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        Cosmetics Compliance & Enforcement

How to Report a Cosmetic Related Complaint Home
          Cosmetics
          Cosmetics Compliance & Enforcement
          How to Report a Cosmetic Related ComplaintCosmetics Compliance & Enforcement How to Report a Cosmetic Related Complaint
  	
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In the case of a reaction or problem with a cosmetic product, the first step is to stop using the product and contact your healthcare provider. FDA does not provide medical advice. Then, report the problem to FDA.

Report a Cosmetic Complaint

Tell FDA If You Experience

**A reaction after using a cosmetic**, such as a rash, redness, burn, hair loss, headache, infection, illness or any other unexpected reaction, whether or not it required medical treatment.
	**A problem with a cosmetic product**, such as a bad smell, color change, presence of foreign material in the product, or other signs of contamination.Types of Products that are Considered Cosmetics

Cosmetics products are not the same as drug products, and they are regulated differently by the Food and Drug Administration (FDA, we). Here are some examples of cosmetic products:

Tattoos and permanent makeup
	Face and body cleansers, moisturizers and other skin lotions and creams
	Mascara, lipstick and other makeup
	Deodorants
	Baby lotions and oils
	Hair care products, dyes, conditioners, straighteners/relaxers, perms Hair removal creams
	Nail polishes Shaving products
	Perfumes and colognes
	Face paints and temporary tattoosHow Consumers and Health Professionals Can Report a Problem with Cosmetic Products

If you are a consumer or health professional who wants to report a complaint or adverse event (such as an illness, allergic reaction, rash, irritation, scarring, or hair loss) related to a cosmetic product, you can:

Call an FDA Consumer Complaint Coordinators if you wish to speak directly to a person about your problem.
	Complete and submit an electronic MedWatch Online Voluntary Reporting Form.
	Complete a paper MedWatch Consumer Voluntary Reporting Form and mail or fax it to FDA.*Mail or fax the form to: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852; FAX: 800-332-0178 (toll-free).*Your report is important to help keep cosmetic products on the market safe. When you contact FDA, we ask you to include the following information in your report, if known:

About the Person Affected
	Name and contact information (address, phone, and e-mail address)
		Age, gender, and ethnicity
	About the Product
	Name of the product and the manufacturer
		Product codes or identifying marks on the label or container [Note: do not discard the product packaging and labeling. They provide information that will help FDA investigate the problem]
		When and where the product was purchased
	About the Adverse Event
	Description of the adverse event or reaction
		Description of medical treatment provided, if anyThe Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was enacted on December 29, 2022. MoCRA amends Chapter VI of the Federal Food, Drug, and Cosmetic Act and provides for the most significant expansion of FDA authority to regulate cosmetics since 1938.

How to Report Serious Adverse Events for Industry

The new law requires a responsible person (see definition below) to report serious adverse events (see definition below) associated with the use of cosmetic products in the United States to FDA, within 15 business days. The responsible person must include a copy of the label on or within the retail packaging of such cosmetic product. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days. FDA will also have access to adverse event reports during an inspection.

**Serious Adverse Event**: an adverse event that

(A) results in:
	death;
		a life-threatening experience;
		inpatient hospitalization;
		a persistent or significant disability or incapacity;
		a congenital anomaly or birth defect;
		an infection; or
		significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual; or
	(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.**Responsible Person**: the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

FDA recommends that the industry responsible person submit serious adverse event reports for cosmetic products by using the current Form 3500A that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF). Please submit the completed form along with information to support the report, such as scans of labels and images of the serious adverse event to FDA via email at: CosmeticAERS@fda.hhs.gov or by mail to:

FDA CDER Mail Center
Attn: Cosmetics MedWatch reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993

FDA is developing a process for submitting electronic mandatory adverse event reports for cosmetics.

What FDA Will Do with Your Report

Once a report is received:

FDA will add the report to our database so that we can see if other people are reporting the same problem.
	FDA will use the information to determine if the product or similar products have a history of problems and represent a public health concern that needs to be addressed.
	FDA will keep your identity confidential.FDA may not take action on every report received, but the Agency does check all reports to determine if action is necessary to protect public health.

Search Reports

The CFSAN Adverse Event Reporting System (CAERS) Database is a database that contains information on adverse event and product complaint reports submitted to FDA for foods, dietary supplements, and cosmetics. The database is designed to support CFSAN's safety surveillance program. FDA provides raw data extracted from the CAERS database. The data files, which are available in ASCII format, include:

demographic and administrative information and the CAERS report ID number;
	product information from the case reports;
	symptom information from the reports;
	patient outcome information from the reports.

                                                                                  Content current as of:
      01/18/2024
                  
                   
Regulated Product(s)
		 CosmeticsHow to Report a Cosmetic Related Complaint
 
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