

Dear Mr. Lambert: 
I am writing to report an [injury/illness] caused by a fragrance. On [date] I was exposed to and injured by [Name of fragrance product and manufacturer, if known. Describe the product as completely as possible, particularly any codes or identifying marks that appear on the label or container. Include name and address of the store where product was purchased if applicable]. 

I was exposed to the fragrance [explain the circumstances]. The symptoms I experienced were: [list applicable symptoms - headache, dizziness, increased heartbeat, violent coughing, vomiting, difficulty breathing, asthmatic reaction, rash, allergic skin irritation, skin discoloration, other]. 

[Include the following information if applicable]: I was treated for said [injury/illness] by [name and address of the doctor and/or hospital providing medical treatment] on [date]. 

Please enter this information in the Cosmetic Adverse Reaction Monitoring Program database. I can be reached for follow-up at the phone number/address above. 
Thank you for this opportunity to document my [injury/illness]. 

Sincerely, 
[Your Signature] 

C.C. Health & Environment Resource Center P.O. Box 7277, Pueblo West, CO 81007
 

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