Whether you’re a startup brand introducing your first product or an established brand with many SKUs, the regulatory requirements are the same: companies are responsible for ensuring that their dietary supplements comply with U.S. laws governing safety, quality, and labeling.

The dietary supplement market in the U.S. includes a diverse range of products, including vitamins, minerals, herbal preparations, probiotics, and specialty nutrients. These products fall under the jurisdiction of the Food and Drug Administration (FDA) and are regulated differently than conventional foods or drugs. Unlike some countries, such as Canada or members of the European Union, where pre-market approvals are required, the U.S. system relies primarily on post-market oversight.

Labeling requirements for dietary supplements

Under FDA regulations, dietary supplements must meet stringent labeling requirements to ensure transparency and consumer safety. Every product label must include:

Statement of Identity, Net Quantity of Contents, Supplement Facts Panel, Ingredients List, and Name and Place of Business of the manufacturer, packer, or distributor. Directions for Use and Warning Statements should also be included, if applicable.

Inaccurate or misleading labeling can be call for regulatory action, so having your label(s) reviewed by experts is critical.

Structure-function claims: informing without misleading

Structure-function claims describe how a dietary supplement affects the structure or function of the body (e.g., "supports bone health" or "boosts energy levels"). These claims differ from health claims, which link a nutrient to a reduced risk of a specific disease, and require FDA pre-approval.

To include structure-function claims on labels, these things are required:

1. Notification to FDA: Manufacturers must notify the FDA within 30 days of first marketing a product with such claims.
2. Disclaimer Statement: Claims must include a disclaimer that reads: "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."
3. Scientific Substantiation: Companies must have evidence to substantiate these claims, ensuring they are truthful and not misleading.

NAVIGATING THE REGULATORY LANDSCAPE

Ensuring your dietary supplement is compliant requires understanding the complexities of FDA regulations. Companies may also need to address additional requirements, such as submitting a New Dietary Ingredient Notification (NDIN) for ingredients not marketed in the U.S. before 1994 or conducting a Generally Recognized as Safe (GRAS) assessment for novel food ingredients.

HOW SGS NUTRASOURCE CAN HELP

Our expert services for dietary supplement compliance include:

• Label Reviews: Ensuring your Supplement Facts panel and other label content meets FDA standards.
• Formula Reviews: Confirming that your ingredients are compliant, or if additional regulatory action is required (i.e. NDIN or GRAS).
• Regulatory Submissions: Assisting with NDINs, GRAS filings, and claim notifications.
• Product Testing: Comprehensive testing for contaminants, stability, active ingredients, and more.
• Scientific Support: Substantiation for structure-function claims including literature reviews and substantiation packages.

With a custom approach to compliance, we help businesses bring their products to market efficiently, with confidence in their regulatory standing. Our team simplifies the complex regulatory landscape, so you can focus on growing your brand.

From startups to global brands, we specialize in helping companies navigate the regulatory challenges of the dietary supplement market. Let us support your journey with expert advice and solutions tailored to your needs.

For more information on our services, contact us today.