Food Safety Lessons for Cannabis-Infused Edibles

By Kathy Knutson

Food Safety Lessons for Cannabis-Infused Edibles details the world of cannabis-infused edibles and the way its manufacturing is evolving as the industry moves from isolation to regulatory compliance. The cannabis industry has unique challenges as cannabis-infused edibles are not regulated as food, drugs or dietary supplements at the federal level. Despite these current conditions, the industry is aware of the need to examine the safety of these edibles and prepare for a future of federal compliance. The book looks at the cannabis industry through a scientific lens to increase awareness and expertise in food safety within the field of cannabis-infused edibles.

• Includes lessons learned by the food industry
• Presents unique challenges in the manufacture of cannabis-infused edibles
• Provides information of US Federal food safety compliance
• Explores the current state of research regarding edibles

• Language: English
• Publisher: Academic Press
• Release date: Apr 28, 2020
• ISBN: 9780128195376

Kathy Knutson

Dr. Kathy Knutson works nationwide with food and cannabis manufacturers on recall investigations, problem-solving, training, and FDA compliance. Dr. Knutson writes a food safety blog on ConnectFood. She trains and consults on writing Hazard Analysis and Critical Control Points (HACCP), food defense, and food safety plans; laboratory methods and results; environmental monitoring; Standard Operating Procedures (SOPs); Good Manufacturing Practices (GMPs); and FDA’s Food Safety Modernization Act (FSMA). As Project Manager with ImEpik, she updated the online curriculum for a Preventive Controls Qualified Individual (PCQI) certificate and developed a course for GMPs for the cannabis industry. Dr. Knutson is a consultant with Kornacki Microbiology Solutions, NSF International, EAS Consulting Group, and Kathy Knutson Food Safety Consulting LLC.

Book preview

Food Safety Lessons for Cannabis-Infused Edibles

Kathy Knutson, Ph.D

Principal, Kathy Knutson Food Safety Consulting LLC, Green Bay, Wisconsin, United States

Table of Contents

Cover image

Title page

Copyright

Chapter 1. Introduction

Introduction to the author: it’s personal

Introduction to cannabis vocabulary

Introduction to cannabis regulation

A brief history of cannabis regulations

Descheduling is the future

The Food and Drug Administration regulation

Opinion on cannabis regulation

The Canadians

Chapter 2. Overview of the cannabis industry

Vertical integration

Growing operations

Marijuana grown for research

Postharvest steps for cannabis products

Marijuana licensing in Colorado

Hemp-derived and cannabis concentrate

Cannabis-infused edibles

Retail marijuana store

Chapter 3. Begin with the end in mind®: the dispensary

The dispensary

Washington

Florida

California

Colorado

Michigan

Nevada

Home delivery

Taxation and licensing

Chapter 4. Good manufacturing practice compliance is not optional

Introduction to good manufacturing practices

Implementation of GMPs

Absolutes for training in the cannabis industry

GMPs are only the beginning of safety for cannabis-infused edibles

GMP certification is facility-specific

Chapter 5. Chemistry of cannabidiol and Δ9-tetrahydrocannabinol

Concentrates are the products of extraction

Biochemistry

Organic chemistry

Analytical chemistry

Chapter 6. The hazard analysis

Beyond Hazard Analysis and Critical Control Points (HACCP)

Resources for the hazard analysis

The steps of writing a hazard analysis

Summary

Chapter 7. Preventive controls

Definition of a preventive control by the FSPCA [2]

Allergen preventive controls

Supply chain preventive controls

Process preventive controls

Sanitation preventive controls

Chapter 8. Nobody is talking about environmental monitoring

Environmental monitoring

Pathogen testing of edibles

Indicator tests

Pathogen testing for environmental monitoring

Initiation of an environmental monitoring program

Seek and destroy

Summary

Chapter 9. Operation: manufacturing of edibles

Characteristics of cannabis-infused edibles

Foods made into cannabis-infused edibles

Product development

Build food safety into product development

Written standard operating procedures

Chapter 10. Operation: packaging and labeling of edibles

The role of packaging

The role of labeling

The role of security

Chapter 11. Training needed in the cannabis industry

Importance of training

Resources specific to the cannabis industry

Chapter 12. Jobs in the cannabis industry

Transfering skills to the cannabis industry

Where do I start for a job in the cannabis industry?

Characteristics of a cannabis industry employee

Chapter 13. Final thoughts

Marijuana Business Conference (MJBizCon)

Nevada field trip

December 2019

Appendix 1

Appendix 2

Index

Copyright

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Notices

Knowledge and best practice in this field are constantly changing. As new research and experience broaden our understanding, changes in research methods, professional practices, or medical treatment may become necessary.

Practitioners and researchers must always rely on their own experience and knowledge in evaluating and using any information, methods, compounds, or experiments described herein. In using such information or methods they should be mindful of their own safety and the safety of others, including parties for whom they have a professional responsibility.

To the fullest extent of the law, neither the Publisher nor the authors, contributors, or editors, assume any liability for any injury and/or damage to persons or property as a matter of products liability, negligence or otherwise, or from any use or operation of any methods, products, instructions, or ideas contained in the material herein.

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ISBN: 978-0-12-819512-3

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Chapter 1

Introduction

Abstract

Cannabidiol products are widely available in the United States, and patients in 33 states have access to medical marijuana. In the United States, cannabis companies are licensed and regulated at the local and state levels. Canada legalized cannabis for smoking at the federal level in October of 2018 and followed with the legalization of cannabis-infused edibles in October of 2019. Legalization of cannabis in the United States requires the descheduling of marijuana off the federal Drug Enforcement Administration's list of scheduled drugs. After descheduling, cannabis regulation can align with existing regulations for pharmaceuticals, food and dietary supplements under the enforcement of the Food and Drug Administration.

Keywords

Cannabinoid; CBD; Deschedule; Dietary supplement; Dispensary; FDA; Hemp; Legalize; Licensing; Marijuana; Regulation; THC

Introduction to the author: it’s personal

I work in the cannabis industry, and I don't get high

As a food scientist, I am used to writing in the third person about science, not about me. In scientific and technical writing, we are trained to not use the word it and to write about the methods, observations, and analysis of data. Well, this book will have plenty of observations, but they will be my observations and, in some cases, a single data point. I will ask the questions I had about the cannabis industry, the questions that you probably have too. I will describe my lessons learned in getting the answers to those questions. I speak only of which I know. I am a bucolic girl from Wisconsin, a foodie, a locavore, and a cook. Training of adult learners is my career passion.

Note

Definitions of vocabulary start in a later section of this chapter. Turn ahead for definitions if you need them sooner.

My first exposure to weed was at a dry cleaner

Nearly everyone has a personal story of their first exposure to cannabis. Until 2017, I had almost no exposure to marijuana in my 50-plus years of life. I grew up in a small town outside Madison, Wisconsin. My first job was working six   hours per week at the one dry cleaner in town and closing up after the full-time ladies finished. I was 16 and alone when one   day a high school teacher of mine came in to pick up his dry cleaning. I knew him well from after-school activities he supervised. It was custom to staple anything found in the pockets of the clothes to the paper ticket stapled to the plastic bag. When I retrieved his dry-cleaned sport coat from the turning rack, there on the ticket was stapled a baggie of weed. As I did with all the customers, I simply asked if the stapled item belonged to him. He was not able to get a yes or a no out among the stammering, but he paid the dry-cleaning bill and left with the sport coat and baggie of weed. At that time, I literally had no idea it was weed. Given his reaction, it is only my logical conclusion that it was weed. It could have been oregano.

In the last week of high school, I was at a friend's house and smelled something funny. I followed the smell and found her older brother with a few friends in the living room smoking weed. He asked me if I wanted to try it, and I said no. Beside the one time, I was never exposed to weed or asked to smoke weed through my entire K–12 education and 10 years of university education. I just did not have friends who smoked. I grew up in a time when cigarettes were advertised on billboards and in magazines. Kids smoked. Adults smoked. Restaurants and bars were smoke-filled. I tried a cigarette once. That hurt my lungs. Most of my extended family did not smoke cigarettes. Again, I just did not have friends who smoked cigarettes, yet alone weed.

Fast-forward through jobs, marriages, and raising my two sons, and someone in my house tried to flush weed down the toilet and it floated. Someone left a mostly empty bag of weed on the passenger side of my husband's car, after someone used the car to drive with a friend to an amusement park. I was not amused. Thus began my journey of learning about cannabis use. They say education begins at home.

In 2017 I was talking with my colleague, Rick Biros of Innovative Publishing, at the Food Safety Summit. Innovative Publishing Company LLC owns Food Safety Tech and manages the Food Safety Consortium annual meeting and exhibits. I have known Rick since 2000 and my days as Outreach Manager for the National Center for Food Safety and Technology (NCFST), renamed as the Institute of Food Safety and Health. Rick was telling me that his son, Aaron Biros, had graduated from college and joined his company to write a cannabis publication. The thought was so foreign to me that I burst out loud laughing. Oops. Rick kindly explained the role of the Cannabis Industry Journal and how the cannabis industry was growing. That was my first lesson.

In the fall of 2017, I received a call from another NCFST colleague, Sanford Wolgel. Sanford was looking at writing a state application for a cannabis-infused edible manufacturer and wanted to know if I was available to help with the Good Manufacturing Practices and maybe other documentation such as Standard Operating Procedures. That was my second lesson. While the project with Sanford did not go to fruition, I listened to and learned everything I could from Sanford about the cannabis industry. He had worked in laboratory operations and product development, knew the chemistry of cannabis, and still is an expert in regulations.

Note

The words product and products are obviously the singular and plural forms. However, use of product can be plural as well. In other words, products is plural. Product can be either singular or plural in use. English is fun.

My role as a consultant

While most of my career has been in academia and laboratory operations, I dipped my toe into the consulting pool in the beginning of 2016, when I became employed by Jeff Kornacki of Kornacki Microbiology Solutions, Inc. In addition to my work with Jeff, I was a Lead Instructor for the Food and Drug Administration (FDA) Preventive Controls for Human Food (PCHF) rule in the training of Preventive Controls Qualified Individuals (PCQIs) and a member of the Expert Services Team at ConnectFood where I assisted in writing food safety and Hazard Analysis and Critical Control Point (HACCP) plans. In this gig economy, I was looking for more work as an independent consultant. I thought I could take my food safety expertise and transfer my skill set to cannabis-infused edibles. I will talk more about transferring your skill set to the cannabis industry in a later chapter. The next step was to call Rick Biros. Rick got me connected to Aaron Biros, and my inauguration into the cannabis industry started with the publication of a series of my articles in Aaron's online journal, the Cannabis Industry Journal. That was my third lesson.

Box 1.1

Preventive controls

Preventive and preventative are synonyms, and the FDA chose to use preventive. Preventive controls are procedures to control identified hazards in a food or cannabis-infused edible facility. Chapter 6, The Hazard Analysis, and Chapter 7, Preventive Controls, will detail the steps for writing a food safety plan to include a hazard analysis and preventive controls.

I was ready to learn more about the cannabis industry. I continued to talk with Sanford and Aaron about the industry and research online. The perfect opportunity came for me in 2018 to attend a major cannabis conference and exhibit. I was scheduled to deliver the PCQI course close to San Jose just ahead of the annual conference managed by the National Cannabis Industry Association (NCIA), called the Cannabis Business Summit & Expo. As an exhibitor, Aaron had an extra badge for me to get in without paying, and my flight was covered by the training I delivered, so I attended. At the time, I was talking up the application of the FDA requirement for a written food safety plan and implementation of preventive controls because that is what I know. Most of the cannabis industry was not there yet, so I did not gain much traction, but I learned a lot about the entire industry, not just the edibles industry. That was my fourth lesson, and my knowledge and experience kept growing from there through networking and eventually projects in the cannabis industry.

Purchasing cannabidiol

Learning about cannabis is personal. For over 50   years, I have lived every day with an autoimmune disorder, similar to rheumatoid arthritis. I have inflammation, pain, and fatigue. With the cannabidiol (CBD) market penetrating everywhere in the United States, even folksy Green Bay, Wisconsin, where I live, and reading and hearing about the medical benefits of CBD, I purchased a CBD tincture in the fall of 2018. A tincture is an oil that is portioned out with a dropper and consumed orally. If you hold the tincture under your tongue as long as possible, the effect will be quicker as the CBD absorbs into blood vessels. Otherwise, swallowing the tincture starts the path of the digestive tract to the circulatory system to the liver for metabolism there. The effect then takes an hour plus or minus. Like alcohol consumption, an empty or full stomach makes a difference. I experimented with time of day and number of drops. Too late in the day made me stay up too late and not get enough sleep. Too much of the tincture put me into a deep afternoon nap. CBD is not a cure for me but is part of my assault on my disorder.

I had purchased the CBD at a nutrition store and later noticed a whole store in Green Bay dedicated to the sale of CBD and CBD products. It amazes me that a whole business can subsist on the sale of CBD. CBD is extremely expensive at $50–$75 for about 0.4 oz or 45   mL for the tinctures I have purchased. When talking with the store owner and manager, I was told the clear majority of sales goes not to young people, but to people like me in their 50s or older for the relief of pain. My husband reminded me also of the discretionary income that I have, but a young person may not have, which may be a reason why middle-aged to elderly individuals purchase CBD products.

I am now often asked what CBD product or brand a person should buy. Right there is a reason the United States needs FDA oversight of marijuana and cannabis products because I should not and do not dish out medical advice. CBD products are everywhere in retail stores such as supermarkets, nutrition stores, pharmacies, doctors' offices, and gas stations. The availability of CBD products is similar to the availability of over-the-counter (OTC) pain medications. Small specialty brands of OTC drugs compete with large name brands and generic brands. Some consumers have brand loyalty and only purchase from the large brand names. Our language uses the brand name as a synonym for the medication when we ask for Tylenol, Excedrin, or Motrin. Other consumers go for the lower cost generic OTC medication, feeling confident that the same drug is offered in both the name brand and generic medication.

I have brand loyalty to the Alive brand of vitamins I purchase from Nature's Way. The company is a national company headquartered in my home of Green Bay. I have researched the product and know people who work at Nature's Way, so I am an informed and confident customer. When shopping, I do not compare vitamin products or cost; I just buy the Alive vitamins. A CBD product can be purchased by brand or by cost. A quality CBD product should be expensive. If the CBD product is cheap, that's a red flag of the quality. When comparing brands, there are so many new companies in the marketplace that the reputation of a new company versus an old company is meaningless to me. I admit there may be a slight advantage of buying from an older company that has gone through the growing pains of the industry, but even an established company is a new company because the industry is so young. As you read on, you will see that there are many cannabinoids in addition to CBD and each may have a role in addressing health concerns on an individual basis. I have heard wonderful success stories for both humans and animals with the use of CBD. Consumers should do as much research as possible, before purchasing a CBD product, on the company and on the benefits of CBD as a remedy for their personal health issues. Seek professional resources of information independent of any one company, and be wary of any company advertising a health claim as that is absolutely illegal without expensive drug studies to support the claim.

You might think it is simple to compare the cost of CBD product brands in an apple-to-apple kind of way. My limited experience has been frustrating. Purchasing a larger volume or weight of CBD product may or may not be a cost savings. For example, in buying a bottle of CBD tincture, the variables are cost, total volume, total CBD per bottle, serving size, and CBD per serving. I can easily calculate cost per volume of two different sizes of bottles. However, the important information is the dosage of CBD. If I want a dose of 10   mg of CBD and the serving sizes and CBD per serving vary between two bottles, it gets confusing. A typical serving size is 1   mL, which is 20 drops, and the tincture is delivered with a dropper. My current CBD tincture is 25   mg per 1   mL or 20 drops. The math tells me that a dose of 10   mg is in eight drops. If I compare that tincture to a different brand, I may need only five drops of the different brand. Once I figure out the number of drops that delivers the dose of 10   mg, I calculate the cost for each tincture for the dose to choose the cheaper option. I am good at math but standing in the store and trying to figure that out is too much. This leads to my personal experience: buy a bottle and try it.

Field trips

In 2018 I started visiting dispensaries when I traveled for work into a state with legal recreational cannabis. My first trip to a dispensary was in Seattle, Washington. I consider these visits like field trips in school. As part of my job, I simply must go to dispensaries to learn more about the cannabis industry! When Illinois writes and implements legislation for legal recreational cannabis, it will be the 11th state in the United States to do so. Until then, that only gives me 10 states where recreational cannabis is legal. I have been to a dispensary in Seattle, San Diego, and Denver. As a special guest, I visited a dispensary in Florida, but I could not purchase. Florida only has medical marijuana, along with 32 other states, which requires a state-issued medical card to enter the dispensary. So you see my field trip options are limited. Living in Wisconsin, we do not even have medical marijuana, and I do not have access to medical marijuana for my pain.

December 24, 2018, will live in infamy for me as the day I first inhaled Δ⁹-tetrahydrocannabinol (THC). I had already had too much Christmas wine, so I felt nothing from the THC. I have tried unsuccessfully to get high. I haven't tried very hard because I was on work trips in states where recreational cannabis was legal and that was not the time to experiment. Those stories are told in Chapter 3, Begin with the End in Mind®: The Dispensary. In Chapter 10, Operation: Packaging and Labeling of Edibles, I tell the story of my field trip in Colorado. I may have been high for 5   minutes, so in my mind that doesn't count. That's like saying I was tipsy from an alcoholic drink for 5   minutes. That doesn't count.

Figure 1.1 Illinois became the 11th state to legalize recreational use of marijuana [6]. Used with permission from e.Republic.

Box 1.2

I'm just curious, what 11 states have legal recreational cannabis?

I am trying to make this a party trick of mine—to list all 10 states with recreational cannabis. By the time you are reading this book, Illinois will be the 11th state with recreational cannabis. Using the visual aid here (Fig. 1.1), I start on the west coast and travel east: Alaska, Washington, Oregon, California, Nevada, Colorado, Illinois, Michigan, Vermont, Maine, and Massachusetts, as well as the District of Columbia. I hear Vermont is lovely, and I have never been to that state. Field trip, anyone?

Introduction to cannabis vocabulary

To work in the cannabis industry, at some level, you need to be comfortable with chemistry and botany. At one point, I counted that I had taken 10 college chemistry courses, so I do know chemistry, but it took time to feel comfortable with the vocabulary of cannabis. Here are some basic terms everyone should know to work in the cannabis industry [1,2], and these will be used throughout the next chapters. I am thankful to Weedmaps for their comprehensive Cannabis Dictionary [3].

THC: a major cannabinoid in cannabis and causes psychoactive intoxication.

Black market: operating a business illegally. An example of a black market operation is the sale of a cannabis product to a minor. In contrast, the gray market is operating a business legally where laws exist, complying with most parts of the laws but not all. In the cannabis industry, an example of operating in the gray market is when cannabis-infused edibles are sold in packaging through which the edible can be seen. The state code for packaging requires opaque packaging to conceal the edible.

Bud: see Flower. Bud and flower are terms that are often used interchangeably.

CBD: one cannabinoid found in hemp and cannabis with nonintoxicating and potential medicinal or therapeutic properties. Cannabinoids that are structurally related to THC and CBD are tetrahydrocannabivarin (THCV), cannabichromene (CBC), cannabigerol (CBG), and cannabinol (CBN).

Cannabinoids: lipophilic chemical compounds that react with receptors in the brain and immune system. Over 100 different cannabinoids have been identified in the cannabis plant [4].

Cannabis: a flowering plant in the genus Cannabis. Cannabis species are Cannabis sativa, Cannabis indica, and Cannabis ruderalis. C. ruderalis may not be a separate species. Cannabis hybrids are developed with a cross of C. indica and C. sativa. In addition to the proper name of the plant, cannabis is a general term with the synonyms of marijuana and weed and its use is not italicized or capitalized.

Cannabis-infused edible: a.k.a. marijuana-infused product (MIP). Cannabis-infused edibles are cannabis products made for ingestion, including food; dietary supplements in the form of pressed pills, capsules, or teas; and tinctures.

Concentrate: the product of hemp or cannabis extraction that contains THC and CBD. Extraction may be followed by the processes of winterization, decarboxylation, or distillation.

Deschedule: to remove marijuana from the Schedule I drug list of the Drug Enforcement Administration (DEA).

Dispensary: store for the sale of cannabis products.

Edible: see cannabis-infused edible.

FDA: Food and Drug Administrtion, a federal agency in the Department of Health and Human Services. In addition to food and dietary supplements, the FDA regulates medical devices, tobacco, animal and veterinary products, cosmetics, pharmaceuticals, radiation-emitting devices, and biologics including vaccines and blood. No matter where the federal regulation of cannabis-infused edibles falls, regulations will be under the jurisdiction and enforcement of the FDA.

Flower: general term that refers to the smokable, trichome-covered part of a female cannabis plant, also known as nuggets, nuggs, nugs, or bud [5]. The cannabis flower does not have the look of a traditional flower, such as a rose, daisy, or lily, but all the botanical parts are present.

Hemp: C. sativa strains grown for its fiber and oil seeds. Hemp grown for hemp-derived CBD is legal with the signing of the 2018 Farm Bill.

Manifest: written record for transport of hemp, cannabis, or cannabis products.

Marijuana: slang term for cannabis. The connotation of the term marijuana is for the drug-like or medicinal use of cannabis.

Medical marijuana: general term for the legal sale of cannabis products to qualifying patients with a state medical card. The sale of medical marijuana is electronically tracked on