Skip to content

Selling Food Online in the US: The Rules You Need

You have a recipe people love. You want to turn it into a product. Maybe it is candy, hot sauce, granola, or frozen meals. The part most first-time food entrepreneurs underestimate is not the recipe — it is everything that happens after the recipe is finalized. Commercial production, food safety regulation, packaging compliance, labeling, shelf-life testing, and distribution.

This guide walks through the end-to-end process of launching a food product in the United States, with the compliance obligations woven in at the stage where they actually apply — not as a separate document you deal with later.

On the Sustalium platform, the compliance document most first-time food entrepreneurs are missing is not the FDA registration or the food safety plan — it is the Declaration of Compliance for their packaging. They have the food safety documentation. They do not have the food contact material compliance. And when a retailer or Amazon asks for it, the gap stops the launch.

Not sure which regulations apply to your food product? Use the Sustalium Global Compliance Map — select your product category and target country, and see every regulatory framework that applies, from FDA food safety to state-level packaging rules.

Step 1: Scale the Recipe to Commercial Production

A recipe that works in your home kitchen does not automatically work at commercial scale. Ingredients behave differently in 50-gallon batches than in a single saucepan. You need a commercial formulation that is consistent, reproducible, and documented.

Most first-time food entrepreneurs choose one of two paths:

  • Shared commercial kitchen — Rent time in a licensed commercial kitchen. This is the lowest-cost path. You produce the food yourself using the kitchen's equipment. The kitchen's food safety license covers the facility, but you are responsible for your product's compliance.
  • Co-packer / contract manufacturer — Hire an established food manufacturer to produce your product to your specifications. The co-packer handles production, packaging, and often procurement. They typically hold the facility-level food safety certifications. You remain responsible for the product formulation, labeling, and regulatory compliance.

If you use a co-packer, negotiate who is responsible for which compliance documents before signing — especially the food safety plan, the certificate of analysis for each batch, and any third-party audit reports like SQF or BRC.

Step 2: Nail the Food Safety Requirements

The FDA's Food Safety Modernization Act (FSMA) is the controlling regulation for most food products in the US. The specific requirements depend on your product type and scale:

  • Preventive Controls for Human Food (21 CFR Part 117): Applies to most food facilities. Requires a written food safety plan, hazard analysis, preventive controls, and a recall plan. Certain small businesses are exempt or subject to modified requirements.
  • Seafood HACCP (21 CFR Part 123): Applies to seafood and fish products. Requires a HACCP plan built around the specific hazards associated with seafood.
  • Juice HACCP (21 CFR Part 120): Applies to juice and juice products.
  • Low-Acid Canned Foods (21 CFR Part 113): Applies to shelf-stable low-acid canned foods. Requires registration with the FDA and filing of scheduled processes.

If your product contains meat, poultry, or certain egg products, you shift from the FDA to USDA FSIS jurisdiction — which is a separate regulatory framework with its own facility requirements and labeling rules.

Step 3: Get the Label Right

Food labeling is one of the most common FDA enforcement triggers — and one of the most fixable before you go to market. The FDA requires:

  • Statement of identity (the common name of the food)
  • Net quantity (weight or volume)
  • Ingredient list (descending order by weight)
  • Name and address of the manufacturer, packer, or distributor
  • Nutrition Facts panel (formatted per FDA specifications)
  • Allergen declaration (FALCPA: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans; plus sesame under FASTER Act)

Label claims — "organic," "gluten-free," "non-GMO," "natural" — each have their own regulatory requirements. A claim that the product is "gluten-free" when it tests above 20 ppm is a misbranding violation. A claim that it is "organic" without USDA organic certification is a federal offense.

If you are selling in California, check whether any ingredients require a Proposition 65 warning — acrylamide in roasted coffee, lead in certain spices, cadmium in chocolate, and dozens of others.

Step 4: Solve Packaging Compliance

Your food packaging is subject to two sets of rules — food contact material safety and packaging environmental compliance:

  • FDA food contact: Every material that touches the food — the bag, the box lining, the container — must be FDA-cleared for food contact under 21 CFR or a Food Contact Notification. Your packaging supplier should provide a Declaration of Compliance. If they cannot or will not, you cannot legally use the packaging.

See the full guide: [FDA Food Contact Material: Compliance & Declaration Guide]

  • CA TPPA: Your packaging must not contain intentionally added lead, cadmium, mercury, or hexavalent chromium, and the incidental sum of these metals must be below 100 ppm. This applies to the label ink, the adhesive, and any coating — not just the substrate.

See the full guide: [CA TPPA: Toxics in Packaging Compliance Guide]

Step 5: Choose Your Sales Channel

Where you sell determines additional compliance requirements:

  • Direct-to-consumer (your website): You control the entire experience, but you are responsible for all compliance — food safety, labeling, packaging, sales tax, shipping regulations.
  • Retail stores: Each retailer has its own supplier requirements beyond FDA regulation. Expect to provide certificates of insurance, third-party food safety audit results (SQF/BRC), annual testing reports, and a signed supplier agreement. Major retailers may require UPC codes, EDI compliance, and slotting fees.
  • Amazon and online marketplaces: Amazon's food category requires FDA compliance documentation, UPC codes, and often third-party food safety certifications. A listing can be removed if a buyer reports a quality issue or if Amazon's automated compliance system flags a missing document.
  • Farmers markets and local: Generally the lowest compliance burden, but your state's cottage food laws determine what you can produce from a home kitchen. Most cottage food laws restrict sales to non-potentially-hazardous foods (baked goods, jams, dry mixes) and limit where and how you can sell.

Step 6: Prepare Your Shelf Life and Stability Documentation

If your product has a shelf life, you need documentation to support the date on the label:

  • Shelf-life testing — Laboratory testing that confirms the product remains safe and stable through the labeled shelf life under expected storage conditions.
  • Challenge studies — For products that rely on pH or water activity for safety (acidified foods, some sauces), a challenge study demonstrates that pathogens cannot grow under the product's formulation.

Retailers and distributors will request this documentation. An expired or "best before" date without supporting testing data is a quality control gap that buyers will flag.

Step 7: FDA Inspections — What Triggers One and What Happens

The FDA does not pre-approve food products, but it does inspect facilities. Inspections can be routine (scheduled based on facility risk classification), for-cause (triggered by a consumer complaint, an adverse event report, or a recall), or follow-up (to verify correction of previously identified issues).

During an inspection, the FDA investigator will ask to see your food safety plan, your hazard analysis, your preventive controls documentation, your recall plan, and your supplier verification records. If documentation is missing, incomplete, or inconsistent, the investigator issues a Form 483 — a list of observations of non-compliance. A Form 483 is not a final enforcement action, but it is a public record and a warning. Repeated or uncorrected observations can lead to a Warning Letter, which is publicly posted on the FDA's website and can trigger retailer delistings and distributor contract reviews.

The best defense against an FDA inspection is documentation that is organized, accessible, and current before the investigator arrives. The FDA gives you advance notice of a routine inspection, but for-cause inspections are unannounced, and the clock starts the moment the investigator walks in.

How Sustalium Helps You Launch

Most first-time food entrepreneurs discover compliance requirements one at a time — the FDA label requirement when their co-packer asks for it, the packaging declaration when a retailer demands it, the Prop 65 check when they list on Amazon. That reactive approach delays launch and leaves gaps.

Sustalium gives you a structured platform to manage food business compliance from day one:

  • Product compliance profile — A single place to document your FDA food safety registration, ingredient list, nutritional data, packaging declarations, and shelf-life test reports
  • Food contact packaging compliance — Generate FDA Declarations of Compliance and CA TPPA packaging certificates for your product packaging
  • Retailer-ready compliance pages — When a distributor, retailer, or marketplace asks for your compliance documentation, share one link instead of emailing PDFs
  • Built to scale — Start with one product. Add SKUs, document new formulations, and maintain compliance across your catalog as you grow

From Recipe to Retail — Without the Compliance Surprises

The food products that succeed are not always the best-tasting. They are the ones that got to market without a labeling violation, a packaging recall, or an FDA warning letter. Plan your compliance alongside your product development.

With Sustalium, build your food business compliance documentation for just €10 per document.

Start Your Food Business Compliance Now →

Last updated: July 17, 2026