Does MoCRA Cover Cosmetics Sold Only Online?

A DTC founder asked me recently whether MoCRA even applied to her, since her lip balm brand exists entirely on Shopify and Instagram, no retail shelf anywhere. The answer surprised her: MoCRA doesn't care how you sell the product. It cares whether the product is a cosmetic distributed in U.S. commerce, and an online store selling to U.S. customers is commerce.

Where this myth comes from

It's an understandable mix-up. A lot of older regulatory thinking, and some outdated blog posts still floating around, treat retail distribution as the trigger point for compliance obligations, as if a product only becomes "real" once it's on a shelf at a physical store. MoCRA, the Modernization of Cosmetics Regulation Act from 2022, doesn't work that way. It applies based on facility and responsible person roles tied to the product, not the sales channel.

If you manufacture or process a cosmetic product for distribution in the United States, or you're the named responsible person for a cosmetic marketed there, the duties attach regardless of whether the customer clicks "buy" on a website, walks into Target, or picks it up at a farmers market.

What actually triggers the duties

MoCRA's core obligations run through a few connected pieces:

• Facility registration: the facility where the cosmetic is manufactured or processed registers with FDA
• Product listing: each product gets listed with FDA, tied to a registered facility
• Responsible person: a named individual or entity takes on responsibility for the product, including maintaining safety substantiation
• Adverse event recordkeeping: the responsible person keeps records of adverse events reported by consumers and reports serious ones to FDA

None of these hinge on whether the sale happened through a website checkout, a wholesale account, or a pop-up market table. A cosmetic manufactured in the U.S. and sold exclusively through your own website still needs a registered facility and a product listing under the same rules as one sold through a national retail chain.

The exemption that actually matters, and it isn't "online only"

MoCRA does carve out an exemption for some small businesses from the facility registration and product listing requirements, based on factors like the business's size, not its sales channel. If you think you might qualify as a small business under MoCRA's exemption criteria, that's worth confirming directly against current FDA guidance, since the specific thresholds and conditions are exactly the kind of detail that's worth checking at the source rather than assuming from something you read once.

What the exemption does not do is create a blanket "online-only brands are exempt" category. Plenty of small online brands do fall under the small business exemption, but that's because of their size, and separately because of certain product categories being excluded from the exemption (which is its own detail worth checking directly), not because their storefront happens to be digital.

A quick way to think about it

Question	Does it change your MoCRA duty?
Do you sell only on your own website?	No
Do you sell only through Instagram DMs or a marketplace?	No
Do you manufacture the product yourself versus a contract manufacturer?	Determines who registers the facility, not whether registration is owed
Is your business small enough to qualify for the exemption?	Yes, this is the actual relevant factor
Is your product a sunscreen or another OTC drug category?	Changes the entire framework, since drugs aren't regulated as cosmetics

What to actually check if you're DTC-only

Confirm where your product is physically manufactured or processed and who holds responsibility for that facility. If you're using a contract manufacturer, that's usually the facility that registers, though the responsible person role for the product still needs a clear owner, which is often the brand itself. Then confirm your product listing is filed and kept current as your formula or label changes.

If you've been treating "we're online only" as a reason to defer this, it's worth revisiting now rather than after an inquiry. Cosmetic Comply's ingredient matching and screening work already covers Canadian filings, with U.S. support on the way, so if you're trying to get your ingredient list into clean INCI form ahead of a MoCRA listing, that groundwork doesn't need to wait on the channel question at all.

Sales channel was never the test. Whether the product is a cosmetic distributed in U.S. commerce is, and a Shopify checkout satisfies that just as much as a retail register does.