The United States is the world's largest supplement market, operating under FDA oversight with DSHEA (Dietary Supplement Health and Education Act) regulations. Unlike Canada, most supplements don't require pre-market approval, allowing for faster market entry.
Growing interest in personalized nutrition, clean label products, transparency in sourcing, immunity and gut health focus
Highly competitive, low barrier to entry, price-sensitive consumers, strong e-commerce and DTC growth
Regulated by: Food and Drug Administration (FDA) - Center for Food Safety and Applied Nutrition (CFSAN)
Unlike Canada, most supplements can go to market without FDA approval. The FDA regulates supplements post-market, meaning you're responsible for safety and labeling compliance. This allows much faster time-to-market (4-8 weeks vs. 6-12 months for Canada).
You can make structure/function claims ("supports heart health") without FDA approval, but disease claims ("treats heart disease") are prohibited. Claims must be truthful and not misleading, with substantiation.
All supplements must use the standardized Supplement Facts panel format (different from Nutrition Facts for foods). We ensure your labels meet FDA requirements.
FDA-registered, GMP-certified manufacturing partners
1000-unit MOQ (vs. industry standard 5000+)
Fast turnaround: 4-6 weeks for white label and custom formulations
Full label compliance review included
Structure/function claim development and substantiation
Expert navigation of FDA regulations
Our manufacturing partner network spans the US, with facilities in California, Utah, Nevada, and the East Coast. We optimize logistics to minimize shipping costs to your warehouse or fulfillment center. Typical shipping: 2-5 business days within continental US.
$8,000-15,000 for first 1000-unit production run
Includes manufacturing, packaging, testing, compliance
Highly competitive market - differentiation crucial
FDA can shut down products post-market for non-compliance
State-specific regulations (e.g., California Prop 65)
Amazon and retailer-specific compliance requirements
Consumer skepticism - third-party testing recommended
We've helped launch 20+ supplement brands in the US market across categories from sports nutrition to beauty-from-within to functional mushrooms. Our FDA-compliant labeling and quality manufacturing partnerships ensure smooth market entry.
For the US market, typical timeline is 4-6 weeks for white label products (existing formulas) or 4-6 weeks for custom formulations. This includes manufacturing, third-party testing, and compliant labeling. No FDA pre-market approval required for most supplements, allowing faster market entry than Canada.
Our minimum order quantity is 1,000 units regardless of market. Most manufacturers require 5,000-10,000 units, but our low MOQ approach lets you test the United States market without massive upfront investment. This is especially valuable when entering a new geographic market.
For the United States market, expect $8,000-15,000 for your first 1,000-unit production run at our MOQ. This includes manufacturing, packaging, third-party testing (COA, microbial, heavy metals), and compliant labeling. Costs vary based on dosage form, ingredients, and packaging. <a href="/contact" class="text-mint-600 hover:text-mint-700 underline">Contact us</a> for a custom quote.
Yes - supplements manufactured to FDA standards can be sold anywhere in the US. However, some states have additional requirements (California Prop 65, for example). Our manufacturing partners produce to the highest standards, ensuring compliance across all states. United States products can be sold nationwide with no additional regulatory requirements (beyond ensuring you meet any state-specific labeling laws).
We understand the unique characteristics of the United States market, from consumer preferences to regulatory nuances to distribution channels. Our 1,000-unit MOQ lets you test the United States market without massive risk. We provide FDA-compliant labeling, GMP-certified manufacturing, and third-party testing as standard. Plus, we can help you expand to Canada when you're ready, giving you dual-market capability.
We're a full-service supplement partner, not just a manufacturer. Our services include: custom formulation, white label and private label, manufacturing coordination with GMP-certified facilities, third-party quality testing, FDA-compliant labeling, label compliance review, fulfillment services, and marketing support. We handle everything from concept to customer delivery.
Our expert team will guide you through the entire process - from formulation to FDA compliance to manufacturing to market entry. Get started with United States's leading supplement manufacturing partner.