The U.S. Food and Drug Administration (FDA) has published guidance dated October 2026 that explains how it will use its authority over mandatory cosmetics recalls under section 611 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The question-and-answer document matters to any company whose name appears on a cosmetic label sold in the United States, because that company is the “responsible person” FDA can order to act.
The guidance describes the findings FDA must make before it intervenes, the hearing and notification steps that follow, and the evidence the agency may consider. It carries nonbinding recommendations rather than new requirements, and FDA states that it still expects most violative cosmetics to be recalled voluntarily. Even so, the document gives regulatory teams the clearest view yet of how mandatory cosmetics recalls would unfold.
Where The Authority Comes From
Section 611 arrived through the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), signed into law on December 29, 2022. Before MoCRA, cosmetics recalls occurred voluntarily under 21 CFR part 7, subpart C. Section 611 adds a backstop that lets FDA order a responsible person to cease distribution and recall a cosmetic when specific criteria are met. The authority reaches any article that meets the cosmetic definition in section 201(i), with soap excluded.
The Two Findings FDA Must Make
FDA can invoke section 611 only after determining that two conditions are met. First, there must be a reasonable probability that the cosmetic is adulterated under section 601 or misbranded under section 602. Second, there must be a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death, which the guidance abbreviates as SAHCOD.
Several of the listed grounds connect directly to MoCRA obligations that companies already manage.
- Adulteration includes manufacturing under conditions that do not meet the good manufacturing practice (GMP) requirements of section 606.
- Adulteration also covers a product, or any of its ingredients, that lacks adequate safety substantiation under section 608(c).
- Misbranding includes labeling that is false or misleading, or a label missing the information required under section 609.
- Misbranding also applies when required label information is not prominent and conspicuous enough for an ordinary individual to read and understand.
For the second finding, the guidance points to the definition of serious adverse event in section 604, which includes death, inpatient hospitalization, infection, and significant disfigurement such as second- or third-degree burns or significant hair loss.
How The Process Unfolds
FDA starts by notifying the responsible person in writing and offering a chance to cease distribution and recall voluntarily. If the company does not act within the time and manner FDA prescribes, the agency may order it to stop distribution immediately. FDA must then offer an informal hearing, held within 10 days of the order, under 21 CFR part 16.
After the hearing, FDA has three options. It can vacate the order, continue the cease-distribution order until a date it specifies, or amend the order to require a recall, complete with notification requirements, a timetable, and a schedule for updates to FDA. Only the FDA Commissioner can order a recall or vacate a recall order.
FDA may also require the responsible person to notify the supply chain and the public. For recall orders, the agency will publish a press release naming the product and describing the risk. A recall generally ends under the process in 21 CFR 7.55, once FDA determines the order’s requirements have been satisfied.
What Evidence FDA May Weigh
The guidance states that FDA will evaluate all applicable evidence. That may include significant safety observations from establishment inspections, sample analyses of raw materials, finished products, and facility environment swabs, and epidemiological data suggesting injuries or disease from the product. FDA also considers the vulnerability of the population using the product, such as infants, pregnant women, or the elderly, along with serious adverse event data, consumer and trade complaints, and whether the company failed to act voluntarily.
What This Means For Your Business
The guidance adds no new compliance duties, but it shows which existing records and processes would carry weight in a recall review. Safety substantiation files, GMP documentation, complaint logs, and serious adverse event records all appear in FDA’s grounds or evidence. Quality Smart Solutions advises cosmetics companies to confirm that these records are current, easy to retrieve, and consistent with what appears on the label.
Companies should also check that the contact details on packaging reach someone who can respond to an FDA notice, and that a written recall procedure identifies who notifies distributors and retailers. Teams that already maintain MoCRA cosmetics compliance programs for facility registration, product listing, and labeling can build on that work.
Frequently Asked Questions
Is FDA’s Mandatory Cosmetics Recall Guidance Legally Binding?
Many teams wonder whether the document changes their obligations. It does not. FDA describes the guidance as its current thinking and allows alternative approaches that satisfy the applicable statutes and regulations. Section 611 itself is statutory, however, so an order issued under it must be followed. Comments can be submitted under docket number FDA-2025-D-2246.
Do Products That Are Both Cosmetics And Drugs Fall Under Section 611?
Companies selling products with both cosmetic and drug claims, such as anti-dandruff shampoos, often ask this first. Cosmetics that also meet the requirements of Chapter V of the FD&C Act, which covers drugs and devices, are not subject to section 611. They may instead face other mandatory recall authorities under section 613, so classification still shapes which rules apply.
What Happens If A Company Does Not Follow A Section 611 Order?
Companies reasonably want to understand the stakes. Refusing or failing to follow an order is a prohibited act under section 301 of the FD&C Act, and a person who does so could face injunction or criminal prosecution under sections 302 and 303. The informal hearing, not non-compliance, is the route for disputing whether adequate evidence supports an order.
Key Takeaways
- FDA’s October 2026 guidance explains how it would use section 611 to order a cosmetic to stop distribution or be recalled.
- FDA must find a reasonable probability of adulteration or misbranding and a reasonable probability of serious adverse health consequences or death.
- Safety substantiation, GMP, labeling, complaint, and adverse event records sit at the centre of FDA’s listed grounds and evidence.
- Voluntary recall remains the expected route, so a current recall procedure and accurate label contact details are practical preparation.
Preparing Before An Order Arrives
The guidance clarifies an authority that has existed since MoCRA but had little published detail on how FDA would apply it. Companies selling cosmetics in the United States can use it as a prompt to review substantiation files, labeling, and adverse event processes against the grounds FDA lists. To assess your records through a MoCRA compliance review, speak with a regulatory specialist at Quality Smart Solutions.
