Importing dairy: it's FDA, not USDA-for-safety

A common misconception among first-time importers: "milk products need USDA certification." Dairy and dairy-containing foods, including ice cream, are foods under FDA's rules, and FSVP applies to them as it does to other imported food. USDA's role is narrower.

WARNING: This article explains the regulatory landscape as a starting point. Dairy import rules have several product-specific carve-outs, so verify the specifics for your exact product with FDA guidance or counsel before relying on it.

What applies:

• FSVP — dairy is not among the exemptions in 21 CFR 1.501, so your FSVP hazard analysis and supplier verification cover it.
• Federal Import Milk Act (FIMA) — importing milk or cream is prohibited unless the person shipping it into the United States holds a valid permit (21 U.S.C. 141; regulations at 21 CFR part 1210). This is on top of FSVP, not instead of it. The regulation defines "milk" and "cream" (21 CFR 1210.3), so check your product against those definitions.
• Standards of identity apply where one exists. Ice cream has one (21 CFR 135.110), and FDA's food labeling rules in 21 CFR part 101 apply as well.

Where USDA comes in:

USDA licenses imports of certain dairy products under a tariff-rate quota (7 CFR part 6, subpart B). That license is about the duty rate, not about whether the product is safe to sell. USDA also runs an inspection and grading service for dairy plants and products (7 CFR part 58), which is separate from FDA's import requirements.

Conditions for milk or cream under FIMA (21 U.S.C. 142):

• A physical examination of the cows within one year before importation
• For raw milk or cream, a tuberculin test of the cows within one year before importation
• A minimum sanitary score for the dairy farm or plant
• Bacterial count limits, which differ for raw and pasteurized milk and cream
• A temperature of no more than 50°F at the time of importation

TIP: Ice cream as a finished frozen dessert generally doesn't fit FIMA's definitions of milk or cream, but verify per product, since formulation matters. Its FSVP obligations apply regardless.