CBD Gummies and Federal Hemp Rules: What FDA and Congress Have Said

CBD Gummies and Federal Hemp Rules: What FDA and Congress Have Said

Federal hemp policy shapes what CBD gummies manufacturers can legally make, sell, and claim — yet the federal regulatory framework for hemp-derived CBD remains incomplete years after the 2018 Farm Bill made hemp federally legal. The FDA has acknowledged CBD's safety profile, issued guidance on what is and isn't permitted, and threatened enforcement action against bad actors, but has not yet established a comprehensive regulatory pathway for CBD in food and dietary supplements. Congress has periodically weighed in but has not passed legislation to fill the gap. This article covers what FDA and Congress have actually said, where the regulatory gaps remain, and what that means for consumers buying CBD gummies today.

The 2018 Farm Bill: What It Did and Didn't Do

The Agriculture Improvement Act of 2018 (commonly called the 2018 Farm Bill) removed hemp — defined as cannabis containing no more than 0.3% delta-9 THC on a dry weight basis — from the Controlled Substances Act's definition of marijuana. This made hemp cultivation, processing, and interstate transport federally legal and created the legal foundation for the commercial CBD market that followed.

Critically, the 2018 Farm Bill did not change FDA's regulatory authority over food, dietary supplements, and drugs. Congress explicitly preserved FDA's jurisdiction under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This created an immediate regulatory tension: hemp was now federally legal, but CBD — the primary active ingredient in most hemp products — had been approved as a drug ingredient (in the epilepsy medication Epidiolex) before it entered the food and supplement market. Under the FD&C Act's "drug exclusion rule," a substance that has been approved as a drug or studied in an IND (Investigational New Drug application) cannot be marketed as a dietary supplement or added to food without specific FDA authorization. CBD fits both criteria, placing CBD gummies in a legal gray area despite hemp's Farm Bill legalization. [PMID 31741371]

What FDA Has Said About CBD in Food and Supplements

FDA has issued multiple statements and guidance documents addressing CBD since the 2018 Farm Bill. The agency's positions can be summarized as follows:

CBD cannot legally be added to food or dietary supplements under current law. FDA has consistently stated this position, citing the drug exclusion rule. The agency's website explicitly states: "It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement." This applies to CBD gummies and other edible hemp products. FDA has acknowledged the tension this creates with the rapidly growing hemp market and has indicated it is exploring regulatory pathways, but the formal legal position has not changed.

FDA has exercised selective enforcement. Despite the formal legal position, FDA has not broadly banned CBD gummies from the market. The agency has issued warning letters to specific companies making egregious health claims (particularly disease treatment claims — "cures cancer," "treats epilepsy") and to manufacturers whose products were significantly mislabeled, but has not conducted mass market enforcement against CBD edibles generally. This selective enforcement approach has allowed the hemp market to grow while FDA works on longer-term regulatory solutions.

FDA has prohibited specific health claims. Regardless of the broader regulatory uncertainty, FDA has been clear that CBD gummy manufacturers cannot make disease treatment claims. Statements like "treats anxiety," "cures insomnia," "prevents inflammation," or any other claim that characterizes the product as treating a disease or medical condition are prohibited for unapproved products. Permissible language stays in the realm of general wellness ("may support sleep," "may help you feel calm") without claiming to treat, cure, or prevent specific conditions. Manufacturers who cross into disease claims receive FDA warning letters and are required to correct their labeling and advertising.

FDA acknowledged CBD's generally favorable safety profile in 2023 guidance. In a January 2023 statement, FDA acknowledged that while it was not approving a regulatory pathway for CBD supplements at that time, it recognized existing data suggesting CBD has a "favorable safety profile" for most users at typical doses. The agency cited concerns about potential risks at high doses and drug interactions — particularly CBD's inhibition of cytochrome P450 liver enzymes — as reasons for continued caution, but did not characterize CBD as presenting a public safety crisis at commercial supplement doses. [PMID 30624194]

What Congress Has Said

Congressional engagement with CBD regulation has been active but has not yet produced comprehensive legislation. Key legislative developments include:

Congressional pressure on FDA to act. Following the 2018 Farm Bill, multiple members of Congress — particularly those representing agricultural states with hemp industries — urged FDA to develop a clear regulatory pathway for CBD supplements. Congress included a directive in the 2018 Farm Bill itself (Section 12619) requiring FDA to consider allowing hemp-derived CBD in dietary supplements. FDA's subsequent inaction drew ongoing criticism from the Senate Agriculture Committee and individual legislators.

Hemp Access and Consumer Safety Act proposals. Multiple bills have been introduced in the House and Senate to explicitly authorize CBD in dietary supplements and food, overriding the drug exclusion rule for hemp-derived CBD. These bills have generally aimed to allow CBD supplement products with labeling requirements, dosage limitations, and mandatory third-party testing. None had been enacted into law as of early 2025. Congressional inaction left the regulatory gap that the 2018 Farm Bill created unresolved.

The 2023 Farm Bill reauthorization process. The 2018 Farm Bill expired in 2023 and required reauthorization. Congressional negotiations included significant debate over hemp provisions, particularly around novel cannabinoids (delta-8, delta-9 hemp gummies, THCA) that had proliferated since 2018. Multiple proposals aimed to tighten the regulatory framework for intoxicating hemp products while establishing clearer pathways for non-intoxicating CBD products. As of early 2025, Farm Bill reauthorization had not been completed, with temporary extensions maintaining the status quo while negotiations continued.

What the Regulatory Gap Means for Consumers

The incomplete federal regulatory framework has practical implications for anyone buying CBD gummies:

No mandatory federal testing requirements. Unlike pharmaceutical drugs (where FDA requires rigorous clinical testing before approval) or conventional food (where FDA oversight of manufacturing and ingredients is extensive), CBD gummies do not face mandatory federal testing, labeling, or quality assurance requirements at the product level. Manufacturers are not required to submit their products for FDA review or to publish third-party test results. This is why independently seeking out batch-specific COAs from accredited labs matters — there is no federal requirement that forces manufacturers to provide this information.

No standardized potency or serving size requirements. Federal law does not establish standard serving sizes, maximum potency limits, or dosing guidelines for CBD gummies. A product can label itself as "25 mg CBD per gummy" without meeting any federal verification standard. This is why label accuracy studies have found significant variation between labeled and actual CBD content across the commercial market.

Health claims remain prohibited regardless of regulatory uncertainty. Whatever the ultimate regulatory outcome, FDA's prohibition on disease treatment claims applies now. A CBD gummy product making specific medical claims on its website or label is operating outside FDA guidelines. Consumer-facing health claims should stop at general wellness language. [PMID 28885619]

State regulation fills some gaps. In the absence of comprehensive federal standards, many states have enacted their own hemp product regulations — testing requirements, labeling mandates, age restrictions, and potency limits. State regulations vary significantly, and some states have established more rigorous consumer protection frameworks than others. A CBD gummy purchased from a state with active hemp product oversight may have more regulatory backing than one purchased from a state with minimal rules or via out-of-state online sale.

The Path Forward

The most likely regulatory trajectories involve either Congress legislating CBD supplement authorization (bypassing FDA's drug exclusion rule) or FDA establishing its own enforcement discretion framework with labeling and testing requirements short of full drug approval. Industry groups have consistently advocated for the former; FDA's January 2023 statement declining to act was widely interpreted as pushing the issue back to Congress.

For consumers, the practical takeaway is that federal regulatory oversight of CBD gummies remains incomplete — meaning the burden of quality verification falls disproportionately on the consumer rather than on a regulatory framework. Batch-specific COAs from accredited labs, manufacturer transparency about sourcing and testing practices, and avoidance of disease-claim marketing remain the primary tools available to consumers navigating this regulatory environment. [PMID 31741371]

Disclaimer: This article is for informational and educational purposes only and does not constitute legal or regulatory advice. Hemp and CBD regulations change frequently at both federal and state levels. Consult a qualified legal professional for guidance specific to your situation.