What are the requirements for supplement labeling?

Over 77% of U.S. adults take dietary supplements, making clear and accurate labeling more critical than ever. Understanding what are the requirements for supplement labeling is essential for both manufacturers to ensure compliance and for consumers to make informed choices.

Quick Summary

The U.S. Food and Drug Administration (FDA) mandates specific labeling requirements for dietary supplements, including a statement of identity, net quantity, manufacturer information, a list of ingredients, and a 'Supplement Facts' panel detailing nutritional content.

Key Points

• Statement of Identity: Labels must clearly state the product name and identify it as a 'dietary supplement'.

• Supplement Facts Panel: This panel, with mandatory formatting, must detail serving size, servings per container, and the quantity of each dietary ingredient.

• Ingredient List: All ingredients, including non-dietary ones like fillers, must be listed in descending order of weight.

• Manufacturer Information: The name and address of the manufacturer, packer, or distributor are mandatory.

• Accurate Claims: Any claims made on the label must be truthful and not misleading, and cannot claim to 'cure' diseases.

• Adverse Event Reporting: A U.S. address or phone number for reporting serious adverse events is required.

• Allergen Disclosure: The presence of major food allergens must be clearly stated on the label.

Understanding the Essential Components of a Supplement Label

Dietary supplement labels are governed by the U.S. Food and Drug Administration (FDA) to ensure consumer safety and product transparency. Every label must contain several key components, typically presented on the Principal Display Panel (PDP) and the Information Panel.

The Principal Display Panel (PDP) and Information Panel

The PDP is the main part of the label, showing the product's statement of identity and net quantity. The Information Panel, usually to the right of the PDP, contains detailed information like the Supplement Facts panel and ingredient list.

The Statement of Identity and Net Quantity

The statement of identity is the product name, clearly identifying it as a 'dietary supplement'. The net quantity indicates the amount of product in the package by weight, volume, or count.

The Supplement Facts Panel

This panel provides nutritional details in a standard format. It includes:

• Serving Size and Servings Per Container: Lists the recommended serving size and the total number of servings.
• Dietary Ingredients: Lists all dietary ingredients. For proprietary blends, the total weight is declared, with ingredients listed in descending order by amount.
• Quantitative Amounts: Shows the amount of each ingredient per serving by weight and, if applicable, as a percentage of the Daily Value (%DV).

The 'Other Ingredients' Section

Non-dietary ingredients like fillers and flavorings are listed in a separate 'Other Ingredients' section in descending order by weight.

Manufacturer Information and Warnings

The label must include the manufacturer's name and address. Any major food allergens must also be clearly declared.

Comparison of Standard vs. Proprietary Blend Labeling

Feature	Standard Ingredient Labeling	Proprietary Blend Labeling
Individual Amounts	Declared by weight per serving.	Not required.
Total Weight	Not applicable.	Total weight of blend is declared.
Order of Ingredients	No specific order.	Listed in descending order by weight within the blend.
Transparency	High transparency of specific amounts.	Lower transparency of individual amounts.
Purpose	Provides specific nutritional information.	Protects manufacturer's formula.

Conclusion

Compliance with supplement labeling requirements is vital for both legal adherence and consumer trust. FDA regulations ensure accurate information on products, from identity to the Supplement Facts panel. Manufacturers must follow these rules to avoid penalties and show commitment to safety. Manufacturers can refer to official FDA resources for more details.

Frequently Asked Questions

What is the primary law that governs dietary supplement labeling?

The Dietary Supplement Health and Education Act of 1994 (DSHEA), which amended the Federal Food, Drug, and Cosmetic Act, is the primary law that governs dietary supplement labeling and regulations.

What is a 'proprietary blend' on a supplement label?

A proprietary blend is a mixture of dietary ingredients where the total weight of the blend is listed, but the specific quantity of each individual ingredient within the blend is not disclosed.

Does a supplement label need to list 'other ingredients' like fillers and additives?

Yes, any ingredients that are not considered 'dietary ingredients,' such as fillers, binders, flavorings, and color additives, must be listed separately in an 'Other Ingredients' section.

Are health claims on supplement labels allowed?

Supplements can have 'structure/function' claims that describe the product's effect on the body's structure or function, but they cannot make claims that the product can diagnose, cure, mitigate, treat, or prevent a disease.

What is the 'Daily Value' (%DV) on a supplement label?

The Percent Daily Value (%DV) is a nutritional reference that indicates how much a nutrient in a single serving contributes to a total daily diet, helping consumers understand the product's potency.

Where should the manufacturer's contact information be located?

The name and address of the manufacturer, packer, or distributor must be listed on the information panel of the label.

How should allergens be declared on a supplement label?

Major food allergens, such as milk, eggs, or soy, must be clearly identified and declared on the label according to specific regulatory requirements.