Regulation of Edible Hemp Products
Sara M. Morrow
Food Safety Specialist II, Ohio Department of Agriculture Division of Food Safety
Abstract
The growing, cultivation, and processing of hemp and hemp products was made legal by the United States Department of Agriculture (USDA) Farm Bill in 2018. The Farm Bill required each state and tribal nation to submit, for approval, a hemp program that describes how hemp and hemp products will be regulated in their jurisdictions. Though the Food and Drug Administration (FDA) only recognizes hemp seed as generally recognized as safe (GRAS), some states and tribal nations with approved hemp programs are allowing—in addition to hemp seed and hemp seed oil—the introduction of hemp and hemp products into food and dietary supplements. Due to the recent nature of the passage of the 2018 Farm Bill, there is limited information on what, if any, food safety issues state regulatory programs are finding when regulating hemp producers. To gather information related to what food safety issues state regulatory programs may be finding, an online survey was disseminated and a follow-up phone interview was conducted of employees from state regulatory programs requesting information related to their hemp programs. This set of data was then analyzed using Microsoft Excel. Deficiencies were noted during pre-opening inspections as well as during routine inspections. The reporting states indicated that employee and industry training are important components in administering hemp programs. Ongoing monitoring of state and tribal nation hemp programs and creation of training programs is recommended.
Key words: hemp, cannabidiol, Cannabis sativa L., CBD, food safety
Regulation of Edible Hemp Products
Background
Hemp (Cannabis sativa L.) is a crop that has long been used for a variety of products. Confusion regarding hemp and its relative, marijuana, has led to regulations against hemp and the interchanging of the terms amongst the general public. Hemp is typically Cannabis plants that have little concentration of tetrahydrocannabinol (THC), the element that causes psychoactive effects. Plants that are usually grown for recreational drug use often are significantly higher in THC than the plants used for hemp cultivation (2018 Farm Bill, 2018).
Records exist that detail hemp being cultivated as far back as 1000 B.C. Hemp is a hardy plant that may be successfully grown in a wide variety of climates. Hemp may be used to make items such as paper, sails, ropes, clothing, oil for lamps, and may be used in food. Hemp seeds may be a food additive and the oil, cannabidiol (CBD) may be extracted and consumed alone or added to food products. CBD often is touted as being therapeutic to help alleviate a wide range of ailments including seizures, pain, and some mental disorders.
In the United States, hemp has a colorful history ranging from encouraged growing and cultivation during World War II for the production of textiles, ropes, and other war-time needs (with a propaganda video entitled “Hemp for Victory” and commodity subsidies), to making hemp an illegal Schedule 1 controlled substance, and currently is considered legal for growing and cultivation (Ash, 1948). By the middle of the 19th century, up to 75,000 tons of hemp was produced in the United States. In 1937, the Marihuana Tax Act was enacted in the United States which taxed hemp cultivation. In 1970, the Controlled Substances Act classified hemp and marijuana as a Schedule I controlled substance, effectively making it illegal (Herer, 1990).
The popularity of hemp and hemp products made a resurgence in the 21st century as a sustainable source of many of the items we use, as well as identifying the potential positive health effects of consuming or applying hemp products. The 2014 USDA Farm Bill allowed for the growth and cultivation of hemp and hemp products for research purposes without first obtaining a permit from the Drug Enforcement Agency (DEA). Cultivators were required to register with each state or Tribal Nation's 2014 Hemp Pilot Program which was approved by the USDA (2014 Farm Bill).
The 2018 Farm Bill made the cultivation of hemp legal for purposes beyond research and removed hemp from the list of Schedule 1 controlled substances. The Farm Bill also defined hemp as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis” (2018 Farm Bill). However, in order for an entity to cultivate hemp and produce hemp products, the state or tribal nation must have a USDA approved program. In order to have an approved program, each state's or tribal nation's regulatory agencies must submit plans to USDA which include the testing requirements for THC: the plants must be tested within 15 days of harvest; test results must be able to be shared with local law enforcement; product cannot be placed into commerce until the test results are received; and product that contains above 0.3 THC must be destroyed in accordance with DEA procedures (2018 Farm Bill).
Though hemp cultivation and production has now been made legal, the FDA only recognizes hemp seed and hemp seed oil as generally recognized as safe (GRAS) (FDA, 2020). The FDA does not approve the addition of other hemp products, including CBD, to food products, dietary supplements, cosmetics, or as a standalone consumable, except for one epilepsy medication that contains CBD. By not allowing other hemp products to be added to food products distributed in interstate commerce, the FDA may complicate the production of hemp products and their addition to food products. Each state has the ability to create and enforce food safety regulations for food products, dietary supplements, and cosmetics for intrastate distribution, however, the FDA has jurisdiction over food products, dietary supplements, and cosmetics distributed in interstate commerce. As of May 20, 2020, despite the majority of hemp products not being considered GRAS, the FDA has issued warning letters only to producers making hemp-containing products which are labeled as dietary supplements or which make health claims (FDA Warning Letters). In May 2020, a recall was initiated in the United States for a CBD oral tincture produced in Florida that contained high levels of lead.
As of April 29, 2020, there are 42 states or tribal nations that have approved hemp programs; 21 with plans in progress, under review or revision; and 18 that have chosen to continue to operate programs under the 2014 Farm Bill (USDA Hemp website). Although the 2018 Farm Bill allows states to create hemp programs, there is limited information on the experience these programs have had in terms of challenges in licensing and inspection and safety of hemp food processors.
Problem Statement
There is limited information for new hemp regulatory programs on what challenges are faced by state agencies in the regulation of hemp food and food component processors.
Research Questions
1. Are state regulatory agencies finding deficiencies when conducting pre-opening inspections of hemp food and food component processors?
2. What violations are state regulatory agencies finding when conducting routine inspections of hemp food and food component processors?
3. Have there been any foodborne illness outbreaks or recalls associated with hemp-containing food products in states with USDA approved hemp programs?
4. What can state food safety regulatory agencies learn about regulating hemp processors based on the experience of other agencies?
Methodology
This research was conducted using a multi-faceted approach in order to gather as much accurate data as possible. Since hemp programs in many states are relatively new, a survey was developed, utilizing SurveyMonkey, and was sent to the contact email listed on each state’s hemp program webpage. The short survey consisted of 10 questions designed to ascertain whether the state had conducted any hemp processor inspections, as well as to discover if they found any violations. There also were questions designed to gather other information related to the inspections of hemp processors such as frequency of inspection.
The respondents were asked to provide their name, email, and phone number in order to conduct a follow-up interview via phone. The follow-up interview was designed to allow respondents to further elaborate on answers provided in the online survey. For example, an interview question asked respondents to elaborate on what they found hemp producers to be least prepared for when conducting initial or pre-licensing inspections. Another interview question asked respondents to describe successes of their programs and what advice they may have for states that do not yet have a USDA approved program.
The data was then input into Microsoft Excel, analyzed, and placed into graphs and charts for ease of comparison.
Results
As of September 1, 2020, there were 20 states with USDA-approved hemp programs. Of those 20 states, nine (45%) allow hemp in food products. The remainder allow only hemp seed and hemp seed oil per FDA’s GRAS list. As of January 27, 2021, the researcher was able to interview and gather information from eight of the nine states.
All eight states involved reported there were common deficiencies noted when conducting pre-opening inspection of hemp food and food component processors. Four of the states reported that labeling was found to be deficient four out of eight times (50%). The labeling deficiencies occurred with both food labeling (allergens, statement of responsibility) and on required THC labeling including not listing the THC content, listing a THC content that was higher than the product’s actual THC content, or listing THC content that was lower than the product’s actual THC content). Of these four reporting states, one state reported using ingredients from an unapproved source, one reported that the firm’s operator was unaware the products could not enter interstate commerce, and one out of eight (13%) indicated that the THC concentration in the products was above the allowable limit and did not agree with what was listed on the label. One state reported inspectors found one out of eight (13%) of the state’s hemp producers inspected were attempting to operate out of their homes.
During routine inspections of hemp food/food component processors, one-half of the states reported they did not document any deficiencies and utilized enforcement discretion and education before and while regulating. Among the other four states, violations noted during the inspections included:
· operating without the appropriate hemp permit
· operating without a Food Safety Plan
· using an unapproved source for both hemp and food ingredients
· incorrect labeling related to both food labeling and hemp labeling.
When asked about complaints received regarding hemp food and food component processors, five out of eight of the states (63%) reported they had not received any complaints or reports of foodborne illness associated with hemp-containing food products or components. Two of the eight states (25%) reported receiving complaints regarding products having too high of a THC concentration. One complaint was investigated and determined to be unfounded and the other complaint investigation was ongoing at the time of the survey. One state reported one complaint received regarding an unlicensed processing firm. Two of the eight states (25%) also reported recalls of hemp food products and food components had been conducted. One recall was due to too high of a THC concentration, discovered upon collecting regulatory samples, and the other was due to too high of a lead content, again found upon collecting regulatory samples.
Challenges found by respondents when implementing hemp programs included a lack of adequate funding for the program, a lack of adequate staffing for the program, limited access to training programs for both employees and industry, the political nature of hemp products, and the lack of scientific information related to the safety of hemp products. Another challenge reported by the states was the lack of guidance from the Food and Drug Administration (FDA) regarding hemp in food products.
Respondents indicated that states with prospective hemp programs should ensure they are including all applicable interested parties in the planning and implementation stages. Interested parties include various government entities, the hemp industry, and the general public. Another recommendation was to encourage states to reach out to other states for guidance, support, and information related to hemp programs. The respondents also recommended creation of employee and industry training programs during the creation of the hemp program.
Two states indicated that, since the 2018 USDA Farm Bill only addressed delta-9 tetrahydrocannabinol, they have found they are unable to conduct enforcement activities for products which have a high amount of delta-8 tetrahydrocannabinol. Delta-8 tetrahydrocannabinol may have similar psychoactive effects to delta-9 tetrahydrocannabinol but, due to the lack of guidance and research, the state hemp programs cannot enforce regulations for this byproduct.
Conclusions
Available guidance related to hemp-containing food products is severely lacking. Not only does there appear to be a lack of guidance regarding hemp food safety and THC content for government agencies and inspectors, there is also a lack of information available for hemp producers and other hemp stakeholders. Informational documents related to the regulations, food safety, and THC varieties would be beneficial.
When creating and implementing hemp programs there may be a lack of collaboration between state regulatory agencies involved, the hemp industry, and the general-public. Including these stakeholders would be beneficial when creating hemp programs, educating producers and regulators, and while enforcing the regulations.
Hemp-containing food producers, which had not previously conducted food production activities, tended to have the majority of deficiencies when conducting pre-licensing or routine inspections. They were less fluent in labeling requirements related to both food labeling and THC labeling.
Recalls or foodborne illness complaints were not frequently reported for hemp-containing food products. This could be due to the choice of individual states to practice discretion in enforcement, or to the lack of information provided to the public regarding hemp-containing food products.
Recommendations
The establishment of a collaborative effort between regulatory agencies and hemp industry and producers needs to occur at the onset of the development of a comprehensive hemp program. By working cooperatively, individual state hemp programs may gather information from industry related to the processing of hemp to create a well-rounded hemp program and to train regulators who will be inspecting hemp-containing food processors. Including public input regarding hemp programs also may be beneficial for determining public trends related to the consumption of hemp-containing food products and to assist regulators with focusing their efforts during inspections and enforcement activities.
It would be beneficial to create a sample training program that could be disseminated to state and tribal nations and amended to suit their state-specific regulations. This could be accomplished through a nonprofit entity such as AFDO establishing hemp-specific programs. The training could be created to be specific to industry members, regulatory agencies, and the general public. This approach would allow for training of employees and industry at the start of the hemp program implementation, which was recommended by many of the reporting states. This training program should be the result of a collaboration between federal and state regulatory agencies, hemp-containing food producers, and other stakeholders to ensure a thorough, well-rounded training program.
Continuing to gather information related to pre-opening inspections, routine inspections, complaints, and recalls, and expanding data collection to the tribal nations may present a more complete picture of what hemp programs are finding and what food safety issues may be unique to hemp food products. This continued research also could help in tailoring training programs to hemp-containing food producers who are not familiar with food safety regulations.
Conducting further research on the safety of hemp in food products would also be beneficial. Additional research would provide more information for states and tribal nations when creating and implementing hemp programs. More research also may assist with the allowance of interstate shipment of hemp-containing food products and dietary supplements. Continued research related to the various types of THC is needed as well.
Acknowledgments
I would like to thank all the state regulatory agency employees who took time out of their busy schedules to complete my survey and speak with me on the phone, allowing me to properly gather my data. I also would like to extend a heartfelt thank you to Katherine Fedder, my mentor throughout this research project. Her guidance and expertise have been invaluable. My eternal gratitude also extends to Terri Gerhardt, Chief, and Jodi Taylor, Assistant Chief, of the Ohio Department of Agriculture’s Division of Food Safety for recommending me for the International Food Protection Training Institute’s Fellowship Program and for all their continued encouragement in both this project and my career. Finally, I would like to acknowledge the other members of the IFPTI Cohort IX for the many discussions and support.
References
2014 Farm Bill, 7 C.F.R., §7606, 2014.
2018 Farm Bill, 7 C.F.R., §297, 2018.
Ash, A. L. (1948). Hemp: Production and utilization. Economic Botany; 2 (2), pp 158-169
U.S. Food and Drug Administration (2020, November 05). GRAS Notices. https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=GRASNotices
U.S. Food and Drug Administration (2020, November 10). Warning letters. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters
Herer, J. (1990). The forgotten history of hemp. Earth Island Journal; 5 (4), pp 35-38.
Author Note
Sara M. Morrow
Food Safety Specialist II, Ohio Department of Agriculture Division of Food Safety
This research was conducted as part of the International Food Protection Training Institute’s Fellowship in Food Protection, Cohort IX
Correspondence concerning this article should be addressed to:
Sara M. Morrow, Ohio Department of Agriculture Division of Food Safety,
8995 East Main Street, Reynoldsburg, OH 43068
sara.morrow@agri.ohio.gov
*Funding for this statement, publication, press release, etc., was made possible, in part, by the Food and Drug Administration through grant 5U18FD005964 and the Association of Food and Drug Officials. Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.