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California Manufacturing Regulations: What You Need To Know

By Aaron G. Biros
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In late November, California released their proposed emergency regulations for the cannabis industry, ahead of the full 2018 medical and adult use legalization for the state. We highlighted some of the key takeaways from the California Bureau of Cannabis Control’s regulations for the entire industry earlier. Now, we are going to take a look at the California Department of Public Health (CDPH) cannabis manufacturing regulations.

According to the summary published by the CDPH, business can have an A-type license (for products sold on the adult use market) and an M-type license (products sold on the medical market). The four license types in extraction are as follows:

  • Type 7: Extraction using volatile solvents (butane, hexane, pentane)
  • Type 6: Extraction using a non-volatile solvent or mechanical method
    (food-grade butter, oil, water, ethanol, or carbon dioxide)
  • Type N: Infusions (using pre-extracted oils to create edibles, beverages,
  • capsules, vape cartridges, tinctures or topicals)
  • Type P: Packaging and labeling only

As we discussed in out initial breakdown of the overall rules, California’s dual licensing system means applicants must get local approval before getting a state license to operate.

The rules dictate a close-loop system certified by a California-licensed engineer when using carbon dioxide or a volatile solvent in extraction. They require 99% purity for hydrocarbon solvents. Local fire code officials must certify all extraction facilities.

In the realm of edibles, much like the rule that Colorado recently implemented, infused products cannot be shaped like a human, animal, insect, or fruit. No more than 10mg of THC per serving and 100mg of THC per package is allowed in infused products, with the exception of tinctures, capsules or topicals that are limited to 1,000 mg of THC for the adult use market and 2,000 mg in the medical market. This is a rule very similar to what we have seen Washington, Oregon and Colorado implement.

On a somewhat interesting note, no cannabis infused products can contain nicotine, caffeine or alcohol. California already has brewers and winemakers using cannabis in beer and wine, so it will be interesting to see how this rule might change, if at all.

CA Universal Symbol (JPG)

The rules for packaging and labeling are indicative of a major push for product safety, disclosure and differentiating cannabis products from other foods. Packaging must be opaque, cannot resemble other foods packaged, not attractive to children, tamper-evident, re-sealable if it has multiple servings and child-resistant. The label has to include nutrition facts, a full ingredient list and the universal symbol, demonstrating that it contains cannabis in it. “Statute requires that labels not be attractive to individuals under age 21 and include mandated warning statements and the amount of THC content,” reads the summary. Also, manufacturers cannot call their product a candy.

Foods that require refrigeration and any potentially hazardous food, like meat and seafood, cannot be used in cannabis product manufacturing. They do allow juice and dried meat and perishable ingredients like milk and eggs as long as the final product is up to standards. This will seemingly allow for baked goods to be sold, as long as they are packaged prior to distribution.

Perhaps the most interesting of the proposed rules are requiring written standard operating procedures (SOPs) and following good manufacturing practices (GMPs). Per the new rules, the state will require manufacturers to have written SOPs for waste disposal, inventory and quality control, transportation and security.

Donavan Bennett, co-founder and CEO of the Cannabis Quality Group

According to Donavan Bennett, co-founder and chief executive officer of the Cannabis Quality Group, California is taking a page from the manufacturing and life science industry by requiring SOPs. “The purpose of an SOP is straightforward: to ensure that essential job tasks are performed correctly, consistently, and in conformance with internally approved procedures,” says Bennett. “Without having robust SOPs, how can department managers ensure their employees are trained effectively? Or, how will these department managers know their harvest is consistently being grown? No matter the employee or location.” California requiring written SOPs can potentially help a large number of cannabis businesses improve their operations. “SOPs set the tempo and standard for your organization,” says Bennett. “Without effective training and continuous improvement of SOPs, operators are losing efficiency and their likelihood of having a recall is greater.”

Bennett also says GMPs, now required by the state, can help companies keep track of their sanitation and cleanliness overall. “GMPs address a wide range of production activities, including raw material, sanitation and cleanliness of the premises, and facility design,” says Bennett. “Auditing internal and supplier GMPs should be conducted to ensure any deficiencies are identified and addressed. The company is responsible for the whole process and products, even for the used and unused products which are produced by others.” Bennett recommends auditing your suppliers at least twice annually, checking their GMPs and quality of raw materials, such as cannabis flower or trim prior to extraction.

“These regulations are only the beginning,” says Bennett. “As the consumer becomes more educated on quality cannabis and as more states come online who derives a significant amount of their revenue from the manufacturing and/or life science industries (e.g. New Jersey), regulations like these will become the norm.” Bennett’s Cannabis Quality Group is a provider of cloud quality management software for the cannabis industry.

“Think about it this way: Anything you eat today or any medicine you should take today, is following set and stringent SOPs and GMPs to ensure you are safe and consuming the highest quality product. Why should the cannabis industry be any different?”

FDA Issues Warning To CBD Companies

By Aaron G. Biros
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On November 1st, the U.S. Food and Drug Administration (FDA) published a press release addressing warning letters issued to four companies. The warning letters, sent to companies marketing cannabidiol (CBD) products with therapeutic claims, cites unsubstantiated claims about their products’ ability to treat or cure cancer and other diseases.

A snippet of the warning letter issued to Greenroads

According to the press release, the four companies that received warning letters are Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC. The press release called their marketing campaigns “deceptive” for “unproven treatments.” Here is the letter they sent to Greenroads Health.

“As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes,” reads the FDA statement. “Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective.”

According to the press release, the FDA has issued ninety warning letters in the past ten years, with around twelve this year, to companies making fraudulent claims about cancer therapies. Here are some examples of claims made by companies that the FDA took issue with:

  • “Combats tumor and cancer cells;”
  • “CBD makes cancer cells commit ‘suicide’ without killing other cells;”
  • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and
  • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors,” says FDA Commissioner Scott Gottlieb, M.D. “We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products. There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

 

Colorado To Begin Requiring Potency Testing For Medical Infused Products

By Aaron G. Biros
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After a delay due to their proficiency testing program roll out, the Colorado Marijuana Enforcement Division (MED) will now require all medical infused products and concentrates be tested for potency and homogeneity, starting November 1st, 2017.

After November 1st, all production batches of concentrates from medical product manufacturers will need to have a potency test before being sold, transferred or processed. The same goes for medical infused products, such as edibles and topicals. The homogeneity test refers to making sure THC or other active ingredients are distributed evenly throughout the product.

According to Alex Valvassori, author of a regulatory compliance-focused blog post on Complia’s website, these new testing requirements could lead to a surge in pricing, passed on to patients. He also recommends dispensaries take a close look at labels coming in from suppliers. They need to make sure potency data is listed clearly on the label to stay compliant.

Production batches created before November 1st are not required to meet the new testing regulations, but any and all batches after that date will be required to perform those tests.

Consumer Education: Transparency is King

By Gabrielle Wesseldyk
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Making Cannabis Transparent: The Future of the Industry is Information and Data

The last decade has been marked by great strides in the cannabis industry, as public awareness surrounding the health benefits of marijuana-infused products has spread and products have become increasingly well researched and scientifically advanced. Despite this significant progress, however, cannabis legislation and regulations continue to vary widely between states, ultimately contributing to a lack of clarity within the industry.

This issue was at the forefront of the DispensaryNext Conference and Expo agenda held in Denver a few weeks ago. During the expo’s Consumer Safety and Education discussion, a panel of industry leaders including Kevin Gallagher, director of compliance and government affairs at Craft Concentrates and executive director of the Cannabis Business Alliance (CBA); Eileen Konieczny, registered nurse and president of the American Cannabis Nurses Association; Kevin Staunton, director of business development at RM3 labs; and moderator David Kotler, a partner at Cohen Kotler P.A., highlighted a number of important issues for cannabis patients and adult-use consumers, as well as what’s next for physicians, testing labs and dispensaries across the industry. A number of common themes resonated in their discussion of opportunities and challenges, ultimately pointing to a need for increased research and data, and most notably, a growing demand for transparency industry-wide.

Medical practitioners and dispensary technicians need qualified and legitimate information.

Konieczny opened by stressing that the industry must stop calling dispensary sales associates “budtenders.” “I prefer the term ‘dispensary technician.’ These are knowledgeable people who are on the front lines, helping patients understand the products available to them. They deserve a title to reflect that our industry and their knowledge is much more than ‘bud,’” says Konieczny.

These are knowledgeable people who are on the front lines, helping patients understand the products available to them. The most prominent information gaps in the industry lie at the level of dispensary technicians and medical practitioners. The ideal scenario for patients who are looking to use cannabis as medicine is that their medical practitioner is educated about the endocannabinoid system and that the products are available locally so that a treatment plan can be developed based on their needs. But the reality is that many patients enter their local dispensary without much knowledge or support at all, relying on the professionalism of the dispensary staff to help them navigate the dizzying array of products.

Putting the patient’s safety and success first, it is imperative that everyone involved has the proper data and information to make the best choices. However, dispensary technicians should be extremely careful to avoid making health or benefit claims. As Gallagher noted, “It is not only illegal, but also unethical to make medical claims as a dispenser. There is a difference between a claim and a personal experience. A dispenser can tell their customer that a certain strain helped them personally, but they cannot tell the customer that the strain will cure their specific ailment.”

The industry needs transparency.

New cannabis consumers may have a certain degree of misunderstanding of the products they are consuming and unfortunately, manufacturers do not offer a high level of transparency in disclosing ingredients, thereby preventing these customers from becoming better informed.

While educating the public is essential, educating the industry is of equal importance.Furthermore, labels often contain small barely legible type, along with confusing and unnecessary content. According to Gallagher, the labels need to be simpler. “Products are overloaded with redundant, confusing language that most consumers don’t understand. This turns them off—especially if they’re inexperienced in this realm,” says Gallagher. When customers who are new to cannabis find products off-putting, it hurts not only the industry, but also their own health. Ill-informed consumers may have trouble understanding how cannabis can help them, and therefore they can miss the benefits it provides.

While these issues are prevalent, there are many ways they can be resolved—with transparency at the core.

Research is critical and paramount.

For cultivators or manufacturers, research and data hold the key to attracting new consumers. By providing details about what is in a product and implementing certifications to show the product is contaminant-free, manufacturers are able to provide transparency and offer differentiation.

During the panel, Konieczny pointed out another common mistake that many manufacturers make—not sharing test results. “Not many are posting their test results, and yet this is one of the leading avenues that can increase revenue,” says Konieczny. “Most people just want to feel well again, so providing test results adds a layer of legitimacy for patients who are wary to try a new product.”

With all of this in mind, it is perhaps most important to consider the way that this information is conveyed. Facts and research are useless if they are not accessible to consumers, who may not comprehend complex data. “We need to present information in plain language, keeping it clear and simple to understand,” expressed Konieczny. The simpler the delivery, the better it will be understood and knowledge is a very powerful tool for patients, consumers and the bottom line.

Educating the educators.

While educating the public is essential, educating the industry is of equal importance. For instance, thoroughly training dispensary technicians to ask the correct questions and identify first-time users will ensure consumer safety while avoiding improper use.

The industry as a whole depends on transparencyEducating professionals on better product labeling is another critical way that the industry is working to improve itself. There has recently been a push at the manufacturing level for standardization in product labeling, as establishing a clear standard can aid customers in successfully using cannabis. “In working groups with Colorado’s MED (Marijuana Enforcement Division), we aim to standardize specific product categories, remove irrelevant names, and harmonize medical and retail labeling regulations,” says Gallagher. “Ultimately, we want to consolidate language and make it more transparent in promoting public health and safety so that it can be easily read and understood.”

All panelists agreed transparency is paramount for the future of the cannabis industry and for growing a brand. Using lab data can provide value, setting a brand apart and building loyalty among consumers looking for someone they can trust.

“Transparency is king,” Gallagher urges. “The more we educate consumers and professionals, the more clarity we will see at all levels, ultimately minimizing risk and creating greater demand among those consumers. The industry as a whole depends on transparency.”

Dr. Allison Justice

What Does it Really Mean To Be Organic in Cannabis?

By Dr. Allison Justice
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Dr. Allison Justice

If you ask an organic chemist, it’s any molecule with a carbon attached. If you ask a consumer of USDA Certified Organic vegetables, they might say it is food produced without chemicals pesticides, that it is safer and cleaner and even more nutritious. Possibly another consumer will say it’s just a hoax to pay more for food, but what does the USDA Certified Organic Farmer say?

Most will agree it is a very rigorous process of record keeping, fees, rules and oversight. The farmers have limited choices for pesticides and fertilizers; they incur higher labor costs, suffer potentially lower yields and generally have higher input costs. However, at the end of the day the farmer does get a higher price point.

With so many misconceptions about organic food, it is difficult to know what is actually organic by definition. First let’s think about what the word pesticide means. A pesticide is “a substance used for destroying insects or other organisms harmful to cultivated plants or to animals.” By definition, a vacuum used to suck off spidermites is a pesticide, so instead we should say that no synthetic pesticides are used. These are pesticides that enter and reside for long periods of time within the plant, which are potentially harmful to the end consumer. Though organic food does not contain synthetic pesticides, the perception of the food being healthier is also not always accurate. Growers often use foliar applied teas or manures, which increase the chance of the product containing E. coli or other harmful microbes. In addition, certain sanitizing agents or gamma irradiation is not allowed, so the post-harvest cleaning is not always as thorough as for conventional foods. When cannabis is sold as a dried product, the consumer cannot wash the flower as they might do before eating an apple. As growers, we should make sure we are disinfecting the flower before harvest and keeping the plant/processes clean throughout curing.

I often hear cannabis growers saying they are producing an organic product, but this simply cannot be true. The term “organic” is a labeling term for agricultural products (food, fiber or feed) that have been produced in accordance to the federal government’s USDA organic regulations. Due to our (cannabis growers) ongoing disagreements with the federal government, this is not a term we can put on our product. However, we can still grow to the same standards as USDA-certified farmers. How can we do this? By using OMRI (Organic Materials Review Institute) approved products. OMRI is a third-party, nonprofit organization that lets growers know if a product can be used in certified Organic production. You can find this seal on many fertilizers or pesticides.

Next, if it is a pesticide product that is not OMRI approved, check to see if it is registered by the EPA (Environmental Protection Agency). The EPA will provide ingredients and crops that are approved, amounts which can be used safely and storage/disposal practices on the label. Products that are put through the EPA registration are evaluated for their environmental, human and residual risks. Companies pay a hefty fee for this process, and much research goes into providing this information – ALWAYS READ THE LABEL!

A couple of exceptions to an EPA registration are pesticides that are 25B-exempt and biological control. 25B-exempt pesticides are pesticides that pose minimal or no risk to humans. A complete list of these products can be found here. Examples of these pesticides include rosemary, garlic, spearmint, etc.

Biological control is a method for controlling pests by the use of natural enemies. Biological control agents are allowed in organic production. If you are still wondering which pesticides or fertilizer are OK to use in cannabis and you do not live in a state with already enforced regulation, check out allowed lists in states that do.

So we know we cannot be considered a USDA organic cannabis farmer, but we CAN strive to meet the same standards:

  • Follow your state’s regulations; they are there for a reason!
  • Use OMRI products, 25B-exempt products and BCAs.
  • Keep an eye out for upcoming third-party certification companies, such as Clean Green or MPS (beware of the ones that want you to only use their products), because we need more than the state to regulate what we put onto our crop.
  • Finally, always think about the microbial load you’ve put on your plants. Although many can be very beneficial and help to produce high quality crops, many species can be harmful to the end user.
Soapbox

Labeling Cannabis Products is a Booming Market

By Marsha Frydrychowski
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Legal marijuana sales are expected to hit $6.7 billion in 2016, with the market expected to climb to $21.8 billion in sales by 2020. As legal cannabis sales rise, cannabis labels are quickly becoming one of the fastest growing markets for label manufacturers.

An Industry Gaining Legitimacy

Since California first legalized medical cannabis in 1996, the cannabis industry has grown considerably. Voters in four states legalized recreational cannabis last week on Election Day, including California, which is currently the world’s 6th largest economy. Voters in another four states legalized medical cannabis as well, bringing the total to 28 states with some form of legalization measure.

The market is moving ahead and will not be limited to small businesses and dispensaries either. Already, more than 50 publicly traded companies have blitzed the market, including pharmaceuticals, medical growers and even major tech companies.

An example of a cannabis flower label in Oregon with all of the required information.
An example of a cannabis flower label in Oregon with all of the required information.

What’s more, public support for full cannabis legalization is at an all-time high 61 percent, according to a recent survey from the AP-NORC Center for Public Affairs Research. The market is here to stay.

Cannabis flower labels

Legal cannabis has primarily consisted of dispensaries selling cannabis flower or leaves (ready-to-smoke marijuana) in pouches or childproof containers. Regulations have essentially required two cannabis labels for the pouches: a branded label on the front and a regulatory label on the back. Many dispensaries also use pre-printed pouches.

Similar to the way alcohol labels must contain information for alcohol content, the informational labels that sit on the backs of pouches are legally required to provide certain accurate information, including:

The universal symbol required on all cannabis products in Colorado
The universal symbol required on all cannabis products in Colorado
  • THC %
  • CBD %
  • Net weight in grams
  • Lab name and test number confirmation
  • Batch number
  • Date tested
  • Strain name
  • Warning Label

And cannabis flower labels are just the beginning. Many smoke-free product categories are emerging with similar labeling requirements. These often allow for increased branding opportunities that will afford better profit margins for label suppliers. Some of the many products in this young category include:

  • Edibles — such as dark chocolates, baked goods, snack crackers and teas infused with cannabis.
  • Topicals — such as pain-relieving lotions and creams.
  • Tinctures — cannabis-infused oils that are applied in drops to the tongue.

Bottom line: For label and packaging suppliers, cannabis represents one of the fastest growing market opportunities today and the opportunities extend way beyond labeling for the flower itself.

Managing Compliance

As more and more states move toward legalization and regulation, uneven laws in different states are increasingly governing the market. Businesses must respond to ever-changing requirements, including labeling standards. While many dispensaries have gotten away with minimalist labels, states are increasingly demanding dispensaries meet more stringent legal requirements. For example, Oregon passed new labeling requirements this year and products that failed to meet them by October 1, 2016 were not allowed on store shelves.

Label suppliers entering the market must keep abreast of the changing regulations and be able to help brands navigate them. They need to work to understand the intricacies of this new market, rather than simply looking to redirect the capabilities they already possess. See the original post here.

 

The Practical Chemist

Building the Foundation of Medical Cannabis Testing – Understanding the Use of Standards and Reference Materials – Part 2

By Joe Konschnik
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In the last article I referred to the analogy of the analytical reference material being a keystone of the laboratory foundation, the stone upon which all data relies. I then described the types of reference materials and their use in analytical testing in general terms. This article will describe the steps required to properly manufacture and deliver a certified reference material (CRM) along with the necessary documentation.

A CRM is an exclusive reference material that meets strict criteria defined by ISO Guide 34 and ISO/IEC 17025.  ISO is the International Organization for Standardization and IEC is the International Electrotechnical Commission. These organizations work together to set globally recognized standards. In order for a reference material to be labeled as a CRM it must 1) be made with raw or starting materials which are characterized using qualified methods and instruments, 2) be produced in an ISO-accredited lab under documented procedures, and 3) fall under the manufacturer’s scopes of accreditation. Verifying a CRM supplier has these credentials is easily done by viewing their certificates which should include their scopes of accreditation. Restek_accredit

There are many steps required to produce a CRM that meets the above three criteria.  The first step requires a review of the customer’s, or end-user’s requirements to carefully define what is to be tested, at what levels and which analytical workflow will be used.  Such information enables the producer to identify the proper compounds and solvents required to properly formulate the requested CRM.

The next step requires sourcing and acquiring the raw, or starting materials, then verifying their compatibility and stability using stability and shipping studies in accordance with ISO requirements. Next the chemical identify and purity of the raw materials must be characterized using one or more analytical techniques such as: GC-FID, HPLC, GC-ECD, GC-MS, LC-MS, refractive index and melting point. In some cases, the percent purity is changed by the producer when their testing verifies it’s different from the supplier label. All steps are of course documented.

restek_CRMThe producer’s analytical balances must be verified using NIST traceable weights and calibrated annually by an accredited third party provider to guarantee accurate measurement. CRMs must be prepared using Class A volumetric glassware, and all ampules and vials used in preparation and final packaging must be chemically treated to prevent compound degradation during storage. Next, CRMs are packaged in an appropriate container, labeled then properly stored to maintain the quality and stability until it’s ready to be shipped. All labels must include critical storage, safety and shelf life information to meet federal requirements. The label information must be properly linked to documentation commonly referred to as a certificate of analysis (COA) which describes all of the above steps and verifies the traceability and uncertainty of all measurements for each compound contained in the CRM. Restek_CRM2

My company, RESTEK, offers a variety of documentation choices to accompany each CRM. Depending on the intended use and data quality objectives specified by the end-user, which were defined way back at the first step, three options are typically offered:  They include gravimetric only, qualitative which includes gravimetric, and fully quantitative which includes all three levels of documentation. The graphic to the right summarizes the three options and what they include. 

It’s important to understand which level you’re purchasing especially when ordering a custom CRM from a supplier. Most stock CRMs include all three levels of documentation, but it’s important to be sure.

Understanding what must be done to produce and deliver a CRM sets it apart from other reference material types, however it’s important to understand there are some instances where CRMs are either not available, nor required and in those situations other types of reference materials are perfectly acceptable.

If you have any questions or would like more details about reference materials please contact me, Joe Konschnik at (800) 356-1688 ext. 2002 by phone, or email me at joe.konschnik@restek.com.