FDA CBD and Hemp Regulation: Federal Oversight, Legal Framework & Policy

Executive Summary

The Food and Drug Administration faces mounting pressure to establish a comprehensive regulatory framework for cannabidiol (CBD) and hemp-derived products, nearly eight years after the 2018 Farm Bill legalized hemp cultivation nationwide. Despite hemp's federal legal status under the Agricultural Improvement Act of 2018, the FDA has maintained that CBD cannot be lawfully marketed in food or dietary supplements without agency approval—a position that has created a multi-billion dollar regulatory gray zone. Industry stakeholders, consumer advocates, and members of Congress have urged the agency to issue clear guidelines, while the FDA has repeatedly cited safety concerns and data gaps. As of July 2026, the agency has yet to finalize a pathway for CBD products, leaving manufacturers, retailers, and consumers navigating uncertain legal terrain. The regulatory vacuum has spawned a largely unregulated market estimated at over $8 billion annually, with products ranging from tinctures and gummies to beverages and cosmetics flooding retail shelves without standardized testing, labeling, or safety oversight. The stakes extend beyond commerce. Millions of Americans use CBD products for conditions including anxiety, chronic pain, and sleep disorders, often without physician guidance or reliable information about dosing, purity, or potential drug interactions. The FDA's inaction has drawn criticism from public health experts who warn of contamination risks, mislabeling, and the proliferation of products containing undisclosed levels of delta-9-tetrahydrocannabinol (THC). Meanwhile, hemp farmers and processors face banking restrictions, interstate commerce barriers, and the constant threat of enforcement action. The debate over CBD regulation intersects with broader questions about cannabis policy reform, state-federal conflicts, and the agency's capacity to oversee rapidly evolving product categories.

Why This Matters

FDA regulation of CBD and hemp affects farmers in all 50 states, a consumer market exceeding 60 million Americans, and a supply chain employing over 100,000 workers. The regulatory uncertainty touches multiple stakeholder groups with billions of dollars at stake. Hemp farmers cultivated approximately 54,000 acres in 2025, down from a peak of 146,000 acres in 2019, according to U.S. Department of Agriculture data. The acreage decline reflects market instability driven by regulatory ambiguity and oversupply. Processors and manufacturers have invested hundreds of millions in extraction facilities, formulation labs, and distribution networks without clear rules governing their products' legal status. Consumers represent the largest affected group. A 2025 survey by the Brightfield Group found that 22% of U.S. adults reported using CBD products in the past year, primarily for anxiety relief, pain management, and sleep improvement. Most users purchase products without consulting healthcare providers, relying instead on retailer recommendations and online reviews. The absence of FDA oversight means no standardized dosing guidelines, no mandatory adverse event reporting, and no systematic monitoring of product quality. Public health implications extend beyond individual consumers. Pediatricians have reported increasing use of CBD products in children, including infants, without clinical evidence supporting safety or efficacy in pediatric populations. The American Academy of Pediatrics has called for FDA regulation to prevent marketing to minors and establish age restrictions. Veterinarians face similar challenges as pet owners administer CBD products to animals based on anecdotal claims rather than veterinary guidance. The economic impact reaches state governments that have established hemp programs under the 2018 Farm Bill framework. States including Kentucky, Colorado, Oregon, and North Carolina have built regulatory infrastructure, licensing systems, and testing requirements for hemp cultivation. Federal regulatory clarity would enable these states to align their programs with national standards and facilitate interstate commerce currently hampered by conflicting state rules. Financial institutions remain hesitant to provide banking services to CBD businesses due to federal regulatory uncertainty, forcing many operators to conduct cash-only transactions. This creates security risks, tax compliance challenges, and barriers to business growth. The FDA's regulatory decisions will determine whether CBD businesses can access conventional banking, payment processing, and capital markets.

Background and History

The modern CBD regulatory debate began with the Agricultural Improvement Act of 2018, but its roots extend back decades through evolving interpretations of the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act.

Pre-2018: Hemp Prohibition and Early CBD Emergence

Under the Controlled Substances Act of 1970, codified at 21 U.S.C. § 812, Congress classified marijuana as a Schedule I controlled substance. The statutory definition of marijuana included all parts of the Cannabis sativa plant, making no distinction between psychoactive and non-psychoactive varieties. This classification effectively prohibited hemp cultivation in the United States for nearly five decades, despite hemp's historical use for fiber, seed, and oil production. The 2014 Farm Bill created the first modern exception through Section 7606, which authorized state departments of agriculture and higher education institutions to establish pilot programs for hemp research. The provision defined hemp as Cannabis sativa containing no more than 0.3% delta-9-THC on a dry weight basis. Between 2014 and 2018, 41 states established pilot programs that enabled limited hemp cultivation for research purposes, though the legal status of hemp-derived products remained ambiguous. During this period, CBD products began appearing in retail stores, gas stations, and online marketplaces. Manufacturers extracted CBD from hemp grown under pilot programs or imported hemp from Europe and Asia. The Drug Enforcement Administration maintained that CBD remained a Schedule I controlled substance regardless of its source, while some companies argued that hemp-derived CBD fell outside the Controlled Substances Act's marijuana definition.

The 2018 Farm Bill: Legalization and Regulatory Gaps

President Donald Trump signed the Agricultural Improvement Act of 2018 into law on December 20, 2018. Section 10113 removed hemp from the Controlled Substances Act's definition of marijuana, establishing hemp as an agricultural commodity. The law defined hemp as Cannabis sativa and derivatives containing no more than 0.3% delta-9-THC on a dry weight basis. The legislation explicitly preserved FDA authority over hemp-derived products. Section 10114 stated that nothing in the law would affect the FDA's authority under the Federal Food, Drug, and Cosmetic Act or Section 351 of the Public Health Service Act. This provision proved critical to subsequent regulatory debates. Within weeks of the Farm Bill's enactment, the FDA issued a statement on January 11, 2019, clarifying its position. Then-Commissioner Scott Gottlieb said the agency could not conclude that CBD was generally recognized as safe (GRAS) for use in food or dietary supplements. The FDA noted that it had approved Epidiolex, a CBD-based drug for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, in June 2018. Under the Federal Food, Drug, and Cosmetic Act's drug exclusion rule in 21 U.S.C. § 331(ll), the agency maintained that CBD could not be added to food or marketed as a dietary supplement because substantial clinical investigations had been made public before the substance was marketed for those uses.

2019-2021: Enforcement Discretion and Congressional Pressure

Throughout 2019 and 2020, the FDA sent warning letters to CBD companies making therapeutic claims but generally exercised enforcement discretion regarding CBD products marketed without disease claims. The agency sent 22 warning letters in 2019 and 20 in 2020 to companies claiming their CBD products could treat cancer, Alzheimer's disease, opioid addiction, and other serious conditions. The FDA held a public hearing on May 31, 2019, receiving testimony from industry representatives, consumer advocates, medical professionals, and state regulators. Participants urged the agency to establish a regulatory pathway while raising concerns about product safety, quality control, and marketing practices. In November 2019, the FDA released a consumer update warning about CBD's potential risks, including liver injury, interactions with other drugs, drowsiness, and effects on male reproductive systems based on animal studies. The agency stated it was working to answer questions about CBD's safety but provided no timeline for regulatory action. Congressional frustration grew as the CBD market expanded without federal oversight. In April 2019, Senate Majority Leader Mitch McConnell and Representative James Comer sent a letter to FDA Commissioner Gottlieb requesting a meeting to discuss CBD regulation. In May 2021, Representatives Chellie Pingree, Collin Peterson, and Thomas Massie introduced the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act, which would have directed the FDA to issue regulations within one year. The bill did not advance.

2022-2024: Regulatory Stalemate and State Action

In January 2023, the FDA released a statement acknowledging it lacked sufficient data to establish a risk-based regulatory framework for CBD products. The agency outlined several safety concerns, including potential liver damage at high doses, drug interactions with medications metabolized by cytochrome P450 enzymes, and unknown effects of long-term use. The FDA called for additional research but offered no concrete regulatory proposals. Frustrated by federal inaction, several states established their own CBD regulations. California enacted Assembly Bill 45 in October 2023, creating a regulatory framework for hemp-derived CBD in food and beverages, with requirements for testing, labeling, and serving size limits of 25 milligrams per serving. Colorado, Oregon, and Vermont implemented similar state-level frameworks between 2023 and 2024. The patchwork of state regulations created interstate commerce challenges. Products legal in California could not be shipped to states without CBD food frameworks. Manufacturers faced conflicting testing requirements, labeling standards, and THC thresholds across different jurisdictions.

2025-2026: Renewed Calls for Federal Action

In March 2025, the Government Accountability Office released a report examining FDA oversight of CBD products. The GAO found that the FDA had tested 300 CBD products between 2018 and 2024, with 45% containing THC levels exceeding legal limits and 30% containing CBD concentrations significantly different from label claims. The report recommended that the FDA develop a comprehensive regulatory strategy with defined timelines. In September 2025, a coalition of hemp industry groups, including the U.S. Hemp Roundtable and the Hemp Industries Association, petitioned the FDA to establish a regulatory pathway for CBD in dietary supplements. The petition proposed a framework including maximum daily serving sizes, good manufacturing practice requirements, and adverse event reporting. As of July 2026, the FDA has not responded substantively to the petition or issued proposed regulations. The regulatory vacuum persists as the CBD market continues expanding, with new product categories including CBD-infused beverages, baked goods, and cosmetics entering the marketplace without federal oversight.

Key Players

Food and Drug Administration

The FDA holds primary regulatory authority over CBD and hemp-derived products under the Federal Food, Drug, and Cosmetic Act. The agency's Center for Food Safety and Applied Nutrition oversees food and dietary supplement applications, while the Center for Drug Evaluation and Research regulates pharmaceutical products. FDA Commissioner Robert Califf has stated the agency needs additional resources and statutory authority to effectively regulate CBD products. The FDA's position remains that CBD cannot be lawfully marketed in food or dietary supplements without agency approval, though enforcement has focused primarily on therapeutic claims rather than the mere presence of CBD.

U.S. Department of Agriculture

The USDA oversees hemp cultivation through the U.S. Domestic Hemp Production Program established under the 2018 Farm Bill. The department published final regulations in January 2021 establishing requirements for state and tribal hemp programs, including testing protocols, disposal procedures for non-compliant plants, and licensing standards. The USDA does not regulate hemp-derived products after harvest, creating a jurisdictional handoff to the FDA that has contributed to regulatory gaps.

Drug Enforcement Administration

Following the 2018 Farm Bill, the DEA removed hemp and hemp-derived products from Schedule I of the Controlled Substances Act, provided they contain no more than 0.3% delta-9-THC. The agency published an interim final rule in August 2020 establishing that synthetically derived tetrahydrocannabinols remain Schedule I controlled substances. The DEA's interpretation of "synthetically derived" has created uncertainty regarding delta-8-THC and other hemp-derived cannabinoids produced through chemical conversion processes.

U.S. Hemp Roundtable

This industry coalition represents hemp farmers, processors, manufacturers, and retailers advocating for federal regulatory clarity. The organization has lobbied Congress for legislation directing the FDA to establish a CBD regulatory pathway and has submitted formal comments to the agency outlining proposed frameworks. The Roundtable estimates its members represent over 70% of the U.S. hemp industry by revenue.

Consumer Healthcare Products Association

The CHPA represents manufacturers of over-the-counter medicines and dietary supplements. The organization has urged the FDA to establish clear regulations for CBD in dietary supplements, proposing a framework similar to the agency's oversight of other botanical ingredients. CHPA members have largely avoided entering the CBD market pending regulatory clarity, citing concerns about enforcement risk and liability.

American Herbal Products Association

The AHPA has developed voluntary guidelines for the hemp and CBD industry, including testing standards, labeling recommendations, and good manufacturing practices. The organization has advocated for FDA regulation while working to promote industry self-regulation in the absence of federal oversight. AHPA published a guidance document in 2024 recommending maximum daily CBD serving sizes of 50 milligrams for adults.

National Association of State Departments of Agriculture

NASDA represents state agriculture agencies that oversee hemp cultivation programs. The organization has called for federal regulatory clarity to enable interstate commerce and reduce compliance burdens on farmers and processors operating across multiple state jurisdictions. State agriculture officials have expressed frustration that their regulatory efforts cannot address post-harvest product issues under FDA jurisdiction.

Vicente Sederberg LLP and Cannabis Law Firms

Specialized law firms including Vicente Sederberg, Hoban Law Group, and Harris Bricken have represented CBD and hemp businesses navigating regulatory uncertainty. These firms have provided guidance on compliance strategies, submitted comments to federal agencies, and advocated for regulatory reform. Legal experts from these firms frequently testify before Congress and participate in FDA stakeholder meetings, offering industry perspectives on proposed regulatory frameworks.

Legal and Regulatory Framework

The regulatory status of CBD and hemp products involves the intersection of agricultural law, controlled substances law, food and drug law, and state-federal jurisdictional questions. The Agricultural Improvement Act of 2018, Public Law 115-334, established the foundational legal framework. Section 10113 amended the Controlled Substances Act to exclude hemp from the definition of marijuana, defining hemp as Cannabis sativa containing no more than 0.3% delta-9-THC on a dry weight basis. This threshold derives from a 1976 taxonomic study by Canadian researcher Ernest Small, who proposed the 0.3% distinction as an arbitrary dividing line between fiber and drug varieties of cannabis. The Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 301 et seq., provides the FDA's authority to regulate CBD products. Section 321(ff) defines dietary supplements as products intended to supplement the diet containing vitamins, minerals, herbs, or other botanicals. However, Section 331(ll), added by the Food and Drug Administration Modernization Act of 1997, prohibits marketing a substance as a dietary supplement if it is an active ingredient in an approved drug and substantial clinical investigations have been made public before the substance was marketed as a supplement or food. The FDA approved Epidiolex (cannabidiol oral solution) on June 25, 2018, for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years and older. The approval was based on clinical trials involving over 500 patients. Because these clinical investigations were made public before CBD was widely marketed in food or dietary supplements, the FDA maintains that the drug exclusion rule prohibits CBD in those product categories. Industry advocates have challenged this interpretation, arguing that CBD was marketed in food and dietary supplements before Epidiolex's clinical investigations became public. The FDA has not formally adjudicated this question through rulemaking or enforcement actions that would create binding precedent. The Public Health Service Act, 42 U.S.C. § 262, provides additional FDA authority over biological products. While not directly applicable to most CBD products, this statute reinforces the agency's broad jurisdiction over substances intended to affect the structure or function of the body. State laws create additional regulatory layers. As of July 2026, 15 states have enacted specific regulations for CBD in food products, establishing testing requirements, THC limits, serving size restrictions, and labeling standards. These state frameworks vary significantly. California limits CBD servings to 25 milligrams per serving in food and beverages. Colorado requires third-party testing for potency, pesticides, heavy metals, and microbial contaminants. Vermont prohibits CBD in alcoholic beverages but permits it in other food categories. The Tenth Amendment's reservation of powers to states creates federalism questions when state CBD regulations conflict with federal law. States cannot authorize conduct that violates federal law, but they can establish additional requirements for products that are federally legal. The FDA has not preempted state CBD regulations, creating a dual regulatory system where products must comply with both state and federal requirements. Interstate commerce issues arise from the Commerce Clause, Article I, Section 8 of the U.S. Constitution. Products legal under one state's CBD framework may not be shipped to states without such frameworks, as the FDA's position that CBD is not lawfully marketed in food applies nationwide. This creates market fragmentation and compliance challenges for businesses operating across state lines.

State-by-State Breakdown

California

California enacted Assembly Bill 45 in October 2023, establishing the first comprehensive state regulatory framework for hemp-derived CBD in food and beverages. The law authorizes CBD in food products at concentrations not exceeding 25 milligrams per serving, with a maximum of 75 milligrams per package for multi-serving products. Manufacturers must comply with good manufacturing practices and third-party testing requirements. The California Department of Public Health oversees implementation, with regulations taking effect in January 2024. As of July 2026, over 1,200 CBD food products have been registered under the California framework.

Colorado

Colorado's hemp regulations, established under House Bill 19-1090, require all hemp-derived CBD products to undergo testing by state-licensed laboratories for potency, pesticides, heavy metals, and microbial contaminants. The state permits CBD in food products with no specific serving size limits but requires accurate labeling of CBD content. Colorado's Marijuana Enforcement Division oversees hemp product compliance. The state has issued over 800 hemp processor licenses as of mid-2026, making it one of the largest hemp product manufacturing centers in the United States.

Oregon

Oregon established CBD food regulations in 2021 through Senate Bill 1561, which directed the Oregon Health Authority to develop rules for hemp-derived CBD in food. The state permits CBD in food products at concentrations up to 50 milligrams per serving for adults. Products intended for consumption by individuals under 21 are prohibited from containing CBD. Oregon requires batch testing and certificate of analysis documentation for all CBD products sold in the state.

Vermont

Vermont's hemp regulations, implemented by the Agency of Agriculture, Food and Markets, permit CBD in food products excluding alcoholic beverages. The state requires testing for cannabinoid potency and contaminants, with results available to consumers through QR codes on product labels. Vermont limits CBD servings to 30 milligrams for food products and prohibits marketing CBD products to minors.

New York

New York initially prohibited CBD in food products following the 2018 Farm Bill, with the New York City Department of Health ordering restaurants and retailers to remove CBD-infused food items in 2019. The state reversed this position in 2022 with regulations permitting CBD in food at concentrations up to 25 milligrams per serving. New York requires manufacturers to register with the Department of Agriculture and Markets and comply with testing and labeling standards. As of July 2026, the state has registered over 600 CBD food manufacturers.

Texas

Texas established hemp regulations under House Bill 1325 in 2019, permitting hemp cultivation and processing. However, the Texas Department of State Health Services has not authorized CBD in food products, maintaining that such products violate state food safety laws pending FDA approval. This creates a situation where hemp-derived CBD can be legally produced in Texas but cannot be added to food products sold in the state. CBD topical products and tinctures remain available in Texas retail stores.

Florida

Florida permits hemp-derived CBD products under Chapter 581 of the Florida Statutes, which established a hemp program following the 2018 Farm Bill. The state does not specifically authorize CBD in food but has not prohibited such products. The Florida Department of Agriculture and Consumer Services oversees hemp cultivation and processing, with over 400 active hemp cultivation licenses as of 2026. Enforcement of CBD food products has been minimal, creating a de facto permissive environment.

Kentucky

Kentucky, a leading hemp producer with deep historical ties to hemp cultivation, established comprehensive hemp regulations under Kentucky Revised Statutes Chapter 260. The state permits hemp-derived CBD in food products and has developed testing standards through the Kentucky Department of Agriculture. Kentucky has positioned itself as a hemp research center, with the University of Kentucky conducting extensive studies on hemp cultivation, processing, and product development.

North Carolina

North Carolina's hemp program, established under the North Carolina Industrial Hemp Commission, permits CBD in food products sold within the state. Manufacturers must register with the commission and comply with testing requirements for potency and contaminants. North Carolina has emerged as a significant hemp producer, with over 1,500 licensed hemp farms as of 2026, primarily in the eastern and piedmont regions.

Ohio

Ohio established hemp regulations in 2019 but has not specifically authorized CBD in food products. The Ohio Department of Agriculture oversees hemp cultivation, while the Ohio Board of Pharmacy has asserted jurisdiction over CBD products, creating regulatory uncertainty. Legislation introduced in 2025 to clarify CBD food product status has not advanced through the state legislature.

Market and Business Implications

The CBD market has grown to an estimated $8.3 billion in annual sales as of 2026 despite regulatory uncertainty, with projections reaching $15 billion by 2028 if federal regulations provide market clarity. The absence of FDA regulations has created both opportunities and risks for businesses across the hemp supply chain. Manufacturers have entered the market with minimal barriers to entry, leading to intense competition and price compression. Wholesale CBD isolate prices declined from approximately $5,000 per kilogram in 2019 to under $500 per kilogram in 2025, according to Hemp Benchmarks data. This price collapse has forced many hemp farmers and extractors out of business while enabling consumer product companies to source CBD at commodity prices. Multi-state operators in the regulated cannabis industry have largely avoided the hemp-derived CBD market due to regulatory uncertainty and brand risk. Companies including Curaleaf, Trulieve, and Green Thumb Industries have focused on state-licensed cannabis markets rather than federally legal hemp products. This has left the CBD market dominated by smaller companies, startups, and established supplement manufacturers willing to operate in regulatory gray zones. Capital markets have treated CBD businesses cautiously. Traditional venture capital investment in CBD companies peaked at approximately $700 million in 2019 and declined to under $200 million in 2025 as regulatory uncertainty persisted. Public markets have shown limited appetite for CBD-focused companies, with several high-profile SPAC mergers failing to close due to diligence concerns about regulatory risk. Banking access remains constrained despite hemp's federal legal status. Many financial institutions apply enhanced due diligence to CBD businesses, requiring extensive documentation of supply chain compliance, testing protocols, and legal opinions. Some banks refuse to provide services to CBD companies entirely, citing reputational risk and regulatory uncertainty. This has forced many CBD businesses to operate with limited banking access, creating cash management challenges and restricting growth. Payment processing presents similar obstacles. Major credit card networks including Visa and Mastercard have issued guidance restricting CBD transactions, leading many processors to decline CBD merchant accounts. This has driven CBD businesses to alternative payment processors charging higher fees and imposing transaction limits. The regulatory vacuum has enabled product innovation without safety guardrails. Companies have introduced CBD-infused beverages, baked goods, candies, cosmetics, and pet products without FDA review. Some products have entered the market with questionable formulations, including CBD combined with other botanicals, synthetic cannabinoids, or pharmaceutical ingredients. The lack of mandatory adverse event reporting means safety signals may go undetected. Retail distribution has expanded across multiple channels. CBD products are available in natural food stores, vitamin shops, pharmacies, gas stations, and online marketplaces. Major retailers including CVS, Walgreens, and Kroger have introduced CBD topical products but have generally avoided ingestible CBD products pending regulatory clarity. This retail caution reflects concerns about liability exposure and potential FDA enforcement. Insurance markets have responded to CBD regulatory uncertainty with restrictive policies. Product liability insurance for CBD manufacturers often includes high premiums, significant deductibles, and exclusions for certain claims. Some insurers have exited the CBD market entirely, forcing businesses to operate with limited coverage or seek specialty insurers. The tax treatment of CBD businesses creates additional financial burdens. While hemp-derived CBD businesses are not subject to Internal Revenue Code Section 280E, which prohibits deductions for businesses trafficking in Schedule I or II controlled substances, they face other tax challenges. State sales tax treatment of CBD products varies, with some states taxing CBD as a supplement, others as food, and some applying special excise taxes. International trade in CBD products remains limited by regulatory divergence across jurisdictions. The European Union permits CBD in food products subject to novel food regulations, but approval processes have been slow. Canada regulates CBD as a cannabis product requiring licensing under the Cannabis Act. Most Asian markets prohibit CBD entirely. This global regulatory patchwork limits export opportunities for U.S. CBD manufacturers.

What Experts Say

Legal scholars, public health researchers, and industry analysts have proposed various regulatory frameworks ranging from dietary supplement pathways to food additive petitions to new statutory authority for CBD as a distinct product category. Robert Mikos, a law professor at Vanderbilt University specializing in federalism and drug policy, has argued that the FDA's drug exclusion interpretation is overly restrictive. According to Mikos, the agency could exercise enforcement discretion to permit CBD in dietary supplements while maintaining oversight through good manufacturing practice requirements and adverse event monitoring. He has noted that the FDA has previously exercised such discretion for other substances with both pharmaceutical and supplement applications. Marielle Weintraub, president of the American Herbal Products Association, has advocated for a regulatory framework modeled on the FDA's oversight of other botanical dietary ingredients. In public comments submitted to the FDA, Weintraub proposed establishing monograph standards for CBD including identity specifications, purity requirements, and maximum daily serving sizes. The AHPA framework would permit CBD in dietary supplements at doses up to 50 milligrams per day for adults based on safety data from clinical trials. Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California San Diego, has emphasized the need for additional safety research before widespread CBD marketing. According to Grant, existing clinical data from Epidiolex trials provide limited information about long-term safety, effects in healthy populations, and interactions with common medications. He has recommended that the FDA require post-market surveillance and adverse event reporting as conditions of any regulatory pathway. Shawn Hauser, a partner at Vicente Sederberg LLP specializing in hemp and cannabis law, has argued that the FDA lacks statutory authority to effectively regulate the CBD market without congressional action. According to Hauser, the agency's resource constraints and existing regulatory frameworks are ill-suited to the unique characteristics of hemp-derived products. She has advocated for legislation creating a new regulatory category for hemp-derived cannabinoids with tailored safety standards, testing requirements, and enforcement mechanisms. The National Organization for the Reform of Marijuana Laws has taken the position that CBD regulation should be minimal given the substance's safety profile and the absence of significant adverse events despite widespread use. NORML has argued that the FDA should focus enforcement on false therapeutic claims and contaminated products rather than restricting access to CBD in food and supplements. The American Academy of Pediatrics has called for strict regulation of CBD products to prevent pediatric exposure. In a 2024 policy statement, the AAP recommended prohibiting CBD in products appealing to children, establishing age restrictions for CBD purchases, and requiring child-resistant packaging. The organization cited case reports of accidental pediatric ingestions and the lack of safety data in children as justification for precautionary regulation. Dr. Yasmin Hurd, director of the Addiction Institute at Mount Sinai, has conducted research on CBD's potential therapeutic applications for substance use disorders. According to Hurd, CBD shows promise for reducing drug cravings and anxiety in individuals with opioid use disorder, but she has cautioned that consumer CBD products are not standardized or validated for therapeutic use. She has recommended that the FDA establish quality standards to ensure product consistency while supporting continued research on CBD's medical applications. The Consumer Healthcare Products Association has proposed a tiered regulatory approach based on CBD concentration and intended use. According to CHPA recommendations, low-dose CBD products under 25 milligrams per serving could be regulated as conventional foods, while higher-dose products would require dietary supplement new dietary ingredient notifications. The organization has argued this approach would balance consumer access with appropriate safety oversight.

What's Next

The FDA faces multiple decision points in the coming months, including responses to pending petitions, potential proposed rulemaking, and congressional pressure for action before the end of 2026. The hemp industry coalition's September 2025 petition requesting a dietary supplement pathway for CBD requires an FDA response. Under the Administrative Procedure Act, agencies must respond to formal petitions within a reasonable timeframe, though no specific deadline applies. Industry observers expect the FDA to issue a response by the end of 2026, either granting the petition and initiating rulemaking, denying it with explanation, or requesting additional information. Congressional action remains possible through several legislative vehicles. The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act, reintroduced in March 2026, would direct the FDA to issue regulations within 12 months of enactment. The bill has bipartisan support with 47 House cosponsors as of July 2026 but has not received a committee hearing. Advocates are working to attach CBD regulatory language to must-pass legislation including the Farm Bill reauthorization expected in 2027. The Government Accountability Office's March 2025 report recommended that the FDA develop a comprehensive regulatory strategy with defined timelines. The agency's response to GAO recommendations will provide insight into its regulatory intentions. Federal agencies typically respond to GAO recommendations within 180 days, suggesting an FDA response by September 2025, though no public response has been issued as of July 2026. State regulatory activity will likely continue expanding in the absence of federal action. Legislation pending in Illinois, Michigan, and Washington would establish state-level CBD food frameworks similar to California's model. These state regulations will create additional pressure on the FDA to establish national standards that preempt the patchwork of state requirements. Enforcement actions may provide regulatory signals. The FDA has generally exercised enforcement discretion regarding CBD products that do not make disease claims, but the agency could shift to more aggressive enforcement to pressure Congress or industry toward regulatory solutions. Conversely, continued enforcement restraint would signal the agency's acceptance of the status quo pending legislative action. Industry consolidation appears likely as regulatory uncertainty persists. Smaller CBD companies lacking resources to navigate complex compliance requirements may exit the market or be acquired by larger supplement manufacturers. This consolidation could reduce product diversity but improve overall quality as established companies with regulatory expertise enter the market. Research developments will influence regulatory debates. The National Institutes of Health has funded multiple studies examining CBD's safety, pharmacokinetics, and therapeutic potential. Results from these studies, expected between 2026 and 2028, will provide additional data to inform FDA decision-making on appropriate regulatory frameworks. International regulatory developments may create pressure for U.S. action. If the European Union completes novel food approvals for CBD and establishes clear regulatory standards, U.S. industry will face competitive disadvantages in global markets. This could motivate domestic companies to intensify lobbying for federal regulations enabling international trade. The 2028 presidential election and potential administration changes could affect regulatory priorities. A new FDA commissioner appointed in 2029 might bring different perspectives on CBD regulation, either accelerating action or deprioritizing the issue in favor of other public health concerns.

Further Reading

• Agricultural Improvement Act of 2018, Public Law 115-334 (full text at https://www.congress.gov/bill/115th-congress/house-bill/2)
• FDA Statement on Cannabidiol, January 11, 2019 (https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-signing-agriculture-improvement-act-and-agencys-regulation)
• U.S. Government Accountability Office, "CBD Products: FDA Should Develop a Comprehensive Regulatory Strategy," GAO-25-106536, March 2025
• Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (https://www.govinfo.gov/content/pkg/USCODE-2021-title21/html/USCODE-2021-title21-chap9.htm)
• Controlled Substances Act, 21 U.S.C. § 812 (https://www.govinfo.gov/content/pkg/USCODE-2021-title21/html/USCODE-2021-title21-chap13-subchapI-partB-sec812.htm)
• USDA U.S. Domestic Hemp Production Program regulations, 7 CFR Part 990 (https://www.federalregister.gov/documents/2021/01/19/2021-00967/establishment-of-a-domestic-hemp-production-program)
• California Assembly Bill 45, Hemp and Hemp Products (https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202320240AB45