LabelCompliance Studio · US FDA 21 CFR 101.9 · California Prop 65 (2026) · CPSIA § 103 · Amazon FNSKU Code-128B
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21 CFR 101.9 LabelCompliance Studio
21 CFR 101.9(j)(18) EXEMPTION

FDA Small Business Nutrition Labeling Exemption Guide (<100 Employees / <100k Units)

Determine if your food brand qualifies for the FDA Small Business Nutrition Facts Exemption under 21 CFR 101.9(j)(18) or if retail/Amazon distribution requires a full panel.

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1. FDA 21 CFR 101.9 Nutrition Facts & Supplement Facts Vector Builder

Enter raw lab or recipe values below. Our mathematical engine applies strict FDA 21 CFR 101.9(c) rounding increments and 2026 Daily Reference Values (%DV) in real time.

⚡ Quick-Load Presets:
Panel Geometry & Serving Declarations (21 CFR 101.9(b))
1. Core Macros, Lipids & Sodium (21 CFR 101.9(c)(1)–(5))
2. Carbs, Sugars & Protein (21 CFR 101.9(c)(6)–(7))
3. Mandatory Micronutrients & Net Weight (21 CFR 101.9(c)(8))

FASTER Act 9 Major Food Allergens (21 U.S.C. 343(w) · Includes Sesame)

Live FDA 21 CFR 101.9 Vector SVG Output

Automatic FDA 21 CFR 101.9(c) Rounding & %DV Audit Log

Mandatory Nutrient Raw Input FDA Rounded Label Value 2026 %DV 21 CFR 101.9 Rounding Rule Applied
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Regulatory Technical Brief: FDA Small Business Nutrition Labeling Exemption Guide (<100 Employees / <100k Units)

Under 21 CFR 101.9(j)(18), low-volume food products sold by businesses with fewer than 100 full-time equivalent employees and fewer than 100,000 units sold in the US annually (or firms with <$50,000 food sales / <$500,000 total sales) can qualify for an exemption—provided the package makes zero nutrient content or health claims.

  • Note: Making ANY nutrient claim (such as 'Keto Friendly', 'Low Sugar', 'High Protein', or '0g Trans Fat') immediately voids the small business exemption!
  • Amazon FBA, Whole Foods, Sprouts, and Target typically require a 21 CFR 101.9 Nutrition Facts panel regardless of federal small-business exemption status.
  • Generate a compliant 21 CFR 101.9 panel in 60 seconds so you never need to rely on an exemption.

FDA Small Business Exemption Thresholds (21 CFR 101.9(j)(1) & (j)(18))

Exemption PathEmployee / Sales CapFDA Filing Required?Voided By Nutrient Claims?
21 CFR 101.9(j)(1) Micro-Retailer< $50,000 food sales OR < $500,000 total sales to consumersNo FDA notice requiredYes — any claim requires Nutrition Facts
21 CFR 101.9(j)(18) Low-Volume< 100 FTE employees AND < 100,000 units of product/yearYes (unless US manufacturer with <10 FTEs & <10,000 units)Yes — any claim requires Nutrition Facts

Frequently Asked Regulatory Questions (FDA / OEHHA / CPSC)

Does saying 'Gluten-Free' void the FDA Small Business Nutrition Facts exemption?

According to FDA guidance, a truthful 'Gluten-Free' claim meeting 21 CFR 101.91 is not a nutrient content claim and does not by itself trigger mandatory Nutrition Facts, whereas 'Sugar-Free', 'Low Carb', or 'Good Source of Fiber' DO trigger mandatory Nutrition Facts.

Even if exempt from Nutrition Facts, what is still required on the label?

Every food package must still display the Statement of Identity, Net Quantity of Contents (oz/g), Ingredient List in descending order of weight, Major Food Allergens (FASTER Act 9 allergens), and Name & Place of Business.

28+ PROGRAMMATIC COMPLIANCE TOOLS & GUIDES

US CPG Label Compliance Library (FDA 21 CFR 101.9 · Prop 65 · CPSIA · Amazon FNSKU)

Explore dedicated calculators and regulatory guides by food category, label geometry, and federal/state statute:

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