Do you need to register your Shopify store as an FDA food facility?

Is your Shopify store itself an FDA food facility?

FDA registers premises, not online stores. A facility, under 21 CFR 1.227, is a structure under one ownership at one general physical location that manufactures, processes, packs or holds food for US consumption. If you resell sealed packages, the question is which premises you control.

A private residence is not a facility, which settles most kitchen-table businesses. FDA reads that narrowly: the home has to meet customary expectations for a private residence, and the carve-out does not reach commercial premises in which a person also happens to live.

The exception ends where the home does: a separate structure on the same property, fitted out for production, counts as commercial premises rather than a private residence.

Product type rarely rescues anyone. Supplements are food under the FD&C Act, and beverages — alcohol and bottled water included — sit on FDA's list of included foods, though no FDA page we read on September 5, 2026 names coffee or tea.

FDA's requirements sit alongside other federal, state and local ones, not instead of them. No FDA page we read on September 5, 2026 uses the term cottage food at all, and our grocery guide covers where a cottage-food permit stops.

Which food sellers are exempt, and does a reseller qualify?

Section 1.226 exempts exactly seven categories: foreign facilities whose food is processed further abroad, unless that further step is only labeling or something equally minor; farms; retail food establishments; restaurants; non-profit food establishments in which food is prepared for, or served directly to, the consumer; fishing vessels, unless they also process fish; and facilities that USDA regulates exclusively, throughout the entire facility, for meat, poultry or egg products. Most online sellers are none of the other six, so the retail exemption is the one to test.

A retail food establishment is one whose primary function is selling food directly to consumers. FDA measures that as a share, not a size: a year of food sales to consumers, by value, must outweigh sales to all other buyers. There is no income threshold, and consumers does not include businesses.

Reselling sealed packages does not change that test, and neither does selling online: FDA's guidance says establishments selling directly to consumers over the internet or by mail order may be retail food establishments, provided they meet the other criteria. Whether a maker's duties reach a reseller is the question our infant-formula page works through.

21 CFR 1.226, 1.227 and FDA's registration Q&A, read September 5, 2026.

Who registers when a 3PL or warehouse holds your stock?

Holding food is a registrable activity on its own, and the registration form has categories for ambient, refrigerated and frozen storage. A storeroom at your retail location, under the same ownership, is part of that establishment; a warehouse elsewhere sells nothing to consumers from that address, so it registers.

A short stay does not rescue it: stock passing through a fulfillment center in a couple of days feels too transient to count, and FDA's guidance closes that reading.

The duty falls on the owner, operator or agent in charge of that facility, who may authorize someone else to file. A warehouse whose customers are businesses generally cannot claim the retail exemption, because selling to consumers is not its primary function.

Only the warehouse side is documented in the FDA pages we read on September 5, 2026, and whether that warehouse is a distinct facility turns on its location and ownership — a third party's warehouse or your own. Whether that also clears the merchant is a question none of the FDA pages we read on September 5, 2026 addresses. Whether such a partner will take your category is answered on our Shopify Fulfillment Network page.

What happens if you cross the line, or skip registering?

The line moves when your activity or your buyers change, not when your revenue grows. FDA's list of manufacturing and processing activities names mixing, labeling and packaging; packing covers re-packing and the sorting that goes with it, but not turning a raw agricultural commodity into a processed food.

Doing any of that does not automatically end the exemption. A retail food establishment may manufacture and process food and remain one while its primary function is still selling directly to consumers. Shifting toward wholesale buyers is what ends it.

Past the line, registration is a continuing duty, not a one-off form. Registered facilities renew every even-numbered year, between October 1 and December 31.

Skipping it is not a paperwork slip. Where a facility is required to register, FDA states that failing to register, renew, update or cancel is a prohibited act under 21 U.S.C. 331(dd), and the United States can bring a civil action in Federal court to enjoin, or a criminal action to prosecute, the person responsible.