In the competitive health and wellness landscape of 2026, a product label is more than just a brand’s face; it is a critical legal document. With the FDA increasing its scrutiny on the over 100,000 supplement products in the U.S. market, understanding supplement label requirements is essential to prevent “misbranding” and avoid costly product recalls.
Adhering to federal regulations ensures that your brand builds a foundation of transparency and trust with consumers who are more informed than ever.
The 5 Essential Elements of a Supplement Label
To remain compliant, the FDA mandates that every dietary supplement label must prominently feature five specific pieces of information. If any of these are missing or obscured, the product is legally considered misbranded.
- Statement of Identity: The common name of the supplement (e.g., “Magnesium Citrate Supplement”). This must be on the front panel.
- Net Quantity of Contents: The total amount of the product (e.g., “90 Tablets” or “Net Wt. 250g”).
- Supplement Facts Panel: The standardized box detailing serving sizes and dietary ingredients.
- Ingredient List: A declaration of all ingredients not listed in the “Supplement Facts,” such as binders, flavors, or fillers.
- Name and Place of Business: The physical address of the manufacturer, packer, or distributor responsible for the product.
See also: Business Operations and Data Scan
Navigating the Supplement Facts Panel
The “Supplement Facts” panel is the most technically complex aspect of supplement label requirements. It requires specific formatting to ensure consumers can easily read and understand the nutritional profile.
- Formatting: The panel must be enclosed in a box and use specific font sizes. The title “Supplement Facts” must be larger and bolder than the surrounding text.
- Daily Values: Ingredients with an established % Daily Value (%DV) must have that percentage listed based on the serving size.
- Rounding Rules: The FDA has specific rules for rounding calories and nutrient amounts to ensure consistency across the industry.
For a detailed technical breakdown of how to format these panels, you can refer to the professional guide on supplement label requirements.
Claims and Mandatory Disclaimers
One of the most frequent areas for regulatory errors involves the use of “Structure/Function” claims. These claims describe how a nutrient supports a bodily function (e.g., “Supports bone health”).
When using these claims, brands must strictly follow supplement label requirements by including the mandatory FDA 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 be placed in a box and linked to the claim with a symbol, such as an asterisk. Furthermore, brands must notify the FDA within 30 days of marketing a product that makes such claims.
Conclusion: Compliance as Your Brand’s Protection
Mastering supplement label requirements is an investment in your brand’s longevity. A precise and compliant label doesn’t just satisfy regulators; it signals to major retailers and savvy consumers that your product is safe and accurately represented.
By prioritizing transparency in your packaging, you mitigate legal risks and ensure that your brand stands out for its integrity in a crowded marketplace.
