On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information regarding the safety risks and health benefits associated with cannabis products. More than 110 speakers, including academic researchers, trade associations and cannabis product manufacturers, presented to the FDA panel during the all-day hearing. Below we outline the notable points from the hearing, including statements by FDA officials and interesting speaker comments.
This hearing must be viewed as part of the FDA’s information-gathering process. The agency made no pronouncements regarding its regulatory approach toward cannabis and cannabis-derived compounds. In announcing this hearing in early April, former Commissioner Scott Gottlieb cautioned that the questions surrounding possible legal pathways for cannabidiol (CBD) and other cannabis-derived compounds will take time to resolve fully. Furthermore, the FDA will accept submissions to the public docket associated with the hearing until July 2, 2019. We do not expect FDA to make any pronouncements prior to considering all this information.
A. Opening Remarks by Acting Commissioner Ned Sharpless
1) The FDA’s role in regulating cannabis and cannabis-derived products is not new.
a) Cannabis contains many biological compounds, including tetrahydrocannabinol (THC) and CBD.
b) Adding such compounds to a food product or cosmetic, or marketing these compounds as a drug or dietary supplement, clearly falls under the FDA’s jurisdiction.
2) There have been recent shifts in the laws regarding cannabis.
a) An increasing number of states have legalized cannabis for medical and/or recreational use.
b) The 2018 Farm Bill removed hemp (with less than 0.3% THC) from the Controlled Substance Act’s definition of “marihuana.”
3) The 2018 Farm Bill explicitly preserved the FDA’s regulatory authority, and therefore the normal FDA processes apply, depending on whether a product enters the market as a food, drug or dietary supplement.
a) New drugs with cannabis or cannabis-derived products must get preapproval.
i) For example, the FDA recently approved Epidiolex, a drug containing CBD that treats pediatric epilepsy.
(1) “It is critical that we continue to do what we can to support the science needed to develop new drugs from cannabis.”
b) Food additives must generally be approved or be Generally Recognized as Safe (GRAS).
i) The FDA recently evaluated three GRAS notices for hemp seed ingredients and had no objections. Thus, these ingredients can lawfully be added to food.
c) Because cannabis-derived products such as CBD have been approved as drugs—see, e.g., Epidiolex—the Federal Food Drug and Cosmetic Act (FDCA) provides an additional barrier in adding such products to foods and dietary supplements.
i) The FDA takes the position that the statute’s exception for substances marketed as food and/or dietary supplements before clinical trials began for an approved drug does not apply in this case.
ii) Further, although the FDCA explicitly authorizes the FDA to issue regulations to create exceptions to the above rule, Acting Commissioner Sharpless emphasized that the FDA has never acted under this authority and, thus, such action would be “new terrain.”
4) The FDA knows little about the health risks associated with CBD and other cannabis-derived products.
a) The agency needs to see additional research specifically focusing on CBD.
5) The FDA is aware that many companies currently market cannabis products in violation of federal law.
a) The FDA’s chief concern is that the marketing of such products with unproven, inaccurate and fraudulent health claims places the health and safety of consumers at risk by causing patients to forego effective and necessary medical treatment.
b) Moreover, the FDA does not have a policy of enforcement discretion with respect to any CBD products.
B. Repeat Questions and Concerns Expressed by FDA Staff on Panel
1) Availability of Data
a) FDA panelists routinely asked speakers to submit any data, studies or research to the public record.
2) Possible Dosing Limits
a) FDA panelists routinely asked speakers about how the FDA could theoretically establish dosing limits. Most of the speakers did not have strong answers to these questions, as cannabis and cannabis-derived compounds affect individuals in different ways based on a multitude of factors.
i) The panelists were especially interested in how the effects of these products varies by type of ingestion, such as consuming edibles, vaping, smoking and topical applications.
b) A representative from the American Epilepsy Society expressed concerns over patients using cheaper, “generic” CBD products available on the market as opposed to the more expensive, FDA-approved Epidiolex drug.
i) When a panelist asked how patients handle dosing for these products, the representative replied that “they make it up as they go along.”
3) Preserving Incentives for Drug Research
a) FDA panelists expressed concerns regarding the possibility that allowing the commercial sale of CBD and other products could affect the incentives for research into the use of cannabis in life-saving drugs.
i) This question was posed to two separate speakers discussing research into the use of CBD to treat Alzheimer’s and Parkinson’s.
C. Main Themes
1) Concerns About Fraudulent and Dangerous CBD Products on the Market
a) Many speakers—including many proponents of CBD legalization—spoke about the vast amount of CBD products on the market making false or misleading claims.
i) A researcher from Virginia Commonwealth University gave numerous examples of individuals getting sick from mislabeled CBD products and “synthetic” CBD products.
ii) Speakers presented results from testing select CBD products on the market that revealed many of the top-selling products have vastly different amounts of CBD and THC than what the label stated.
b) Many speakers pushed for greater FDA regulatory leadership to enforce clear labeling rules.
2) Conflicting Ideas on the Extent of Current Data/Research on Safety of CBD
a) Acting FDA Commissioner Sharpless and many of the academic speakers expressed concerns about the lack of research studies on the effects of CBD.
b) At the same time, many proponents argued that there was a significant amount of data showing that CBD is generally safe.
3) Regulating Legal Cannabis Would Be No Different than Regulating Any Other Products
a) Many speakers asserted that the FDA’s regulation of cannabis as a food or dietary supplement would be nothing new for the agency.
i) The FDA can use the New Dietary Ingredients (NDI) notification process.
ii) The FDA can issue regulations ensuring Good Manufacturing Practices (GMPs)
D. Select Examples of Notable Speaker Comments
1) Consumer Health Care Products Association
a) The association announced support for the status quo for CBD when it comes to medicinal uses, but would like to see a path forward for legal use of CBD in dietary supplements, based on the exception for prior use.
b) At the same time, the association urged greater FDA enforcement (i.e., more than warning letters) against companies that market unsafe or mislabeled CBD products, citing misleading health benefits.
2) Grocery Manufacturers Association
a) The trade association representing food, beverage and consumer product companies pressed the FDA for a clear, national legal pathway to sell CBD products and strong FDA regulatory leadership to enhance consumer trust in the safety of these products.
3) Maryland Packaging
a) The food packaging company’s CEO explained that brand-owner clients want the company to manufacture and co-pack products that contain CBD.
b) The CEO urged the FDA to establish a legal pathway to safely distribute these products, because by not taking action, the FDA encourages black market dealings; and those manufacturing such products take fewer safety precautions and are less likely to follow approved procedures and regulations.
c) The CEO suggested that the FDA establish a legal path to reward the companies that follow the rules.
4) Food Marketing Institute (FMI)
a) The food retail industry advocate representing both small and large supermarket chains told the FDA panel that there is mass confusion among client store chains regarding the legality of CBD products. Strong consumer demand is pushing supermarkets to increasingly ask FMI questions about the legality of stocking and selling CBD products.
b) FMI urged the FDA to establish a legal pathway that would ensure these CBD products are safe and beneficial to consumers.
5) State Officials
a) Brenda Morris of Florida’s Department of Agriculture expressed concerns about the patchwork of state laws and enforcement priorities. Morris explained that this problem will only get worse as many states consider legislation to regulate hemp following the passage of the 2018 Farm Bill.
b) Joseph Reardon of North Carolina’s Department of Agriculture encouraged the FDA to establish a legal pathway for hemp-derived CBD that would aid North Carolina’s farmers.
6) Consumer Reports
a) Consumer Reports presented the results of a telephone survey of more than 4,000 adults.
b) The survey revealed that:
i) Many adults use CBD. One out of four adults reported using CBD at least once in last 24 months, and one out of seven use CBD regularly.
ii) A majority of CBD users find it effective. This percentage was especially high for people using CBD to reduce stress and anxiety.
iii) Consumers consider CBD to be safe
a) The cannabis-derived ingredients manufacturer suggested that 0.1% THC should be the FDA’s limit for its use in food and/or dietary supplements, as opposed to the 0.3% limit in the 2018 Farm Bill.
8) Natural Products Association (NPA)
a) The largest trade organization representing the dietary supplements and natural products industry urged the FDA to establish a safe harbor for CBD products.
b) In contrast to what Acting Commissioner Sharpless stated in his prepared remarks, NPA argued that issuing a regulation to authorize CBD products would not be new ground for the FDA. A similar precedent was established for red yeast rice, where FDA distinguished between traditional red yeast rice and red yeast rice artificially manipulated.
9) Council for Responsible Nutrition (CRN)
a) Another trade association for the dietary supplement industry argued that the FDCA provision preventing the addition of FDA-approved drugs in food and dietary supplements is not focused on safety concerns, but rather on commercial incentives to discover and market new drugs.
b) CRN encouraged the FDA to address first the issue of whether CBD is precluded by Section 321(ff)(3)(B) of the FDCA. The section states that a dietary supplement does not include a drug or an article authorized for investigation as a new drug that was not previously marketed as a dietary supplement before addressing how the products should safely enter markets across the separate channels: drug, food or dietary supplement.
10) Community Alliances for Drug Free Youth
a) The organization strongly urged the FDA to not allow any amounts of THC in consumer products, arguing that there is no research identifying a safe level of THC.
b) Further, the organization asserted that just like in alcohol and tobacco, age limits would not work.
In short, the public hearing represents an important information-gathering step for the FDA deciding what actions to take in regard to cannabis and cannabis-derived products. As stated above, absent congressional intervention, we do not expect swift or imminent direction from the FDA on potential legal pathways for marketing CBD and other cannabis-derived compounds in foods and dietary supplements.