Food business legal FAQ

Short answers to the questions we get most often from food, beverage and dietary supplement companies. Each links to a fuller discussion where we have one.

Does FDA approve my food label before I sell?

No. There is no pre-market approval for a conventional food or dietary supplement label. Nobody at FDA reviews your artwork and clears it. You are responsible for compliance on your own, and the first agency review may be a detained shipment or a Warning Letter.

Do I have to register my facility with FDA?

Yes, if the facility manufactures, processes, packs or holds food for consumption in the United States. Registration must be renewed between October 1 and December 31 of every even-numbered year, regardless of when you first registered.

What happens if I miss the registration renewal?

Your registration expires at 11:59 PM on December 31 of the renewal year and is removed from your account. Selling food in the U.S. without a valid registration is a prohibited act and can result in detained shipments and civil or criminal penalties.

My product is made by a co-packer. Do I still need to register?

The facility that makes the product is the one that registers. If you want to hold a registration in your own name, you need written permission from the manufacturer.

How many allergens do I have to declare?

Nine. The original eight under FALCPA, plus sesame, which became the ninth major allergen on January 1, 2023. If you are working from a label template that predates 2023, it is out of date.

Can I call my product "natural"?

There is no FDA regulation defining "natural" for food labeling. That is precisely why it is risky. The absence of a definition has not stopped plaintiffs' firms from bringing consumer class actions over the word, and those cases turn on what a reasonable consumer would understand, not on a regulatory threshold.

What is the difference between a structure/function claim and a health claim?

A structure/function claim says a nutrient or ingredient affects the structure or function of the body. A health claim links a substance to a disease or health-related condition. Health claims are tightly controlled and generally must be authorized. Structure/function claims do not require pre-approval but carry their own obligations.

What are those obligations?

For a dietary supplement, two. 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 — "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease" — linked to each claim.

What is a new dietary ingredient?

An ingredient not marketed in the United States before October 15, 1994 that is not present in the food supply as an article used for food. If your supplement contains one, you must submit a premarket safety notification to FDA at least 75 days before introducing the product into interstate commerce.

What is FSVP and do I need one?

The Foreign Supplier Verification Program. If you import food or dietary supplements into the U.S., you must have a program verifying your foreign suppliers meet U.S. food safety standards. It is your obligation as importer, not your supplier's, and FDA can require you to produce it.

How far in advance does Prior Notice have to be filed?

At least 2 hours before arrival by road, 4 hours by rail or air, and 8 hours by water. For international mail, before the article is sent.

Why do imported products get refused at the border?

Labeling violations are among the leading causes. The compounding problem is that once FDA identifies a labeling issue with your products, future shipments are more likely to be examined.

Can I sell dietary supplements on Amazon without FDA clearance?

There is no FDA clearance to get. But Amazon enforces FDA compliance independently and will remove non-compliant listings, so the practical answer is that your product needs to be compliant before you list.

How much does a federal trademark cost?

USPTO fees are currently $350 per class for a standard electronic filing, with surcharges for things like free-form goods descriptions. Attorney fees are separate. Our flat fee filings run $899 to $1,999 depending on whether you need a search, a legal opinion, and coverage for both a name and a logo.

Can I trademark my recipe?

No. A trademark protects brand identifiers — names, logos, slogans. A recipe is generally protected, if at all, as a trade secret, which requires that you actually treat it as one.

Do I need an operating agreement for my LLC?

Not every state requires one, but if you have two or more members you should have one. At minimum it should address what happens when the business needs more money, what happens when the members deadlock, and what happens when someone wants out.

Can I start a food business from my home kitchen?

In many states, yes, under a cottage food law — with limits on what you can make, how much you can sell, where you can sell it, and how it must be labeled. The rules are state-specific.

Do I need a lawyer to start a brewery or distillery?

You need a federal permit from the TTB and state and often local licensing, and the sequence matters. Many people manage the paperwork themselves. Where counsel earns its fee is in the lease, the distribution agreement, and the label approvals.

Does my lease really control whether I can change my menu?

It can. A permitted use clause can limit your concept. An exclusive use clause granted to a neighboring tenant can stop you adding a product category. A continuous operation clause can dictate the hours you stay open. Read the lease before you change the business.

What does "outside general counsel" mean?

An arrangement where we function as your legal department on an ongoing basis without you hiring one. It suits companies too complex to operate without a lawyer and not yet large enough to employ one full time.

Do you work with clients outside Michigan?

Yes. Our practice is national. Federal regulatory work — FDA, TTB, USPTO — is not state-limited, and we work with food and beverage companies across the country.

How do you bill?

For defined regulatory work — label review, FDA registration, trademark filing — flat fees, published on this site. For ongoing counsel, we scope it with you in advance. We would rather have the pricing conversation early than surprise you.

Still have a question?

Ask us. If the answer is short, we will just tell you.