Last week Cannabis Industry Journal, a sister publication of Food Safety Tech, published its interview with AOAC International officials about the organization’s commitment to cannabis lab testing, where it sees this area headed in the future and the launch of its food authenticity and fraud program. AOAC first entered the realm of cannabis testing a few years ago and is making strides to get further involved with “methods regarding chemical contaminants in cannabis, cannabinoids in various foods and consumables, as well as microbial organisms in cannabis,” according to the article. AOAS also recently launched a food authenticity and fraud program to develop standards and methods geared toward economically adulterated foods. Read more about AOAC’s latest development on the food front as well as its push in cannabis lab testing in the article, “Spotlight on AOAC: New Leadership, New Initiatives in Cannabis and Food”.
Cannabis edibles—i.e., capsules, chewable gummies, lollipops, cookies, etc. —are becoming more popular and commonplace as laws legalizing cannabis are passed in certain states. Some people are consuming these edibles simply for pleasure, while others are ingesting it for medical reasons, such as reliving epilepsy symptoms, easing chronic pain and combating nausea from chemotherapy. While safety regulations are in place for the foods we eat, who is responsible for the safety of these cannabis consumables?
The 2018 Food Safety Consortium features a Cannabis Quality track | November 13–15 | Learn MoreSince customers can order cannabis edibles online from just about anywhere (including Amazon), they assume these products must be safe. But, as it turns out, that’s not necessarily true. Currently, there’s no regulatory standard for edible cannabis products. Very few consumers realize that it is a “buy-at-your-own-risk” market.
The FDA makes certain that foods sold in the United States are safe and properly labeled. But, currently, they do not regulate cannabis edibles.
Cannabidiol (CBD) infused edibles seem to be more “socially acceptable” than smoking cannabis because they sidestep some of the stigmas, such as the odor. This makes them appealing to a wider audience.
It’s entirely possible that some of the edibles you purchase aren’t manufactured from food-grade ingredients. A document from the Denver Department of Public Health and Environment recently noted that some CBD products being sold in the United States are coming from unregulated, unsafe and unsanitary manufacturing facilities. Further, some of these edibles contain unapproved ingredients, have been produced in unsafe conditions, and had unsubstantiated health claims on their labels.
In many cases, the edibles being sold and consumed in the United States may:
- Not have the desired effect that consumers are seeking.
- Be dangerous for consumption, due to inappropriate levels of CBD.
- Contain ingredients that are not food grade and are, therefore, unsafe to ingest.
- Be hazardous due to cross-contamination or cross-contact issues.
- Transmit foodborne illnesses due to poor sanitation and hygiene in the facilities where they were produced.
There have been a number of cases of foodborne illness (and potential hazards) in cannabis edibles recently. In August 2017, Dixie Brands voluntarily recalled six cannabis products after the Denver Department of Public Health and Environment discovered they were produced with potentially unsafe, non-food-grade oils. That same summer, The Growing Kitchen recalled MaryMint Tincture, a breath spray product, after a health inspector found it being stored on a shelf at room temperature (not refrigerated). There was concern about whether the oil was shelf stable, and the potential botulism risk from the unrefrigerated oil in this product.
Another company, At Home Baked, made bubble hash, a form of cannabis concentrates, in its cannabis edibles. Their recall included a variety of products, including their brownie mixes, blondie mixes, rice krispy treats, and Stixx candy. It seems they were manufacturing their products in a washing machine that was in poor working condition (eroding, rusted and containing substantial amount of mold.) Unregulated “facilities”— such as old, moldy, rusty washing machines—are dangerous and extremely concerning in terms of public health and safety.
Denver is one of a few areas in the United States that is regulating the production of edibles on a food safety level. And in Denver alone, there has been a tremendous number of cannabis investigations in recent years, many of them ending in recalls. However, most U.S. jurisdictions are choosing not to regulate food safety around the production of cannabis and edibles. As a result, many unsafe cannabis edibles are being produced and sold to the public, which presents a significant risk to consumers.
Since these products (and the cannabis industry in general) are not regulated, many people producing edibles have not had even the most basic food safety training. Numerous production facilities overlook the most basic food safety rules: They don’t wash their hands, they don’t prevent cross-contamination, and they don’t pay attention to critical items like time and temperature control, proper storage, pest control, sanitation, etc. Yet, they are preparing consumable products and selling them to the public, who believe the edibles are safe.
Because there’s no federal regulation, lab testing varies among each state that permits the use of medical and recreational cannabis. Unfortunately, that means there aren’t consistent safety standards in the cannabis industry, as there are in the food service industry.
The FDA requires a (HACCP) plan for most food manufacturing and food service industries. This means that food businesses will take great strides to only sell food that is safe for consumption, and will not cause injury or illness. As the cannabis industry continues to produce cannabis-infused edibles and other products, people in the business can learn from the existing food safety protocols and procedures. Particularly, they should look to maintain compliance with food safety regulations and take all necessary steps to ensure a safe product for consumers (e.g., clean facilities, food-grade ingredients, no cross-contamination, proper labeling, etc.)
Fortunately, there are a growing number of CBD and THC edible producers that are hiring food safety and cannabis experts to help them elevate their safety standards before the FDA starts to regulate. As with all industries, there are many producers that are ready, willing and trying to do the right thing.
As more people purchase and consume cannabis edibles, it’s becoming increasingly important to buy from reputable companies that follow proper safety protocols. Cannabis companies should produce and handle edibles like food businesses produce and handle food – with the utmost attention to safety.
In addition to Operations, Detection, Compliance and Supply Chain, this year’s call for abstracts for the Food Safety Consortium will include a new category: Cannabis quality. A series of presentations on the topic will address regulations, edibles manufacturing, cannabis safety and quality and laboratory testing.
The cannabis quality series will be co-hosted with Food Safety Tech‘s sister publication, Cannabis Industry Journal.
Before submitting an abstract, following are a few points to keep in mind:
- The abstract should be about 300 words
- Presentations will be judged on educational value
- Don’t submit a sales pitch!
- Presentation time is about 45 minutes—this includes a 10-15 Q&A session
The abstract submission deadline is Thursday, May 31. Click here for more information.
A HACCP plan has historically been applied by the food manufacturing and food service industries to ensure the sale of food that is safe for consumption. As the cannabis industry grows in the manufacture of cannabis-infused products, namely edibles, lessons can be learned from the progress and success of programs like Good Manufacturing Practices, HACCP, Juice HACCP and FSMA. One side of the coin is compliance with regulations; the other side of the coin is taking all necessary steps to ensure a safe product for the consumer.
A webinar next month, Lessons from Food Safety: Applications to the Cannabis Industry, organized as a partnership between Cannabis Industry Journal and the National Environmental Health Association (NEHA) will cover the above topics, along with the disparities in state-to-state cannabis safety and quality regulations, and implications for infused-product manufacturers. The webinar will be held at 1 pm ET on May 2. To learn more, follow this registration link.
HACCP is discussed often by food safety professionals. While the industry is well aware of the program and its necessity, the cannabis industry is far greener in this area. Food safety consultant Kathy Knutson, Ph.D. developed a series on HACCP for the cannabis industry for our sister publication, Cannabis Industry Journal. It also serves as a great primer for the novice in the food industry. You can read the article, “Hazard Analysis and Critical Control Points (HACCP) for the Cannabis Industry: Part 1”, by following the link below.
“As more people gain access to and ingest cannabis products, it’s only a matter of time before food safety becomes a primary concern for producers and regulators,” says Steven Burton, CEO and founder of Icicle Technologies, Inc. Without federal regulation, there are so many questions about the food safety hazards associated with the use of cannabis in food products. In an article published in Food Safety Tech’s sister publication, Cannabis Industry Journal, Burton discusses the Top Four Safety Hazards for the Cannabis Industry, which includes pathogenic contamination from pests and improper handling.
Instead of action against violative food, FDA is now equipped to take regulatory action against importers that fail to provide necessary assurance of food safety.
“His actions resulted in technically more deaths than that of Charles Manson,” said Darin Detwiler, senior policy coordinator for food safety at STOP Foodborne Illness.
Marijuana has catapulted into mainstream thinking via activism, state decriminalization, and medical reforms while investors and banks are beginning to trust the market more, further legitimizing the nascent industry
A renewed recognition of the importance of individual employee behavior within food processing and manufacturing organizations is shining a spotlight on awareness and accountability, but a standardized measure of food safety culture must be defined.
The landmark case sets a precedent for the food safety industry.
With cannabis-infused edibles gaining a bigger market share in 2014 (See the marijuana edibles regulatory update here), it comes as no surprise that cannabis-infused beverages are growing in popularity. Some of these beverage manufacturers operate in a very interesting legal environment because of the differentiation between compounds found in hemp and marijuana, two different varieties of cannabis.
“Under federal legislation, there is an exemption for hemp and as long as we process our CBD (Cannabidiol) molecules from the hemp plant, we are allowed to sell our products federally,” says Chris Bunka, CEO of Lexaria, a company that makes a hemp-infused tea.
A number of scientific research studies have suggested that the compound CBD has medical properties that can help mitigate symptoms like inflammation, anxiety, chronic pain, and much more.
Because of the federal exemption for hemp, Lexaria can enjoy interstate commerce and other freedoms that manufacturers using marijuana flowers do not, such as access to banking services. Dried marijuana flowers contain the psychoactive compound, Tetrahydrocannabinol (THC). This compound is responsible for the regulatory and legal schism between the states that have legalized marijuana and the federal government, which still considers it to be a Schedule I narcotic.
Much unlike a number of marijuana edibles manufacturers operating in states where marijuana is currently legal, hemp-infused beverage manufacturers operate in full FDA compliance.
Michael Christopher, founder of Loft Tea, is working with a laboratory and bottler that are both 100% FDA compliant. “We definitely operate up to and abide by all FDA best practices with our laboratory and as far as producing and handling material we use best manufacturing practices and processes,” says Christopher.
“We have to partner with a bottler and laboratory who have the reputation to build trust with our brand as an industry leader in safety and quality,” says Christopher. “Until the FDA gives us complete guidelines on cannabis-infused products, we will continue to operate above and beyond best manufacturing practices with our infusions.”
Because these manufacturers view their hemp tea as a health and wellness product, it is only a matter of time before we see these types of products lining the shelves of health-food stores nationally. However, before this happens, an FDA regulatory framework specific to hemp-infused products is needed to address this growing industry.
“The hemp infusion industry has a lot of opportunity when presented in the right framework,” Christopher says. “There is still education needed in the marketplace to get it to the point where it will be on the shelves in stores like Whole Foods.”
Until that time comes, expect to see a steady growth of interest and inquiry from consumers, manufacturers, and regulators alike in the cannabis industry, whether federally legal or not.
A lot has changed since last year’s article, “Marijuana Edibles: A Regulatory Nightmare.” Marijuana has since catapulted into mainstream thinking via activism, state decriminalization, and medical reforms while investors and banks are beginning to trust the market more, further legitimizing the nascent industry. According to an article from the Washington Post, Colorado’s legal marijuana industry reached $700 million in 2014 and is expected to grow to $1 billion by 2016.
Innovators are beginning to analyze trends on a national level, looking toward federal rescheduling of the drug as a catalyst for more state reforms and wider legalization measures. Federal legalization is in the back of many minds, as the introduction of pivotal state and federal legislative reforms promises more access to banking services, medical research, and more state independence.
While a black market mentality remains prevalent, widespread state reforms, increased venture capital investment, and further legitimization of an industry with less barriers of entry have fostered a perceived reduction in risk. States like Oregon, Washington, and Colorado that have already legalized marijuana for recreational and medical sales are beginning to implement strict packaging rules, requirements for traceability, QA programs, testing and laboratory monitoring requirements, and other regulations that would suggest FDA oversight down the road.
State regulatory bodies such as the Colorado Marijuana Enforcement Division (MED) have matured and expanded their oversight to include certifications and requirements for lab testing and analysis. Marijuana testing facilities can now be certified by the MED to test for residual solvents, poisons or toxins, harmful chemicals, dangerous molds, mildew or filth, harmful microbials such as E. coli or Salmonella, pesticides, and THC levels and Cannabinoid potency.
According to an article from theCannabist.com, edible marijuana took 45% of the market share in 2014 and continues to grow, proving that food manufacturers and processors will gain a bigger share of the market.
BioTrackTHC develops a seed-to-sale traceability system that is the state-mandated reporting system used by any business that touches the plant in compliance with Washington’s i502 regulations (The company also won the contract bid for New Mexico’s and New York’s state-run traceability systems). “From day one, all retail products under i502, including infused edibles, must have laboratory-submitted passing test results and data in the traceability system before it can be unlocked for shipment to retailers,” says Patrick Vo, CEO of BioTrackTHC.
Regulations, especially those addressing traceability, are crucial for advancing the industry and fighting the black market, performing recalls, and improving product quality and safety. Vo adds, “As more states adopt a centralized traceability system, food safety will improve as we see the industry grow.”
“Most of the marijuana edibles producers we advise are working comfortably within their state health department regulations versus a year ago when they were struggling to implement routine compliance,” says Stephen Goldner, CEO of Regulatory Affairs Associates. “But there is a long way to go to make this new marketplace meet the standards routinely met by US food producers in other markets such as nutritional supplements and medical foods.”
Many edible producers are sadly mistaken to ignore FDA labeling and production regulations just because the producer only ships within their own state, according to Goldner. “Whenever FDA has found label or food safety violations of products, whether they are food, drugs or any other product, it has always acted quickly to seize the product, inspect the producer and insist that violative labeling or production practices be remedied,” he says, adding that it won’t be surprising to see FDA start to “seize marijuana-infused food products that make drug claims, especially from the leading current producers” as a way for the agency to insert itself into the inspection and compliance process. “These companies need to have FDA food GMP’s solidly in place and properly documented,” says Goldner.
“Those who have experienced the most consistent and long term success in this industry are those who play above board, those who take the extra effort and make the investment in effort, time, and money to treat their business as if it was already federally legal and had to adhere to standards that other industries must follow,” says Vo. He agrees with the view held by many that long term planning is vital in this industry. “Those who have implemented best practices, QA programs, and traceability software will succeed in the long run, and the bad actors will eventually, by their own poor practices, be filtered out by regulatory and market forces.”
In the near future, the industry will look to other states in regulatory experiments on opposite sides of the spectrum. “New York, which legalized medical marijuana in 2014, is handing out 5 licenses to operate 4 dispensaries each, and allowing licensees to have a grow facility to supply their respective dispensaries. The Commissioner of the New York State Department of Health will have authority on licensing, testing, and medical requirements for patients seeking treatment with medical marijuana,” says R. David Marquez, who operates a Long Island law firm focusing on the cannabis industry.
New York is implementing very strict rules regarding cultivating and processing the plant. California, on the other side of the spectrum, already operates a somewhat loosely regulated medical marijuana market and has been doing so since 1996. The bill to legalize marijuana recreationally in the state is widely expected to pass vote and be implemented in 2016. This would open up an enormous market potential and contribute to the growth of the industry on a national level.
Because marijuana edibles are theoretically both a food and a drug, it is only appropriate that the FDA should look to regulate the industry in the future. In the meantime “Those who have invested the time and money in staying compliant now will be far ahead of the game tomorrow,” says Patrick Vo, who is looking toward federal legalization.
It seems that manufacturers and processors at the forefront of quality and safety testing will succeed in the long run.
Footnote: This is a regulatory update on the cannabis industry with an emphasis on edible marijuana. CannabisIndustryJournal.com, the newest publication, will be launched in September of this year. CannabisIndustryJournal.com will educate the marketplace covering news, technology, business trends, safety, quality, and the regulatory environment, aiding in the advancement of an informed and safe market for the global cannabis industry. Stay tuned for more!