Last verified 16 Sep 2026 · Sources
FDA’s small business exemption, under 21 CFR 101.9(j)(18), can excuse your product from carrying a Nutrition Facts panel if your business employs fewer than 100 full-time equivalent (FTE) employees and sells fewer than 100,000 units of that specific product in the US in a 12-month period (FDA Small Business Nutrition Labeling Exemption). Qualifying at that level generally requires filing an annual notice with FDA. A smaller tier (under 10 FTE employees and under 10,000 units of that product per year, for non-importers) skips the notice entirely (FDA’s Small Business Nutrition Labeling Exemption Guide). Add a nutrient content claim or health claim anywhere on the package, in labeling, or in advertising, and the exemption stops applying no matter how small your business is.
| Quick facts | Small business exemption |
|---|---|
| Regulation | 21 CFR 101.9(j)(18) |
| Applies to | Small manufacturers deciding if a product can skip the Nutrition Facts panel |
| Key numbers | Under 100 FTE & 100,000 units/yr: file annual notice. Under 10 FTE & 10,000 units: no notice needed |
The rule
21 CFR 101.9(j)(18) sets the exemption’s two conditions, checked together, per product: FTE employee count and annual units sold of that specific product in the US. FDA’s guidance states the qualifying levels as “fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product are sold in the United States in a 12-month period” (fda.gov). “Units” means units of that one product sold nationally, not total company revenue or units across an entire product line, and the FTE count is a business-wide average, not just the team on that product.
Within that same exemption, a lower tier removes the filing requirement altogether. FDA’s guide states: “If a person is not an importer, and has fewer than 10 full-time equivalent employees, that person does not have to file a notice for any food product with annual sales of fewer than 10,000 total units” (FDA Small Business Nutrition Labeling Exemption Guide). 21 CFR 101.9(j)(18)(iv) confirms that wording is limited to non-importers by design: an importer with fewer than 100 FTE employees and fewer than 100,000 units of the product can still claim the exemption itself, but has to file the notice regardless of how small its volume is.
This is separate from the narrower retailer exemption in 101.9(j)(1), which applies to direct-to-consumer sellers with $500,000 or less in total annual sales, or $50,000 or less in food sales. It is aimed at small retail sellers rather than the manufacturer-focused exemption you’re most likely checking.
The numbers
| Tier | FTE employees | Units of the product/year | Annual notice required |
|---|---|---|---|
| Standard small business (j)(18) | Under 100 | Under 100,000 | Yes |
| No-notice tier (non-importers) | Under 10 | Under 10,000 | No |
| Retailer exemption (j)(1), separate | n/a | ≤$500,000 total sales or ≤$50,000 food sales | No |
For the standard tier, the annual notice includes the firm’s name and address, the type of firm, the 12-month claiming period, average FTE count (total paid hours divided by 2,080), the product’s name and brand, units sold in the US during the period, manufacturer information if different from the filer, and a certification from a responsible company representative. It can be filed through FDA’s web-based system, by fax, by email to sbusiness@cfsan.fda.gov, or by mail to FDA’s Center for Food Safety and Applied Nutrition (HFS-820, 5001 Campus Drive, College Park, MD 20740-3835). FDA does not send a reminder; the notice is the filer’s responsibility every year.
On the label
Say you make granola and sell 40,000 bags a year through a handful of regional stores, with three part-time employees. Your business fits comfortably under both the 100-FTE/100,000-unit line and the 10-FTE/10,000-unit line on employees but not on units, so the notice still has to be filed each year to keep the exemption active for that SKU. If you later add “good source of fiber” to the bag, that single claim ends the exemption for that product regardless of how few units it sells, and a full Nutrition Facts panel with a correctly declared RACC-based serving size becomes necessary.
If you sell 6,000 units a year of one spice blend, with six employees total, that product sits under the 10/10,000 no-notice tier, so no filing is needed, as long as the label carries no nutrition claims.
Mistakes we see
- Counting units per business instead of per product. The threshold is 100,000 units of that specific product, not total units shipped across a whole catalog.
- Forgetting the notice is annual. The exemption isn’t a one-time filing; it lapses without a fresh notice covering the current 12-month period.
- Adding a claim and assuming the exemption still holds. “High protein” or “low sodium” on an exempt product cancels the exemption the moment it’s printed or advertised, not just when the panel would otherwise appear.
- Treating federal exemption as the whole picture. State cottage-food law and individual retailer requirements are separate from this federal rule and can still require a panel.
- Not checking employee count as a business-wide average. FTE count covers the whole company, not just staff working on the exempt product.
Related rules
This exemption sits inside the broader map of who needs a Nutrition Facts panel at all. See when-is-nutrition-labeling-required for the full set of 101.9(j) exemptions side by side. Because any claim ends this exemption, nutrient-content-claims is essential reading before printing anything like “low sodium” on an otherwise-exempt product. If you sell both retail and wholesale, or across USDA- and FDA-regulated categories, also check usda-vs-fda-jurisdiction.
If you don’t qualify, or you’re planning a claim
Knowing where each product sits on units and claims lets you add a claim on your own schedule, with the panel ready when you need it. If it’s a single product that no longer qualifies, or one about to carry its first claim, enter your recipe, then see your label: your calories, the claims you qualify for and your allergen line are free, no card required, every other value and %DV stays hidden until you unlock, and $29 unlocks every other nutrient value and %DV, every FDA format your product qualifies for, and your ingredient statement and allergen declaration. If you run multiple SKUs and track exemption status, unit counts, and claims across each one, the Studio plan ($299 a year: every product you make, plus the compliance binder and PDF reports) adds spec-sheet import, a review calendar, and change history so nothing slips past its threshold unnoticed, and the Co-packer plan ($1,199 a year: everything in the Studio plan plus client folders and white-label documents) covers labels you run on behalf of others. Build the real panel free or see pricing for every plan.
FAQ
What are the exact thresholds for the small business exemption?
Under 21 CFR 101.9(j)(18), the exemption can cover your product if your business employs fewer than an average of 100 full-time equivalent (FTE) employees and sells fewer than 100,000 units of that specific product in the US in a 12-month period, per FDA's own guidance ([fda.gov](https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/small-business-nutrition-labeling-exemption)).
Do I have to file anything with FDA to use this exemption?
Yes, generally: an annual notice identifying the product and confirming eligibility. A narrower tier skips the notice: non-importers with fewer than 10 FTE employees selling fewer than 10,000 units of that product per year don't have to file at all (FDA's Small Business Nutrition Labeling Exemption Guide).
Does a nutrient content claim like 'low sodium' cancel the exemption?
Yes. Any nutrient content claim, health claim, or other nutrition information on the package, in labeling, or in advertising ends the exemption for that product, regardless of unit volume or employee count.
Is the exemption per business or per product?
Per product. One SKU can be exempt while another from the same company isn't, based on that product's own unit volume and whether it carries a claim.
Does the exemption cover imported food?
Yes, but on different terms. 21 CFR 101.9(j)(18)(iv) limits the no-notice tier to a person who 'is not an importer' with fewer than 10 FTE employees and fewer than 10,000 units sold; an importer can still claim the exemption at the standard fewer-than-100-FTE, fewer-than-100,000-unit level, but must file the annual notice. The no-notice shortcut simply isn't available to importers.
Does this exemption override my state's cottage-food rules or a retailer's requirements?
No. It's strictly a federal exemption from FDA's Nutrition Facts requirement. State cottage-food law and individual retailer requirements are separate and can still call for a panel.
Related rules
Nutrition labeling requirement, Nutrient content claims, USDA vs FDA Jurisdiction, Database vs Lab Analysis. See the full all labeling rules.