FDA Labeling Guidelines for Dietary Supplements: A Comprehensive Guide

Creating an informative and compliant label for your dietary supplements is essential to protect your company from FDA enforcement action and to generate more informed consumers. In this guide I provide an overview of FDA's labeling rules for dietary supplements.

FDA Labeling Guidelines for Dietary Supplements: A Comprehensive Guide

The Food and Drug Administration (FDA) has established a set of regulations for dietary supplement labels. These regulations require that the label include the name of the product, a statement that it is a dietary supplement, and the name or type of dietary ingredient. Additionally, dietary ingredients of natural origin must be present at 80% of the declared value. Creating a supplement label that complies with FDA regulations is essential to protect your company from FDA enforcement action and to generate more informed consumers.

As an expert in SEO, I understand the importance of creating an informative and compliant label for dietary supplements to ensure that your product meets all FDA requirements and provides consumers with accurate information about its contents. In this guide, I will provide a comprehensive overview of the FDA's labeling rules for dietary supplements, format options, and next steps to take when considering creating your own labels.

What is a Supplement Information Panel?

The nutrition label on a dietary supplement is called a Supplement Information Panel. If your product falls into one or more of those categories, it must carry a supplement label that complies with FDA regulations.

The FDA has a set of extensive examples of labels with information on supplements that comply with regulations as part of its frequently asked questions resource for the industry.

Formatting Your Supplement Label

You should also use a larger font size than all other print sizes on the nutrition label for the title Supplement Information. One serving of a dietary supplement is equivalent to the maximum amount recommended, as appropriate, on the label for consumption per meal or, in the absence of recommendations, to 1 unit. We recommend choosing white vinyl or white, transparent, metallic or holographic plastic to print the supplement information label.

Declaring Dietary Ingredients

In addition, dietary supplements are products intended for ingestion, are not represented for use as conventional food or as the sole element of a meal or diet, and are labeled as dietary supplements. The FDA also allows you to declare the amount per serving, the amount per unit, and the amounts of more than one serving if your supplement has different serving sizes.

You should list dietary ingredients that contain daily values in the same order as on conventional food labels, except that vitamins, minerals, and electrolytes are grouped together.

Supplement Information Component

The supplement information component of a dietary supplement label has the most important and complex requirements. The supplement information panel that appears on the labels of intermediate sized packages should include a font size of no less than 6 points, except that the type no less than 4.5 points can be used on 20 to 40 square inch packages that include more than 16 dietary ingredients.

Conclusion

As dietary supplements become increasingly popular, it is essential to comply with labeling guidelines in order to avoid misinformation and serious side effects. To save you time and help you comply with regulations, I have created this comprehensive guide to FDA labeling rules for dietary supplements that combines all the essential labeling information under one roof.

By following these guidelines and creating an informative and compliant label for your dietary supplements, you can ensure that your product meets all FDA requirements and provides consumers with accurate information about its contents.