Selling dietary supplements is a legitimate and growing business, but it comes with more regulatory requirements than most consumer products. You need to navigate FDA labeling rules, find a manufacturer, choose where to sell, and market your products without running afoul of advertising restrictions. Here’s how to do it from the ground up.
Understand FDA Rules Before You Start
Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA), which treats them differently from drugs. You don’t need FDA approval before selling a supplement, but you are responsible for ensuring your product is safe, properly labeled, and not marketed with claims that it can treat or cure a disease. The FDA can take action against you after the fact if your product is adulterated, mislabeled, or makes prohibited claims.
Every supplement label must include several mandatory components: an identity statement (the product name identifying it as a dietary supplement), a net quantity of contents, nutrition labeling in the form of a Supplement Facts panel, a complete ingredient list, and the name and address of the manufacturer, packer, or distributor. If your product contains a new dietary ingredient, one that wasn’t sold in the U.S. before October 15, 1994, you must submit a pre-market notification to the FDA at least 75 days before selling it.
The distinction between allowed and prohibited claims is critical. You can make “structure/function” claims like “supports immune health” or “promotes joint flexibility,” but you cannot claim your supplement treats, cures, or prevents any disease. Saying “reduces cholesterol” crosses the line into a drug claim. Any structure/function claim must include this disclaimer on the label: “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.”
Choose a Manufacturing Model
Most supplement sellers don’t manufacture their own products. The two main paths are private label manufacturing and contract manufacturing, and the choice affects your startup costs, product uniqueness, and brand flexibility.
Private label means you buy a pre-existing formula from a manufacturer and put your own brand name on it. You don’t get to change the ingredients, dosage, or delivery form. If the manufacturer offers a turmeric capsule, you sell that exact turmeric capsule with your label. The upside is low minimum order quantities, sometimes just a few cases or a few hundred bottles, and lower upfront costs. This is the fastest way to get a product to market.
Contract manufacturing gives you full control over the formulation. You choose the specific ingredients, dosages, and product form (capsules, gummies, powder, liquid). You can use branded, research-backed ingredients or more generic versions. The tradeoff is higher upfront costs and higher minimum order quantities, since the manufacturer is creating a unique formula for your brand. This path makes more sense once you’ve validated demand and want a differentiated product.
Whichever route you choose, your manufacturer must follow Current Good Manufacturing Practices (cGMP) as outlined in FDA regulation 21 CFR Part 111. This covers everything from ingredient testing and facility cleanliness to proper record-keeping. Ask any manufacturer you’re considering for proof of cGMP compliance and third-party audit results before signing a contract.
Register Your Business and Get Insurance
You’ll need a standard business entity, typically an LLC or corporation, along with any state and local business licenses required in your area. If you’re selling a consumable product, you’ll also need to register your facility with the FDA as a food facility, even if a contract manufacturer handles production. This registration is free and done through the FDA’s online portal.
Product liability insurance is not optional in the supplement industry. If a customer claims your product caused harm, you need coverage. The average annual cost for product liability coverage is roughly $1,192, with manufacturing businesses typically paying between $736 and $1,854 per year. Most small businesses carry a $1 million per-occurrence limit with a $2 million aggregate limit. Your premiums will depend on the type of supplements you sell, your sales volume, and your supply chain. Products with stimulants or weight-loss claims tend to carry higher risk and higher premiums.
Pick Your Sales Channels
You can sell supplements through your own website, on marketplaces like Amazon, in retail stores, or through a combination. Each channel has different requirements and economics.
Your Own Website
Selling direct-to-consumer through a Shopify, WooCommerce, or similar storefront gives you the highest margins and the most control over branding. You’ll need a payment processor that accepts supplement sales, as some processors flag this category as higher risk. Expect to invest in content marketing, email marketing, and paid advertising to drive traffic.
Amazon
Amazon is one of the largest supplement marketplaces, but it has strict category requirements. Your products must meet FDA cGMP standards, and you need verification from an Amazon-approved third-party inspection and certification organization. If Amazon flags your products for review, you have 90 days to submit compliance documentation or your listings will be suppressed. Budget for the cost of third-party verification on top of Amazon’s standard seller fees, which typically run 15% of each sale for supplements.
Retail and Wholesale
Getting shelf space in health food stores, gyms, or larger retailers involves building relationships with buyers and often offering wholesale pricing at 40% to 50% off retail. Retailers may require proof of insurance, cGMP certification, and third-party testing results before they’ll carry your product.
Label and Package Your Products
Your label is both a marketing tool and a legal document. Beyond the FDA-mandated elements (Supplement Facts panel, ingredient list, identity statement, net quantity, and manufacturer information), your packaging needs to stand out on a shelf or in a product listing thumbnail.
Work with a designer who has experience in supplement packaging. They’ll know to leave space for required disclosures while creating a professional look. Get your label text reviewed for compliance before printing. A single prohibited claim on your label can trigger an FDA warning letter, force a product recall, or get your listings pulled from Amazon.
Third-party testing and certification seals can boost consumer trust. Programs like NSF International, USP Verified, and Informed Sport test products for label accuracy and contaminants. These certifications cost money and take time, but they give you a marketing advantage and may be required by certain retailers or platforms.
Market Without Getting Your Ads Rejected
Advertising supplements online is trickier than advertising most consumer products. Google, Meta (Facebook and Instagram), and other platforms have specific restrictions on supplement advertising that go beyond FDA rules.
Google Ads prohibits promotion of unapproved pharmaceuticals and supplements. The platform maintains a list of specific banned products, many of which are weight-loss capsules, sexual enhancement pills, or supplements containing ingredients the FDA has flagged as unsafe. Beyond that specific list, Google will reject ads that make disease-treatment claims or promote products with certain restricted ingredients like ephedra or DMAA.
Meta’s ad policies similarly restrict health claims. Ads that promise specific results (“lose 10 pounds in a week”) or reference before-and-after transformations are frequently rejected. The safest approach is to focus ad copy on general wellness benefits, lifestyle imagery, and customer testimonials that describe personal experience without making medical claims.
Because paid advertising is restricted and competitive, many successful supplement brands lean heavily on organic marketing. Content marketing through blogs, YouTube videos, and podcasts that educate your audience about health topics can drive traffic without triggering ad-platform filters. Influencer partnerships are also common in the supplement space, though the FTC requires that any paid or gifted endorsement be clearly disclosed.
Set Your Pricing and Margins
Supplement pricing depends on your cost of goods, which includes raw materials, manufacturing, packaging, labeling, and shipping to your warehouse or fulfillment center. Private label products with common ingredients like vitamin D or fish oil might cost $3 to $6 per bottle to produce, while custom-formulated products with branded or specialty ingredients can run $8 to $15 or more.
Most supplement brands target a retail price of three to five times their cost of goods. A product that costs $5 to make and fulfill might retail for $20 to $30. If you’re selling through Amazon or retail, factor in platform fees and wholesale discounts before setting your price. Subscription models, where customers receive monthly shipments at a small discount, help stabilize revenue and improve customer lifetime value.
Handle Fulfillment and Shipping
You can ship orders yourself, use a third-party logistics (3PL) provider, or use Fulfillment by Amazon (FBA) if you’re selling on that platform. Supplements are relatively small and lightweight, which keeps shipping costs manageable. The main consideration is storage conditions: some products are sensitive to heat or humidity, so your fulfillment setup needs climate-appropriate warehousing.
If you’re selling across state lines, which you almost certainly will be with an online store, check whether the states where you have customers require you to collect sales tax. Most e-commerce platforms handle tax calculation automatically, but you’re responsible for registering and remitting in states where you have tax obligations.