Small Business Nutrition Label Exemption: Do You Qualify?

Quick Answer

The FDA small business exemption allows companies with fewer than 100 full-time-equivalent employees AND fewer than 100,000 units of a specific product sold in the United States in the prior 12 months to skip the Nutrition Facts panel on that product. The exemption must be requested annually via FDA Form 3570. The exemption does NOT cover ingredient lists, allergen declarations (FALCPA), country-of-origin labeling, name/place-of-business identification, or net weight statements — all remain mandatory. Most small businesses targeting retail distribution choose to label anyway because retailers commonly require nutrition information regardless of FDA exemption status.

The FDA small business exemption is one of the most misunderstood corners of food labeling law. Small food entrepreneurs assume they\'re automatically exempt; many aren\'t. Others assume the exemption removes all labeling requirements; it doesn\'t. This guide walks through who qualifies, how to file, what the exemption does and doesn\'t cover, and why most small businesses choose to label voluntarily anyway.

The Eligibility Test

Two criteria, both required. You qualify for the exemption on a specific product if:

Your company has fewer than 100 full-time-equivalent employees. This includes parent companies, subsidiaries, and affiliates. A small brand owned by a larger conglomerate doesn\'t qualify based on its own employee count alone.
Fewer than 100,000 units of that specific product were sold in the United States in the prior 12 months. The threshold is product-specific (per SKU), not company-wide.

Both criteria must be met simultaneously and on a rolling basis. A company with 80 employees that sells 120,000 units of a hit product loses the exemption for that product but keeps it for slower-moving SKUs.

How to File: FDA Form 3570

File FDA Form 3570 via the FDA\'s Office of Nutrition and Food Labeling — typically through the CFSAN online portal. The form requires:

Company legal name, address, and contact information
Number of full-time-equivalent employees
Specific product names being exempted
Unit sales for each product in the prior 12 months
Statement that the product does not bear any nutrient content claim

No FDA fee. No approval required — the exemption is self-attested. You must keep records supporting the eligibility claim available for FDA inspection. Renew annually for continued use.

What the Exemption Does NOT Cover

The exemption is narrow. It only removes the Nutrition Facts panel requirement. Everything else still applies:

Ingredient list in descending order of predominance by weight
Allergen declaration per FALCPA + FASTER Act (the 9 major allergens including sesame)
Country of origin labeling where applicable
Name and place of business of the manufacturer, packer, or distributor
Net weight or net contents statement
Statement of identity (what the product is, in plain English)
Specific warnings required for certain products (juice unpasteurized warning, raw seafood, etc.)
State-level requirements — California Prop 65, Maine\'s "BPA-free" rules, etc.

Critical point: An exempt product with an undeclared allergen still triggers the same FDA enforcement and class-action exposure as a non-exempt product. The exemption is for nutrition facts only — allergen rules apply universally.

What Voids the Exemption

Several actions automatically remove a product from the exemption:

Any nutrient content claim — "Excellent source of," "Low sodium," "High in fiber," "Reduced sugar," etc. Even claims that seem casual ("Made with whole grains") can trigger the requirement.
Any health claim linking a nutrient to a disease ("Calcium may reduce the risk of osteoporosis")
Any structure/function claim typically associated with supplements ("Supports immune health")
Crossing the 100-employee or 100,000-unit threshold mid-year
Failure to file Form 3570 in a timely manner

The Retail Reality

Even if you legally qualify for the exemption, most retailers won\'t accept exempt products into their stores. Here\'s the typical retailer hierarchy:

Farmers markets, roadside stands, direct-to-consumer at events: Exempt products accepted.
Local specialty grocers, food co-ops: Often accept exempt products with proper ingredient + allergen disclosure.
Regional grocery chains: Mixed — many require Nutrition Facts panels regardless of FDA exemption.
National chains (Whole Foods, Kroger, Safeway): Almost universally require Nutrition Facts panels.
Mass retailers (Walmart, Target, Costco): Require Nutrition Facts panels and often a Certificate of Analysis (lab-tested values).

The economic logic is clear: if your growth path leads to retail expansion, voluntary labeling is the better choice. Our free generator produces compliant labels in 5 minutes — the time-and-cost barrier that justified the exemption in 1990 is essentially zero today.

When the Exemption Genuinely Makes Sense

The exemption is most valuable for:

Cottage food operations selling at farmers markets and through direct channels with no retail intent.
Subscription box and DTC brands with stable, modest volume.
Experimental products being test-marketed in limited geographic areas before commitment.
Custom or small-batch production where SKU volume genuinely stays under 100,000 units.

For everything else, voluntary labeling using a free tool like NutriFacts is the more practical path. See the FDA Requirements Guide for the full label specs, or open our free generator to start.

Frequently Asked Questions

What are the eligibility criteria for the small business exemption?

Two criteria, both must be met: (1) the manufacturer has fewer than 100 full-time-equivalent employees (counting affiliates and parent companies), AND (2) fewer than 100,000 units of the specific product were sold in the United States in the prior 12 months. The exemption is product-specific — a company might exempt one SKU but not another based on unit volume.

How do I file for the exemption?

Submit FDA Form 3570 to the FDA Office of Nutrition and Food Labeling. The form requires company information, employee count, product names, and unit sales data. There is no FDA fee for filing. The exemption is granted automatically upon filing (no FDA approval required) and must be renewed annually for each exempt product.

What does the exemption NOT cover?

The exemption only removes the Nutrition Facts panel requirement. All other federal labeling rules still apply: ingredient list (in descending order of weight), allergen declaration (FALCPA + FASTER Act for the 9 major allergens), country-of-origin labeling, name and place of business of the manufacturer/packer/distributor, net weight statement, and any required warning statements. State-level requirements (e.g., California Prop 65) also remain unaffected.

Can I lose the exemption mid-year?

Yes. If your business exceeds either threshold during the year (100 employees or 100,000 units sold), the exemption no longer applies — and you have 18 months from the threshold crossing to bring labels into compliance. For fast-growing brands, the exemption is a temporary cost saver, not a long-term strategy.

Do retailers accept products that use the small business exemption?

Varies. Farmers markets, direct-to-consumer online sales, and local specialty grocers generally accept exempt products. National grocery chains (Whole Foods, Kroger, Walmart) typically require Nutrition Facts panels regardless of FDA exemption status. Many regional grocery chains also require labels because they cover multiple states and standardize on the strictest applicable requirement. Verify retailer requirements before relying on the exemption.

Does the exemption apply to online direct-to-consumer sales?

Yes — the exemption is based on company size and unit volume, not sales channel. A small business selling exclusively on its own website can use the exemption. Selling through Amazon, however, brings additional requirements: Amazon's seller policies often require nutrition information regardless of FDA exemption status.

What if I make a nutrient claim on an exempt product?

You lose the exemption for that product. Any nutrient claim ("Excellent source of Vitamin D," "Low sodium," "High protein") triggers the full FDA labeling requirements including a Nutrition Facts panel, regardless of company size. Make claims sparingly while exempt.

Is voluntary labeling worth it even when exempt?

Often yes. Voluntary labels enable retail expansion, build consumer trust, support marketing claims, and protect against future growth that ends the exemption anyway. Our <Link href="/generator">free generator</Link> produces FDA-compliant labels in 5 minutes — the cost of labeling is essentially zero, making the exemption mainly useful for products you're certain will stay below the volume threshold.