CBD (Cannabidiol): FDA Regulation, Warning Letters & Compliance Guide

What Is CBD?

Cannabidiol (CBD) is a non-intoxicating cannabinoid extracted from Cannabis sativa L. (hemp). It is the second most abundant cannabinoid after THC and has been incorporated into thousands of consumer products — oils, tinctures, gummies, beverages, topical creams, pet treats, and cosmetics. The global CBD market was valued at roughly $7.7 billion in 2023, with the U.S. accounting for the majority of sales.

CBD's UNII is 19GBJ60SN5. The FDA-approved pharmaceutical form is Epidiolex (cannabidiol oral solution), developed by GW Pharmaceuticals (now Jazz Pharmaceuticals), approved June 25, 2018 for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. The FDA expanded the indication to include tuberous sclerosis complex on August 3, 2020.

That drug approval is the root of nearly every regulatory problem the CBD industry faces today.

FDA Regulatory Status

CBD occupies a unique position in FDA regulation: it is simultaneously a legal agricultural commodity (when derived from hemp) and an illegal food additive and dietary supplement ingredient under federal law.

The FDA's position rests on two statutory provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act):

• Section 201(ff)(3)(B) [21 U.S.C. 321(ff)(3)(B)] — The "drug preclusion clause." Because CBD was the subject of substantial clinical investigations before it was marketed as a food or dietary supplement, it is excluded from the definition of "dietary supplement." Epidiolex's IND (investigational new drug application) predates any commercial marketing of CBD in food or supplements.

• Section 301(ll) [21 U.S.C. 331(ll)] — It is a prohibited act to introduce into interstate commerce any food to which CBD has been added, because CBD is an active ingredient in an approved drug that was not previously marketed in food.

These provisions mean CBD cannot legally be sold as a dietary supplement, added to conventional food or beverages, or used in animal feed anywhere in the United States — regardless of state law.

The January 2023 Decision

On January 26, 2023, the FDA issued its definitive statement: existing regulatory frameworks for foods and dietary supplements are "not appropriate" for CBD. The agency simultaneously denied three citizen petitions requesting that FDA issue regulations allowing CBD in supplements. The FDA cited safety concerns including potential liver toxicity, drug interactions, and possible harm to the male reproductive system.

The agency stated it would work with Congress to develop a new regulatory pathway — effectively punting the issue to legislators.

FDA Enforcement Discretion

Despite this clear legal position, the FDA has exercised significant enforcement discretion. Thousands of CBD products remain on shelves nationwide. The FDA has primarily targeted companies that:

1. Make explicit disease-treatment claims (cancer, Alzheimer's, COVID-19, anxiety disorders)
2. Market CBD products for children or in child-appealing packaging
3. Sell CBD products for food-producing animals
4. Use high-risk delivery forms (ophthalmic drops, IV solutions, inhalers)

Companies selling CBD products without health claims and with accurate labeling have faced comparatively little federal enforcement — though this does not make their products legal.

The Legal Paradox: Legal to Grow, Illegal to Sell in Food

The 2018 Agriculture Improvement Act (Farm Bill) removed hemp — defined as Cannabis sativa L. with no more than 0.3% delta-9 THC on a dry weight basis — from the Controlled Substances Act. This made it legal to cultivate, process, and sell hemp and hemp-derived compounds, including CBD.

However, the Farm Bill explicitly preserved FDA's authority over food, drugs, and dietary supplements. Section 297D of the Agricultural Marketing Act states that nothing in the hemp provisions affects FDA's jurisdiction under the FD&C Act.

The result is a paradox: farmers can legally grow hemp. Extractors can legally produce CBD isolate. But the moment that CBD is added to a food, beverage, or dietary supplement, the product becomes adulterated under federal law.

Section 781 and the November 2025 Overhaul

On November 12, 2025, Congress enacted Section 781 of the FD&C Act as part of the Continuing Resolution and Appropriations Package (H.R. 5371). This provision fundamentally reshapes the federal definition of hemp, with a one-year transition period ending November 12, 2026.

Key changes:

• Total THC standard: Hemp is now defined by total THC concentration (including THCA and delta-8 THC), not just delta-9 THC. The 0.3% dry weight threshold remains but now captures all THC isomers.
• Product-level cap: Final hemp products intended for human or animal use (ingestion, inhalation, or topical) must contain no more than 0.4 mg of total THC per container — effectively eliminating most full-spectrum CBD products from the market.
• Synthetic cannabinoid ban: Synthetically derived cannabinoids are prohibited.
• FDA cannabinoid lists: FDA was required within 90 days (by approximately February 10, 2026) to publish lists of naturally occurring cannabinoids, THC-class cannabinoids, and cannabinoids with THC-like effects. The FDA missed this deadline.

Section 781 does not create a legal pathway for CBD in food or supplements. It tightens restrictions on THC-containing hemp products while leaving CBD's food/supplement status unchanged.

Warning Letter Enforcement Trends

CBD is one of the most actively enforced ingredient categories in the FDA's warning letter program. Policy Canary tracks 53 regulatory items linked to cannabidiol, the vast majority being warning letters.

Enforcement by Year

Year	Approximate Warning Letters	Primary Focus
2021	5-6	Unapproved drug claims, CGMP violations
2022	20+	Peak enforcement — CBD as food additive, disease claims, COVID-19 claims
2023	6-8	Disease claims, Delta-8 THC crossover products
2024	~9	Copycat packaging (child-appealing), Delta-8 THC
2025	5+ (YTD)	Animal CBD products (CVM), ophthalmic products

Common Violation Categories

Unapproved new drug claims — The most frequent violation. Companies claiming CBD treats cancer, anxiety, pain, arthritis, Parkinson's, Crohn's disease, PTSD, or other conditions. Examples from the database include:

• CBD American Shaman, LLC (November 2022) — CFSAN warning for CBD in human foods, pet foods, dietary supplements, and an OTC sunscreen
• Discover Health, LLC d/b/a Discover CBD and Strain Snobs (November 2023) — Multi-center warning covering finished pharmaceuticals, animal drugs, human foods, and animal foods
• Root Bioscience Brands, LLC dba Naternal (August 2024) — Unapproved new drugs and misbranding

Adulterated food (CBD as unsafe food additive) — Warning letters citing Section 402(a)(2)(C)(i), which deems food adulterated when it contains an unsafe food additive. CBD is not GRAS and has no food additive petition on file. Companies cited include:

• 11-11-11 Brands (November 2022) — CBD-infused herbal tea
• Infusionz, LLC (November 2022) — CBD gummies and candies, with specific concern about child-appealing formats
• Naturally Infused LLC (November 2022) — CBD food products

Unapproved new animal drugs — The FDA's Center for Veterinary Medicine has been increasingly active. The April 2025 wave targeted three companies simultaneously:

• Bailey's Wellness, LLC dba Bailey's CBD
• Holista LLC dba HolistaPet
• House of Alchemy LLC dba CBD Dog Health / MycoDog

A separate May 2025 CVM wave targeted companies selling CBD for food-producing animals, including Plantacea, LLC dba Kahm, Free State Oils, Hope Botanicals, and Kingdom Harvest.

COVID-19 claims — During 2021-2023, multiple CBD companies received warning letters for claiming their products could treat or prevent COVID-19, including Heaven's Organic LLC, Cureganics, Nature's Highway, CBD Social, UPSY LLC, and Functional Remedies LLC.

FTC Enforcement

The Federal Trade Commission has pursued parallel enforcement on CBD marketing practices. In December 2025, the FTC returned $27.6 million to over 1.2 million consumers harmed by unauthorized billing schemes involving CBD and other wellness products — specifically deceptive subscription/continuity billing practices by Legion Media, KP Commerce, and related entities. The FTC also requires "competent and reliable scientific evidence" — specifically human clinical trials — for any claims that CBD treats diseases.

State-Level Frameworks

With no federal pathway for CBD in food or supplements, states have created a fragmented patchwork of regulations. This creates significant compliance complexity for companies operating in multiple states.

States With CBD Food/Supplement Frameworks

Several states have enacted their own regulatory schemes permitting CBD in food or supplements within their borders, subject to state-specific requirements (labeling, testing, licensing):

• Colorado, Oregon, California — Comprehensive state frameworks with testing and labeling requirements
• Florida, Texas, New York — Conditional models with varying restrictions and licensing requirements
• Utah, Indiana, Kentucky — Frameworks aligned with hemp-derived CBD, often requiring registration

States With Restrictive Approaches

• Idaho, Nebraska — Have historically maintained stricter interpretations, limiting CBD product availability
• Alabama, Arkansas — Restrict CBD to patients with qualifying medical conditions

The Interstate Commerce Problem

Even in states that permit CBD in food and supplements, the products remain illegal under federal law when shipped across state lines. This means:

• Products manufactured and sold entirely within one state may be tolerated by that state's regulators
• The moment a product enters interstate commerce, it falls under FDA jurisdiction and the federal prohibition applies
• E-commerce sales of CBD food and supplement products are inherently interstate transactions

Key Deadlines and Legislative Outlook

Date	Event
January 26, 2023	FDA concluded existing frameworks not appropriate for CBD; denied citizen petitions
November 12, 2025	Section 781 enacted — new hemp definition with one-year transition
~February 10, 2026	FDA deadline to publish cannabinoid classification lists (90 days post-enactment — missed)
January 2026	HEMP Act introduced (Griffith/Veasey) — would direct FDA to create CBD regulatory pathway
November 12, 2026	Section 781 takes full effect — total THC standard, 0.4 mg/container cap
~2029 (if HEMP Act passes)	Automatic fallback milligram limits for THC (5 mg/serving, 30 mg/package) and CBD (10 mg/serving, 50 mg/package oral) if FDA fails to finalize rules within 3 years

The HEMP Act (January 2026)

Representatives Morgan Griffith (R-VA) and Marc Veasey (D-TX) introduced the Hemp Enforcement, Modernization, and Protection (HEMP) Act in late January 2026, which would:

• Direct FDA to regulate CBD through formal rulemaking under a new FD&C Act chapter for "cannabinoid hemp products"
• Require FDA to establish milligram limits for CBD products
• Create manufacturing specifications and third-party testing requirements
• Establish a Cannabinoid Hemp Products Advisory Committee
• Set age restriction of 21+ for purchase
• Enable FDA product recalls
• Institute automatic fallback limits for intoxicating cannabinoids (THC) of 5 mg per serving / 30 mg per package if FDA does not finalize rules within three years (non-intoxicating cannabinoids like CBD would have higher limits: 10 mg/serving, 50 mg/package for oral products)

Executive Order 14370 (December 18, 2025)

President Trump issued an executive order directing the Attorney General to complete the ongoing rulemaking process related to marijuana rescheduling to Schedule III "in the most expeditious manner" and develop a regulatory framework for hemp-derived CBD products. The order specifically references risks from inaccurate labeling and inconsistent quality control. However, the order expressly states implementation must be "consistent with applicable law" and does not override Section 781 or existing FD&C Act prohibitions.

Affected Product Categories

CBD enforcement and regulatory risk spans multiple product categories:

• Dietary supplements — Oils, tinctures, capsules, gummies marketed as supplements. Explicitly prohibited under the drug preclusion clause.
• Beverages — CBD-infused waters, teas, coffees, seltzers. Adulterated as food containing an unsafe additive.
• Functional foods — CBD-infused chocolates, baked goods, candy. Same adulteration issue; child-appealing formats draw heightened scrutiny.
• Topical cosmetics and skin care — CBD creams, lotions, serums. The FDA has been less aggressive on topicals that make only cosmetic claims (moisturizing, soothing), but disease claims (pain relief, anti-inflammatory) trigger drug classification.
• Pet products — CBD treats, oils, and supplements for dogs, cats, and horses. Subject to both CVM (animal drug) and CFSAN (animal food) enforcement.
• Tobacco/vape products — CBD vape cartridges and e-liquids require premarket authorization from the Center for Tobacco Products.

What Companies Should Do

Immediate Actions

1. Audit all product claims. Remove any language suggesting CBD treats, cures, mitigates, or prevents any disease. This includes indirect claims on social media, influencer content, and customer testimonials curated on company websites. Structure/function claims require a substantiation file and 30-day FDA notification.

2. Assess Section 781 exposure. If any products contain measurable THC (including THCA and delta-8), model compliance against the 0.4 mg/container total THC cap effective November 12, 2026. Full-spectrum products will likely need reformulation or discontinuation.

3. Eliminate child-appealing packaging. The FDA and FTC have jointly targeted products mimicking children's snack brands. Any packaging that could appeal to minors is a high-priority enforcement trigger.

4. Segregate interstate and intrastate sales. If operating under a state CBD framework, ensure products sold across state lines are not making food or supplement claims that violate federal law.

Ongoing Compliance

5. Implement third-party testing. Certificate of Analysis (COA) for every batch — potency, contaminants (heavy metals, pesticides, residual solvents, microbial), and THC content. This is already required in many state frameworks and will likely become federal law under the HEMP Act.

6. Follow GMP requirements. Even without a formal CBD pathway, FDA expects products marketed for human consumption to comply with current Good Manufacturing Practice regulations. 21 CFR Part 111 (dietary supplement GMP) is the relevant standard.

7. Track the HEMP Act. If enacted, this bill would create the first federal regulatory pathway for CBD products. Companies should prepare for potential milligram limits, mandatory third-party testing, age-gating (21+), and FDA recall authority.

8. Monitor state developments. State frameworks continue to evolve independently of federal action. Maintain a compliance matrix for every state in which products are sold.

9. Document everything. Maintain records of sourcing (hemp certificates of origin), manufacturing processes, testing results, and label reviews. If FDA initiates contact, a well-documented compliance program demonstrates good faith.

What Not to Do

• Do not rely on the 2018 Farm Bill as a defense for selling CBD food or supplements. The Farm Bill legalized hemp cultivation, not CBD in food.
• Do not assume enforcement discretion equals legality. The FDA can and does act against CBD companies — 53 enforcement actions in Policy Canary's database confirm this.
• Do not make health claims based on preliminary research. The FTC requires human clinical trials for disease claims about CBD. Preclinical studies and customer testimonials do not meet this standard.