Although Cannabis-containing products are broadly available to consumers, the U.S. Food and Drug Administration (FDA), though committed to protecting public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate Cannabis and Cannabis-derived products, has not yet obtained sufficient scientific information to conclude that such products are safe for use in human or animal food. Additionally, it is illegal under federal law to add cannabidiol (CBD) to food or market it as a dietary supplement.
It is within the context of the rapidly growing food segment that Food Safety Magazine reached out to those in this industry to identify best practices and challenges as this market moves forward. The panelists included Brad Churchill, CEO of Choklat (partially owned by Namaste Technologies), Nancy Whiteman, CEO, Wana Brands, Celeste Miranda, Celeste Miranda & Associates (formerly The Cannabis Marketing Lab), Lisa Tollner, Sensi Products, and Dave Neundorfer, CEO of Open Book Extracts (OBX).
Food Safety Magazine: What process control steps and/or best practices have you put in place to ensure quality and safety of your edibles products?
Brad Churchill: Choklat’s process control elements and best practices have been designed to meet all possible legislation that could apply to our products with regards to the [Canada] Food and Drug Act and Regulations, Safe Food for Canadians Act and Regulations, and the Cannabis Act and Regulations. The programs developed by our quality assurance director, Sarah Beresford, are based on the Food Safety Enhancement Program principles and the Global Food Safety Initiative programs, to ensure that the Prerequisite Programs, Standard Operating Procedures, and HACCP [Hazard Analysis and Critical Control Points] plan identify and address or eliminate relevant risk(s) for every ingredient, process step, and final product from receiving to shipping.
Nancy Whiteman: Safety is Wana Brands’ number one priority. Even though Cannabis is not yet federally regulated, we have implemented the highest standards in food safety and compliance programs, and we were one of the first edibles companies to produce in line with cGMPs [Current Good Manufacturing Practices] and HACCP practices. Beginning with our very first batch of products in 2010, every Wana product has met or exceeded testing requirements for potency and microbiological contaminants even before it was required by regulation. We have a quality assurance team in place in Colorado that provides support to all of our out-of-state markets (California, Michigan, Illinois, Ohio, Oregon, Arizona). Recently, Wana has invested into getting our leadership team certified in the Food Safety Preventive Controls for Human Food Alliance course. Our brand-new facility for Wana Wellness Hemp Gummies has a robust food safety plan to ensure they are fully compliant with FDA regulations.
In March 2019, Wana unveiled a new child-resistant and resealable container solution that provides compliant, sustainable product storage that is reusable, recyclable, and more sustainable. Wana’s new packaging combats the four adversaries of marijuana storage—moisture, oxygen, static charge, and UV light—by being airtight, anti-static, and UV-light opaque. Additionally, we finish each package with a safety seal so that customers can be sure that their product has not been tampered with prior to purchase.
Celeste Miranda: As a Cannabis and CBD media company, we don’t deal directly with manufacturing edible products, but I can say that control steps and best practices are paramount as the industry becomes more regulated and competition increases. Without these processes in place, business can suffer from a back-end and customer-facing standpoint.
Lisa Tollner: We follow GMPs to ensure consistent quality and safety. Ingredients are checked and recipe amounts checked. We also use an automated system for the final extrusion and packaging, which precisely fills each container.
FSM: What effects have the latest regulations had on your business, in terms of product safety and quality?
BC: Choklat, fortunately, is in the unique position of not growing flower or extracting the concentrates itself. For us, cannabinoids are simply ingredients that we combine with other ingredients to make our confections, and we are experts at sourcing the best ingredients that money can buy. Choklat has been producing high-end, high-quality chocolate from only the finest ingredients and selected cacao beans since 2008. Our expansion into edibles and the regulatory requirements we must meet for the Cannabis Act and Regulations means we are now documenting all the procedures and standards we’ve been using for 10 years already. Aside from the inconvenience of more paperwork, there will be very few disruptions and changes to the processes we already have in place.
NW: From the beginning, Wana Brands has followed cGMPs and HACCP practices and tested for potency and impurities. This meant when testing regulations went into effect in Colorado, Wana’s operations weren’t affected. But other companies that weren’t prepared for these regulations were hit hard, and some were even forced to close their doors. We believe that safety and quality should be a top priority, and every edibles producer should be following cGMPs and HACCP practices and testing for potency and impurities.
Like most edibles companies, we did have to overhaul our manufacturing processes to accommodate the 2016 state regulations that required companies to put the universal THC symbol on every edible. While this was complicated and expensive to implement, it ultimately became another assurance that the industry takes public safety seriously.
CM: Again, we don’t have direct interaction within our media company with government regulators, but from dealing with many businesses who do, I can say that an increase in regulations has led to many Cannabis companies upping their game to accommodate and differentiate themselves in an already crowded space. I’ve seen more attention to quality control, documentation, and safety concerns than ever.
LT: There are state regulations that all licensed Cannabis manufacturers must follow. Many of the regulations are standard for any food product, have not impacted the business, and are sensible for any product being consumed. However, the packaging has been over-regulated, in my opinion.
Dave Neundorfer: There is currently a lack of consistent state and federal regulation in the CBD and hemp extract industry. Consequently, there is significant variation in product quality at every stage of the supply chain, from bulk ingredients to finished goods for consumers. While we recognize regulating a new industry can be challenging for FDA, we believe that establishing standards is critical for consumer health and safety.
OBX is using the current regulatory environment to raise the bar for the industry and implement what we believe are some of the strongest quality control and quality assurance practices on the market. We have built a state-of-the-art, food-grade manufacturing facility that adheres to the FDA’s cGMPs. Our facility houses extraction and purification equipment, a quality control lab, a product formulation R&D lab, a commercial kitchen, and a fully automated packaging and labeling system. To ensure the safety and purity of all of our products, we have implemented rigorous testing procedures. We use a licensed, independent third-party lab to produce a full-panel Certificate of Analysis [COA] on each batch of hemp that is delivered to our facility before we accept it. We then test internally at each stage of the process as the hemp moves through extraction, purification, formulation, and packaging, and we test the finished product with a licensed, independent third-party lab once more before it leaves the facility.
OBX eagerly invites intelligent regulation of the CBD industry at the state and federal levels. These regulations should include registration and audit of processing facilities, product testing requirements, and labeling standards. We support the FDA’s desire to protect a pharmaceutical path for CBD, but CBD has been used to enhance quality of life for thousands of years, has been recognized as safe by the World Health Organization after reviewing myriad safety studies, and should be permitted for use in dietary supplements, food, and beverages. The delay in FDA regulation has created a patchwork of state regulations, which will only continue as more time passes and is increasingly difficult to navigate. OBX also plans to work with the U.S. Department of Agriculture [USDA] to establish rules regarding the growth and production of hemp in the United States that are more favorable for our company and our farmers. We recently shared our thoughts on the USDA’s Interim Final Rules during the public comment period.
FSM: How do you determine the dose of the Cannabis-related ingredient (e.g., THC or CBD) in your products? Do you have a testing lab you trust, or do you do this in-house? Are there existing standards for testing?
BC: Choklat will be utilizing third-party laboratory testing for THC and CBD amounts in the “in process” and final products destined for market. In-house, dosing is controlled by:
• Sourcing only extracts of known purity, accompanied by third-party laboratory testing results, which meet all the requirements for the finished product as per the Cannabis Regulations
• Standardized recipes (lots) for all product formulations, ensuring accuracy and consistency in THC and CBD levels
• The existing standards, which require potency and terpene profile testing and trending, aflatoxin and ochratoxin testing, pesticide testing, heavy metals analysis, foreign matter testing, and microbiology testing
NW: By regulation, all products are required to be third-party tested by an independent lab. In-house testing is used primarily to ensure internal protocols are accurate.
We have multiple checkpoints for dosing. We require that the oil that we purchase come with the results for potency, pesticides, and contaminants from a third-party lab. We use the results of this testing to calibrate the oil that is added to each batch, adjusting it for differences in oil potency. We then test the final product again to ensure that the dosage is exactly where it should be. This is important because cooking methods and production processes can alter the intended dosage of a product so that the resulting amount of Cannabis in the product may be materially different from what was planned. And while Wana is strict with dosing products and third-party testing each batch to ensure proper dosage, unfortunately, there are no federal or national industry standards for testing cannabinoid potencies. Several reference methods do exist that are currently accepted in Colorado, but none of them have been validated to the level of a standard. This often results in different labs using different methods for testing, which in turn results in very different readouts for products from the same production batch. We would like to see industry standards or best practices enacted for testing.
CM: I’d always recommend a combination of in-house and third-party testing for dosing and accuracy considerations.
LT: From speaking with consumers over 10 years, we have found that 5–10 mg of THC is ideal for most people where they can address a need and still be functional. Those with higher THC tolerances can adjust upward from there. For CBD, it can be higher since it is not psychoactive, and 20–30 mg is common.
We send to a third-party testing lab to confirm the potency, and then again as part of a complete compliance test before the product is released to the market.
DN: The OBX product development and formulation team has spent a significant amount of time balancing the most up-to-date scientific literature with downstream consumer research. What is abundantly clear is that CBD is processed by each person very differently, as each person has a unique endocannabinoid system. In addition, the form in which the product is delivered (topical versus ingestible, oil versus water soluble) also influences the effect that it has on a consumer.
We have generally found that at least 20 mg is required to deliver any therapeutic effect. We focus on ensuring that each product leaving our facility contains the amount of CBD that we claim, which we verify through both in-house and third-party testing laboratories. By focusing our efforts on safety, quality, and consistency, we give our clients and the end consumer the information and confidence they need to find the right dose for them.
OBX has extensive tracking and testing infrastructure in place so that we can monitor the quality of every input and output moving through our facilities. We test every output from each step of the process in our in-house quality control and quality assurance testing laboratory, and every finished good is tested by a licensed, independent third-party lab before leaving our facility. We provide each of our clients and their customers with access to the COAs that detail the composition and purity of the products.
We are excited that many of the consumer-facing brands have placed QR codes and website links on product labels to allow consumers to access the COAs, but we’re eager to see an industry-wide standard established so that consumers can verify the safety of what they are putting in or on their bodies.
FSM: What are the major challenges you’ve encountered relative to packaging your products? Is there concern that consumers won’t read the information about serving size and dose on the label?
BC: Packaging and work flow related to the physical packaging of products have been by far the most onerous and prohibitive step of this entire process. Each proposed product must use child-resistant packaging. Up to this point, Cannabis companies have been hand-packaging and sealing products—which isn’t bad if the package of product retails for $100 or more. However, we are talking about single, low-dose servings that will retail for less than $10.
Economies of scale begin to break down when a manufacturer is required to hand-package and seal such small items in volumes of thousands of units per lot. Yes, there is equipment on the market that will portion and package single-serving items into child-safe bags, but this equipment is priced in the hundreds of thousands of dollars per piece—a very prohibitive price for a small- or medium-size company.
There are also the extensive requirements of labeling. A simple 10 mg-dosed chocolate bar box now comes with a 17-page checklist to make sure it complies with the regulations, and all of the packaging must come with rigid third-party certifications of child resistance. Not even the cigarette industry has to comply with such restrictions. Imagine packaging cigarettes one by one!
NW: Historically, there has been a lack of acceptable packaging options for Cannabis companies, with many of the bigger packaging companies refusing to serve the industry due to the sector’s legal status. Plus, labeling regulations and product quality standards meant Wana products had previously been sold in multiple layers of plastic and packaging, leading directly to the industry’s carbon footprint problem.
In March 2019, Wana unveiled a new container solution that provides compliant, sustainable product storage that is reusable and recyclable. Wana’s new packaging combats the four adversaries of marijuana storage—moisture, oxygen, static charge, and UV light—by being airtight, anti-static, and UV-light opaque. Wana’s new FDA food-grade approved plastic product containers reduce both its environmental and storage footprints by eliminating the need for three layers of packaging, including a cardboard box, vial, and plastic reclosable bag. The containers are machine-labeled with all relevant safety, compliance, and branding information. The aesthetically pleasing, sustainable packaging is recyclable.
The sleek, modular storage solution streamlines operations across the Cannabis supply chain, saving time, money, and space. By eliminating three layers of packaging, Wana Brands is able to save labor costs. By purchasing Wana Brands products in its new packaging, consumers will reduce their environmental impact with less plastic waste. The new packaging is available in Colorado, Michigan, Illinois, Ohio, and Oregon.
In terms of information on serving size and dose, we make sure that they are displayed prominently on our label, our website, and marketing materials. We also provide extensive budtender training to educate budtenders on our product.
CM: From a media company’s perspective, challenges concerning packaging can vary from design and graphic considerations to how things are actually displayed on both physical and digital storefronts. We direct brands to take these aspects into consideration, knowing that accurate labeling to meet any specific regulations is highly important.
LT: The challenges have been a consistent understanding of the regulations across the market, as some of the regulations have varying interpretations. We have found that most consumers are careful and do read the labels and instructions.
DN: As with every decision that we make in our facility, our team has spent a significant amount of time studying best practices from adjacent industries. Much of the challenge for packaging products is finding the best package for each SKU [stock keeping unit] and customer segment. With quality at the forefront, our product development and formulation team put each formulated product through rigorous stability testing to verify that the packaging we are utilizing for each product is effective in preserving quality and efficacy. For any consumer goods that we manufacture and label in-house, label and information design are critical parts of the product development process. Since our inception, we have acted as a consultant to our clients on this topic. We support the brands and companies we work with in developing clear and well-positioned language to ensure that consumers can easily view the ingredients and dosing instructions. At OBX, we constantly ask ourselves how we can do our part to support deeper consumer education. We have found product packaging an effective avenue to achieve this.
FSM: What does your growing industry need to ensure public safety going forward?
BC: There is a very extensive set of regulations, testing protocols, and laws in place to protect the public when it comes to licensed Cannabis producers and processors who create the products, and also the retailers who sell the products. I would like to see legislative relaxation with respect to distribution, packaging, and portioning; only then can the industry compete with the black market. Public safety is already regulated during production (via monitoring of production practices and portion control) and sale (no minors in the stores). Right now, we need balance between legislated directive and consumer demand/preference to displace the black market.
Edible Cannabis is a great alternative to the combustible methods of consumption, eliminating the potential hazards and health damage that smoking and vaping can incur. However, if it’s made prohibitively expensive to manufacture and sell, the lion’s share of consumers will still gravitate to a more cost-effective option such as flower, even if it’s less healthy for them to smoke it.
NW: The need for education can’t be stressed enough. Consumers need to understand they should “start low and go slow.” As stigma around Cannabis dissipates and consumers are more comfortable discussing use, understanding around Cannabis consumption will increase.
Adults must keep Cannabis products safely out of the reach of children and educate youth on the dangers of underage consumption.
The public is safer with the regulated adult-use Cannabis industry. With stamping and regulation of shapes, the Cannabis industry can safely claim that between child-resistant packaging, prohibited use of cartoon characters, opaque packaging, and warning statements, that Colorado infused-products manufacturers are doing more than any other industry to make edibles less appealing to kids while maintaining colors and flavors that do appeal to the adult markets we serve. Legal Cannabis products are less likely to be accidentally ingested by kids than dish detergent packets, diaper rash cream, and even alcohol-infused chocolates. With more than 5 million infused-product units sold each year and diminishing cases of accidental ingestion, the industry feels strongly that it is headed in the right direction.
Banning legal edibles or regulating edibles out of existence merely pushes a safe, regulated, taxable industry with professionally produced, lab-tested products packaged in childproof packaging into the illicit market where homemade edibles with no testing or limits on potency and no required packaging become a much more dangerous situation for children.
The legal Cannabis industry takes power and money out of the hands of drug cartels and puts funds into state coffers and has the real potential to help offset the federal government’s budget shortfalls. Recent studies have found that opioid use decreases in states that legalize marijuana. The legal Cannabis industry provides safety procedures and regulations that protect our youth, and states where Cannabis is legal have seen a reduction in teen use.
CM: I think the industry needs to increase and adopt more standardized and regulated systems and processes all across the production line from inception to final sale. This will help increase viability of our industry and allow it to blossom from a space that was once not taken completely seriously into the full-fledged behemoth that it is sure to become.
LT: The best way to inform the public is through education: in the literature, websites, in the media, etc. I believe the public understands this and is moving cautiously on its own. Government oversight is overdoing it and causing unnecessary cost, which the public ends up paying for.
DN: OBX believes that our industry needs intelligent regulation by FDA. We have worked hard to do our part by proactively building a facility with the cleanliness and work flows of a pharmaceutical lab, while also developing operating procedures that put quality and purity at the heart of everything that moves through our facility.
We are eager for FDA to establish facility registration procedures, manufacturing safety guidelines, and testing and labeling standards to support the safe introduction of CBD into the dietary supplement and food and beverage industries. We believe this regulation is critical to ensure that every product on the market is safe for the public, not only those products created by OBX.
Furthermore, OBX plans to work with USDA and the North Carolina Hemp Association to ensure that any new hemp rules are fair to farmers who are seeking to participate in the economic upside of the hemp industry and fair to processors like OBX who are working hard to develop a sustainable supply chain to support the growing demand in this new industry.
Food Safety Magazine thanks the panelists for their insightful comments.
Resource
www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.
