How to Market Dietary Supplements in the US? An Overview from Definition to Compliance

In the US, products similar to health foods are referred to as dietary supplements. Compared to health foods in China, there are significant differences in the naming, marketing requirements in America. To help companies better understand the compliance requirements for dietary supplements in the US, CIRS Group has summarized the relevant regulations for reference.

1. Definition of Dietary Supplements

Dietary supplements are product intended for consumption that contains one or more dietary ingredients: vitamins, minerals, herbs (botanicals) or other plants, amino acids, and dietary substances that supplement the total dietary intake, or a concentrate, metabolite, component, extract, or combination product of the above substances.

2. Pre-Market Requirements

To market dietary supplement products in the United States, prior approval from the FDA is not required. However, if the product contains a new dietary ingredient (NDI), the manufacturer or distributor must submit a New Dietary Ingredient Notification (NDIN) to the FDA at least 75 days before the product is marketed. The submitted NDIN must conclude that the dietary supplement containing the new dietary ingredient is reasonably expected to be safe.

3. Labeling Requirements

The US has clear requirements for dietary supplement labels, which must clearly indicate the following information:

1) Product name, and it must indicate that it is a dietary supplement. It can also be named directly using dietary ingredients, such as iron supplement or herbal supplement;

2) The name and business location of the manufacturer, packager, or distributor;

3) Dietary ingredient list (nutrition facts);

4) List any other ingredients not included in the dietary ingredient list;

5) Net content.

In addition, there is a mandatory requirement that the label must include a US address or phone number so that consumers can promptly contact the manufacturer, packager, or distributor to report any serious adverse reactions that may occur after consumption.

4. Claim Requirements

According to US regulations, the following three types of claims may be used on dietary supplement labels (for specific details, please refer to What Claims Are Permitted on US Food Labels?):

• Nutrient Content Claims: Statements on the product label that directly or indirectly indicate the high or low levels of nutrients in the product.
• Health Claims: Statements indicating a relationship between the product’s ingredients and a disease or health condition. If a company wishes to use such claims, it must submit the specific details and supporting evidence to the FDA 120 days prior to the product’s market launch, in accordance with regulatory requirements.
• Function Claims: These describe the role of nutrients or dietary ingredients in supporting the normal structure or function of the human body, or the manner in which they maintain such structure or function. For example, calcium helps build strong bones, and fiber helps maintain regular bowel movements. These claims do not require prior FDA approval, but companies must submit a Claim Notification to the FDA within 30 days of the product’s first market entry.

5. Conclusion

Understanding US dietary supplement regulations is essential for compliantly exporting and selling products in the United States. If you have any questions or require assistance regarding U.S. dietary supplement labeling/advertising compliance or function claim notifications, please contact the Food Division of CIRS Group.

About CIRS

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, feed and pet food, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of team members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% hold Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.