What does FDA's new guidance do?
The enactment of the Modernization of Cosmetics Regulation Act (MoCRA) in 2022 provided FDA with the clear authority to mandate cosmetic recalls. Accordingly, FDA may order a recall when it determines there is a reasonable probability that a product is adulterated or misbranded and could cause serious adverse health consequences or death (SAHCOD). FDA's new draft Q&A guidance explains when and how the Agency will exercise this authority, including the factors it will consider and the procedural steps it will follow before ordering a mandatory recall. The guidance also clarifies the obligations of "responsible persons" (the manufacturer, packer, or distributor whose name appears on the finished product's label) and highlights the types of compliance deficiencies that may trigger recall action.
Why does this matter now?
FDA is actively building its post-MoCRA enforcement framework, and this guidance signals how quickly routine compliance issues could escalate into mandatory recall actions.
How will FDA determine if a mandatory recall is necessary?
In determining whether to initiate a mandatory recall, the Agency may rely on significant safety observations during an inspection; analytical results obtained from raw materials, finished products, or swabs of facility equipment; and epidemiological data indicating injuries have already occurred. FDA may also consider the vulnerability of exposed populations, serious adverse event reports, consumer or trade complaints, and whether the responsible person has already ceased distribution or initiated a voluntary recall. The guidance offers examples of conditions that constitute a reasonable probability of causing SAHCOD, including death, life-threatening events, inpatient hospitalization, birth defects, infections, and various forms of disfigurement, and notes that FDA conducts its assessment under customary or usual conditions of use. Only the FDA commissioner can order or vacate a recall.
What process will FDA follow, and what could I be required to do if FDA recalls my product?
Step 1 – Initial Determination by FDA. If FDA determines mandatory recall criteria are met, it will first notify responsible persons in writing and provide an opportunity to voluntarily cease distribution and recall the product within a specific time and in a specific manner.
Step 2 – Cease Distribution Order. If the company does not do so, FDA may then issue a cease distribution order.
Step 3 – Informal Hearing (within 10 days). FDA will then provide an opportunity for an informal hearing for any responsible person subject to a cease distribution order within 10 days of the order. This hearing allows the responsible person to challenge whether adequate evidence exists to justify the order.
Step 4 – Post-hearing outcomes. After the informal hearing, FDA may:
- Vacate the order (if inadequate grounds exist)
- Continue the order to simply cease distribution until a specific date or
- Amend the order to require a full recall and add notification requirements and timetables for the recall, or to specify when updates need to be provided to the Agency
Step 5 - Notification. FDA may require, when it deems necessary, the responsible person to notify the public and any parties who manufacture, distribute, import, or sell the product about a cease distribution order or amended recall order. FDA intends to include notification requirements in the order itself. Additionally, if an amended recall order is issued, FDA will issue a press release with recall details, product images (if available), and alerts to consumers and retailers.
Step 6 – Recall Termination. A recall ends when FDA determines that all requirements of the recall order have been satisfied and reasonable efforts have been made to remove or correct the product in accordance with the recall strategy, commensurate with the degree of hazard.
What happens if I don't respond to FDA's recall order?
Manufacturers must comply immediately with FDA orders to cease distribution and provide required notices to distributors and consumers. Refusing or failing to comply with a mandatory recall order constitutes a prohibited act under Section 301 of the FD&C Act, exposing responsible persons to injunction proceedings and potential criminal prosecution.
What cosmetic companies should be doing now
In light of FDA's expanded authority and the procedural roadmap outlined in the draft guidance, cosmetic companies should consider taking the following proactive steps:
- Evaluate recall readiness and internal escalation procedures
- Audit safety substantiation files under MoCRA
- Assess GMP compliance and inspection preparedness
- Review labeling and claims for recall-triggering risk
- Prepare for rapid response to FDA inquiries or inspections
How do I submit comments and prepare my compliance strategy?
Manufacturers should use the 60-day public comment period to help inform the guidance. You may submit comments electronically at regulations.gov or in writing to the Dockets Management Staff (reference Docket No. FDA-2025-D-2246) to ensure your concerns are addressed. We recommend that you proactively audit your products for adequate safety substantiation under Section 608(c) and good manufacturing practices under Section 606, as deficiencies in either area can trigger mandatory recall action.
Please contact the authors with any questions you have about FDA's draft guidance, or how to submit comments.