Import Alert Guide
Import Alert 45-02 — Foods, Illegal or Undeclared Colors
A plain-language guide to FDA Import Alert 45-02, which allows detention without physical examination of foods containing illegal and/or undeclared color additives. What it covers, its two distinct charges, and what per-shipment testing or labeling evidence typically involves.
The Short Version
What Is Import Alert 45-02?
Import Alert 45-02 permits FDA to detain, without physical examination, foods that appear to contain illegal and/or undeclared color additives. It captures two distinct problems: a color that isn't permitted in food (or isn't used in a permitted way), and a color — even a permitted one — that wasn't properly declared on the label. A single violation can be enough to place a firm and product on the alert, after which covered shipments are automatically detained unless the firm is on the Green List.
- Alert Number
- 45-02
- Products Covered
- Foods with color-additive violations — commonly candy, snacks, beverages, spices, and sauces
- Charge 1 — Illegal Color
- Adulteration — unsafe color additive within Section 721(a) (Section 402(c); OASIS UNSAFE COL)
- Charge 2 — Undeclared Color
- Misbranding — undeclared artificial color additive (Section 403(k); OASIS COLOR LBLG)
- Mechanism
- Detention Without Physical Examination (DWPE), with Green List exemption
- Official Text
- FDA Import Alert 45-02
The Background
Two Different Problems, One Alert
Color additives in food are tightly regulated in the U.S. Many colors permitted elsewhere in the world are not approved here, and even approved colors must be declared correctly on the label. 45-02 exists because both kinds of violation are common in imported food — historically across candy, snack foods, beverages, spices, and sauces from many countries.
Illegal (non-permitted) color means the food bears a color additive that is unsafe within the meaning of the law — for example, colors such as Ponceau 4R, Amaranth (former FD&C Red No. 2), Auramine O, Carmoisine, or Rhodamine that aren't approved for that use in the U.S. This is an adulteration problem, and clearing it generally means proving by analysis that the non-permitted color isn't present.
Undeclared color means a color additive — even a permitted one like FD&C Yellow No. 5 (tartrazine) or Yellow No. 6 (sunset yellow) — is present but wasn't properly named on the label. Listing "artificial colors" generically, rather than the specific certified color, can itself be a violation. This is a misbranding problem, and it is sometimes correctable by relabeling rather than by testing alone.
The Evidence
What Clearing a Shipment Typically Involves
The path depends on which charge applies. An illegal-color case usually turns on analytical evidence; an undeclared-color case can turn on the label. Reading the notice carefully is the first step.
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Identify the Charge and Color
The notice specifies whether the issue is an illegal (non-permitted) color, an undeclared color, or both, and names the color at issue. That determines whether the response is analytical, a labeling correction, or a combination.
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Test and/or Correct
For a non-permitted color, an independent laboratory analyzes a representative sample under documented custody to show the color isn't present. For an undeclared permitted color, the fix may center on correcting the ingredient declaration so the label complies.
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Your Team Submits
Analytical results, custody records, and any corrected labeling are organized into a case file; you and your authorized parties submit to the FDA compliance office named on the notice. FDA makes the final admissibility decision.
Testing isn't always the whole answer here. Because an undeclared-color violation can be a labeling issue, some 45-02 cases are resolved partly through a corrected label rather than analysis alone. Where sampling and testing are needed for a non-permitted color, we coordinate that piece — see our laboratory testing coordination guide.
Be Realistic
What This Alert Means in Practice
Honest limitations
- One violation can list you. A single finding of an illegal or undeclared color can be the basis for adding a firm and product to the alert.
- Perishable and seasonal goods are vulnerable. Detention delays can outlast the shelf life of perishable items or cause seasonal and holiday products to miss their delivery window.
- A non-permitted color can't be "declared away." If the color itself isn't allowed in the U.S., correcting the label does not fix it — the product remains adulterated regardless of disclosure.
- Release is not removal. Clearing one shipment does not take the firm off the alert. Removal requires identifying, correcting, and documenting the manufacturing or labeling problem in a petition to FDA.
Related
Related Alerts & Guides
Cosmetics — Color Additive Violations
The cosmetics counterpart — color additive adulteration and misbranding in cosmetic products.
Read the guide IA 99-19Food Products — Salmonella
Another broad food alert — pathogen contamination rather than color-additive violations.
Read the guide IndustryCandy, Snacks & Beverages
Category overview: common detention reasons for confectionery and beverages and the testing they require.
View industriesFood Detained Under 45-02?
Bring Us the Notice — We'll Sort Testing From Labeling
Send your FDA Notice of Action, the color and charge it cites, and product details. You'll get an honest, case-specific read on whether the path is analytical, a labeling correction, or both — before any commitment.
Urgent detention matters receive priority intake review.
FDA Detention Sampling is an independent private company. We are not affiliated with, endorsed by, or part of the U.S. Food and Drug Administration. This guide is a plain-language summary of Import Alert 45-02; the official alert text published by FDA is authoritative and controls. Sampling, laboratory testing, documentation, and coordination services do not guarantee FDA release, admissibility, acceptance of laboratory results, removal from any import alert, or any specific regulatory outcome. FDA makes the final admissibility decision.