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Do you need a nutrition label to sell at a farmers market?

A farmers market stall is not its own exemption from Nutrition Facts. FDA’s How to Start a Food Business page lists farmers markets, along with retail food establishments such as grocery stores and restaurants, as examples of food businesses that are not regulated by FDA. It says state and local government regulate those retail businesses. The same page says FDA regulates foods and food ingredients introduced into or offered for sale in interstate commerce, except meat, poultry, and certain processed egg products, which USDA regulates.

If a packaged food is subject to 21 CFR 101.9, a Nutrition Facts label is required unless an exemption in 101.9(j) applies. Shipping a food to another state, or otherwise introducing it into interstate commerce, is the setting in which those FDA rules are written to apply. A sale that stays inside one state’s retail rules can still be covered by that state’s cottage-food or retail-food law. This page quotes the federal tests. It is not a determination that a particular stall is exempt.

If you are building the panel anyway, the label maker formats a draft. The dollar and employee tests are quoted in full on the small-business exemption page.

When Nutrition Facts are required

Section 101.9 is the nutrition-labeling rule. Paragraph (j) lists the exemptions. Three of them come up for market sellers, and each one fails if the food carries a nutrition claim or other nutrition information:

Bulk food has its own display rule: nutrition information may be posted on the bulk container or provided another way the section allows. 21 CFR 101.9(j)(16). That is an exemption from the package label, not from having the information available.

The small-business tests

Direct sales to consumers, 21 CFR 101.9(j)(1). Food offered for sale by a person who makes direct sales to consumers, for example a retailer, can be exempt when annual gross sales to consumers are not more than $500,000, or annual gross sales of food to consumers are not more than $50,000. The food must bear no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Sales are the most recent 2-year average of business activity. A firm in business less than 2 years uses reasonable estimates that annual sales will not exceed those amounts. 21 CFR 101.9(j)(1)(ii).

Low-volume products, 21 CFR 101.9(j)(18)(ii). For a 12-month period, a product can be eligible when, during the preceding 12 months, the person claiming the exemption employed fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product were sold in the United States. A product that was not sold in the preceding 12 months can qualify when fewer than 100,000 units are reasonably anticipated during the claim period. Labels, labeling, and advertising must not provide nutrition information or make a nutrient content or health claim. A notice is filed before the period begins, except that a person who is not an importer and has fewer than 10 full-time equivalent employees does not have to file a notice for a food product with annual sales of fewer than 10,000 total units. Full-time equivalent employees use a 2,080-hour year. The filing address, the 18-month transition if the numbers are later exceeded, and the unit definitions are on the exemption page, quoted from the same section. FDA also explains the program on its small business nutrition labeling exemption page.

Claims that bring the nutrition label back

Both small-business exemptions, and the immediate-consumption exemption, are conditioned on the absence of nutrition claims and other nutrition information. A nutrient content claim is a claim that expressly or implicitly characterizes the level of a nutrient of the type required in nutrition labeling. 21 CFR 101.13(b). An expressed claim is any direct statement about the level or range of a nutrient. The regulation’s own examples are “low sodium” and “contains 100 calories.” “High,” “rich in,” and “good source” are defined in 21 CFR 101.54. A health claim characterizes the relationship of a substance to a disease or a health-related condition and is covered by 21 CFR 101.14.

The condition is not limited to the front of the package. 21 CFR 101.9(j)(1) says the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. A sticker, a price sign that states a nutrient level, a website, or an ad can matter. Putting “20 g protein” or “no added sugar” on the bag is nutrition information even when the bag has no Nutrition Facts panel. Once that information is there, the exemption does not apply, and the panel has to follow 21 CFR 101.9, including the rounding rules.

A practical checklist

  1. Is the food a packaged product the customer takes away, or food served to eat immediately? Immediate consumption is 21 CFR 101.9(j)(2), and only while the no-claim condition holds.
  2. Is the food staying in in-state retail sale, or is it introduced into interstate commerce? FDA’s starting-a-food-business page points retail food establishments and farmers markets to state and local regulation, and points interstate food to FDA. Read the state rule either way.
  3. For a Nutrition Facts exemption under 101.9(j)(1), do the $500,000 or $50,000 figures fit the most recent 2-year average, or a reasonable estimate if the firm is newer than 2 years?
  4. Or, under 101.9(j)(18)(ii), were there fewer than 100 full-time equivalent employees and fewer than 100,000 units of that product? If a notice is required, was it filed before the period?
  5. Does the package, any labeling, or any advertising make a nutrient content claim, a health claim, or another nutrition statement? If yes, the exemptions above do not apply.
  6. A Nutrition Facts exemption is an exemption from 21 CFR 101.9, not from every other label rule. Statement of identity, net quantity, ingredients, major allergens, and the responsible name and address can still apply to an FDA-regulated package. State cottage-food rules can require them too. See cottage food labels.

Checking the boxes is not a determination that the food is exempt. Serving sizes, if you do print a panel, still come from 21 CFR 101.12. Bakery amounts are on the baked goods page.

Questions

Does selling at a farmers market require a Nutrition Facts label?

A farmers market is not an exemption in 21 CFR 101.9(j). FDA’s How to Start a Food Business page lists farmers markets among food businesses that are not regulated by FDA, and says state and local government regulate retail food establishments. FDA regulates food introduced into or offered for sale in interstate commerce. If 21 CFR 101.9 applies, Nutrition Facts are required unless an exemption in that section applies. State rules can require a label even when FDA does not regulate the stall.

Which small-business tests can exempt Nutrition Facts?

21 CFR 101.9(j)(1) can exempt food sold directly to consumers when annual gross sales to consumers are not more than $500,000, or annual gross sales of food to consumers are not more than $50,000, using the most recent 2-year average. 21 CFR 101.9(j)(18)(ii) can exempt a product when the person employed fewer than 100 full-time equivalent employees and fewer than 100,000 units of that product were sold in the United States. Both require that labels, labeling, and advertising carry no nutrition claim and no other nutrition information.

When does a claim mean the label is required?

A nutrient content claim under 21 CFR 101.13, a health claim under 21 CFR 101.14, or other nutrition information on the label, in labeling, or in advertising removes the 21 CFR 101.9(j)(1) and 101.9(j)(18) exemptions. Examples of expressed nutrient content claims in 101.13 include “low sodium” and “contains 100 calories.” A sign, sticker, website, or social post can be labeling or advertising for this purpose.

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