Under FDA regulations, most packaged food and beverage products are required to include a Nutrition Facts panel on their labels. However, the FDA recognizes that this requirement can be burdensome for very small businesses and therefore provides a Small Business Nutrition Labeling Exemption for qualifying companies. In general, a business may qualify for the exemption if it has fewer than 100 full-time equivalent employees and fewer than 100,000 units of the product sold in the U.S. per year.
Businesses with fewer than 10 employees and fewer than 10,000 units sold annually are typically exempt without filing a formal notice, while businesses not meeting that threshold must submit a notification to the FDA claiming the exemption.
Importantly, this exemption applies only to the Nutrition Facts panel—it does not eliminate other labeling requirements—such as ingredient statements, allergen disclosures, net quantity of contents, or name and place of business.
The exemption is also not available if the label makes any nutrient content claims (e.g., “low sugar,” “high protein,” “low calorie”) or certain health claims. If such claims are made, full nutrition labeling is required regardless of company size. Additionally, the exemption must be renewed annually if a filing is required, and companies should closely monitor sales growth to ensure continued eligibility.
Because misuse or misunderstanding of the exemption can lead to misbranding issues, enforcement action, or costly relabeling, businesses should carefully assess whether they qualify and maintain documentation supporting their exemption status.
How Lindsey Zahn P.C. Can Help
Lindsey Zahn P.C. is an alcohol beverage and food law firm that works with food and beverage companies to navigate FDA labeling requirements and exemption eligibility, including:
- Evaluating eligibility for the FDA Small Business Nutrition Labeling Exemption.
- Preparing and filing required FDA exemption notifications and annual renewals.
- Reviewing product labels for compliance with FDA food labeling requirements beyond the Nutrition Facts panel.
- Advising on the impact of nutrient content or marketing claims on exemption status.
- Assisting companies as they scale and transition out of the exemption, including timing and compliance planning.
- Helping domestic and international brands enter the U.S. market with compliant labeling strategies
If you have questions about whether your products qualify for an exemption or want to ensure your labels are compliant as your business grows, we encourage you to contact us.
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