FDA compliance checklist for launching a food product
This is the list we walk new clients through. It is written for a company that is bringing a packaged food or beverage to market in the United States for the first time.
It is not legal advice for your specific product. It is the shape of the problem, so you know what you are dealing with before you commit to a production run.
1. Decide what your product legally is
Before anything else: is your product a conventional food, a dietary supplement, or something that FDA will treat as a drug?
This is not a marketing question. It determines which regulations apply, what your label has to look like, and what you are allowed to say. A powder sold as a beverage mix and the same powder sold as a supplement have different labels and different rules.
Get this wrong and everything downstream is wrong.
2. Register your facility with FDA
Any facility that manufactures, processes, packs or holds food for U.S. consumption must register with FDA.
Two things founders regularly miss:
Registration is biennial. You must renew between October 1 and December 31 of every even-numbered year. The date you first registered is irrelevant — if you register on September 30 of a renewal year, you still have to renew that same December. Miss it and your registration expires at 11:59 PM on December 31. Selling food in the U.S. on an expired registration is a prohibited act and can mean detained shipments or civil and criminal penalties.
If someone else makes your product, you are not automatically covered. If you use a co-packer, co-manufacturer or private label supplier, the facility that makes the product registers. If you want to hold the registration yourself, you need written permission from the manufacturer.
3. If you are importing, add three more requirements
Importing is where new companies get hurt, because there are separate obligations that have nothing to do with your label.
Foreign Supplier Verification Program. Importers of food and supplements must have an FSVP in place verifying that foreign suppliers meet U.S. food safety standards. FDA has cited the absence of an FSVP as one of its most common findings. You need the plan before the goods ship, and FDA can demand to see it.
U.S. Agent. A foreign facility must designate an agent physically located in the United States and reachable by FDA 24 hours a day.
Prior Notice. FDA must receive prior notice of each imported food shipment before it arrives — no less than 2 hours ahead for road, 4 hours for rail or air, and 8 hours for water. Miss it and the shipment can be refused at the port.
4. Build the label correctly
Your label needs, at minimum:
Statement of identity on the principal display panel
Net quantity of contents, lower portion of the principal display panel
Ingredient list in descending order of predominance by weight
Name and place of business of the manufacturer, packer or distributor
Allergen declaration covering all nine major allergens
Nutrition Facts or Supplement Facts panel, on the principal display panel or the information panel immediately to its right
Sesame became the ninth major allergen on January 1, 2023. If you are working from a template or an example label that predates that, it is out of date.
5. Decide what you are willing to claim
Claims are where the real risk lives, and it is worth separating three categories in your head.
Nutrient content claims — "low fat," "good source of fiber," "high in protein." These have defined regulatory meanings and specific thresholds. You cannot use them descriptively.
Health claims — statements linking a substance to a disease or health-related condition. These are tightly controlled and mostly require an authorized claim.
Structure/function claims — statements that a nutrient affects the structure or function of the body. For dietary supplements, these carry two obligations: you must notify FDA of the claim within 30 days after you first market the product with it, and the label must carry the DSHEA disclaimer, linked to each claim.
A word on the disclaimer: FDA has recently signaled enforcement discretion on the requirement that it appear on every panel where a claim appears. It has not signaled any flexibility on the requirement that the disclaimer be on the label and linked to each claim. Do not read the first part as permission to drop it.
And a broader point. The most expensive labeling mistakes of the last few years have not been technical panel errors. They have been front-of-pack marketing claims that a plaintiff's firm decided were misleading. If a claim is doing a lot of work for your brand, it deserves a lawyer's attention before it deserves a designer's.
6. If it is a dietary supplement, check your ingredients early
If your product contains an ingredient that was not marketed in the U.S. before October 15, 1994, and is not present in the food supply as an article used for food, it is a new dietary ingredient. You must submit a premarket safety notification to FDA at least 75 days before you introduce it into interstate commerce.
Seventy-five days is a long time when your co-packer is scheduled and your launch date is on a deck. Find out whether this applies to you at formulation, not at production.
7. Protect the brand before you spend on it
File the trademark before you print packaging, buy the domain and start paid acquisition on the name.
Federal applications currently cost $350 per class in USPTO fees for a standard electronic filing, with surcharges for things like free-form goods descriptions. The application fee is the small number. The expensive version is discovering, after you have built brand equity, that someone else has priority and you are rebranding.
8. Get your commercial agreements in order
Not FDA, but this is where food companies actually lose money:
A co-packer agreement that addresses who owns the formula, who is liable for a recall, and what happens to your inventory if they go under
An operating agreement if you have partners, addressing additional capital contributions, deadlock, and transfers of ownership
Insurance that actually covers product recall, which general liability often does not
The order that matters
If you do nothing else in order, do these three in this order: decide what the product legally is, clear the ingredients, then design the label. Companies that design the label first and ask the legal questions second are the ones who end up reprinting.
If you want help working through this for a specific product, get in touch.