If you sell cosmetics in the United States, you likely already know that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has brought the biggest changes to the industry in over 80 years. But a recent regulatory update has added some sharp teeth to these new rules: Mandatory Recall Authority.
Previously, cosmetic recalls were almost exclusively voluntary. The FDA could encourage a brand to remove a product, but they generally couldn’t force it. With the release of new draft guidance regarding Section 611 of the FD&C Act, that landscape is changing.
Here is what you need to know to keep your brand compliant and your customers safe.
The Shift: From Voluntary to Mandatory
Historically, most cosmetic recalls occurred voluntarily when a manufacturer realized something was wrong. While the FDA still expects and encourages voluntary cooperation, Section 611 gives the agency the power to step in if a “Responsible Person” (the manufacturer, packer, or distributor named on the label) refuses to act.
Under this new authority, if the FDA determines that a recall is necessary and the responsible person does not voluntarily cease distribution, the FDA can issue a direct order to stop distribution immediately.
When Can the FDA Order a Recall?
The FDA cannot simply order a recall for minor issues. The agency must determine that two specific criteria are met:
- Adulteration or Misbranding: There is a reasonable probability that the cosmetic is adulterated (e.g., contaminated, manufactured under insanitary conditions) or misbranded (e.g., false labeling).
- Serious Health Risk (SAHCOD): There is a reasonable probability that using or being exposed to the cosmetic will cause “Serious Adverse Health Consequences or Death” (SAHCOD).
“Serious adverse health consequences” isn’t just a label, it is defined strictly to include significant injuries like infections, severe burns, significant disfigurement, or conditions requiring medical intervention.
The Process: What Happens Next?
The FDA’s draft guidance outlines a strict process for these situations:
- Notification: The FDA will first notify the responsible person in writing, offering them the chance to voluntarily recall the product.
- Order to Cease Distribution: If the company refuses or fails to act, the FDA can order them to immediately stop distributing the product.
- Hearing: The company has the opportunity for an informal hearing within 10 days to justify why the order should be vacated.
- Public Warning: If the order stands, the FDA will ensure the public is notified, potentially through press releases and alerts to retailers and consumers.
What This Means for ShipMonk Merchants
As your fulfillment partner, ShipMonk acts as a critical link in your supply chain. While the legal responsibility for the recall lies with the “Responsible Person” named on the product label, 3PLs like us play a vital role in executing the “Cease Distribution” part of the order.
If your beauty brand is subject to a mandatory recall under Section 611:
- Notifications may broaden: The FDA may require you to notify all distributors, packers, and manufacturers involved with the product.
- Immediate Action is Required: If we receive a mandatory recall request—whether from you, a packer, or directly via an FDA order—we must act immediately to freeze inventory and stop shipments.
Your Next Step
Review your current recall strategy. Do you have a plan in place if the FDA contacts you with a Section 611 notification?
If you ever need to initiate a recall—voluntary or mandatory—please reach out to your ShipMonk support team immediately. We are here to help you navigate the logistics quickly and efficiently, ensuring you stay compliant and your customers stay safe.
Frequently Asked Questions: MoCRA Mandatory Recall Authority
The FDA must determine that a cosmetic is adulterated or misbranded and that it poses a risk of serious adverse health consequences or death (SAHCOD). A mandatory order cannot be issued unless both criteria are met.
The “Responsible Person” is the specific manufacturer, packer, or distributor whose name and address appear on the product label. This entity bears the primary legal responsibility for executing the recall.
No, the FDA must first give the Responsible Person the opportunity to voluntarily cease distribution and recall the product. A mandatory order is only issued if the company refuses or fails to act voluntarily within the prescribed time.
SAHCOD refers to health hazards that result in death, life-threatening experiences, or significant injuries such as severe burns, infections, or permanent disfigurement. It does not include minor, reversible reactions like temporary skin irritation.
Yes, the Responsible Person can request an informal hearing within 10 days of the order to argue why it should be vacated. If the brand does not request a hearing or the appeal fails, the order stands.
A 3PL must immediately freeze inventory and stop shipments once notified by the Responsible Person or the FDA. While the brand is legally liable for the product, the 3PL is responsible for executing the physical “cease distribution” requirement.
Refusing a mandatory recall order is a prohibited act that can lead to product seizure, court injunctions, and criminal prosecution. The FDA will also issue public warnings to alert retailers and consumers directly.
