Is My Small Food Businesses Exempt from Providing Nutrition Facts?

For small food businesses, navigating the intricacies of FDA regulations can be daunting, especially when it comes to determining whether you are required to include Nutrition Facts labels on your products. Fortunately, the FDA provides specific exemptions for small businesses, making it possible for many to avoid the complexities and costs associated with nutrition labeling. However, it's essential to understand the conditions under which these exemptions apply and how to go about requesting them.

Understanding Small Business Exemptions

The FDA defines a small business as one that meets specific criteria related to sales volume and production quantity. To qualify for an exemption from providing Nutrition Facts labels, your business must generally meet the following conditions:

Sales Volume

Your business must have less than $500,000 in annual gross sales of food products. Alternatively, if your business makes more than $500,000 in annual sales, your food product must generate less than $50,000 of those sales.

Production Quantity

Your business must sell fewer than 100,000 units of the food product annually. This includes all sizes, forms, and packages of the product.

If your business meets these criteria, you may be exempt from the requirement to provide a Nutrition Facts label on your food products. However, it's important to note that this exemption does not apply to all food products or all business situations.

Submitting an Exemption Request

While small businesses may qualify for an exemption, the process is not automatic. To ensure compliance, you may need to submit an exemption request form to the FDA. This form provides the FDA with the necessary information to confirm that your business qualifies for the exemption.

The exemption request form, along with detailed instructions on how to complete and submit it, can be found on the FDA's website. It’s crucial to follow these instructions carefully and provide all required information to avoid delays or issues with your exemption status.

To access the form and more information, visit the FDA’s Small Business Nutrition Labeling Exemption page.

Who Isn’t Exempt?

Not all food businesses are eligible for these exemptions. Here’s a quick summary of who isn’t exempt:

• Businesses that make nutrient content claims or health claims:

• If your product packaging includes claims like "low fat," "high fiber," or "heart-healthy," you must provide a Nutrition Facts label, regardless of your business size or sales volume.

• Businesses that exceed the sales or production thresholds: If your business sells more than $500,000 in food products annually or produces more than 100,000 units of a particular product, you are not exempt and must provide Nutrition Facts labels.

• Products with multiple establishments: If your product is sold by multiple retail establishments or chains with 20 or more locations, the exemption does not apply.

Understanding whether your business qualifies for a small business exemption is critical to staying compliant with FDA regulations. If your business does not meet the exemption criteria, you must ensure that your food products include a complete and accurate Nutrition Facts label.

Need Help with Nutrition Labels for Your Food Products?

We specialize in helping small food businesses comply with FDA regulations. If you're unsure whether your business qualifies for an exemption or need assistance with creating Nutrition Facts labels, we're here to help. Visit our Nutrition Analysis Services page to learn more about the services we provide or contact us with any questions.