Who regulates you, and when

Skincare is regulated differently from the food businesses it gets compared to: heavier at the federal level, much lighter at the state level, with one obligation that never scales away.

Mostly federal, unlike food

There is no cottage exemption because cottage food laws cover food. Cosmetics are federal: labeling, safety substantiation, and under MoCRA facility registration and product listing.

FDA does not approve cosmetics before sale. It sets requirements and acts when they are not met, which puts the burden of getting it right before launch entirely on you.

What FDA actually requires

Correct labeling: identity, net quantity, INCI ingredient declaration in descending order, business name and address, and any necessary warnings.

Safety substantiation, which has no small-business exemption.

Registration and listing under MoCRA, with small-business exemptions that do not apply to products that are also drugs.

And if the product carries an SPF or a therapeutic claim, the whole OTC drug framework: a monograph, a Drug Facts panel, and no exemptions.

Where states come in

Business licensing, sales tax, zoning and home occupancy. Some states require a cosmetic manufacturer registration of their own.

California is the one to check regardless of where you are, because its ingredient reporting and Proposition 65 warning requirements apply to products sold into the state and an online brand sells there by default.

What changes as you grow

Crossing the small-business threshold brings registration and listing into scope. Taking on wholesale brings a documentation demand that is commercial rather than legal but arrives with the same urgency. And adding an SPF product moves that product into a different regime entirely.

The obligation that does not change with size is the one people assume will: safety substantiation applies from the first unit.

References