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FDA Dietary Supplement Label Regulations

Quality Smart Solutions ensures your labels meet DSHEA and 21 CFR codes of federal regulations. We review your labels, advise on structure-function claims, prepare a substantiation dossier (if required), and file a premarket notification with the FDA. We guide your products to market and help you stay compliant with the FDA Dietary Supplement Regulations.

Dietary supplements are health and wellness products that contain dietary ingredients, including minerals, vitamins, herbs, amino acids, botanicals, and other categories of ingredients that can be used to supplement diets. The forms of dietary supplements include but are not limited to tablets, powders, capsules, gummies, and liquids. The supplements are used to improve health, used for the prevention of ailments, and for the maintenance of overall wellness. 

Based on the CRN Consumer Survey on Dietary Supplements conducted in 2019, 77% of Americans consume dietary supplements. The majority of both are males and females, aged 18+ years. Among the age groups, adults between the ages of 35 – 54 years old share 18% consumption, the highest usage of dietary supplements. Consequently, the nutritional supplement industry is witnessing massive growth, primarily in vitamins and protein supplements.

FDA Dietary Supplement Requirements

The FDA governs dietary supplements in the USA. FTC governs the marketing and advertisement of dietary supplements.  Failure to comply with the dietary supplement regulations can result in an FDA warning letter, FTC fines, stop sale, recall, and potential litigation. If you export dietary supplements to the United States it may result in entry refusal and the U.S. Customs and Border Protection Agency detaining your goods. As a manufacturer, importer, or distributor of dietary supplements and dietary ingredients, you’re solely responsible for assessing the safety and labeling of your products. You must ensure products adhere to all the requirements of FDA and DSHEA regulations. Here is a list of requirements to keep in mind for your dietary supplement.

FDA Dietary Supplements
Labeling Requirements

You must follow the labeling requirements, such as nutrition labeling, ingredient labeling, and nutrient content, health claims, dietary supplement packaging regulations, etc.

Supplement Facts Panel

Having a ‘Supplement Facts Panel’ is mandatory for every dietary supplement to be marketed in the USA. The panel must have all information required by FDA.

Notification to the FDA

According to the Federal Food, Drug, and Cosmetic Act, the FDA must be notified within 30 days of your dietary supplement first being marketed in the USA.

Health Claims

The FDA and FTC require health claims about the safety of your dietary supplements that must be supported with reliable scientific evidence.

Types of Dietary Supplement Labels We Have Reviewed

We have reviewed a wide range of Dietary Supplement Product Labels, including but not limited to the following.

Sports Nutrition
Greens
Probiotics
Multi Vitamins
Nootropics
Anti-Oxidants
Traditional Medicine
Gummies

End to End Solutions for Dietary Supplements in USA

Our team consists of professionals who have extensive experience with dietary supplement label reviews, preparation of health claim substantiation dossiers, supplement facts panel creation and filing 30 day dietary supplement notifications with the FDA

Some of our Clients We Have Helped Ensure FDA Compliance

Proven Expertise. Companies that have put their trust in us to become FDA-compliant.

5 Star Google Reviews

Frequently Asked Questions - FDA Dietary Supplement Regulation

Notifications are required for any new ingredient being formulated into a Supplement or to register any structure-function health claims to be made for your product. It is important that all claims being made, and all ingredients, are verified for compliance.
For a new ingredient, the notification to FDA should be submitted roughly 75 days prior to market introduction. For a structure-function claim notification, it must be filed within 30 days of marketing of the dietary supplement in the USA. During that time, the FDA may issue additional questions or requirements regarding your ingredient or claim. Our specialists are ready to help with your notifications or any related questions. Please contact our team!

FDA regulations require that certain information appears on dietary supplement labels. Information that must be on a dietary supplement label includes:

  • a descriptive name of the product stating that it is a “supplement;”
  • the name and place of business of the manufacturer, packer, or distributor.
  • a complete list of ingredients.
  • the net contents of the product.
  • must have nutrition labelling in the form of a “Supplement Facts” panel. This label must identify each dietary ingredient contained in the product.

For assistance with Dietary Supplement labelling, please reach out to our friendly staff.

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