State rules, and why the federal layer dominates

Makers arriving from food look for a cottage exemption. Supplements do not have one, and the reason is that the federal layer is where this category is regulated.

No cottage exemption here

Cottage food laws are state food laws covering food. A dietary supplement is a separate category under federal law, so a cottage food registration authorizes nothing here.

And the federal rule that matters has no size threshold: 21 CFR 111 has applied to all dietary supplement manufacturers regardless of size since June 2010.

So the question is not whether you are small enough to be exempt. There is no exemption.

What the states actually do

Business licensing and sales tax. Zoning and home occupancy, which govern whether manufacturing may happen where you live regardless of the product.

Some states operate their own food or supplement manufacturer licensing that applies on top of the federal position, and some require registration of the facility with a state department.

Those are administrative rather than substantive, and they can still stop you trading.

California, again

Proposition 65 applies to products sold into California, and supplements are a category where it bites: heavy metals occur naturally in botanicals and in some minerals at levels that trigger warning requirements.

An online brand sells into California by default. Treat it as applying unless you have deliberately excluded the state, and understand your heavy metal results well enough to know where you stand.

What to check

Ask your state specifically: does manufacturing dietary supplements require a state license, may it be done at a residential address, and is there any state registration.

Then treat the federal requirements as the real work, because they are, and they arrive from the first unit rather than at a threshold.

References