Dietary Supplement Labels: Top 10 Errors That Trigger Holds

Introduction

The dietary supplement industry continues to grow rapidly, but with this growth comes increased scrutiny from regulatory bodies. A single error on your supplement label can result in costly holds, rejected shipments, and damaged brand reputation. Many manufacturers don’t realize that approximately 40% of supplement import detentions stem from labeling issues that could have been easily avoided with proper knowledge and review.

Whether you’re launching a new product or updating your existing line, understanding common labeling pitfalls is critical to maintaining FSVP compliance and keeping your products moving smoothly through customs and onto store shelves. Let’s examine the top errors that trigger holds and how you can avoid them.

Top 10 Errors That Trigger Holds

1. Missing or Incomplete Ingredient List

One of the most frequent triggers for FDA holds is an incomplete list of ingredients. Your label must include every ingredient in the product – both active and inactive.

Common mistakes include:

• ✔️ Omitting proprietary blends while only listing the active ingredients
• ✔️ Failing to list excipients, binders, and fillers
• ✔️ Not disclosing all ingredients in capsule shells or coatings

Remember that even seemingly minor ingredients need to be included. For example, if your capsules contain gelatin, silicon dioxide as a flow agent, or magnesium stearate as a lubricant, all must be listed.

2. Incorrect Serving Size

Serving size errors can lead to immediate holds because they directly impact how consumers use the product. FDA inspectors frequently flag products when:

• ✔️ The serving size doesn’t match the dosage in the directions
• ✔️ There’s inconsistency between the serving size and the product’s form (e.g., stating “2 capsules” when the product is a powder)
• ✔️ The claimed amounts of nutrients don’t align with the serving size

For example, if your directions suggest taking one capsule daily, but your serving size is listed as two capsules, this creates confusion about the actual recommended intake.

3. Improper Claims

Health claims are perhaps the most scrutinized aspect of supplement labels. The FDA strictly prohibits dietary supplements from making claims about treating, curing, or preventing diseases.

Problematic claims often include statements that the product:

• ✔️ “Reduces inflammation associated with arthritis”
• ✔️ “Helps prevent heart disease”
• ✔️ “Fights cancer cells”
• ✔️ “Treats depression or anxiety”

Even subtle implications of disease treatment can trigger holds. Structure/function claims (describing how a nutrient affects body structure or function) are permitted but must be accompanied by the required 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.”

4. Omission of Allergen Information

Failing to disclose allergens is not just a compliance issue—it’s a serious safety concern. The FDA requires clear identification of major food allergens:

• ✔️ Milk
• ✔️ Eggs
• ✔️ Fish
• ✔️ Crustacean shellfish
• ✔️ Tree nuts
• ✔️ Wheat
• ✔️ Peanuts
• ✔️ Soybeans

Many supplement manufacturers overlook allergen identification, particularly when ingredients are sourced from multiple suppliers. For example, if your vitamin D is derived from lanolin (sheep’s wool), this should be noted for consumers with wool allergies.

5. Misleading Usage Instructions

Unclear or misleading usage instructions frequently trigger holds during import reviews. Problematic areas include:

• ✔️ Vague directions like “Take as needed”
• ✔️ Contradictory information about dosage
• ✔️ Failing to specify timing (with meals, before bed, etc.)
• ✔️ Omitting maximum daily intake warnings

Instructions should be specific and consistent with the supplement facts panel. For instance, “Take 1 capsule twice daily with meals. Do not exceed 2 capsules in 24 hours.”

6. Lack of Supplement Facts Panel

Every dietary supplement must have a properly formatted Supplement Facts panel. Common errors include:

• ✔️ Using a Nutrition Facts panel (for foods) instead of a Supplement Facts panel
• ✔️ Incorrect formatting of the panel
• ✔️ Missing percent Daily Values for applicable nutrients
• ✔️ Improper ordering of ingredients

The Supplement Facts panel must follow specific formatting requirements regarding fonts, lines, and layout. Even minor deviations can result in holds.

7. Improper Font Size and Readability

The FDA has specific requirements for label readability:

• ✔️ Most information must appear in at least 6-point font
• ✔️ Certain required statements must appear in specific minimum sizes
• ✔️ Poor contrast (like white text on a light background) is prohibited
• ✔️ Required information must be clearly visible against the background

Decorative or stylized fonts might look appealing from a marketing perspective, but if they compromise readability, they can trigger regulatory issues.

8. Inconsistent Labeling with Product Variants

When you offer multiple versions of a supplement (different flavors, formulations, or strengths), inconsistencies across labels can raise red flags:

• ✔️ Different serving sizes for essentially identical products
• ✔️ Varying claims between product variants
• ✔️ Inconsistent formatting of supplement facts panels

Reviewers often compare different products within the same line, so maintaining consistency is crucial for avoiding holds.

9. Missing Contact Information

Every dietary supplement label must include the name and address of the manufacturer, packer, or distributor. Missing or incomplete contact information is a surprisingly common error:

• ✔️ Omitting the street address
• ✔️ Providing only a website or phone number instead of a physical address
• ✔️ Not identifying the business relationship (manufacturer, distributor, etc.)

This information is essential so consumers can report adverse events or ask questions about the product.

10. Failure to Indicate Suggested Use

While it might seem obvious, many labels fail to clearly state how the supplement should be used. This required element should explain:

• ✔️ The purpose of the supplement
• ✔️ How it should be consumed
• ✔️ Who should use it (if applicable)

Without this information, consumers may misuse the product, potentially leading to safety concerns that trigger regulatory action.

Conclusion

Avoiding these common label errors not only prevents costly holds and rejections but also builds consumer trust. While dietary supplement labeling regulations may seem complex, attention to detail during the label design phase can save significant time and resources later.

Regular label reviews, especially when formulations change or regulations update, are essential best practices for maintaining FSVP compliance. Many companies find that a professional compliance review before printing is the most cost-effective approach to preventing import delays.

Ready to ensure your dietary supplement labels are fully compliant and import-ready? Global Import Agent specializes in comprehensive label reviews specifically designed to catch these common errors before they cause problems at the border. Our team of FDA regulatory experts can review your labels, identify potential compliance issues, and provide actionable guidance to correct them—all before you invest in printing and packaging.

Don’t wait for a costly hold or rejection. Contact us today for a quick, affordable dietary supplement label review that can save you time, money, and headaches. We’ll help ensure your products move smoothly through customs and into consumers’ hands without unnecessary delays. Visit our website or call us to learn how we’ve helped hundreds of supplement brands maintain perfect compliance records.