Frederick A. Stearns is a partner in the law firm of Keller and Heckman LLP in Washington, D.C. For more than 30 years, he has worked on a wide range of regulatory issues facing manufacturers of dietary supplements, foods, cosmetics, prescription and over-the-counter drugs, and medical devices. This work includes assessing FDA regulatory requirements, evaluating product labeling and promotional claims, and responding to FDA enforcement actions. In addition, Stearns has worked with numerous companies to conduct FDA due diligence reviews, both for internal control purposes and as part of product line or corporate acquisitions. 

Area Code 420 (AC 420): What is your experience working with cannabis and CBD clients?

Stearns: Many of my clients are in the food and dietary supplement industries, either selling finished products or providing ingredients/components to finished product manufacturers. There has been tremendous consumer interest in cannabis-derived ingredients for several years now, and companies have naturally sought to meet that demand.

The 2018 Farm Bill offered great promise for opening up the hemp market and making cannabis-derived ingredients more readily available (subject to the law’s provisions). I have worked with companies to understand the Food and Drug Administration’s (FDA) regulatory requirements and how they would apply to cannabis-derived ingredients for use in multiple product categories. This has been a very interesting area in which to work since it has been new territory to explore, presenting unique regulatory challenges for companies (and their lawyers) to address.

AC 420: How do you stay up-to-date on the constant changes in cannabis law and regulations?

Stearns: I follow a lot of different sources of information about the food and dietary supplements industries (e.g., multiple online industry newsletters, legal trade press, and popular press, and other media). For several years, I have been a member of the Food and Drug Law Institute’s (FDLI) Cannabis Task Force. This group meets regularly to evaluate new developments in the cannabis space and offer programs on topics that would be of interest to the industry. Overall, keeping up with developments means paying attention to what’s happening in a wide range of areas.

AC 420: In your opinion, what is the outlook for the cannabis industry?

Stearns: There are obviously different segments to the cannabis industry and each has its own challenges. The recreational/adult use market is driven by state initiatives and is perhaps the most vulnerable since marijuana is still a Schedule I controlled substance.  

The medical marijuana industry enjoys more widespread support and is less likely to be disrupted, given the recognition that medical marijuana can legitimately help a subset of chronic disease sufferers. The recent Executive Order to reschedule marijuana from Schedule I to Schedule III should lend support to the future use of cannabis and selected components for therapeutic purposes.

The cannabis-derived ingredients industry faces the challenge of having to satisfy existing FDA requirements for ingredients to be used in foods or dietary supplements. CBD is probably the best-known of these components, although it has certain obstacles associated with it. Other cannabinoids may have some promise in foods and dietary supplements, with a comparatively easier regulatory path. It all depends on the particular ingredient(s) of interest.

AC 420: Do you know if any cannabis companies are making money?

Stearns: As with any industry, some participants are doing better than others. I am not directly involved on the financial side, but the sheer number of parties involved, particularly in states with legalized recreational use frameworks, suggests that there is money to be had. Location, marketing, and product offerings certainly affect how brisk business may be.

AC 420: Will hemp be illegal by the end of 2026?

Stearns: For those who may not know, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (signed Nov. 12, 2025) significantly narrowed the federal definition of hemp by: 1) limiting it to a total THC concentration of not more than 0.3% on a dry weight basis (rather than just focusing on delta-9 THC); 2) effectively prohibiting synthetic production; and 3) limiting the total THC content to not more than 0.4 milligrams per container. These changes go into effect on Nov. 12, 2026, unless modified before then.

It seems to me that this delay was intended to provide some additional time for, but to also instill some urgency in, relevant stakeholders to work with Congress to develop a more acceptable regulatory framework. There will certainly be challenges in developing new provisions, especially in a midterm election year, but a wide range of parties have a vested financial interest in developing something better than what the appropriations bill currently provides.

The 2018 Farm Bill certainly resulted in some unintended consequences that needed to be addressed, but this legislation appears to have swung too far in the other direction. The optimist in me believes that there will be a deal.      

AC 420: CBD legal status is complex and evolving. Where does it stand today?

Stearns: FDA’s position on CBD has been clear for many years: it does not qualify as a dietary ingredient for use in dietary supplements, and it does not have an appropriate regulatory status for use in food. In mid-2019, FDA indicated that it would consider initiating a rulemaking process that would allow CBD to be used in these types of products. However, the agency also identified several safety-related issues that it felt would need to be addressed to allow this use.

Ultimately, in January 2023, FDA concluded that it would not be able to pursue this rulemaking and that Congress would need to develop a statutory framework to govern CBD (and possibly other cannabis-derived ingredients). Since then, many bills have been introduced in Congress to tackle one or more of the issues presented by CBD, although none have been enacted.

In the meantime, numerous states have adopted their own programs allowing the use of CBD as an ingredient in dietary supplements and/or conventional foods, although the permitted levels, labeling requirements, and other provisions vary considerably. As a result, marketing CBD-containing products requires tailoring them to the particular state(s) in which they will be sold.

AC 420: Do you still find companies making unproven claims for cannabis and CBD?

Stearns: Few things in the marketing area surprise me at this point in my career. As long as there is market demand, there will be companies looking to meet that demand and differentiate themselves from other products. Claims help sell goods, and many consumers want to believe that there is something they can do on their own to manage/better their health.

Unfortunately, unscrupulous companies will take advantage of that interest and make unfounded claims that appeal to consumers’ emotions. This is certainly not new and certainly not limited to the cannabis/CBD space. Although regulatory agencies, both FDA and state, provide some oversight, they can’t review and take action against all violators.