Nutrition label exemptions: what 101.9(j) actually says

An exemption is not a smaller label. It is a legal condition about who sells the food, how much they sell and whether they make nutrition claims. Serving Fact cannot verify those facts for you; this is the checklist to take to your labeling professional.

1. Direct sales to consumers — 101.9(j)(1)(i)

Food offered for sale by a person who makes direct sales to consumers may be exempt when the business has:

• annual gross sales to consumers of not more than $500,000, or
• annual gross sales of food to consumers of not more than $50,000.

The condition is strict: the food must bear no nutrition claims and no other nutrition information in the label, labeling or advertising. One claim takes the product out of the exemption. Sales are based on the most recent two-year average; a business open less than two years needs reasonable estimates.

2. Low-volume small business — 101.9(j)(18)

There is a separate low-volume exemption for small businesses, with limits based on employees and units sold, and it requires a notice filed with FDA. It is not automatic, and the 18-month transition after losing eligibility matters. This is the one that most often gets confused with the direct-sales exemption.

3. Restaurants and other food service

101.9(j)(2) exempts food served in restaurants and similar establishments, provided there are no nutrition claims. Menu labeling is a different rule (101.11) and generally applies to chains with 20 or more locations. A jarred sauce sold at retail is packaged food, not a restaurant meal.

4. What does not qualify

• A product with a “low sodium”, “good source”, “organic” or any other nutrition claim.
• A product sold through retail, distribution or interstate commerce outside the direct-sales model.
• A product that uses the label to advertise a nutrient content or health benefit.
• Assuming that a state cottage-food license is also an FDA labeling exemption.

Checklist before claiming an exemption

1. I sell directly to consumers, not through retail or distribution.
2. My two-year average is under $500,000 in total consumer sales, or under $50,000 in food sales.
3. My label, website, ads and social posts make no nutrition claims.
4. I am not using a low-volume small-business exemption without the FDA notice.
5. A labeling professional reviewed the specific product and state rules.

If you need the label, build it from the recipeor open the tool.