The short answer
Plant-based meat, milk, cheese and egg alternatives are FDA-regulated foods, even when they look like meat. The main issues are product names, allergens and any new ingredient that has not been used in U.S. food before.
What exporters should watch for
🏛️ FDA, not USDA
Products made without meat, poultry or egg ingredients are regulated by FDA. Plants making them register with FDA, name a U.S. Agent and follow preventive controls. Hybrid products that contain meat fall under USDA.
🏷️ Naming
FDA’s draft guidance accepts names like “oat milk” or “plant-based burger” when the plant source is clear, and recommends a voluntary statement comparing nutrients with dairy milk. A 2025 draft guidance covers plant-based alternatives to meat, eggs and seafood.
🥜 Allergens
Soy, wheat, tree nuts and peanuts are common bases and must be declared. Pea, chickpea and fava proteins are not major allergens but can cause reactions, so many brands add a clear source statement.
🧪 New ingredients
Ingredients new to the U.S. food supply need GRAS status or approval. Color ingredients that make a burger “bleed”, for example, needed color additive approval from FDA.
Common reasons shipments are stopped
- Misleading dairy or meat names
- Undeclared soy, wheat or nuts
- New ingredients without GRAS status
- Protein claims without the right calculation
- No FSVP at the U.S. importer
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your product — we’ll confirm what FDA requires, in writing, by email.
Frequently asked questions
Can a plant-based drink be called “milk” in the U.S.?
FDA’s draft guidance accepts names such as “soy milk” or “oat milk” when the plant source is clear, and recommends a voluntary statement on how the nutrients compare with cow’s milk.
Does a plant-based burger factory need FDA registration?
Yes. Facilities making plant-based foods for the U.S. must register with FDA, name a U.S. Agent and file Prior Notice. USDA rules only apply if the product contains meat or poultry.
Do new protein ingredients need FDA approval?
Ingredients that are new to U.S. food need GRAS status (often through a GRAS notice) or food additive approval. Common proteins such as soy, pea and wheat are already widely used.
Sources
- FDA — Draft guidance: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements
- FDA — Plant-based milk and animal food alternatives
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
- FDA — Import Alerts by Publish Date
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.