Cannabis, Hemp, THC, and CBD

Regulatory Impact of the 2025 Continuing Resolution on Hemp Products

The 2025 Continuing Resolution (H.R. 5371), enacted November 12, 2025, introduces the most significant federal changes to hemp regulation since the 2018 Farm Bill. Section 781 fundamentally alters how hemp-derived cannabinoid products are defined and regulated under federal law, with implementation scheduled for November 12, 2026.

Rather than relying solely on delta-9 THC concentration, the new framework adopts a “total THC” standard and imposes strict per-container limits for finished hemp-derived products. These changes materially affect CBD manufacturers, distributors, retailers, and investors operating in the ingestible, inhalable, and topical product markets.

The revisions also narrow the definition of hemp to exclude synthetic cannabinoids and substances not naturally produced by Cannabis sativa L., potentially reclassifying certain products as Schedule I controlled substances under the Controlled Substances Act.

For companies operating in the hemp and cannabinoid space, these developments create immediate compliance planning considerations well in advance of the 2026 effective date.

Shift from Delta-9 THC to “Total THC” Regulation

The new law shifts away from measuring only delta-9 THC and instead applies a broader “total THC” calculation that includes additional cannabinoids with similar effects.

Intermediate products must comply with a 0.3% total THC limit on a dry-weight basis after decarboxylation. Finished products intended for ingestion, inhalation, or topical use are subject to a strict per-container cap. These changes affect:

• Formulation strategy
• Package sizing
• COA testing protocols
• Supply chain verification

Products that exceed the new thresholds may no longer qualify as lawful hemp under federal law.

Synthetic Cannabinoids and Reclassification Risk

The revised statute excludes cannabinoids that are not naturally produced by the cannabis plant. Products relying on synthetic or chemically converted cannabinoids may fall outside the federal hemp definition.

This distinction creates a heightened CBD-related regulatory risk for manufacturers using modified or synthesized compounds that were previously marketed as hemp-derived. Businesses should carefully evaluate sourcing, manufacturing methods, and cannabinoid classification before the effective date.

Continued FDA Authority Over CBD and Ingestible Hemp Products

The recent amendments do not create a new FDA pathway for CBD in foods or dietary supplements. FDA’s longstanding position under the FD&C Act remains unchanged.

CBD-containing foods, beverages, and supplements continue to face regulatory scrutiny, particularly where labeling or marketing suggests therapeutic or drug-like effects. Companies must evaluate compliance independently of Controlled Substances Act status.

Even if a product qualifies as “hemp” under federal drug law, it may still violate FDA requirements.

Compliance Planning Before the 2026 Effective Date

The delayed implementation date provides a limited window for proactive compliance planning. Businesses should consider:

• Reassessing total THC calculations
• Reviewing formulation and packaging structure
• Auditing, labeling, and website claims
• Evaluating exposure to reclassification under federal law
  

Early review can reduce enforcement exposure and prevent costly product withdrawals or supply chain disruptions once the revised framework takes effect.

FDA Oversight of Hemp, CBD, and THC Products in 2026

FDA oversight of hemp-derived products continues to focus on intended use, product classification, and marketing claims. Federal drug law status does not determine whether a product complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In practice, FDA enforcement is driven more by whether a product is positioned as a food, dietary supplement, cosmetic, or drug, reflecting the FDA's ongoing hemp enforcement priorities.

Claims And Formulations That Trigger Heightened FDA Scrutiny

Therapeutic and disease-related claims remain a primary trigger for enforcement. Products marketed for pain relief, anxiety, sleep disorders, inflammation, or other medical conditions are likely to be treated as unapproved drugs if they lack FDA approval.FDA also evaluates:

• Express and implied claims on websites and social media
• Structure/function positioning that crosses into disease claims
• Ingestible formats that may violate the drug exclusion rule

Distinctions Between Lawful Hemp Products And Unapproved Drugs

A product may qualify as hemp under federal agricultural law yet still violate the FD&C Act.

Under 21 U.S.C. § 321(g)(1), articles intended for use in diagnosing, curing, mitigating, treating, or preventing disease are regulated as drugs. Absent FDA approval under 21 U.S.C. § 355, such products are considered unapproved new drugs.

This distinction is central to compliance. THC concentration and hemp sourcing do not shield products from drug classification if marketing establishes therapeutic intent.

Warning Letters, Seizures, And Post-Shutdown Enforcement Actions

The FDA continues to issue warning letters to companies marketing CBD and THC products with unlawful claims or unsafe formulations. Enforcement tools may include:

• Warning letters
• Product seizures
• Import alerts
• Injunction actions

Companies should assume that online marketing, labeling, and distributor materials are routinely reviewed to avoid any hemp warning letters issued by the FDA. 

Legal Guidance for Hemp Companies Navigating Regulatory Change

Regulatory volatility requires ongoing planning rather than reactive responses. Businesses that embed compliance into product development, labeling, and marketing are better positioned to adapt to regulatory changes.

Proactive legal review can reduce enforcement exposure and protect long-term market access.

Proactive Compliance Strategies 

Effective compliance strategies typically include:

• Substantiated structure/function claims
• Clear separation from disease claims
• Label review for misbranding risk 
• Ingredient assessment under adulteration provisions 
• Review of the drug exclusion rule for ingestible CBD products

Aligning operations with ongoing federal hemp regulation updates or developments reduces exposure when enforcement priorities change.

Responding To FDA Inquiries And Enforcement Actions

FDA inquiries and warning letters require careful, timely responses, often with guidance from a hemp product compliance attorney who understands evolving enforcement priorities. Early engagement with a legal advisor focused on hemp product compliance can help address agency concerns while preserving future options. 

Companies facing import-related scrutiny or cross-border ingredient sourcing issues may also need coordinated strategies aligned with FDA import requirements.

Ongoing Regulatory Monitoring And Compliance Planning

Long-term compliance requires active monitoring of FDA enforcement activity, guidance publications, and legislative developments affecting hemp-derived products.

Businesses that routinely audit claims, formulations, and distribution practices are better prepared to adjust operations as regulatory expectations evolve.

Ongoing review reduces the likelihood of enforcement action and supports defensible product positioning in a shifting regulatory environment.