Tag Archives: edibles

October 19, 2015

Manufacturing Edibles With Integrity

By Aaron G. Biros

Without federal guidance on food products containing marijuana (a result of the plant remaining a Schedule I narcotic), state regulators and manufacturers are fighting to keep the market safe for consumers. Manufacturers of marijuana edibles are not only trying to ensure consumer safety, but are also attempting to advance industry and legalization efforts nationwide.

Recent investigations in Colorado revealed that certain marijuana edibles, along with some extracts, tested positive for illegal pesticides. Many cannabis businesses are looking to the industry leaders in edibles manufacturing for advice. Marijuana edibles are a food product, so they must first enlist standard food sanitation procedures and then comply with state regulations for cannabis to ensure safety. Some of the product consumers are patients with weakened immune systems, thus highlighting the need for consistent and accurate dosing in products.

Maureen McNamara, founder of Cannabis Trainers, recently sat on a panel with Bob Eschino, co-founder of incredibles and Krystal Kiathara, CEO of Yummi Karma at the Cannabis World Congress and Business Expo, hosted by the International Cannabis Association in Los Angeles. The panelists discussed the need for integrity in manufacturing edibles.

The regulations are not quite there yet and states are adjusting legislation to help promote safety. “It is our job to educate legislators and make sure that our products are accurate and consistent,” said Bob Eschino, co-founder of incredibles.

Maureen McNamara says there are four criteria for producing edibles with integrity: Compliance, training, research and product testing.

“Starting with the foundation of compliance, utilizing strategies involving HACCP plans and FDA guidance, the first pillar is training,” says McNamara. “Food safety training is essential to ensure your team is aware and making a wholesome product.” She also stressed the importance of shelf-life testing and R&D before the product goes onto shelves.

Because food laboratories often will not test products that contain cannabis, many companies work with food scientists and in-house testing. “Moving forward, we need to ensure that we achieve consistent results from the various testing labs,” said McNamara. “But to make edibles with integrity, laboratory testing is paramount.”

August 3, 2015

Hemp-Infused Beverages: FDA Compliance and the Cannabis Industry

By Aaron G. Biros

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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.

June 13, 2014

Marijuana Edibles: A Regulatory Nightmare

By Aaron G. Biros

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With an estimated 8 million to 12 million servings of edible marijuana already sold in Colorado, there is cause for concern over food safety testing, and how manufacturers will tackle challenges like regulatory compliance and quality assurance.

When Colorado made history this year by legalizing recreational marijuana use, lawmakers were tasked with creating a regulatory framework for the production, sale, and use of the previously illegal substance. While Colorado has addressed issues such as taxation and cultivation of the plant, the state has struggled to provide clear guidelines for food safety, testing, and lab certification regarding marijuana edibles, causing difficulties for regulators and manufacturers alike.

Federally, USDA and FDA are reluctant to regulate the nascent industry because marijuana is still considered a Schedule I narcotic by the DEA. The Colorado Department of Public Health and Environment is unwilling to regulate marijuana edibles out of fear of jeopardizing their federal funding.

In lieu of the Department of Public Health and Environment’s oversight, the state allows the Marijuana Enforcement Division, under the Department of Revenue, to handle food safety and lab certification. It appears this regulatory agency may be in over its head as concerns grow over potency testing and labeling in the wake of two deaths allegedly involving the overconsumption of marijuana edibles. Adding insult to injury, the Denver Department of Environmental Health cited 58 violations at 24 edible marijuana establishments this past month.

Still, with an estimated 8 million to 12 million servings of edible marijuana already sold in Colorado, there is an immediate cause for concern in food safety testing. As the edible marijuana industry grows, so do worries over how manufacturers will tackle challenges like regulatory compliance and quality assurance.

Ben Pascal, Co-Founder and Chief Business Officer of Invisible Sentinel, feels that there is a lot more the government should be doing right now. “This is a growing trend that will continue in the United States; these products will continue to gain market share and there should be some sort of guidance on how and when to regulate the safety of these products,” explains Pascal.

Invisible-Sentinel-June-2014 — Invisible Sentinel’s rapid molecular diagnostics product, Veriflow, can help address some the concerns around risk in conducting testing for marijuana edibles,” says Ben Pascal.

With a rapidly growing industry, more producers of pot edibles are finding it harder to meet regulatory compliance goals. “Larger accredited labs in the US find that there is risk in conducting testing for marijuana edibles,” says Pascal. He believes that Invisible Sentinel’s rapid molecular diagnostics product,Veriflow, can help solve some of these issues.

“We make molecular testing more accessible with low cost, ease of use, robust technology, and the ability to bring all of this testing in-house, helping to eliminate risk factors for clients,” describes Pascal. While Veriflow has the capability to alleviate some quality assurance worries, Pascal points to the lack of regulatory oversight as the main issue.

“If you are not going to be regulated by the federal government, holding you to a safety standard, then smaller groups will not make the proper investments to ensure the safety of their product,” Pascal explains. “It is not about cost, it is about the lack of education and knowledge surrounding the implications of food safety issues in this industry.”

After some of these smaller regulatory hurdles are cleared within the state, then we can start to look toward future food safety standards in the marijuana edibles industry on a national level. Colorado’s experiment in legalization foreshadows some of the issues we will face when marijuana is accepted at a federal level.

As this trend continues, we should act preemptively to alleviate regulatory headaches before they are exacerbated, Pascal adds. The nation’s agencies need to be ready to embrace the legalization of marijuana and related food products in order to prevent real safety issues from surfacing.