United States (MoCRA)

What MoCRA Requires When You Discontinue a Product

Canceling a listing under MoCRA doesn't end your obligations. Here's what records and reporting duties stay open.

Diane R.4 min read

Pulling a product off the shelf feels like closing a chapter. Under MoCRA, it's more like putting the chapter on a shelf where someone might still ask you about it. A few obligations don't just evaporate the day you stop selling.

The listing doesn't clean itself up

MoCRA requires facility registration and product listing with the FDA for most cosmetic products sold in the US, tied to a named responsible person for each product. When you discontinue a product, that listing doesn't automatically disappear from the system just because you've stopped manufacturing or shipping it. If your listing needs updating to reflect that the product is no longer being marketed, that's on you to handle, not something that resolves itself with time.

Leaving a discontinued product listed as active indefinitely isn't a neutral choice. It's a stale record that misrepresents your current product line, and it's the kind of thing that looks careless if it ever comes up during an FDA inquiry into something else entirely.

Records don't stop when sales stop

This is the part people underestimate. Safety substantiation and adverse event recordkeeping obligations under MoCRA are tied to the product having been sold, not to the product currently being sold. If someone experienced a reaction to a batch you sold eighteen months ago and reports it after you've discontinued the product, your recordkeeping responsibility around that adverse event doesn't get waived because the product is gone from your catalog.

Practically, this means holding onto:

  • Your safety substantiation file for the discontinued product, showing the basis on which you determined it was safe for its intended use.
  • Any adverse event reports received, along with your response and any follow-up.
  • Formula records and supplier documentation tied to the batches that were actually sold, not just your most recent formula version if it changed over time.

There isn't a universal magic number for how long to keep these on file across every scenario, and retention expectations can be shaped by other factors like state consumer protection rules or your own liability exposure. When in doubt, keep records well past your last sale date rather than treating "discontinued" as a cue to start clearing out files.

A simple discontinuation checklist

  1. Confirm your last date of sale. This anchors your recordkeeping timeline and helps you know how long adverse event obligations realistically need active attention.
  2. Update or withdraw the FDA listing to reflect the product is no longer being marketed, rather than leaving it showing as current.
  3. Archive, don't delete, your safety substantiation file. Move it somewhere retrievable, not somewhere it gets lost in a folder reorganization.
  4. Keep supplier documentation attached to the discontinued formula. If a question ever comes up about a specific batch, you want the SDS and CAS mapping from that era, not your current supplier's paperwork if you've since switched.
  5. Note any reformulation history. If the product went through formula changes during its life, keep a record of which version was sold when, so an adverse event tied to a specific time period can be matched to the right formula.

How this compares to Canada's approach

It's worth noting how differently Health Canada handles this, if you're selling across both markets. In Canada, discontinuations are an active filing action: when you stop selling a product that had a Cosmetic Notification (CN) number, you file a discontinuation through the Cosmetic Notification System, explicitly closing out that notification. MoCRA's structure doesn't have a precisely identical action item, but the spirit is similar. A product's regulatory footprint should reflect reality, whether that means an active filing in Canada or an accurately updated listing status in the US.

Where makers get caught out

The trap isn't usually neglecting the big things. It's assuming that stopping sales is itself the compliance action, when the compliance action is actually updating the listing and holding the file open for a while longer. Small and mid-size makers juggling formulation, sourcing, and everything else understandably treat "we stopped making it" as the finish line.

If you're managing product listings across a changing lineup, whether things are being discontinued, reformulated, or renamed, keeping a clean, current record per product makes this kind of transition much less error-prone. Cosmetic Comply's ability to duplicate a past filing for a variant works in reverse too, in the sense that it keeps your filing history organized enough that closing out an old product doesn't mean losing track of what you need to keep on hand.

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