FDA Registration for Dairy Products
This is the map. Milk, cream, cheese, ice cream, butter, yogurt — same backbone, different standards. Start by finding which one you make.
Key Takeaways
- Dairy is a family — milk & cream, cheese, frozen dairy, butter, cultured — each its own standard.
- The Grade A / PMO system is the backbone that unites all of it.
- Milk & cream = Part 131; cheese = Part 133; frozen dairy = Part 135.
- Butter = ≥80% milkfat (by statute); yogurt = 131.200.
- Raw fluid milk can't cross state lines (1240.61); cheese is the 60-day exception.
- Shared everywhere: pasteurization, Listeria control, milk-allergen labeling.
Which Dairy Product Are You Making?
| Category | Examples | Standard | Go deeper |
|---|---|---|---|
| Milk & cream | Milk, cream, half-and-half, eggnog | Part 131 | Grade A / PMO |
| Cheese | Cheddar, mozzarella, brie, feta | Part 133 | Cheese guide → |
| Frozen dairy | Ice cream, custard, sherbet, gelato | Part 135 | Frozen dairy → |
| Butter | Butter (≥80% milkfat) | By statute | Milkfat minimum |
| Cultured | Yogurt, sour cream, kefir | 131.200 | Grade A / PMO |
What Every Dairy Product Shares
Grade A & the PMO
The Pasteurized Milk Ordinance is FDA's model dairy-sanitation standard, applied through a cooperative program with all 50 states and updated by the National Conference on Interstate Milk Shipments (NCIMS). "Grade A" products are those covered by the PMO — a dairy-only apparatus on top of ordinary food rules.
Pasteurization & raw milk
Pasteurization is the dairy kill step. Raw (unpasteurized) fluid milk is banned from interstate commerce (21 CFR 1240.61); the notable exception is cheese aged ≥60 days.
Listeria control
Most dairy is ready-to-eat, and Listeria monocytogenes is the pathogen that recurs across soft cheese and frozen dairy — RTE zero tolerance, with sanitation and environmental monitoring under Part 117.
Milk allergen & labeling
Milk is a major allergen and must be declared on every dairy product; added ingredients bring their own. See allergen labeling.
Registration, FSVP & Cold Chain
Bringing a Dairy Product to Market
Identify your dairy product
Milk & cream, cheese, frozen dairy, butter, or cultured — each has its own standard.
Meet the standard of identity
Part 131 (milk/cream), Part 133 (cheese), Part 135 (frozen), statute (butter) — or rename.
Pasteurize & address Grade A
Pasteurize as required; meet the PMO / Grade A program where it applies.
Register the facility
The maker/packer/holder registers; foreign facilities add a U.S. Agent.
Control Listeria & label allergens
Part 117 environmental monitoring; declare milk and any added allergens.
Handle imports & cold chain
Prior notice + FSVP; keep the cold chain; maintain the registration.
Get Your Dairy Products to Market
FDA Registration Assistance registers dairy facilities, serves as U.S. Agent, reviews standard-of-identity names and allergen labeling, supports Listeria-focused preventive controls and Grade A questions, and handles FSVP and prior notice for imports. Food Facility Registration is available as a service starting at $858.
Contact us at info@fdaregistrationassistance.com or call +1 (928) 275-8333. Trusted by companies across 135+ countries, with 15+ years of experience.
Frequently Asked Questions
1. Do dairy products need FDA registration?
The facility that makes, packs, or holds dairy products registers as a food facility, and foreign facilities need a U.S. Agent. Dairy is conventional food, but it also sits under a dairy-specific safety system and detailed standards of identity. Registration isn't approval.
2. Is "dairy" one category to FDA?
No — it's a family, each with its own standard: milk and cream (Part 131), cheese (Part 133), frozen desserts like ice cream (Part 135), butter (statutory, 80% milkfat), and cultured products like yogurt. First, know which one you're making.
3. What ties all dairy together?
A shared backbone: pasteurization, the Grade A / PMO system, Listeria control for RTE products, milk-allergen labeling, and facility registration. Whatever the product, these run through all of it.
4. What is the Grade A / Pasteurized Milk Ordinance?
The PMO is FDA's model regulation for milk sanitation, applied through a cooperative program with all 50 states and updated by the National Conference on Interstate Milk Shipments (NCIMS). "Grade A" products are those covered by the PMO — a dairy-specific apparatus on top of ordinary food rules.
5. Can dairy be made from raw (unpasteurized) milk?
Raw fluid milk can't be sold across state lines (21 CFR 1240.61). The main exception is cheese: raw-milk cheese is allowed if aged at least 60 days. Most other dairy for interstate commerce is made from pasteurized milk.
6. What is the standard for butter?
Butter is defined by statute (the Butter Act) as made from milk or cream and containing at least 80% milkfat. A spread with less milkfat than that can't simply be labeled "butter" — it takes a different, accurate name.
7. Where do milk, cream, and yogurt fit?
Milk, cream, and cultured products like yogurt and sour cream are standardized in 21 CFR Part 131, and are largely Grade A products under the PMO — so both the standard of identity and the Grade A sanitation requirements apply.
8. Why is Listeria a recurring theme in dairy?
Many dairy products are ready-to-eat, and Listeria monocytogenes grows at refrigeration temperatures and survives freezing. FDA treats RTE food containing Listeria as adulterated — effectively zero tolerance — so sanitation and environmental monitoring matter across soft cheese, frozen dairy, and other RTE dairy.
9. Do dairy facilities need preventive controls?
Generally yes — under 21 CFR Part 117, the hazard analysis for dairy usually centers on Listeria (with environmental monitoring), pathogens in raw-milk products, and allergens, alongside Grade A requirements where they apply. Some small or qualified facilities have modified requirements.
10. What allergen labeling applies to dairy?
Milk is a major allergen and must be declared on all dairy. Blended, flavored, or processed dairy may bring additional allergens (nuts, soy, wheat, egg), and each must be declared.
11. Do imported dairy products need FSVP and prior notice?
Yes — a registered foreign facility with a U.S. Agent, prior notice per shipment, and an importer FSVP. For Grade A products, FDA also considers whether the product meets Grade A criteria at the port. Cold-chain control matters throughout.
12. Is "FDA registered" the same as "FDA approved"?
No — registration tells FDA a facility exists and what it does; it isn't approval of the product. "FDA approved" based on registration is inaccurate.
13. Which dairy product page should I read next?
Pick the one that matches your product: our cheese page covers the 60-day raw-milk rule and Part 133, and our frozen dairy page covers ice cream, custard, sherbet, and mellorine under Part 135. Milk, cream, butter, and cultured products follow Part 131 and Grade A.
14. How does FDA Registration Assistance help?
It registers dairy facilities, serves as U.S. Agent, reviews standard-of-identity names and allergen labeling, supports Listeria-focused preventive controls and Grade A questions, and handles FSVP and prior notice — starting at $858, for companies across 135+ countries. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.
