The regulatory landscape for cannabis and hemp-derived products has shifted dramatically in 2025. On January 21, U.S. Customs and Border Protection (CBP) issued a Notice of Proposed Rulemaking that promises sweeping changes to the longstanding Section 321 de minimis exemption—a move that will reverberate across the entire supply chain for CBD, hemp-derived THC, and cannabinoid products entering the United States. Let’s break down what’s at stake for cannabis importers under the basic entry process, and how businesses can prepare to stay compliant.

Section 321 De Minimis: The Old Paradigm

Section 321 of the Tariff Act (19 U.S.C. § 1321) has long allowed goods valued at $800 or less per shipment to enter the U.S. without duties or formal customs entry. This was a lifeline for U.S.-bound cannabinoid shipments—especially CBD oils, hemp edibles, vaporizers, and even some cosmetic products—often fulfilled directly to consumers from overseas manufacturers with minimal paperwork.

But the apparent ease of low-value cannabis imports drew scrutiny from regulators and industry watchdogs. The CBP found that bypassing formal entry requirements had become a backdoor for regulated ingestibles and devices, some of which skirted FDA scrutiny or misrepresented their content and claims.

The January 2025 NPRM: A Watershed Moment

In the January 21, 2025 Notice of Proposed Rulemaking, CBP proposes a significant tightening of Section 321:

• First, the basic entry process will require 10-digit Harmonized Tariff Schedule (HTS) codes for each shipment. No more vague or generic classifications—importers and brokers must map every product precisely to its HTS code.
• Second, enhanced pre-arrival data submission will be required. This means importers must provide more information—and do so earlier—when sending CBD or hemp derivatives into the U.S.
• Third, a growing list of ineligible products—particularly those flagged as high-risk by the FDA—will be strictly excluded from de minimis entry. This includes products subject to special FDA oversight, like ingestibles, dietary supplements, vape devices, and certain cosmetics.
• Fourth, more rigorous inspection and enforcement action. CBP will utilize advanced analytics and cross-agency data-sharing to target shipments that appear non-compliant or fraudulent.

For full details, visit the CBP newsroom and the Holland & Knight summary.

Why the Change? Policy Drivers and Sector Impact

CBP’s regulatory overhaul responds to perceived abuses of the de minimis threshold, especially the influx of sensitive or regulated goods—ranging from counterfeit electronics to FDA-regulated ingestibles and cannabis extracts—via dropshipping or small-parcel networks. The Biden Administration and Congress are pushing for enhanced screening to safeguard consumers, protect national security, and level the playing field for compliant domestic operators.

Impact on CBD/Hemp-THC Brands: Key Takeaways

Section 321 cannabis hemp imports 2025 are subject to a much stricter regime. For CBD, cannabinoid, and hemp-derived THC companies:

1. Fewer Imports Qualify for De Minimis. Many cannabinoid ingestibles, supplements, vapes, or cosmetics will need formal entry, not the easier de minimis process, especially where FDA flags them as regulated or high-risk.
2. Seizure and Compliance Risks Rise. More scrutiny means greater risk that shipments will be held, seized, or referred if there’s inconsistency in labeling, HTS classification, declared ingredient, or product claims.
3. Operational Shifts Required. Direct-to-consumer and small-parcel imports must evolve. Importers must now:
   • Engage customs brokers more frequently.
   • Re-examine Importer of Record (IOR) and sourcing strategies.
   • Invest in traceability and data alignment with customs requirements.

The Playbook: Compliant Imports amid Section 321 Reform

For businesses intending to continue low-value cannabis and hemp imports, the following playbook is essential to avoid enforcement action and shipment delays.

1. HTS Code Precision: Map Your Portfolio

• Assign a unique, product-specific 10-digit HTS code to every item. Do not rely on generic or catch-all codes for cannabinoids or hemp. For example, topicals, textiles, dietary supplements, and vape hardware each have distinct codes.
• Use the Harmonized Tariff Schedule online database and validate with expert input.

2. Ensure Supplier and Ingredient Attestations

• Require all upstream suppliers, manufacturers, and brand partners to provide written attestations regarding cannabinoid content, sourcing (including country-of-origin), and compliance with both CBP and FDA/DEA guidelines.
• Insist on documented consistency for all product lots—supply-chain traceability is now a must.

3. Certificates of Analysis (COAs) and Label Alignment

• Prepare Certificates of Analysis for every cannabinoid-labeled product. COAs should clearly match customs and FDA declarations.
• Double-check labels for correct ingredient listings, THC/CBD content, claims (wellness, cosmetic, dietary), and required warnings/disclosures. Incongruent or misleading labeling is a trigger for holds and referrals.

4. Early and Accurate Data Submission

• Submit all required product and shipment data to customs (via ACE or equivalent platform) ahead of the parcel’s arrival.
• Work with logistics partners and brokers to integrate pre-arrival data feeds and flag “trouble” products.

5. Deploy a Robust Importer of Record (IOR) Strategy

• Choose an IOR with cannabis/regulatory experience—either in-house or external—to take responsibility for customs submissions, documentation, and resolving inquiries.
• Review all contracts for IOR services and map liability for errors or non-compliance.

6. Maintain Product and Document Consistency

• Strictly enforce a master data file for each product: HTS mapping, supply documentation, COAs, ingredients, and final label should all match.
• Organize records for quick response if CBP or FDA request additional justification or inspection.

7. Prepare for Enforcement and Seizures

• Identify which of your SKUs are most at risk. For example, CBD oral solutions and hemp-derived cannabinoid vapes are near-certain targets for exclusion or seizure.
• Set aside contingency plans for rerouting supply chains or switching to formal entry for high-risk items.

FDA-Regulated Ingestibles, Cosmetics, and Devices: Higher Hurdles

CBP’s cross-agency data-sharing means any item regulated as an ingestible (foods, supplements, tinctures), cosmetic, or device (including vaporizers) faces close scrutiny. Even hemp-based products are subject to additional documentation and may need pre-market FDA clearance.

• Cannabinoid supplement brands: Must ensure no therapeutic or disease-treatment claims appear on labels, and that all ingredients are pre-approved for use in supplements.
• Cosmetics: Ingredients, label claims, and intended use must clearly fit within FDA rules for cosmetic products and be fully declared to CBP.
• Vapes and devices: New rules require detailed import documentation—serial numbers, manufacturing records, and country-of-origin substantiation.

Practical Tips for a Smooth Transition

• Start Now: Work with customs brokers, compliance consultants, and legal advisors to audit your import practices and prepare for more formal entries.
• Proactive Transparency: Don’t wait for a shipment hold. Proactively submit full documentation, labeling, and ingredient data for high-risk products.
• Educate Your Supply Chain: Make sure all vendors and logistics partners understand new U.S. import expectations for Section 321 cannabis hemp imports in 2025.
• Stay Engaged: Monitor CBP, FDA, and industry resources for additional rulemaking and enforcement guidance.

The Road Ahead: Compliance as Competitive Advantage

Section 321 de minimis changes are here to stay, and scrutiny of cannabinoid and hemp-derived product imports has reached new heights. While operational complexity and costs will rise, brands that align early—through detailed documentation, supply chain transparency, and accurate submissions—will not only avoid costly seizures and shipment delays, but also inspire greater confidence with U.S. partners.

For tailored guidance on cannabis compliance, licensing, and import regulations, continue leveraging the up-to-date resources at CannabisRegulations.ai. Staying informed is your best compliance strategy in 2025 and beyond.