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Mandatory Product Recall Authority

MoCRA: This information is applicable to: All Cosmetic Manufacturers

Under the new MoCRA requirements, the FDA now has the authority to require that you recall a cosmetic product if it is adulterated or misbranded.1 This is new; before MoCRA the FDA could request that a company recall a cosmetic, but it couldn’t make the company do it.

When can a recall be required?

First off, it is unlikely that something like this would happen without your having some advance notice. You probably would have already known there was an issue with the product and would be working with either the FDA or local officials to resolve the problem.

In order to order you to recall a product, the FDA must determine that there is a “reasonable probability” that the product is adulterated or misbranded and that use or exposure to the product could cause a serious adverse health consequence or death. It must serious. Before the FDA orders you to recall a product, they must give you a chance to cease distribution and voluntarily recall the product. Only if you refuse to voluntarily recall the product can the FDA step in an order you to do so.

What if you disagree?

If you disagree with the order, you can request an informal hearing, with has to be held within 10 days of the issuance of the order. At the hearing, the FDA will decide if the order will be canceled (vacated), continued, or amended.

What notice must be made?

If you do have to recall a product, the FDA will issue press releases, product alerts and post the details on their website to let consumers and retailers know about the product recall.2

What should you do now?

While it’s unlikely that a handcrafted soap or cosmetic could be of sufficient danger to cause a serious adverse health consequence or death, it is remotely possible. For example, if a manufacturer issued an alert about a batch of a preservative that was failing, and you used that preservative in a lotion or other cosmetic, you might have product that would go bad because the preservative failed. Or possibly supplier found that a batch of herbs or dried flowers had been contaminated with a bacteria or fungus and you used those herbs or flowers in a product. Unlikely, but still possible.

You should keep sufficient records so that if something were to happen, you could at least identify the batch(es) of product that need to be recalled and have some idea of where they were sold. Normally that information would be part of your ingredient tracking and batch records. See Best Safety Practices for Small Businesses and Good Manufacturing Practices for more information.

NOTE: More details on how the actual recall process, including hearings, will actually work will probably be detailed in regulations implementing MoCRA issued by the FDA at some point in the near future.

1 21 USC 364g(a)
2 21 USC 364g(f)

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