Because of the federal government’s lack of oversight on cannabis, states have had to design their own laws to gain some control of the emerging market. The result is a patchwork of state and federal regulations governing hemp beverages that has made getting a product to market compliantly a significant challenge for brands.
How should they label their products? Where do they register them? How much THC can be in a product? Is there a ratio of CBD to THC that needs to be considered? Are certain claims allowed?
To help make sense of it all, we spoke with Rend Al-Mondhiry, Partner and Co-Chair of the Regulatory Practice Group at Amin Wasserman Gurnani LLP. She advises dietary supplement, food, cosmetic, and over-the-counter medicine companies on FDA, FTC, and NAD compliance, and has become a go-to resource for brands trying to navigate not just federal regulation, but the ever-shifting, state-by-state landscape that has defined the hemp market in the absence of clear federal guidance.
The burning question is which federal agency will hold primary oversight.
The leading proposal would move hemp beverages out of the FDA’s framework and place them under the Alcohol and Tobacco Tax and Trade Bureau (TTB), regulating them similarly to alcohol. But that wouldn’t remove the FDA from the picture entirely. TTB and FDA already collaborate on alcohol regulation through a memorandum of understanding, where TTB reviews formulas while FDA retains authority over whether ingredients are appropriate for beverages.
That existing relationship matters here, because under federal law, beverages are classified as food — a fact Al-Mondhiry notes many people overlook. That classification means every ingredient must either be an approved food additive or generally recognized as safe (GRAS). The FDA has stated clearly that it does not consider cannabinoids to be GRAS. Because both CBD and THC have been studied and approved as drugs, existing law prohibits them from being added to foods and beverages altogether. These are the foundational hurdles that any federal regulatory framework for hemp beverages will need to clear. Legislative proposals are in motion to address them, but the details, including how FDA and TTB would divide responsibility, are still being worked out, contingent on what Congress ultimately decides and what feedback the FDA provides along the way.
The Reality of FDA Enforcement
For brands currently selling hemp beverages across multiple states, compliance is a real burden. Al-Mondhiry describes the labeling challenge as demanding: different states have different warning requirements, some mandate the use of a THC symbol, and child-resistant packaging rules vary by product format and state law. “It’s a lot of information that gets put on the label,” she says, noting that brands must examine each state’s requirements individually and apply them to their specific products.
Enforcement exposure, she explains, depends heavily on where and how a product is sold. Direct-to-consumer sales carry lower risk, not because state regulators lack authority, but because pursuing out-of-state actors is resource-intensive. Retail is a different story. States like Florida, West Virginia, Texas, and Arkansas have been active in sending regulators into stores. “The exposure to enforcement is different than when you’re on the retail shelf,” Al-Mondhiry notes.
Once products cross state lines, they fall under FDA jurisdiction, but federal enforcement in the hemp beverage space has been notably limited. The FDA has issued warning letters, though primarily targeting products appealing to children, items that could be mistaken for non-hemp beverages, or brands making disease claims. For Delta-9 THC beverages in particular, the agency has largely held back. Al-Mondhiry attributes this in part to the FDA being a resource-constrained agency that must prioritize. But she cautions against reading that restraint as a green light: “They could shift, and there could be a string of warning letters tomorrow. You just wouldn’t know until they’re issued.”
Know Before You Sell
For brands entering the hemp beverage market, Al-Mondhiry says the most common mistake is not taking the time to understand the state regulatory landscape before selling into it. Even for direct-to-consumer brands, she warns, assuming you’re flying under the radar is a miscalculation. “It’s easy for regulators to figure out who you’re selling your products to,” she says, and that alone can put a brand on their radar.
Part of the problem, she notes, is that some brands delegate compliance to their retail partners without fully grasping the requirements themselves. That can backfire quickly. States vary widely in how they respond to violations. Some issue warnings and work with brands to come into compliance, while others move straight to enforcement. In aggressive states like Florida, that can mean stop-sale orders, administrative fines, product embargoes, and even mandatory destruction of inventory. “There’s lost product at stake,” Al-Mondhiry says, “so it’s just good to go in informed and make a calculated decision.”
That calculation, she adds, might be simpler than brands expect. Compliance in a given state may be more achievable than assumed, or a brand may decide that a state with particularly complex rules isn’t worth the risk if it’s not a lucrative market. The key is knowing before you’re forced to scramble.
Equally important, she emphasizes, is keeping up with changes. State laws can move quickly and quietly, passed during short legislative sessions and followed by regulations adopted with minimal public notice. “It doesn’t get the attention that federal laws get,” she says. That’s precisely why monitoring is central to what her firm provides clients: tracking state developments, watching enforcement trends, and helping brands build contingency plans as the federal picture continues to evolve.
Think Twice Before Adding That Adaptogen
As hemp beverage brands race to differentiate, many are reaching for functional ingredients such as adaptogens, nootropics, melatonin, and caffeine to add perceived wellness value to their formulations. Al-Mondhiry says this trend carries regulatory and safety considerations that brands can’t afford to overlook.
The first step is to check state laws, as some states may already restrict certain functional ingredients. But beyond compliance, she emphasizes that the more pressing issue is safety, specifically whether combining those ingredients with CBD or THC creates synergistic or antagonistic effects that haven’t been fully studied. The FDA has already flagged concerns about adding caffeine to hemp products due to potential interactions with CBD, and melatonin combined with THC has raised similar questions. “At the end of the day, it’s the responsibility of the brand to ensure that all ingredients in beverages or any other hemp product are safe at the levels provided, and that the combination of ingredients is safe,” Al-Mondhiry says.
That’s a higher bar than many brands may realize. Standard toxicology studies can capture a range of physiological effects such as liver function, heart rate, and somnolence, but may not fully address psychological effects or interactions with common medications. Brands should be asking whether their safety testing is robust enough to account for those variables, and whether their labels carry appropriate advisories for consumers who are on SSRIs, sensitive to caffeine, or otherwise at elevated risk. It’s a question that becomes more urgent as hemp beverages reach a broader and older consumer base, a group increasingly likely to be managing chronic conditions or taking prescription medications alongside their wellness choices.
The FDA Guardrails for Edibles
Many hemp beverage brands also include gummies in their product lineup. Al-Mondhiry notes that many current legislative proposals would allow these products to be regulated under the existing dietary supplement framework, with some additional requirements layered on top. Mandatory child-resistant packaging, for instance, is not new territory. “That’s been done for supplements before,” she says, “so you can have additional restrictions and requirements for these other categories.”
The bigger question for edibles like gummies is potency. Al-Mondhiry points to an emerging consensus around creating a lower-potency category within the supplement framework, one that keeps hemp-derived products from directly competing with marijuana products. Nobody is proposing 10-milligram THC gummies on supplement shelves, she says. Instead, the conversation centers on lower thresholds, perhaps 3 to 5 milligrams, enough to support stress relief, sleep, or relaxation without delivering an intoxicating effect. That distinction matters both regulatorily and politically, as it draws a clearer line between the hemp and marijuana markets.
Inhalable products, she notes, are a different story and largely outside this conversation, as they wouldn’t qualify as supplements regardless. But for gummies, tinctures, and topicals, she sees workable paths within frameworks that already exist. The infrastructure for reasonable restrictions is already in place. As she puts it, “it’s been done for foods, non-hemp foods, and non-hemp supplements, so it can be done for hemp supplements as well.”
