Do you need a Nutrition Facts Label on your product?
Is it in a package and sold to consumers? Then, yes. To be on the safe side, we recommend that you label your products. But, there are a few specific cases where you might be exempt.
Exemptions based on employee/unit numbers
- Employ fewer than an average of 100 full-time equivalent employees; and
- Manufacture fewer than 100,000 units of that product sold annually in the U.S.;
then you are likely exempt from labeling.
However, you must file a notice with the FDA every year you claim this exemption. You can print out a form here or access the online form here (registration required).
Exemptions based on sales income
- Your annual gross sales (all products) are equal to or less than $500,000; or
- Your food and dietary supplement sales to consumers are equal to or less than $50,000;
you probably qualify for an exemption. In this case, you don’t have to file an exemption notice with the FDA.
- Are not an importer; and
- Employ fewer than 10 full-time employees; and
- Sell fewer than 10,000 units per year;
you qualify for an exemption and do not have to file a notice.
Of course, there is an exception to the exemption. And it is thus:
If you display any sort of nutrient content claim (low fat, sugar free, good source of Vitamin C, healthy, etc.) then you are no longer eligible for the small business exemption and must label your products.
A good idea
Reminder: Even if you qualify for an exemption, it can be good to label your products regardless. Labeling not only tells your customers about the nutrient content of your product, it also suggests that the item is made with a certain quality consistency. Consumers will be able to compare your products to others and make more informed choices about their purchase.
We are here to help! Contact us today to discuss our nutrition labeling software. Getting started and only need a few labels? Contact our Consulting Services department!
For more information, visit the FDA’s Small Business Nutrition Labeling Exemption Guidance page here.