How to Report a Cosmetic Product Related Complaint

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. Food and Drug Administration (FDA, we) does not provide medical advice. Secondly, report the problem to FDA.

Report a Cosmetic Product Complaint (Consumers, Patients, and Health Professionals)

Report a Cosmetic Product Complaint (Industry)

Tell FDA If You Experience

• A reaction after using a cosmetic product, 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 Cosmetic Products

Cosmetic products are not the same as drug products, and they are regulated differently by the FDA. Here are some examples of cosmetic products:

• Tattoo ink 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; and
• Face paints and temporary tattoos.

How Consumers and Health Professionals Can Report a Problem with Cosmetic Products to FDA 

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:

• Complete and submit an electronic MedWatch Online Voluntary Reporting Form. FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.

• Mail or fax completed paper forms: Download Form FDA 3500 - Voluntary Reporting (for health professionals) or Form FDA 3500B - Voluntary Reporting for Consumers (for consumers or patients) and submit by mail or fax to FDA:

  MedWatch
  Food and Drug Administration
  5600 Fishers Lane
  Rockville, MD 20852
  FAX: 800-332-0178 (toll-free).

• Call the FDA's Food and Cosmetics Information Center (FCIC) at 1-888-SAFEFOOD (1-888-723-3366).

How Industry Reports Serious Adverse Events

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 (FD&C Act) and provides for the most significant expansion of FDA authority to regulate cosmetics since 1938.

MoCRA added section 605 to the FD&C Act. Section 605 of the FD&C Act requires a responsible person (see definition under Key Terms below) to report serious adverse events (see definition under Key Terms 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.

Mandatory Serious Adverse Event Reporting

It is mandatory for responsible persons to submit serious adverse event reports (SAER) for cosmetic products. Responsible persons can submit SAERs for cosmetic products to FDA using one of the electronic or paper form submission options described below. FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.

1. Electronic Submissions

• Option A: Database to Database Transmission
  • Submitters who have database-to-database transmission capability may directly submit SAERs (also referred to as Individual Case Study Reports (ICSRs)) in the XML format via the Electronic Submissions Gateway (ESG).
  • To prepare for Option A, please see instructions at FDA Adverse Event Reporting System (FAERS) Electronic Submissions | FDA.
  • Contact faersesub@fda.hhs.gov for any inquiries on Option A.
• Option B: Safety Reporting Portal (SRP)
  • SRP is intended for companies without infrastructure for direct ESG submission (Option A).
  • Registration by or on behalf of the responsible person is needed to receive login credentials; please contact FAERSESUB@fda.hhs.gov to request a SRP account.
  • Submit individual SAERs manually, one at a time into a web-based form for electronic submission. Batch submission is not available via SRP.

2. Paper Form Submissions

Please see the Instructions for Completing Form FDA 3500A. 

Submit: 

• The completed Form FDA 3500A - Mandatory Reporting that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF) and

• A combined PDF file as one attachment that includes all relevant information to support the adverse event report, such as scans of labels and images of the 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 

Voluntary Non-Serious Adverse Event Reporting

While MoCRA does not add requirements for responsible persons to submit non-SAERs for cosmetic products to FDA, you may submit non-SAERs voluntarily using Form FDA 3500A, following the same process described above for reporting mandatory serious adverse events.  

For more information about cosmetic adverse events submitted to FDA, please see the FDA Adverse Events Reporting System (FAERS) Public Dashboard for Cosmetic Products, a user-friendly and interactive web-based tool that was created to improve transparency and give the public the ability to query the FDA FAERS database on adverse event reports associated with cosmetic products.

Key Terms

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.