Bringing a dietary supplement to the United States is one of the most attractive opportunities for overseas brands—and one of the easiest ways to lose money if the label is wrong. Unlike most consumer goods, supplements in the US are regulated under a dedicated framework: the Dietary Supplement Health and Education Act of 1994 (DSHEA). …
Bringing a dietary supplement to the United States is one of the most attractive opportunities for overseas brands—and one of the easiest ways to lose money if the label is wrong. Unlike most consumer goods, supplements in the US are regulated under a dedicated framework: the Dietary Supplement Health and Education Act of 1994 (DSHEA). Under DSHEA, the responsibility for a product’s safety and labeling accuracy sits squarely with the brand owner, not the retailer and not the factory alone. If you are sourcing from a Chinese OEM/ODM partner and planning to sell in the US, understanding the labeling rules before you print a single box will save you from Customs holds, FDA warning letters, and costly recalls.
What DSHEA Actually Regulates
DSHEA defines a “dietary supplement” as a product intended to supplement the diet that contains one or more dietary ingredients—vitamins, minerals, herbs, amino acids, metabolites, or other constituents. Products that make disease claims (for example, “treats diabetes”) are reclassified as drugs and require FDA drug approval, which is a completely different and far more expensive pathway. The single most important rule: your supplement may make “structure/function” claims about how it affects the structure or function of the body, but it may not claim to diagnose, treat, cure, or prevent any disease.
The Supplement Facts Panel
The Supplement Facts panel is the heart of any US supplement label and follows a strict FDA format. Since the 2016 Nutrition Facts update, the panel must list serving size, servings per container, and each dietary ingredient with its quantity per serving. Daily Values (DV) are required for most vitamins and minerals. Amounts of dietary ingredients that do not have an established DV—such as most botanicals, proprietary blends, or novel compounds—should still be declared by weight.
A common mistake we see from first-time importers is using a “Nutrition Facts” panel (the food label) instead of a “Supplement Facts” panel. They look similar but are legally distinct. Using the wrong format is an automatic red flag for FDA reviewers and customs brokers.
Ingredient Disclosure & Proprietary Blends
Every ingredient—active and inactive—must appear on the label. Inactive ingredients such as fillers, binders, colors, and flavors are listed separately, usually after the Supplement Facts under “Other Ingredients.”
For blends, DSHEA permits a “proprietary blend” listing where individual weights within the blend are not disclosed, but the total weight of the blend and the individual ingredient names must still be listed in descending order of predominance. Be cautious: some buyers assume a proprietary blend hides their formula. It does not hide the ingredient identities—only the per-ingredient amounts. True protection of a unique formula comes from trade-secret strategy and strong manufacturing agreements, not from the label.
Claims: The Line You Cannot Cross
Structure/function claims describe a benefit related to a body function (for example, “supports immune health” or “helps maintain healthy joints”). These claims do not require FDA pre-approval, but the brand must have substantiation and must submit a notification to the FDA within 30 days of first marketing, plus include the mandatory disclaimer: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Disease claims are strictly off-limits for supplements. Phrases like “lowers cholesterol,” “cures insomnia,” or “treats anxiety” push a product into drug territory. Even subtle wording matters—FDA reviews claims in context, including website copy, social media, and brochures, not just the physical label.
New Dietary Ingredient (NDI) Notifications
If your formula contains a dietary ingredient that was not marketed in the US before October 15, 1994, it is considered a “new dietary ingredient.” Unless it is present in a form that has been chemically unchanged in food, you must file a pre-market safety notification (NDIN) with the FDA at least 75 days before introducing the product. The notification requires a history of use or other evidence of safety. Working with an OEM partner who understands NDIN documentation—and who can supply the required specifications, Certificates of Analysis, and stability data—dramatically reduces the risk of a rejected notification.
cGMP, Facility Registration & Import Practicalities
Since 2007, domestic and foreign facilities that manufacture, package, or hold dietary supplements for US consumption must register with the FDA (via the FURLS system) and comply with Current Good Manufacturing Practices (21 CFR Part 111). Your contract manufacturer should provide its FDA facility registration number and evidence of cGMP compliance. Note that registration is not an approval of your product—it is a prerequisite for legal importation.
On the import side, the US agent information, country-of-origin marking, and accurate entry documentation matter. US Customs and the FDA conduct targeted sampling at the border; mislabeled products can be detained, refused, or required to be relabeled at the importer’s expense. Plan for a buffer: keep master copies of your approved label, a lab Certificate of Analysis, and your substantiation file accessible for any FDA inquiry.
How the Right OEM Partner Reduces Your Risk
Choosing a manufacturer is not just about price per unit. A capable OEM/ODM partner will:
- Provide compliant, template-accurate Supplement Facts panels and review your label artwork before production.
- Supply full specifications, CoAs, and stability studies to support NDIN and claims substantiation.
- Hold or support FDA facility registration and cGMP documentation.
- Advise on dosage forms (softgel, hard capsule, tablet, gummy, powder) that fit both your formula and US labeling realities.
- Communicate clearly about which ingredients are permitted and which require additional notifications.
At Dongying Zuoning Biotechnology Co., Ltd., we work with overseas brands every week to turn compliant formulations into shelf-ready US products. We treat labeling as part of the product, not an afterthought, because a beautiful product that cannot clear Customs is not a product at all.
Ready to Plan Your US Launch?
Labeling compliance sounds technical, but it becomes manageable once you have the right partner and a clear checklist. If you are evaluating a US-market supplement and want a manufacturer who understands DSHEA, cGMP, and export documentation, we would be glad to help.
Contact us:
Wade@zuoningbio.com | +86 187 5469 6289 | www.zuoningbio.com
