Why 2025 looks different for imported cannabinoid ingredients

In 2025, FDA’s import enforcement posture around Foreign Supplier Verification Programs (FSVP) has become much less forgiving—especially for imported botanical extracts and concentrates that are marketed as “hemp-derived” ingredients (including CBD, minor cannabinoids, and nanoemulsified preparations). Even though the broader federal policy questions about CBD in conventional foods remain unresolved, FDA has continued to treat the import side as a clear compliance lane: if you import an ingredient that is a food (or will become a food ingredient), you must meet 21 CFR Part 1, Subpart L.

For beverage brands and co-packers, the practical message is straightforward:

• FDA can challenge the legality of certain cannabinoid uses in foods.
• Separately, FDA can (and does) cite companies for FSVP failures even before it gets to the question of whether the finished beverage is lawful.

This post is informational only and not legal advice.

What FSVP requires (and what FDA is looking for)

FSVP is the FSMA-era rule that makes the U.S. importer responsible for ensuring foreign-supplied food is produced in a manner that provides the same level of public health protection as U.S. requirements, and that the food is not adulterated or misbranded with respect to allergen labeling.

FSVP’s core requirements (at a high level) include:

• Foreign supplier approval
• A hazard analysis for each imported food
• Supplier verification activities based on risk
• Corrective actions when suppliers fail to control hazards
• Robust records you can produce quickly during an FDA FSVP inspection

Official references:

• FDA FSVP overview: https://www.fda.gov/food/food-safety-modernization-act-fsma/foreign-supplier-verification-programs-importers-food
• Regulatory text (21 CFR Part 1, Subpart L): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-L

Who is the “FSVP importer” for beverage supply chains?

Under FSVP, the “importer” is generally the U.S. owner or consignee of the food at the time of entry. If there is no U.S. owner or consignee, the U.S. agent/representative of the foreign owner/consignee can be the FSVP importer.

Why this matters in 2025: FDA warning letters and import entry reviews frequently highlight situations where firms cannot clearly identify:

• who is the importer of record for customs purposes;
• who is the FSVP importer for FDA purposes; and
• which U.S. entity (and unique identifier) is associated with the entry.

Beverage brands that “never touch the ingredient” (because a co-packer or broker arranges drop shipment) can still end up as the FSVP importer if they are the U.S. owner/consignee.

How FSVP dovetails with 21 CFR Part 117 and Part 111 for beverages

When imported material becomes a beverage ingredient: Part 117 is usually in play

If you are manufacturing a conventional beverage in the U.S., the facility is typically subject to 21 CFR Part 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food), unless a specific exemption applies.

Relevant Part 117 concepts that often overlap with FSVP work:

• Hazard analysis: Part 117 requires a hazard analysis for your process and ingredients.
• Supply-chain program: when a hazard requiring a preventive control is controlled by the supplier, you must implement supply-chain controls.
• CGMP: receiving, storage, and handling practices for ingredients (including imported emulsions, distillates, and isolates).

Part 117 reference: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117

Practical takeaway: Don’t treat FSVP as “the importer’s paperwork” and Part 117 as “the plant’s paperwork.” FDA inspectors may expect alignment between:

• the importer’s FSVP hazard analysis and verification; and
• the receiving facility’s ingredient risk evaluation, specifications, and supplier approval.

If your product is positioned as a dietary supplement beverage, Part 111 may apply

Some ingestible products are marketed as dietary supplements even when they look like beverages. If your finished product meets the legal definition of a dietary supplement and is labeled as such, 21 CFR Part 111 (dietary supplement CGMP) can apply.

Part 111 reference: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111

Part 111 has a strong focus on:

• identity testing of dietary ingredients
• specifications and batch production records
• supplier qualification and quality unit oversight

Important: Whether a cannabinoid-containing ingestible can lawfully be marketed as a dietary supplement is a separate federal legal question; this post focuses on the FSVP/import and manufacturing compliance mechanics.

2025 warning letter patterns: where companies are getting cited

FDA continues to post FSVP warning letters (across many categories), and the recurring FSVP gaps that matter most for imported cannabinoid ingredients used in beverages tend to cluster in a few buckets.

Use FDA’s warning letter database and filter by “FSVP” to see current postings: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

Pattern 1: No (or thin) hazard analysis for the imported ingredient

For hemp-derived distillates, isolates, and nanoemulsions, the hazard analysis often needs to address chemical hazards that are common for botanical extracts and concentrate-type ingredients.

FDA commonly expects the hazard analysis to consider, as applicable:

• residual solvents
• pesticide residues
• heavy metals
• microbiological hazards (depending on the matrix)
• process-related contaminants
• unintended constituents or cross-contamination risks

When firms rely solely on a supplier COA without documenting the hazard evaluation logic, it can look like they skipped the required analysis.

Pattern 2: Supplier verification activities don’t match the risk

FSVP verification is not “one size fits all.” FDA expects verification activities to be risk-based and tied to the hazard analysis.

Common verification activities include:

• onsite supplier audits (or audits of relevant process steps)
• sampling and testing
• review of supplier food safety records

When the imported input is a high-value, high-concentration ingredient that will be used in a ready-to-consume beverage, FDA may expect more than periodic COAs.

Pattern 3: FSVP records aren’t available during the inspection

FSVP inspections are document-driven. A frequent failure mode is simply not being able to produce:

• the written FSVP
• supplier approval documentation
• hazard analysis
• verification records
• corrective action records

If your brand uses a broker, freight forwarder, or co-packer, you still need written clarity about where the FSVP records live and how fast you can access them.

Pattern 4: Entry data problems (importer identity, U.S. agent, and identifiers)

A practical enforcement trigger is when entry information is inconsistent or incomplete.

Brands should watch for:

• confusion between customs importer of record vs FSVP importer
• missing or incorrect U.S. agent/representative data where relevant
• mismatches in business names/addresses across entry documents

These issues can create avoidable delays and elevate scrutiny.

Detention risk in 2025: what can trigger holds, exams, or DWPE

Even if you have strong FSVP documentation, certain attributes can raise the odds of shipment holds:

• misdeclared product identity (e.g., declaring a concentrated extract as a generic “flavor” without accurate description)
• inconsistent ingredient descriptions between invoice, packing list, prior notice, and entry filings
• product labeling/marketing materials indicating drug-like claims
• safety red flags such as contaminants, undeclared allergens, or a pattern of noncompliance by the foreign manufacturer

FDA’s import enforcement toolbox includes examinations, sampling, and Detention Without Physical Examination (DWPE) through Import Alerts.

FDA Import Alert database: https://www.accessdata.fda.gov/cms_ia/ialist.html

Compliance takeaway: If your ingredient category is already prone to heightened attention, the cost of “documentation gaps” is higher—because you may need those records to respond rapidly during an admissibility challenge.

Practical documentation sets brands should require from foreign ingredient and emulsion suppliers

Beverage brands often buy cannabinoid ingredients through complex channels (foreign manufacturer → trader → U.S. broker → co-packer). Under FSVP, you need enough documentation to support both supplier approval and ongoing verification.

Below is a practical, audit-ready set of documents to request and maintain.

1) Supplier identity and facility documentation

• Legal entity name, physical address, and contact details
• Facility registrations, where applicable (e.g., FDA food facility registration for foreign facilities that manufacture/process food for U.S. consumption)
• A clear description of which facility performs which steps (extraction, refinement, emulsification, packaging)
• Organizational chart for quality contacts

2) Written specifications (what you’re actually buying)

• Ingredient identity specification (including stated cannabinoid profile)
• Purity/assay ranges and analytical method references
• Solvent limits and impurity limits
• Micro specifications (where relevant)
• Allergen statement and cross-contact controls
• Storage/handling conditions and shelf life

3) COAs—plus method and lab competence support

COAs should be lot-specific and tied to validated/fit-for-purpose methods.

Ask for:

• lot COA with test dates and results
• name/address of the testing lab
• method summaries (e.g., chromatography conditions, LOQ/LOD)
• policy for retests, OOS investigations, and COA corrections

Tip: If you are relying on supplier COAs as a key control, your program should document why that reliance is appropriate, and how you confirm COA integrity (e.g., periodic third-party verification testing).

4) Hazard analysis inputs and process controls

• process flow diagram
• critical process parameters (e.g., solvent recovery, winterization, distillation, emulsification steps)
• contaminant control plan (pesticides, heavy metals, residual solvents)
• sanitation and environmental controls, if applicable

5) Supplier approval evidence and verification activities

Depending on risk, assemble:

• most recent third-party audit report (scope must match the process)
• corrective action responses to audit findings
• supplier performance history (complaints, deviations)
• verification testing plan and results

6) Change control and notification

• written commitment to notify you of changes in: raw material sources, processing aids, emulsifiers, carriers, or manufacturing site
• packaging/contact material changes
• labeling/claims changes if the supplier provides downstream marketing support

Co-packer alert: drop-ship models can quietly make you the “importer”

A frequent 2025 risk scenario is a “drop-ship” model:

• The beverage brand sources an imported ingredient.
• The ingredient ships directly to the co-packer (never enters the brand’s warehouse).
• The co-packer (or a customs broker engaged by someone else) may be listed on entry documents.

If your co-packer is named as the FSVP importer at entry, that co-packer must have a compliant FSVP. Many co-packers are surprised by this during an FDA inspection.

Checklist: if you are a co-packer and may become the FSVP importer

Use this as a practical internal control list.

Confirm role and responsibility up front

• Identify who will be the FSVP importer for each imported ingredient.
• Ensure contracts state who maintains FSVP records and who presents them to FDA.
• Confirm who files prior notice and who manages entry communications.

Ensure you can produce an FSVP quickly

• Maintain a written FSVP for each imported ingredient you are importer for.
• Ensure an FSVP Qualified Individual oversees the program.
• Keep records in a system accessible during FDA business hours (and during holds).

Receiving and traceability controls

• Verify incoming lot identity and match it to COAs.
• Record storage conditions and prevent mix-ups.
• Maintain lot traceability from receiving through batching and finished product.

Align your Part 117 / Part 111 program with FSVP

• Ensure your ingredient approval program reflects the hazards listed in the FSVP hazard analysis.
• If you rely on the customer’s supplier approval, document how you evaluate and accept it.

Entry-document discipline

• Standardize product descriptions across documents.
• Confirm the declared product matches what is actually shipped (including concentration and carrier).
• Escalate any mismatch to the brand before the ingredient is released to production.

What beverage brands should do now (a 30–60 day compliance sprint)

If you are importing or planning to import hemp-derived ingredients in 2026 planning cycles, take these steps immediately.

Step 1: Map your supply chain and name the FSVP importer per SKU

• For each ingredient, list: foreign manufacturer, any traders, U.S. broker, consignee, and receiving facility.
• Determine who is the U.S. owner/consignee at entry.
• Decide who will own the FSVP and ensure entry filings match.

Step 2: Build (or rebuild) hazard analyses that reflect concentrate reality

• Don’t copy a generic botanical extract hazard analysis.
• Address concentration-driven risk (e.g., solvents, metals, pesticides) and process aids.

Step 3: Tighten verification: audit, test, or record-review—then document why

• Set verification frequency based on supplier performance and hazard severity.
• Document the rationale for the chosen verification approach.

Step 4: Align manufacturing compliance

• Ensure your receiving facility procedures and specifications are consistent with the import program.
• If you use a co-packer, align responsibilities and ensure they can pass an FSVP inspection if named as importer.

Enforcement reality check: FSVP compliance doesn’t resolve CBD-in-food legality

Many beverage teams assume that if they have strong FSVP records and contaminant testing, they are “cleared” federally. In practice, there are two separate layers:

1. Import and food safety compliance (FSVP, Part 117/111, contaminant control, truthful documentation)
2. Product legality and claims (including whether certain cannabinoids are permitted in conventional foods and whether marketing implies drug claims)

A mature compliance program addresses both—but FSVP is the piece that can stop your supply chain immediately at the border.

Key takeaways

• In 2025, FDA’s posture shows sustained attention to FSVP hemp cannabinoids imports 2025 compliance issues, with recurring citations tied to hazard analyses, verification activities, and importer identity/entry documentation.
• Beverage brands should treat FSVP as an operational requirement, not a broker add-on.
• Co-packers should assume they may be named as the importer in drop-ship models and build an inspection-ready system.
• Documentation quality (specs, COAs, audits, change control, traceability) is your fastest lever to reduce port disruptions.

Next steps: operationalize your FSVP and beverage compliance program

If your supply chain includes imported distillates, isolates, or emulsified ingredients, use CannabisRegulations.ai to centralize your cannabis compliance documentation, map responsibilities across brands and co-packers, and stay current on evolving licensing and regulations that affect product development and distribution. Get started at https://cannabisregulations.ai/