FDA Registration for Cheese
Cheddar, mozzarella, parmesan, brie, feta, queso fresco — what you can call it, and whether you can use raw milk, both come down to the same two things: moisture and aging.
Key Takeaways
- ~72 cheese standards of identity — classified mainly by moisture (Part 133).
- Each name is a legal recipe — e.g. cheddar ≥50% milkfat in solids, ≤39% moisture.
- Raw-milk cheese must be aged ≥60 days at ≥35°F (1240.61 + Part 133).
- Only aged cheeses qualify for raw milk — fresh soft cheeses need pasteurization.
- Soft, high-moisture cheeses = Listeria risk — RTE zero tolerance.
- Milk is a major allergen; the category is heavily imported and scrutinized.
The Name Is a Legal Recipe
No food category is more standardized. Part 133 classifies cheese largely by moisture, and each class carries a minimum milkfat:
| Class / example | Moisture | Milkfat | Cite |
|---|---|---|---|
| Hard — cheddar | ≤ 39% | ≥ 50% in the solids | 133.113 |
| Extra-hard / grating — parmesan | ≤ 32% | defined minimum | 133.165 |
| Semi-soft | up to ~50% | per standard | Part 133 |
| Soft-ripened — brie/camembert | ~45–57% | per standard | 133.182 |
The 60-Day Raw-Milk Rule
This is the rule that makes cheese unlike any other food. Raw (unpasteurized) fluid milk is banned from interstate commerce — but cheese gets a specific carve-out:
The pasteurized path
Use pasteurized milk, and the raw-milk aging question doesn't arise. This is the route for fresh and soft cheeses, which can't be aged long enough to qualify otherwise.
The 60-day path
Make cheese from raw milk only if it's aged ≥ 60 days at ≥ 35°F (21 CFR 1240.61 + Part 133). In practice, only harder, lower-moisture cheeses can meet this.
Soft Cheese & Listeria
Under preventive controls (Part 117), a cheese hazard analysis typically lands on Listeria (sanitation and environmental monitoring in the plant), pathogens in raw-milk cheese, and allergen control. High-moisture cheeses get the most attention.
Bringing a Cheese to Market
Match the cheese to a standard
Identify the Part 133 standard your cheese meets — moisture and milkfat set the name.
Decide pasteurized or raw-milk
Pasteurize, or (for eligible aged cheeses) meet the 60-day aging rule at ≥35°F.
Register the facility
The maker/packer/holder registers; foreign facilities add a U.S. Agent.
Control Listeria
Part 117 preventive controls with environmental monitoring, especially for soft cheeses.
Get labeling right
Correct standardized name; declare milk (and any added allergens); complete Nutrition Facts.
Handle imports & cold chain
Prior notice + FSVP; expect extra scrutiny on raw-milk and soft cheeses.
Get Your Cheese to Market
FDA Registration Assistance registers cheese facilities, serves as U.S. Agent, reviews standardized names and allergen labeling, supports Listeria-focused preventive controls and raw-milk compliance, 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 cheese products need FDA registration?
The facility that makes, packs, or holds cheese registers as a food facility, and foreign facilities need a U.S. Agent. Cheese is conventional food but the most heavily standardized category, with a unique raw-milk aging rule. Registration isn't approval.
2. What is the 60-day rule for cheese?
Raw fluid milk can't be sold across state lines (21 CFR 1240.61), but cheese from raw milk is allowed if aged at least 60 days at 35°F or above (Part 133). So you either pasteurize, or — for eligible aged cheeses — meet the 60-day aging requirement. It's a rule found nowhere else in food.
3. Can I make any cheese from raw milk?
No — only cheeses that can actually be aged 60 days qualify, generally harder, lower-moisture varieties. Fresh, high-moisture soft cheeses can't meet the aging requirement, so in practice they must be made from pasteurized milk for interstate commerce.
4. Is the 60-day rule considered fully protective?
It's the legal standard, but its adequacy is debated — studies show pathogens like E. coli O157:H7 and Salmonella surviving beyond 60 days in some cheeses, and FDA has run dedicated raw-milk-cheese sampling. Raw-milk cheese, especially imported, gets close attention, so sourcing and testing matter.
5. How does FDA define cheese types?
Through standards of identity in 21 CFR Part 133, defining roughly 72 cheese and cheese-product types. Cheese is classified largely by moisture, and each standard sets a minimum milkfat and maximum moisture — so "cheddar," "mozzarella," or "parmesan" each has a legal recipe.
6. What's the standard for cheddar?
Under 21 CFR 133.113, cheddar must contain at least 50% milkfat in the solids and no more than 39% moisture, made from pasteurized milk or aged at least 60 days if raw. A product that doesn't meet the composition can't be labeled "cheddar."
7. Why does moisture content matter so much?
Moisture drives classification and safety — it determines the standard (hard, semi-soft, soft), the minimum milkfat, and whether the cheese can be raw-milk under the 60-day rule. Higher-moisture cheeses also support more microbial growth, so soft cheeses get more scrutiny.
8. Why are soft cheeses higher risk?
Soft, high-moisture cheeses (queso fresco, brie, feta) support Listeria monocytogenes growth and have been linked to outbreaks. FDA treats RTE food containing Listeria as adulterated — effectively zero tolerance — so sanitation and environmental monitoring are central for these cheeses.
9. Do cheese facilities need preventive controls?
Generally yes — under 21 CFR Part 117, the hazard analysis for cheese typically centers on Listeria (with environmental monitoring), pathogens in raw-milk cheese, and allergens. Some small or qualified facilities have modified requirements.
10. What allergen labeling applies to cheese?
Milk is a major allergen and must be declared on all cheese. Processed and blended cheeses may bring additional allergens through added ingredients, and those must be declared too.
11. Do imported cheeses need FSVP and prior notice?
Yes — a registered foreign facility with a U.S. Agent, prior notice per shipment, and an importer FSVP. Cheese is heavily imported, and raw-milk and soft cheeses face added scrutiny at entry, so supplier verification is important.
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. What's the biggest mistake cheese importers make?
Two: mislabeling a product with a standardized name it doesn't meet, and underestimating raw-milk and Listeria scrutiny on soft cheeses. Confirming the standard of identity and raw-milk status up front prevents most detentions.
14. How does FDA Registration Assistance help?
It registers cheese facilities, serves as U.S. Agent, reviews standardized names and allergen labeling, supports Listeria-focused preventive controls and raw-milk compliance, and handles FSVP and prior notice — starting at $858, for companies across 135+ countries. Contact info@fdaregistrationassistance.com or +1 (928) 275-8333.
