- Clearly define the product with a “dietary supplement” statement and accurate net quantity (e.g., tablet count).
- Follow updated Supplement Facts panel rules, including serving size, nutrients, and formatting changes.
- List all ingredients in descending weight order with proper font size and specific declarations for colors and flavors.
- Substantiate nutrient content claims (e.g., “sugar-free”) and include disclosures when necessary.
- Include required warnings, new dietary ingredient disclosures, and country of origin for imported products.
When it comes to FDA-certified supplements, clear and compliant labeling is not simply a nice-to-have, but a requirement to get your product on store shelves. Whether a vitamin or mineral, an herb or botanical supplement, an amino acid product, or otherwise, all products to be sold to and consumed by people in the United States need to offer clear, comprehensive, and compliant label statements about the product inside.
Thankfully, the Food and Drug Administration makes its FDA supplement labeling requirements quite clear.
In this guide, we will outline the various requirements all supplement products must follow to become FDA certified. If your product labeling meets these standards, consider it FDA-ready!
Statement of Identity
First off, your product label needs to clearly identify the product that can be found inside your packaging. This means that, in addition to your proprietary branding and product naming, you need to identify your product as a “dietary supplement.”
Net Quantity of Contents
Your packaging should clearly identify the total number of individual supplements found inside your container. For instance, a bottle of 100 supplemental tablets should say “100 tablets” clearly on the box and/or bottle.
Supplement Facts Label
Per changes to federal law in 2016, your Nutrition Facts panel, which appears on the outside of your packaging, should include all nutritional details about your product in addition to alterations to the standard fonts/sizes of text, additions about added sugars where applicable, and new footnotes.
The FDA herbal supplement label requirements for the supplement facts panel should outline, when present:
- Serving size
- Servings per container
- Total calories
- Calories from fat
- Total fat
- Saturated fat
- Cholesterol
- Sodium
- Total carbohydrate
- Dietary fiber
- Sugars
- Protein
- Vitamin A
- Vitamin C
- Calcium
- Iron
Other vitamins and minerals present do not need to be listed in the supplement facts panel, per FDA label requirements for dietary supplements.
Ingredient Labeling
Your list of all ingredients used to formulate your product must fall directly below your nutrition label on your packaging. Fonts can be no smaller than 1/16” in height. Ingredients listed must be presented in descending order of predominance of weight.
While spices, natural flavors, and artificial flavors may be labeled as such, certified artificial colors must be declared specifically.
Nutrient Content Claims
Any claims about your product (such as “sugar-free” or “high in fiber” must be substantiated, with that substantiation appearing in the Supplement Facts panel alongside your ingredient label. These claims must also feature a disclosure statement if your supplement features nutrient levels in excess of healthy serving amounts.
It’s worth noting that your packaging cannot suggest that your product can treat, cure, or prevent afflictions.
Disclosure of New Dietary Ingredients
For any ingredients that were not marketed in the U.S. prior to October 15, 1994, you must issue a declaration of their use in your product.
Warning Statement
If your supplement contains high iron content, you must also present a warning statement on the package, which states: “WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.”
Imported Product Disclosure
If your supplements come from a manufacturer outside of the United States, your package should declare the country of origin.
Get the Compliance Help Your Product Needs
If you are bringing a new product to market and want to ensure it is FDA-compliant, allow J&J Compliance Consulting Group to assist you. We can help you navigate FDA dietary supplement label requirements with ease.
Our industry expert team has helped clients across food and drug as well as other industries get the regulatory guidance and quality assurance they need to meet safety standards, match global market requirements, and bring products to market efficiently.
Our team has the expertise to help you navigate FDA supplement label requirements and compliance with confidence, including:
- Labeling review and compliance
- New product development
- Manufacturing compliance
- International market entry
- And more.
Get a quote today.