Who needs a nutrition facts panel in the US
The FDA requires a Nutrition Facts panel on most packaged food sold in the United States. The format and content rules are in 21 CFR 101.9. Unlike Canada, the US has a small business exemption, and it covers a large share of cottage food and small-batch producers. Getting it wrong in either direction costs you: a panel you did not need, or a warning letter for the one you did.
The federal small business exemption
There are two routes, and they have different paperwork.
Low sales, no notice. If your business has annual gross sales of $500,000 or less, or annual sales of food to consumers of $50,000 or less, your products are exempt. You do not file anything.
Low volume, annual notice. If your business has fewer than an average of 100 full-time equivalent employees and sells fewer than 100,000 units of a product in the US in a 12-month period, that product is exempt, but you must file a notice with the FDA every year. Without the notice, the exemption does not apply. If you have fewer than 10 full-time equivalent employees and sell fewer than 10,000 units of the product, no notice is needed, unless you are an importer.
The catch that removes both: any nutrient content claim ("low sodium", "high protein"), any health claim, or any other nutrition information on the label, on your website, or in advertising. You cannot call your granola "high fiber" and claim the exemption. If you make the claim, you need the panel.
Cottage food laws (state by state)
Cottage food laws let home-based producers sell certain foods without a commercial kitchen licence. Each state sets its own, and they vary widely.
Most state cottage food laws do not require a Nutrition Facts panel. Most require basic labelling: product name, ingredient list, allergen statement, producer name and address, and a statement that the product was made in a home kitchen. A few states add more, and the rules change.
The FDA does not override state cottage food law. If your state requires a nutrition label, you need one. If your state does not, and you meet a federal exemption, you are generally in the clear. Check your state's department of agriculture or health for the current rules.
Other federal exemptions
Beyond the small business exemption, the FDA exempts certain product categories:
- Foods served in restaurants, cafeterias, and similar establishments (chains with 20 or more locations have separate menu labelling rules)
- Foods prepared and sold on the premises of a small retailer, such as a bakery selling its own bread
- Plain coffee and tea
- Some spices and flavourings with no significant nutrient content
- Raw fruits, vegetables, and fish (covered by voluntary point-of-purchase nutrition information instead)
- Infant formula, which has its own labelling rules
- Medical foods
What happens if you should have a label and don't
The FDA can issue warning letters, require corrective action, and in serious cases seize product or seek an injunction. For most small producers the first step is a warning letter asking you to come into compliance. State agencies can enforce labelling rules on their own. Correcting a label after the fact is not difficult. A warning letter on file can complicate your relationships with retailers and distributors.
Know you need a panel? Nutrifax builds one from your recipe in about 10 minutes, in the FDA format, with an audit report that shows the calculation. Start free →
How to generate your label
Generating a label in Nutrifax takes about 10 minutes if you have your recipe and ingredient weights ready.
Nutrifax calculates nutrition from USDA FoodData Central, the US Department of Agriculture's food composition database. Health Canada's Canadian Nutrient File is loaded too, so you can pick a Canadian reference food when USDA has no match. Each ingredient is matched to a source food and measure, and the nutrients are summed per serving. Nutrifax then applies the rounding rules in 21 CFR 101.9(c) and outputs a Nutrition Facts panel in the 2016 FDA format. An audit report documents the calculation path (ingredient, measure, data source, and nutrient contribution) so you can show your work.
Two things the software cannot do for you. A blank in the source dataset is not a zero, and Nutrifax does not invent a value to fill the gap. And it cannot see your finished package. Confirm the serving size against the RACC for your category, write your own allergen statement, and check the final label against current regulations for your product.
What the label must include
If you need a Nutrition Facts panel, it must follow the FDA's prescribed format. The current format dates from the 2016 rule, and its compliance deadlines have passed: updated Daily Values, a separate line for Added Sugars, Vitamin D and Potassium in the mandatory list, and serving sizes that reflect what people actually eat.
Core nutrients
The Nutrition Facts panel must declare, in this order:
- Serving size (household measure plus the metric weight)
- Servings per container
- Calories
- Total Fat (with Saturated Fat and Trans Fat as sub-items)
- Cholesterol
- Sodium
- Total Carbohydrate (with Dietary Fiber, Total Sugars, and Added Sugars as sub-items)
- Protein
- Vitamin D
- Calcium
- Iron
- Potassium
Other vitamins and minerals may be declared voluntarily. Percent Daily Value (%DV) must be shown for most nutrients, based on a 2,000-calorie daily diet. The Daily Values are US-specific and differ from the Canadian ones.
Serving size rules
Serving sizes are based on Reference Amounts Customarily Consumed (RACCs), which the FDA publishes for each food category. The serving size on your label must reflect the RACC for your product type, not a portion you pick.
A package that holds less than 200% of the RACC is a single serving, and the whole package must be labelled as one serving. (For foods with a reference amount of 100 g or 100 mL or more, a package between 150% and 200% may be labelled as one or two servings.) A package that holds 200% to 300% of the RACC needs a second column on the panel showing the whole package. Serving sizes are declared as a household measure (cups, tablespoons, pieces) followed by the metric equivalent in grams or millilitres.
Format requirements
The rule requires a single, easy-to-read type style, minimum type sizes, prescribed line weights and spacing, and a box with a hairline rule around the panel. The heading "Nutrition Facts" must be the largest type in the panel. The FDA's sample panels use Helvetica. Packages with 40 square inches or less of available label space may use a simplified or tabular format. Refer to the FDA's guidance documents for the exact specifications.
Common mistakes small producers make
Using the wrong country's label format
The US Nutrition Facts panel and the Canadian Nutrition Facts table are different documents, with different layouts, nutrient orders, Daily Values, and rounding rules. If you sell in the US, use the FDA format. If you sell in both countries, you need a label for each market. This trips up producers near the border and online sellers who ship both ways.
Wrong serving size
An arbitrary serving size instead of the RACC for your category is a compliance failure. "1 cookie" is not a valid serving size just because you sell cookies. The RACC for cookies is 30 g, and your serving declaration is based on that. If your cookie weighs 55 g, the whole cookie is one serving, because it is under 200% of the RACC.
Losing the exemption by making claims
This one is easy to do by accident. Putting "sugar free" or "good source of protein" on your label or website means you now need a full Nutrition Facts panel, even if you otherwise qualify for the small business exemption. The trigger is any nutrient content claim or health claim, wherever it appears: package, website, or advertising.
Rounding errors
FDA rounding rules are specific. Calories under 5 show as 0, up to 50 round to the nearest 5, and above 50 to the nearest 10. Fat rounds to the nearest 0.5 g below 5 g and to the nearest 1 g above. Sodium rounds to the nearest 5 mg up to 140 mg and to the nearest 10 mg above. Carbohydrate, fibre, sugars, and protein round to the nearest gram, with anything under 1 g shown as "less than 1 g" or 0. Round numbers that "look right" will not match. Canadian rounding rules differ, so values from a Canadian table cannot be copied onto a US panel.
Not filing the notice when you need to
The low-volume route (under 100 employees and under 100,000 units) is only valid once you file the annual notice with the FDA. The low-sales route ($500,000 or less) needs no filing. Producers mix these up in both directions: some file a notice they do not need, and some rely on the volume route without ever filing.
Related pages
Sources and reference links
Disclaimer
Educational content only; not legal advice. Confirm the final label against current regulations for your product and jurisdiction.