Recall of Cosmetic Products Sold on the U.S. Market
FDA Procedure Before Issuing a Mandatory Recall Order for Cosmetic Products Sold in America
If the FDA believes there is a reasonable probability that:
(1) the cosmetic is adulterated as per section 601 of the Act or mislabeled as per section 602 of the Act and
(2) the use of the cosmetic causes serious adverse effects on health or death,
The FDA will contact the responsible party in writing with a request to voluntarily stop the distribution of the cosmetic products in the U.S. and to recall the product from the U.S. market (section 611(a) of the FD&C Act)
If the responsible party refuses or does not voluntarily stop distribution or recall the cosmetic product from the U.S. market within the time and manner specified by the FDA, the FDA may require the responsible party to immediately cease distribution of the cosmetic in question, to the extent and in the manner deemed necessary at the sole discretion of the FDA
If deemed necessary, the FDA may also require the responsible party selling the cosmetics subject to the recall order from the U.S. market to notify this order to the concerned parties — including those who manufacture, distribute, import, or sell in the U.S. market the cosmetics subject to the order — as well as to the public consumers.
The FDA will then offer the responsible party receiving the recall order the opportunity for an informal hearing to be held within 10 days from the date of issuance of the recall order and will verify the existence of adequate evidence to justify the recall action (section 611(b) of the FD&C Act). The informal hearing will be conducted in accordance with the procedures outlined in title 21 of the C.F.R., part 16 (Regulatory Hearing Before the Food and Drug Administration)
Definition of Serious Adverse Events/Reactions According to MOCRA for Cosmetic Products
The definition of a serious adverse reaction/event related to the use of a cosmetic product on the U.S. market according to MOCRA - FDA regulations on the import and sale of cosmetic products in America is an adverse event/reaction that results in:
- the death of the cosmetic product user;
- a life-threatening situation;
- hospitalization;
- a persistent or significant disability;
- a congenital anomaly or birth defect;
- an infection;
- significant disfigurement (including severe and persistent rashes, second or third-degree burns, significant hair loss, or a persistent or significant alteration of appearance)
Also considered a serious adverse reaction is the need to undergo surgery to prevent one of the serious adverse effects described above.
The Food and Drug Administration (FDA) has recently updated the guidelines for reporting serious adverse events associated with the use of cosmetic products on the U.S. market. This update follows the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) which takes effect from December 29, 2023, and applies to all cosmetic products to be imported into the United States.
Procedure for Reporting Serious Adverse Reactions to the FDA Related to the Use of Cosmetic Products to be Imported and Sold in America
The party responsible for MOCRA registration is required to report to the FDA the serious adverse events and reactions associated with the use of cosmetic products in the United States within 15 business days from becoming aware of the event or serious adverse reaction. The responsible party must include a copy of the label of the cosmetic product in question. Additionally, if the responsible party receives additional medical information or other information related to the adverse event within a year of the initial report to the FDA, they must send this new information to the FDA within 15 business days.
By responsible party, we mean the manufacturer, packer, exporter, importer, or distributor of cosmetic products on the U.S. market whose name appears on the label of the cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
