FDA Nutrition Label Requirements

Do you need a Nutrition Facts label?

Not every product does. Many cottage-food makers are exempt and only need an ingredient, allergen, and net-weight label. 21 CFR 101.9(j)(1) exempts a person making direct sales to consumers with no more than $50,000 in annual food sales (or $500,000 in sales overall), and 101.9(j)(18) adds a low-volume exemption for firms under 100 employees selling under 100,000 units, which has to be filed with FDA. You do need a panel once you make a nutrient content claim like “low sugar” or “high protein,” which voids both exemptions outright, or once you outgrow the thresholds. Shipping across state lines brings you under FDA rules but does not by itself end an exemption; retail and wholesale buyers, however, generally require a panel regardless of what the law allows. See do I need a nutrition label.

The mandatory nutrients (2016 label)

Since the 2016 update, the panel must declare, in this order:

• Calories
• Total Fat, Saturated Fat, and Trans Fat
• Cholesterol
• Sodium
• Total Carbohydrate, Dietary Fiber, Total Sugars, and Added Sugars
• Protein
• Vitamin D, Calcium, Iron, and Potassium (with amounts and %DV)

Vitamins A and C are now voluntary (they were mandatory before 2016), and “Calories from Fat” was removed.

Serving sizes & RACC

Serving size isn't what you think a serving is. It's based on the FDA's Reference Amounts Customarily Consumed (RACC) in 21 CFR 101.12, stated as a household measure plus grams (for example, “2/3 cup (55g)”). Packages that hold between 200% and 300% of the RACC and could be eaten in one sitting need a dual-column (per serving / per container) panel.

Rounding rules (the tricky part)

The FDA specifies exact rounding for each nutrient. A few examples:

• Calories. Under 5 shows as 0; up to 50 rounds to the nearest 5; above 50 to the nearest 10.
• Fats. Under 0.5g shows as 0; under 5g rounds to the nearest 0.5g; at or above 5g to the nearest 1g.
• Sodium. Under 5mg shows as 0; 5–140mg rounds to the nearest 5mg; above 140mg to the nearest 10mg.
• Carbs, fiber, sugars, protein. Under 0.5g is 0; 0.5–1g shows “less than 1g”; otherwise nearest 1g.

%Daily Values are calculated from the current Daily Values (for example, 78g total fat, 2,300mg sodium, 50g added sugars) and rounded. Vitamins and minerals use 2/5/10% increments; macronutrients round to the nearest whole percent.

Ingredients & allergens (a separate requirement)

Beyond the panel, packaged food needs an ingredient list in descending order of weight and a “Contains” allergen statement for the FDA's Big 9 (milk, egg, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame). These live near the panel, not inside it.

Common mistakes

• Using a “serving” that doesn't match the RACC.
• Forgetting Added Sugars or Potassium (both mandatory now).
• Rounding to the wrong increment (each nutrient has its own rule).
• Missing an allergen because a sub-ingredient contains it.