Recently, products from many device manufacturers have encountered delistings on Amazon, frozen account funds, and even restricted sales privileges. This is not a sudden “accidental injury” by the platforms, but rather the result of strengthened compliance supervision by online platforms like Amazon in recent years.

Tracing back to April 2020, EPA Administrator Andrew Wheeler held a conference call with mainstream e-commerce platforms such as Amazon and eBay, explicitly requiring them to remove non-compliant pesticide devices. Subsequently, Amazon and eBay removed a large number of unregistered or misbranded device products and have since continued to strengthen scrutiny over newly listed devices.

These delisted products often fall into the same compliance misconception: “If a device is exempt from EPA registration, does it require no compliance actions?”

The answer is clearly negative.

I. Definition of Device

According to the FIFRA definition, any instrument or contrivance intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life by physical means is defined as a “device.”

Common devices include:

• Disinfection/Purification: Certain ultraviolet light systems, ozone generators, water filters, air filters, and ultrasonic devices claiming to kill, inactivate, entrap, or suppress the growth of fungi, bacteria, or viruses;

• Bird Repellents: Certain high-frequency sound generators, carbide cannons, foils, and rotating devices claiming to repel birds;

• Insect Control: Black light traps, fly traps, electronic and heat screens, fly ribbons, and fly paper claiming to kill or entrap insects;

• Mammal Repellents: Certain mole thumpers, sound repellents, foils, and rotating devices claiming to repel mammals;

• Electric/Signal: Handheld bug zappers and electric flea combs claiming to control pests via electromagnetic and/or electrical signals;

• Other: For example, products claiming to control burrowing animals via underground explosions caused by the product.

II. Device Compliance Obligations

1. Establishment Registration

Enterprises must apply for a company Establishment Number (EPA Est. No.) from the EPA for all factories producing the device. Once the Establishment Number is obtained, an annual production report must be submitted by March 1 each year, reporting the types and quantities of devices produced at that establishment during the previous year.

2. State Registration (Label Compliance)

Federal exemption ≠ State exemption. Some states (e.g., California, New York) require devices to be reviewed at the state level, with a focus on verifying the compliance of product labels:

· Are the efficacy claims on the label supported by efficacy reports/data?

· Is the EPA Establishment Number (EPA Est. No.) clearly marked on the label?

· Does the label contain necessary information for use and cautionary statements?

3. Notice of Arrival (NOA)

Before each shipment, the enterprise or its U.S. agent must submit a Notice of Arrival (NOA) to the EPA and U.S. Customs and Border Protection (CBP) and await EPA approval. Only after approval is granted may the goods be loaded and shipped.

III. Compliance Cycle and Common Misconceptions

Compliance Cycle: Except for heavy workloads in certain states, the federal compliance process for devices can typically be completed within one month.

Non-FIFRA Regulated Determination(M009): If there is uncertainty regarding whether an innovative product constitutes a device regulated by the EPA, enterprises may submit an M009 device determination application to the EPA.

REACH24H Advice:

For device manufacturers, compliance is not a “stumbling block,” but a “pass” to enter the U.S. market. Under the current high-pressure joint enforcement posture of the EPA and platforms like Amazon, completing establishment registration in advance, standardizing label wording, and strictly executing the NOA process is the optimal solution for ensuring long-term, stable sales in the U.S. market.