FDA-Compliant Labeling for Supplements and Foods

Introduction

Navigating the complex world of FDA labeling requirements can feel like trying to read a recipe written in another language. Whether you’re launching a new supplement or reformulating a food product, understanding FDA labeling compliance isn’t just about avoiding regulatory headaches—it’s about building consumer trust through transparency. The FDA strictly regulates how supplements and foods present information to ensure consumers can make informed decisions about what they put in their bodies. Let’s break down what you need to know to stay compliant and competitive.

Key Elements of FDA-Compliant Labeling

Labeling Requirements

The foundation of any FDA-compliant label includes several non-negotiable elements:

• ✔️ Common Name of the Product: This seems obvious, but your product must clearly state what it is in terms consumers understand—”Vitamin D Supplement” or “Organic Almond Butter” rather than ambiguous marketing terms.
• ✔️ Net Quantity of Contents: The exact amount of product must be prominently displayed in both metric (grams, milliliters) and U.S. customary (ounces, fluid ounces) measurements.
• ✔️ Ingredient List: All ingredients must be listed in descending order by weight. For supplements, this includes both active and inactive ingredients.
• ✔️ Nutritional Information: Food products require the familiar Nutrition Facts panel, while supplements use a Supplement Facts panel. Both must follow specific formatting requirements that the FDA updates periodically.

One manufacturer I worked with had to recall thousands of jars because they failed to update their Nutrition Facts panel to the most recent format—a costly mistake that could have been avoided with proper compliance checks.

Health Claims

This is where many companies stumble. The FDA has strict guidelines about what you can claim your product does:

• ✔️ Authorized Claims: These are health claims the FDA has specifically approved based on significant scientific agreement. For example, “Adequate calcium throughout life may reduce the risk of osteoporosis.”
• ✔️ Structure/Function Claims: These describe how a nutrient affects body structure or function—”Calcium builds strong bones” rather than “Calcium prevents osteoporosis.” These claims don’t require FDA pre-approval but must be truthful and include a disclaimer.
• ✔️ Claim Substantiation: Any claim on your label must be backed by scientific evidence. The more significant the claim, the stronger the evidence needed.

A small supplement company recently faced a $500,000 settlement with the FTC for making unsubstantiated claims about their product’s ability to treat specific health conditions—proof that cutting corners on claims compliance isn’t worth the risk.

Labeling Statements

Beyond your claims, certain statements are required on labels:

• ✔️ Disclaimers: Structure/function claims for supplements must include the 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.”
• ✔️ FTC Compliance: While the FDA regulates labeling, the Federal Trade Commission oversees advertising. Both agencies work together to ensure claims aren’t misleading.
• ✔️ Sourcing Information: If you make claims about how or where ingredients are sourced (e.g., “wild-caught” or “organic”), these must be truthful and verifiable.

Manufacturer Information

Your label must clearly identify who’s responsible for the product:

• ✔️ Name and Address: The label must include the name and place of business of the manufacturer, packer, or distributor.
• ✔️ Contact Information: While not always required, providing a website, phone number, or email address helps build consumer trust and provides a channel for feedback or concerns.

Allergen Information

Food allergens can be life-threatening, making this section critically important:

• ✔️ Major Allergens: Labels must clearly identify any of the eight major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.
• ✔️ Cross-Contamination Warnings: Statements like “Manufactured in a facility that also processes tree nuts” aren’t just helpful—they can be legally required depending on your manufacturing processes.

Steps to Achieve Compliance

1. ✔️ Understand FDA Guidelines: Start by thoroughly reviewing FDA guidelines for your specific product category. The requirements for a sports drink differ from those for a multivitamin.
2. ✔️ Design Your Label: Work with designers who understand FDA requirements. A beautiful label that fails compliance checks is useless.
3. ✔️ Review and Revise Regularly: FDA requirements change. Set calendar reminders to review your labels annually against current regulations.
4. ✔️ Consult with Experts: FDA labeling compliance is complex enough that even experienced manufacturers benefit from expert review. What seems like a minor oversight could lead to major consequences.

Practical Compliance Tips

When working on labeling compliance, focus on these practical steps:

• ✔️ Maintain a regulatory binder with documentation supporting all claims
• ✔️ Create a compliance checklist specific to your product category
• ✔️ Take photographs of competitor products with FDA-compliant labels for reference
• ✔️ Budget for periodic label updates as regulations evolve
• ✔️ Test consumer understanding of your labels before full production

I’ve seen companies save tens of thousands in potential recall costs by investing in professional compliance reviews before printing their packaging materials.

Common Labeling Pitfalls

Watch out for these frequent compliance issues:

• ✔️ Inconsistent serving sizes between the Supplement Facts panel and directions
• ✔️ Using the term “natural” without understanding the FDA’s view on this claim
• ✔️ Failing to use the exact required disclaimer wording
• ✔️ Overlooking font size requirements for certain elements
• ✔️ Missing allergen statements when ingredients change

One supplement manufacturer I advised was using incorrect serving sizes that made their product appear to have more servings per container than it actually delivered—a mistake that could have led to consumer complaints and regulatory scrutiny.

Conclusion

Navigating FDA labeling requirements might seem overwhelming, but it’s an essential investment in your product’s success. Compliant labels don’t just keep you on the right side of regulations—they build consumer trust through transparency and accuracy.

Need help ensuring your supplement or food labels meet all FDA requirements? Global Import Agent specializes in FDA compliance services specifically for food and dietary supplement companies. Our team of FDA regulatory experts can review your labels, provide guidance on permissible claims, and help you navigate the complex world of FSVP compliance—often at a fraction of the cost of regulatory mistakes.

Whether you’re launching a new product or entering the US market for the first time, we’ll help you get your labeling right from the start. Contact us today for a free initial consultation and discover how our affordable compliance services can protect your brand while building consumer confidence.