FDA supplement labeling requirements are critical for any brand selling dietary supplements, and understanding these rules helps ensure your packaging stays compliant. When it comes to dietary supplements, the label isn’t just a marketing tool — it’s a legal document.
The U.S. Food and Drug Administration (FDA) regulates the information that must appear on supplement packaging and how it must be presented, so staying compliant is essential for protecting your brand and earning customer trust.
This guide highlights today’s FDA labeling rules and outlines what brands should know when designing packaging for capsules, gummies, powders, tinctures, and other products.
Understanding FDA Supplement Labeling Requirements
Dietary supplements fall under the Dietary Supplement Health and Education Act (DSHEA), which treats supplements as a category of food. This means supplements do not require FDA preapproval before going to market — but they do require compliant labeling and proper good manufacturing practices (GMPs).
The primary regulations that guide supplement labels include:
- 21 CFR 101 – general food labeling requirements
- 21 CFR 101.36 – Supplement Facts panel formatting and content
- DSHEA (1994) – defines what a dietary supplement is and what claims are allowed
- 21 CFR 111 – Current Good Manufacturing Practices (CGMPs), including packaging and labeling operations
Together, these rules ensure that consumers receive accurate, non-misleading information about what’s inside a supplement product.
Required Elements Under FDA Supplement Labeling Requirements
FDA rules specify several mandatory components that must appear on every supplement package.
1. Statement of Identity
The front of the package (Principal Display Panel) must clearly identify the product as a “Dietary Supplement.”
Examples:
- “Vitamin C Dietary Supplement”
- “Herbal Extract Dietary Supplement”
2. Net Quantity of Contents
This also appears on the front panel. It must list:
- The number of capsules/tablets/softgels
- And/or the net weight or net volume
3. Supplement Facts Panel
This standardized panel is one of the most tightly regulated areas of supplement labeling.
It must include:
- Serving size and servings per container
- List of dietary ingredients
- Amount per serving
- % Daily Value (DV), if established
- Proper formatting, including box borders, line weights, and type size
The FDA’s 2016 label update rules require updated DVs, design layout, and formatting.
4. Ingredient List
Active “dietary ingredients” go inside the Supplement Facts panel. Inactive ingredients (“Other Ingredients”) must be listed outside the Supplement Facts panel. Ingredients not listed in the Supplement Facts panel (e.g., inactive ingredients such as binders or flavors) must be declared in descending order of predominance.
FDA requirements for the Supplement Facts section, although straightforward, are extensive. For a deep dive into this topic, check out our post, How to Create an FDA-Approved Supplement Facts Label.
For botanical ingredients, the plant part (root, leaf, flower, etc.) generally must be stated.
5. Name and Place of Business
Labels must include:
- Manufacturer, packer, or distributor name
- City, state, ZIP
- A domestic mailing address or phone number for consumer adverse event reporting (required under the 2006 Consumer Protection Act)
6. Warning Statements
Required warnings vary by ingredient and product type. Examples include:
- Choking warnings
- Iron-containing supplements for children
- Allergen declarations
7. Structure/Function Claim Disclaimer
If you use structure/function claims such as:
- “Supports immune health”
- “Helps maintain joint flexibility”
You must include the FDA-mandated disclaimer:
“This statement has not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease.”
This disclaimer must appear adjacent to the claim(s) with adequate prominence.
How FDA Supplement Labeling Requirements Apply to Claims
The FDA regulates three major categories of claims on supplement labels
1. Structure/Function Claims
Permit explanations of how a nutrient supports normal body functions.
✔ Allowed: “Supports energy production.”
✘ Not allowed: “Treats chronic fatigue syndrome.”
Brands must notify the FDA within 30 days of first marketing a structure/function claim.
2. Nutrient Content Claims
Claims like “High in Vitamin D” or “Good Source of Magnesium” must meet strict quantitative criteria.
3. Health Claims
These describe a nutrient’s link to disease risk reduction.
They require FDA authorization and cannot be self-declared.
Placement, Layout, and Formatting Rules
While brands often focus on the “what” with labeling, the “how” is equally important.
The FDA specifies:
- Minimum type sizes
- Correct panel placement
- Required box rules around the Supplement Facts
- Separation from marketing material
- Prohibition against misleading graphics
In short: creative design is encouraged — as long as it never interferes with legibility or required information.
Good Manufacturing Practices (CGMP) and Labeling
Under 21 CFR 111, brands must follow CGMPs, which include strict requirements for:
- Label revision control
- Packaging operations
- Ensuring each label version matches the correct product
- Preventing mix-ups, misprints, and mis-labeling
For supplement brands, this means having solid internal processes, sample retention, and quality checks at each step.
For packaging suppliers like Sttark, it means:
- Clear proofing and sample procedures
- Consistent color, placement, and panel formatting
- Reliable versioning and repeatability
Common Mistakes That Violate FDA Supplement Labeling Requirements
Even established supplement brands can overlook key details. Some common pitfalls include:
- Crowding mandatory text with decorative design elements
- Incorrect formatting of the Supplement Facts panel
- Using structure/function claims without the required disclaimer
- Illegible ingredient lists due to low contrast or small font
- Listing allergens incorrectly or omitting required warnings
- Missing domestic address or phone number for adverse events
- Outdated Daily Values or nutrition formatting
Small oversights can lead to misbranding (and costly recalls).
How to Stay Compliant With FDA Supplement Labeling Requirements
Here’s how to simplify the process:
1. Lock in Label Content Before Designing Your Label
Ensure all regulatory language is final before working on creative layout.
2. Use a Packaging Partner Familiar With FDA Rules
Professional printers familiar with FDA formatting guidelines help avoid expensive errors.
3. Retain Printed Proofs
Keeping physical or digital proofs on file ensures consistency, especially when reprinting future batches.
4. Review Claims Carefully
Evaluate every claim from both a marketing and regulatory lens.
5. Stay Up-to-Date
FDA guidance updates periodically, so enforcement trends will shift.
Final Thoughts
Supplement labels must balance regulatory compliance with brand storytelling — and getting it right is essential. The FDA’s rules ensure that consumers know exactly what they’re purchasing and how to use it safely.
At Sttark, we work with supplement brands every day—across powders, gummies, liquids, capsules, tablets, and more—to ensure their labels and cartons are both compliant and beautifully executed. From clear Supplement Facts panels to durable, high-quality materials, your packaging is a critical part of your brand experience.
If you’d like help reviewing a label layout or selecting the right materials for your supplement packaging, we’re here to support you. Contact us.
