- CBD fully legalized in food and supplements;
- Streamlined approval for hemp-derived products;
- CBD legal as a dietary ingredient;
- Expanded consumer safety regulations;
- Intoxicating hemp products under scrutiny.
With a suite of bipartisan bills moving through Congress that could be pillars in a regulatory framework for CBD, what would it look like if they all became law?
First of all, should any or all of the measures pass, the U.S. Food and Drug Administration (FDA) would be required to move swiftly to establish testing, labeling, and manufacturing standards for CBD products – after years of inaction.
The four measures propose specific paths forward for the FDA to approve CBD products while ensuring safety standards in food and dietary supplements. The legislative efforts come amid growing urgency to address legal gray areas that contributed to weak market growth, mainly for over-the-counter CBD oils, and concerns over consumer safety.
Under current regulations, companies cannot legally market CBD products as food or supplements without FDA approval, and the agency has only sanctioned one CBD-based product – Epidiolex, a drug approved back in 2018 to treat certain forms of epilepsy. The lack of regulation has left the over-the-counter CBD gray market in limbo, with businesses and consumers uncertain about what products are compliant with federal law. (It also sparked an illicit, raging gray market in hemp-derived intoxicants, another story entirely).
FDA’s resistance
Despite the federal legalization of hemp under the 2018 U.S. Farm Bill, which removed hemp and its derivatives from the Controlled Substances Act (CSA), the FDA has resisted approving CBD as a food additive or dietary supplement, citing safety concerns. As CBD products continue to proliferate, the FDA has taken a risk-based approach to enforcement, sending warning letters to companies whose products make unsubstantiated health claims or are marketed in ways that could mislead consumers, but doing little else.
The agency has said it is unable to set regulations for CBD because not enough is known about its inclusion in foods or supplements to regulate those products under the FDA’s current structure. The agency’s commissioner, Robert Califf said earlier this year that FDA does not consider hemp-derived CBD safe enough to be sold lawfully as a dietary supplement, and urged Congress to create a new pathway to regulate the substance – which the four bills, or any one of them, would do.
With bipartisan support, H.R. 4849, S. 2451, H.R. 1628, and H.R. 1629 could cut a pathway for the Food and Drug Administration (FDA) to finally create essential legal clarity and set the CBD market free to, hopefully, thrive under federal guidelines.
Vision or fantasy?
All the measures currently floating are being considered as part of the broader discussions surrounding the next U.S. Farm Bill, though not all of them are directly incorporated into the bill text itself. However, all are complementary to the Farm Bill’s ongoing efforts to regulate hemp and CBD. Here’s an envisioned regulatory landscape in which all four bills pass:
CBD fully legalized in food and supplements: H.R. 4849 and S. 2451, collectively known as the “CBD Product Safety and Standardization Act,” would require the FDA to formally legalize CBD as an ingredient in food and dietary supplements. The FDA would establish specific limits on CBD content, ensuring that products do not exceed safe consumption levels. This would allow manufacturers to legally market CBD-infused foods, drinks, and supplements, provided they comply with stringent safety, manufacturing, and labeling requirements. For consumers, this would mean CBD products would have clearer dosage guidelines, verified ingredient lists, and transparency about their contents. Labels would be standardized, listing accurate CBD amounts, potential side effects, and any interactions with medications, much like existing dietary supplements.
Streamlined approval for hemp-derived products: S. 2451 specifically calls for the FDA to expedite the process for evaluating CBD products. This would likely mean a significant reduction in the backlog of approvals and a faster path for new products to reach the market. The FDA would also develop guidelines for manufacturers on how to meet safety standards, reducing ambiguity around what constitutes a compliant CBD product.
CBD legal as a dietary ingredient: Under H.R. 1628 and its companion H.R. 1629, hemp-derived CBD would be formally acknowledged as a lawful dietary ingredient, protected from exclusion based on FDA’s current drug exclusion rule. This would allow manufacturers to use CBD in a wide range of consumer products without fear of regulatory backlash. Hemp-derived CBD would be on par with other dietary supplements, gaining legal protections and a place in the regulated market, ensuring higher product quality and safety standards.
Expanded consumer safety regulations: These bills would impose a clear framework for testing, manufacturing, and labeling CBD products. New regulations would mandate safety testing to ensure that CBD products are free of contaminants and meet potency claims. In practice, this would mean manufacturers would be required to have their products tested by accredited labs, with the results accessible to consumers. The FDA would also likely introduce age restrictions on the purchase of CBD products, in line with its existing guidelines for tobacco and alcohol. Products targeting vulnerable populations – like children, pregnant women, or those on certain medications – would face additional scrutiny or warning labels, addressing FDA concerns about long-term CBD safety.
Intoxicating hemp products under scrutiny: Although the current bills do not directly regulate intoxicating cannabinoids like delta-8 THC, their passage would likely trigger further regulatory action. Given the FDA’s concerns over the safety of these compounds, particularly regarding child safety and accidental ingestion, it’s probable that the agency would develop rules either banning or tightly regulating delta-8 THC, THCA, and similar products. We can only hope.
Bill Summaries
H.R. 4849 – Titled the “CBD Product Safety and Standardization Act,” this bill would require the FDA to set maximum levels for CBD in dietary supplements and food products. Introduced by Rep. Kathleen Rice (D-NY), the bill also mandates that the FDA establish clear labeling requirements to ensure consumers are fully informed about the CBD content in the products they purchase. The bill prioritizes consumer safety, pushing for stricter testing and manufacturing standards for CBD products.
S. 2451 – This companion bill to H.R. 4849, the Hemp Access and Consumer Safety Act, was introduced in the Senate by Sen. Ron Wyden (D-OR). It mirrors the provisions of Rice’s bill but places additional emphasis on expediting the FDA’s regulatory process. The bill requires the agency to act within 180 days of the law’s enactment, forcing a quicker resolution to the longstanding delays in CBD regulation. Like its House counterpart, S. 2451 calls for strict testing standards and consumer protections but with a more pressing timeline for implementation. Importantly, it also seeks to create a regulatory framework for products containing both delta-8 or other synthetic hemp-derived intoxicants, and non-psychoactive natural cannabinoids such as CBD and CBG.
H.R. 1628 – Sponsored by Rep. Morgan Griffith (R-VA), this bill is named the “Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act.” Unlike H.R. 4849, this measure places a broader focus on hemp-derived CBD and its inclusion in dietary supplements specifically. The bill mandates that the FDA recognize hemp-derived CBD as a legal dietary ingredient, which would prevent the agency from arbitrarily rejecting these products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It provides protections for manufacturers by codifying CBD’s legality in supplements, while also prioritizing consumer safety through necessary testing and manufacturing requirements.
H.R. 1629 – A companion to H.R. 1628, this bill, introduced by Rep. Kurt Schrader (D-OR), mirrors the same goals but also aims to streamline the FDA approval process for hemp-derived CBD products. It pushes for a more rapid evaluation of applications, enabling manufacturers to get products on the market more swiftly. H.R. 1629 focuses on consumer protections, similar to the other bills, but emphasizes bolstering the hemp industry’s market potential by reducing regulatory hurdles.