FDA Cosmetic Recall Authority

I couldn't open the final guidance FDA issued on 22 October 2026: its PDF link on fda.gov returns "not found". So what follows is the December 2025 draft from the official docket (FDA-2025-D-2246). It is a 16-question Q&A on how FDA will use its mandatory recall power for cosmetics under FD&C Act §611. FDA's pages describe the final version only in general terms and don't say whether anything changed from the draft.

What the draft says (draft guidance, Dec 2025)

• Scope (Q1-2): It covers anything that meets the FD&C Act §201(i) definition of a cosmetic. Soap is excluded. Products that are also drugs or devices fall outside §611 and come under other recall powers (§613).
• Who is responsible (Q3): The manufacturer, packer or distributor named on the label (§604).
• When FDA can act (Q4): FDA must find a reasonable probability that the product is adulterated (§601) or misbranded (§602). It must also find a reasonable probability that using it will cause serious adverse health consequences or death ("SAHCOD").
• Process (Q5-8):
  • FDA first offers a voluntary stop or recall, in writing.
  • If the firm refuses or misses FDA's deadline, FDA can order it to stop distributing immediately.
  • The firm can ask for an informal hearing under 21 CFR part 16. If granted, it is held within 10 days.
  • After that, FDA cancels the order, keeps it in place until a set date, or turns it into a recall order with notification duties, a timetable and progress updates.
  • Only the Commissioner can order a recall or cancel a recall order.
• What FDA weighs (Q11):
  • inspection findings;
  • test results on raw materials, finished products and swabs from the facility;
  • data showing people have already been harmed;
  • how vulnerable the users are (for example infants, the elderly, pregnant women);
  • serious adverse event reports;
  • consumer and trade complaints;
  • whether the firm refused to act voluntarily.
• SAHCOD examples (Q12): The draft points to the §604 definition of "serious adverse event." That covers death, hospitalisation, infection and significant disfigurement, such as serious persistent rashes, second- or third-degree burns or significant hair loss. Whether a case counts as SAHCOD depends on the facts.
• Telling the public (Q13):
  • FDA can make the firm notify manufacturers, distributors, importers, sellers and the public.
  • For a recall order, FDA will publish a press release naming the product and the risk and, where practical, mentioning similar products that are not affected.
  • It will also post a product image if one is available and send alerts.
• When orders end (Q14-15): A stop order lasts until the date it names. A recall order generally ends when FDA is satisfied it has been met, following the 21 CFR 7.55 termination process.
• Refusing to comply (Q16): Ignoring a §611 order is a prohibited act under §301. The firm risks an injunction or criminal prosecution under §§302-303.
• Overall stance: FDA still expects most cosmetic recalls to stay voluntary under 21 CFR part 7, subpart C.

What's confirmed about the final version

• FDA's guidance page lists it as Final, issued October 2026 by the Office of Inspections and Investigations. The page was last updated 22 October 2026 and points to Federal Register document 2026-21679, which I could not open.
• FDA's cosmetics recall policy page says the final guidance "provides clarity on the FDA's mandatory recall authority for cosmetics under section 611."
• The comment period on the draft ran to 17 February 2026, according to the Federal Register notice for the draft (I saw this in search results only and did not open the notice).

Approach: I searched FDA's food and cosmetics guidance catalogue in our datasets and found no entry for this guidance. I then went to FDA's guidance and recall-policy pages and the draft in the regulations.gov docket; the final PDF and the Federal Register notice could not be opened.

If FDA orders it, the company named on the label (the "responsible person") has to stop distributing the cosmetic straight away. If the order is later turned into a recall order, it must also recall the product, notify the people the order names, follow FDA's timetable and send FDA updates on the schedule it sets. Refusing or failing to follow the order is itself a prohibited act under the FD&C Act ^[1][4].

What the company must do, step by step (FD&C Act §611, 21 U.S.C. 364g)

1. Before any order: answer the voluntary request. FDA must first give the firm a chance to stop distribution and recall voluntarily, "within the time and manner prescribed" by FDA. An order can follow only if the firm refuses or doesn't act in time ^[1].

2. When a stop order arrives (§611(a)): stop distributing immediately. ^[1]

3. Decide whether to ask for a hearing (§611(b)). The firm can have an informal hearing, held within 10 days of the order, on "whether adequate evidence exists to justify the order." ^[1]

4. Follow whatever FDA decides next (§611(c)-(d)). FDA has three options:

   • cancel the order, in which case nothing more is owed;
   • keep the stop order in place until a set date, in which case the firm keeps distribution stopped;
   • amend it into a recall order, in which case the firm must recall the product, meet the notification requirements and the recall timetable, and give FDA updates on schedule.

   Under the stop or recall outcome, the firm must "immediately cease distribution of or recall" the product and "provide notification as required by such order." ^[1]

5. Notify others if FDA requires it (§611(e)). FDA can make the firm send notice of the recall or stop order to manufacturers, distributors, importers, sellers and the public ^[1].

What FDA does itself (§611(f))

• FDA makes sure a press release, alerts and public notices go out to the consumers and retailers who got the product.
• At a minimum these give the product name and the risk. Where practicable, they also tell consumers about similar products that are not affected.
• FDA posts an image of the product on its website if one is available ^[1].
• The firm doesn't control this publicity. Only the Commissioner can order a recall or cancel one ^[1].

If the firm doesn't comply

• §301(iii) makes "the refusal or failure to follow an order under section 364g" a prohibited act ^[4].
• §301(e) also lists §364g among the provisions where failing to make a required report is a prohibited act. In practice this catches missed recall progress updates ^[4].
• The December 2025 draft guidance (Q16) said violations can lead to an injunction or criminal prosecution under §§302-303. I did not pull the penalty sections themselves.

Who carries the duty: the manufacturer, packer or distributor whose name is on the label ^[2].

How FDA says it will run this: the operational detail comes from the December 2025 draft guidance discussed earlier, which I had already opened; I couldn't read the final October 2026 text. In the draft:

• hearings are held under 21 CFR part 16;
• a stop order lasts until the date it names;
• a recall order ends when FDA is satisfied it has been carried out, using the 21 CFR 7.55 termination process.

Neither the statute nor the cosmetics regulations (21 CFR parts 700-740) set out recall-strategy, effectiveness-check or record-keeping steps for a firm under a mandatory order. Those would be in the order itself or FDA's general recall rules in 21 CFR part 7, which our datasets don't hold.

Approach: I searched the Federal Food, Drug, and Cosmetic Act (21 U.S.C. chapter 9, 2023 U.S. Code edition): §611 on mandatory recalls, §604 definitions and §301 prohibited acts. The process detail comes from FDA's December 2025 draft guidance opened earlier in this conversation, because the final October 2026 guidance couldn't be opened.