CBD OIL

The OMC posted the full list of dispensary permit holders on its website, which consisted of Ohio-based medical cannabis dispensary Terrasana Cannabis Co. and West Virginia-based medical cannabis dispensary Harvest Care Medical.

Terrasana applied to receive six dispensary permits at the beginning of this year and was awarded all six. The dispensary business was also granted a cultivation and processing license, said William Kedia, Terrasana Cannabis founder and CEO. 

Both dispensaries are making changes and finalizing a game plan in preparation for the expansion.

“The hiring process will not start until we start construction, just because of the timeline,” Kedia said. “I don’t want people waiting on us to do the project for three to five months until it’s finalized. So, as we get to those time points in our game plan, we will hire appropriately and train everyone so everyone is on the same page and ready to go the minute we get the dispensaries, growing and processing facilities all open at the same time.”

RELATED: Harvest Care Medical Prepares to Launch Medical Cannabis Operations in West Virginia: The Starting Line

As for Harvest Care Medical, who won ten dispensary permits, along with cultivation and processing permits, the company is in the process of locking in its properties and is working with architects, engineers and general contractors, said Chief Development Officer Dustin Freas.

Although both dispensaries are getting ready for the expansion, they are unsure when their dispensary, cultivation and processing sites will officially open.

“Our plan is to have all six built out and open later this year, but between COVID and the wintertime, getting contractors to do the build-out has been a challenge,” Kedia said. “And now you have this mass influx of construction projects in West Virginia with everyone trying to build their dispensaries and processing centers, so finding good quality contractors to complete the project in a timely fashion is going to be a challenge.”

Harvest Care Medical is facing a similar challenge.

“We’re in the middle of a pandemic, so it’s not exactly business as usual,” Freas said. “Ordering supplies and equipment that you need could be on backorder, or a construction crew could get COVID, you know?”

Freas said the dispensary must have its grow site operational within six months from the day of the award with one 90-day extension, meaning he thinks that most cultivators who want to be the first to market patient access could have plants propagated by either May or June.

Both Freas and Kedia said one of the biggest challenges would be making sure the product is available and ready for sale when dispensaries open. 

“There is going to be a time lag between when cultivating facilities are constructed and when products are available,” Kedia said. “So, you plant the seed, and then by the time you actually harvest and market the products, it’s about a 10-12 week process. So, you don’t want to have the dispensary open, and then they have the expectation of having the product, and you don’t have anything on the shelves, so there’s a bit of juggling we are going to have to do to make sure this all lines up correctly.”

Additionally, one of the areas that Freas is trying to lobby and work hard on is increasing the patient count in the state, he said.

“There are currently 85 patients registered and certified for cannabis in the entire state of West Virginia right now,” Freas said. “And they’re not really letting doctors market the service, and the state’s not really putting any money behind it, but this isn’t uncommon.”

Freas said that he’s not indicating that West Virginia is dropping the ball, but it creates a back-end concern when opening ten dispensaries and the patient count is low.

However, Bill Freas, Harvest Care Medical CEO and Dustin’s father said that the cannabis commission in West Virginia has been more supportive than any other state they’ve worked with. 

“They really want this to succeed,” Bill said. “They are working with the people that run the applications, and they’re very receptive, and because of that, I think it’s going to be a lot less pain to get to market.”

Aside from challenges, Freas and Kedia said they are excited to become part of the West Virginia market.

Kedia, who has been a physician for the last 20 years in Ohio, said his first-hand experience with the opioid epidemic was challenging. It initially led him to want to be part of the medical cannabis market in Ohio.

“I really felt then, and I feel even more strongly now, that cannabis and medical cannabis, specifically, is a fantastic alternative to our opioid and pain medication our patients depend on,” Kedia said. “And I do think having this alternative is better for patients and better for patients care, and most importantly, better for the quality of life. So, that’s where I get excited because I can now do what I did for patients in Ohio for patients in other states like West Virginia.”

Kedia’s number one goal with the expansion is to help people, he said. 

“Yes, we need to make money to keep places open, we all have bills to pay, our company has bills to pay, but all that aside, our primary focus has to be centered around patients and their well being, and that is more important to me than anything else,” he said.

And Freas and his father, Bill, have similar expectations and goals for Harvest Care Medical and West Virginia patients.

“Our number one goal is to get quality medical cannabis medicine to the residents of West Virginia as quickly and as effectively as possible,” Bill said. “West Virginia has a lot of challenges. One of the big ones is their opioid crisis. We believe that medical cannabis can be a real help. With all the data supporting it, we’re seeing a real difference in reducing the use of opioids and transitioning people, and we’re very committed to helping people.”

In early February, the West Virginia Office of Medical Cannabis (OMC) announced the successful applicants to receive a medical cannabis dispensary permit.

RELATED: Medical Cannabis Dispensary Permits Announced in West Virginia

District Growers established itself in Washington, D.C., in 2012, part of a medical cannabis market that has grown steadily ever since. 

Founder and President Corey Barnette says that his extensive business background gave him a solid foundation for his entrance into the cannabis space. And now that he’s spent years here, navigating the cultivation side of the industry and monitoring broader trends in the U.S., he says that there are ways for business owners to challenge the working assumptions about social equity and market development.

While he may be in D.C., a smaller market than many of the larger states coming online, he points to the fragmentation of the U.S. cannabis space as a major problem.

“We have to build long-term relationships to build a stronger cannabis community among ourselves to be competitive and profitable for years to come,” he says.

Here, our recent conversation with Barnette helps illuminate that need.

Mila Marshall: You are one of the licensed industry’s few African American growers. How did you find yourself one of the few history makers in the cannabis industry?

 

Corey Barnette: I have a background in business and graduated from Duke School of Business. I had been strategically buying and selling businesses—like an automotive parts manufacturer, a clinical research company and other small businesses. In 2008, I was invited by a colleague to sit on the Board of the San Diego Medical Marijuana Collective, and subsequently ended up purchasing the company. After owning and operating that company I opened a second dispensary, Chi Holistic Collective.

My companies were two of the top 10 largest businesses in San Diego at the time, and, while that success was phenomenal, my family was based in Washington, D.C. The industry was just beginning and I was able to engage and help influence the market using my previous experience. When the Capital market began to move toward medical marijuana, I took advantage of the opportunity to help shape the market and opened District Growers.

California’s regulatory framework for cannabis and hemp-derived products, including CBD, continues to evolve, most recently via updated Proposition 65 warning requirements that came into full effect Jan. 3, 2021. As of that date, anyone offering for sale cannabis and hemp-derived products in California must provide an appropriate warning in accordance with the current regulations, with limited exceptions.

Noncompliance with the new regulations may result in government or private prosecution, with potential penalties of up to $2,500 per day for an alleged violation.

Proposition 65 Warning Requirement

California’s Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Prop. 65, requires the state of California to maintain an updated list of chemicals known to the state to cause cancer or reproductive toxicity.

Persons or companies who offer products for sale in California containing Proposition 65-listed chemicals must provide a “clear and reasonable” warning to the consumer (with limited exceptions) or face the prospect of penalties. Businesses usually choose to apply either the standard or “short form” default warnings provided in the Proposition 65 regulations, as these are deemed presumptively “clear and reasonable,” whereas any other warning language runs the risk of being challenged as noncompliant.

Prior Proposition 65 Requirement Limited to Smokable Cannabis

“Marijuana smoke” was added to the Proposition 65 list in 2009 solely as a cancer-causing agent. After that date, a cancer-specific warning was required for all smokable cannabis. In addition, if a cannabis product contained other Proposition 65 listed chemicals—such as certain heavy metals or pesticides—warnings for those chemicals were also applicable.

However, THC was not a listed Proposition 65 chemical. As such, no warning was required for non-smokable cannabis products, including edibles or hemp-derived CBD products, unless those products contained other listed chemicals.

Until recently.

READ MORE: What Should California Dispensaries Know About Prop. 65? 

New Chemical Listings Expand Warning Requirement, Including to Hemp-Derived CBD

On Jan. 3, 2020, the state of California agency that oversees Proposition 65 (the Office of Environmental Health Hazard Assessment, known as OEHHA) updated the Proposition 65 list to add “cannabis (marijuana) smoke” as a reproductive toxin causing developmental harm (in addition to the prior listing as a cancer-causing agent) and add Δ9-tetrahydrocannabinol (Δ9-THC) as a reproductive toxin causing developmental harm.

The one-year grace period to provide adequate warnings based on these new listings expired on Jan. 3, 2021.

As such, to avoid a potential claim of a Proposition 65 violation:

• persons offering for sale smokable marijuana should now be providing appropriate warnings that address both cancer and reproductive/developmental harm, and
• persons offering for sale any THC-containing products—including, but not limited to, edibles/concentrates/vapes and hemp-derived CBD products—should now be providing an appropriate reproductive harm warning.

It is important to note that the warning requirement applies to any products offered for sale as of Jan. 3, 2021, not just products manufactured or distributed to retailers after that date. Any items “on the shelf” (either physically or online) after Jan. 3, 2021 are subject to the newly applicable Proposition 65 warning requirements, regardless of packaging dates. Products sold online generally require online warnings at the website point-of-sale, in addition to warnings on the product itself.

The “Safe Harbor” Exemption for Low Levels of Exposure: Not So Safe

Proposition 65 does provide an exemption from the warning requirement if a business can demonstrate that the exposures caused by its product create “no significant risk” (if the chemical is listed as a carcinogen) or cause “no observable effect” (if the chemical is listed as a reproductive toxicant). However, it is very difficult for businesses to take advantage of this exemption in a cost-effective manner.

Even where OEHHA has set numeric “safe harbor” thresholds for listed chemicals, those thresholds only identify the volume of chemical per day that is considered safe for a person to be exposed to. Determining how that safe harbor number applies to use of a product containing the chemical requires a product-specific exposure analysis by a toxicologist or other qualified expert. 

An exposure analysis involves a number of complex factors, including the route of exposure (e.g., inhalation, skin contact, eating/drinking) and the amount of product to which the range of potential customers is exposed on a daily basis. 

For products subject to Proposition 65 because of the marijuana smoke or THC listings, this analysis is even more difficult, as neither chemical has an OEHHA-approved safe harbor threshold. As such, the toxicologist or other expert would need to propose such a threshold themselves, based on a review of the totality of available scientific evidence, as the starting point in their analysis.

Not surprisingly, exposure assessments are expensive and time-consuming. In addition, they often result in a determination that a warning is, in fact, required. Finally, even where the assessment would support use of the safe harbor exemption, the cost of defending use of the exemption in potential litigation with a governmental or private enforcer often outweighs the cost and burden of providing a warning.

Impact of New Requirements: Potential Legal Enforcement and Penalties

Persons violating the new Proposition 65 requirements could face enforcement actions by the California Attorney General, district attorneys or (in cities with populations of over 750,000) city attorneys. Importantly, even if government enforcement does not occur, penalties may also be sought by private “citizen” enforcers of Proposition 65, who are very active across California. In addition to seeking recovery of up to $2,500 per day of an alleged violation, enforcers may also seek recovery of their attorneys’ fees in prosecuting the action.

Citizen enforcers must serve a notice of the alleged violation at least 60 days prior to initiating an enforcement action in court. Anyone receiving such a notice should promptly seek advice from an attorney experienced with Proposition 65, with the goals of promptly:

• identifying and enforcing any potential right to defense and indemnification from another party in the chain of distribution for the product at issue;
• determining whether a viable defense to the Proposition 65 claim may exist: for example, businesses employing under ten persons are exempt from providing warnings (although such a business may have indemnified a party in the chain of distribution that is not exempt);
• if appropriate, negotiating a prompt settlement with the citizen enforcer, before the enforcer incurs attorneys’ fees to initiate a court proceeding at the expiration of the 60-day notice period.

For these reasons, anyone offering for sale cannabis and hemp-derived products in California should ensure they are implementing Proposition 65 warnings in accordance with the current listings and regulations, absent a strong technical and legal basis for asserting that an exemption applies.

Donald E. Sobelman is an environmental law partner in Farella Braun + Martel’s San Francisco office. He can be reached at dsobelman@fbm.com.

Wendy M. Hernández earned her law degree from UC Hastings and passed the California bar in 2020 (pending admission). Hernández currently works with Farella Braun + Martel LLP.

District Growers established itself in Washington, D.C., in 2012, part of a medical cannabis market that has grown steadily ever since. 

Founder and President Corey Barnette says that his extensive business background gave him a solid foundation for his entrance into the cannabis space. And now that he’s spent years here, navigating the cultivation side of the industry and monitoring broader trends in the U.S., he says that there are ways for business owners to challenge the working assumptions about social equity and market development.

While he may be in D.C., a smaller market than many of the larger states coming online, he points to the fragmentation of the U.S. cannabis space as a major problem.

“We have to build long-term relationships to build a stronger cannabis community among ourselves to be competitive and profitable for years to come,” he says.

Here, our recent conversation with Barnette helps illuminate that need.

Mila Marshall: You are one of the licensed industry’s few African American growers. How did you find yourself one of the few history makers in the cannabis industry?

 

Corey Barnette: I have a background in business and graduated from Duke School of Business. I had been strategically buying and selling businesses—like an automotive parts manufacturer, a clinical research company and other small businesses. In 2008, I was invited by a colleague to sit on the Board of the San Diego Medical Marijuana Collective, and subsequently ended up purchasing the company. After owning and operating that company I opened a second dispensary, Chi Holistic Collective.

My companies were two of the top 10 largest businesses in San Diego at the time, and, while that success was phenomenal, my family was based in Washington, D.C. The industry was just beginning and I was able to engage and help influence the market using my previous experience. When the Capital market began to move toward medical marijuana, I took advantage of the opportunity to help shape the market and opened District Growers.

California’s regulatory framework for cannabis and hemp-derived products, including CBD, continues to evolve, most recently via updated Proposition 65 warning requirements that came into full effect Jan. 3, 2021. As of that date, anyone offering for sale cannabis and hemp-derived products in California must provide an appropriate warning in accordance with the current regulations, with limited exceptions.

Noncompliance with the new regulations may result in government or private prosecution, with potential penalties of up to $2,500 per day for an alleged violation.

Proposition 65 Warning Requirement

California’s Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Prop. 65, requires the state of California to maintain an updated list of chemicals known to the state to cause cancer or reproductive toxicity.

Persons or companies who offer products for sale in California containing Proposition 65-listed chemicals must provide a “clear and reasonable” warning to the consumer (with limited exceptions) or face the prospect of penalties. Businesses usually choose to apply either the standard or “short form” default warnings provided in the Proposition 65 regulations, as these are deemed presumptively “clear and reasonable,” whereas any other warning language runs the risk of being challenged as noncompliant.

Prior Proposition 65 Requirement Limited to Smokable Cannabis

“Marijuana smoke” was added to the Proposition 65 list in 2009 solely as a cancer-causing agent. After that date, a cancer-specific warning was required for all smokable cannabis. In addition, if a cannabis product contained other Proposition 65 listed chemicals—such as certain heavy metals or pesticides—warnings for those chemicals were also applicable.

However, THC was not a listed Proposition 65 chemical. As such, no warning was required for non-smokable cannabis products, including edibles or hemp-derived CBD products, unless those products contained other listed chemicals.

Until recently.

READ MORE: What Should California Dispensaries Know About Prop. 65? 

New Chemical Listings Expand Warning Requirement, Including to Hemp-Derived CBD

On Jan. 3, 2020, the state of California agency that oversees Proposition 65 (the Office of Environmental Health Hazard Assessment, known as OEHHA) updated the Proposition 65 list to add “cannabis (marijuana) smoke” as a reproductive toxin causing developmental harm (in addition to the prior listing as a cancer-causing agent) and add Δ9-tetrahydrocannabinol (Δ9-THC) as a reproductive toxin causing developmental harm.

The one-year grace period to provide adequate warnings based on these new listings expired on Jan. 3, 2021.

As such, to avoid a potential claim of a Proposition 65 violation:

• persons offering for sale smokable marijuana should now be providing appropriate warnings that address both cancer and reproductive/developmental harm, and
• persons offering for sale any THC-containing products—including, but not limited to, edibles/concentrates/vapes and hemp-derived CBD products—should now be providing an appropriate reproductive harm warning.

It is important to note that the warning requirement applies to any products offered for sale as of Jan. 3, 2021, not just products manufactured or distributed to retailers after that date. Any items “on the shelf” (either physically or online) after Jan. 3, 2021 are subject to the newly applicable Proposition 65 warning requirements, regardless of packaging dates. Products sold online generally require online warnings at the website point-of-sale, in addition to warnings on the product itself.

The “Safe Harbor” Exemption for Low Levels of Exposure: Not So Safe

Proposition 65 does provide an exemption from the warning requirement if a business can demonstrate that the exposures caused by its product create “no significant risk” (if the chemical is listed as a carcinogen) or cause “no observable effect” (if the chemical is listed as a reproductive toxicant). However, it is very difficult for businesses to take advantage of this exemption in a cost-effective manner.

Even where OEHHA has set numeric “safe harbor” thresholds for listed chemicals, those thresholds only identify the volume of chemical per day that is considered safe for a person to be exposed to. Determining how that safe harbor number applies to use of a product containing the chemical requires a product-specific exposure analysis by a toxicologist or other qualified expert. 

An exposure analysis involves a number of complex factors, including the route of exposure (e.g., inhalation, skin contact, eating/drinking) and the amount of product to which the range of potential customers is exposed on a daily basis. 

For products subject to Proposition 65 because of the marijuana smoke or THC listings, this analysis is even more difficult, as neither chemical has an OEHHA-approved safe harbor threshold. As such, the toxicologist or other expert would need to propose such a threshold themselves, based on a review of the totality of available scientific evidence, as the starting point in their analysis.

Not surprisingly, exposure assessments are expensive and time-consuming. In addition, they often result in a determination that a warning is, in fact, required. Finally, even where the assessment would support use of the safe harbor exemption, the cost of defending use of the exemption in potential litigation with a governmental or private enforcer often outweighs the cost and burden of providing a warning.

Impact of New Requirements: Potential Legal Enforcement and Penalties

Persons violating the new Proposition 65 requirements could face enforcement actions by the California Attorney General, district attorneys or (in cities with populations of over 750,000) city attorneys. Importantly, even if government enforcement does not occur, penalties may also be sought by private “citizen” enforcers of Proposition 65, who are very active across California. In addition to seeking recovery of up to $2,500 per day of an alleged violation, enforcers may also seek recovery of their attorneys’ fees in prosecuting the action.

Citizen enforcers must serve a notice of the alleged violation at least 60 days prior to initiating an enforcement action in court. Anyone receiving such a notice should promptly seek advice from an attorney experienced with Proposition 65, with the goals of promptly:

• identifying and enforcing any potential right to defense and indemnification from another party in the chain of distribution for the product at issue;
• determining whether a viable defense to the Proposition 65 claim may exist: for example, businesses employing under ten persons are exempt from providing warnings (although such a business may have indemnified a party in the chain of distribution that is not exempt);
• if appropriate, negotiating a prompt settlement with the citizen enforcer, before the enforcer incurs attorneys’ fees to initiate a court proceeding at the expiration of the 60-day notice period.

For these reasons, anyone offering for sale cannabis and hemp-derived products in California should ensure they are implementing Proposition 65 warnings in accordance with the current listings and regulations, absent a strong technical and legal basis for asserting that an exemption applies.

Donald E. Sobelman is an environmental law partner in Farella Braun + Martel’s San Francisco office. He can be reached at dsobelman@fbm.com.

Wendy M. Hernández earned her law degree from UC Hastings and passed the California bar in 2020 (pending admission). Hernández currently works with Farella Braun + Martel LLP.

Editor’s Note: While CIJ typically omits the word “marijuana” where possible due to antiquated nomenclature and prejudicial connotations, we understand the legal distinction between cannabis containing THC and hemp requires the use of the word when referencing federal government policies and legislative language.

Despite the rapid evolution of the cannabis industry, the assurance of safe manufacturing practices remains unclear.Both the Food and Drug Administration (FDA) and the Drug Enforcement Agency (DEA) have imposed significant hurdles for cannabis operators to remain on the “right side of the law.” Therefore, manufacturers of both hemp and marijuana products have been left to figure things out on their own, or choose to ignore existing guidance because the lack of federal oversight allows them to do so. Inconsistent regulation on manufacturing, packaging, labeling and testing of cannabis products offers the potential for unsubstantiated, non-scientific and often times blatantly false claims on product safety and efficacy.

Science vs. Law

Hemp and marijuana are both species of the Cannabis family, Cannabaceae. Genetically they are identical but are arbitrarily defined by the presence of delta-9 tetrahydrocannabinol (THC). While science does not differentiate between hemp and marijuana, the law does.

The hemp industry declared a small victory with the passing of the Agricultural Act of 2014 (2014 Farm Bill). Under this bill universities and state agriculture departments were allowed to grow hemp under state law. Additionally, “industrial hemp” was officially defined by establishing the legal limit of THC at 0.3% on a dry weight basis. The Agricultural Improvement Act of 2018 (2018 Farm Bill), under the guidance of the United States Department of Agriculture (USDA), took things a few steps further by authorizing the cultivation of hemp and removed hemp and hemp seeds from the CSA. The bill however provides no language that mandates the safe manufacture of hemp-derived consumer goods. The 2018 version also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FFDAC). To the surprise of most, listing cannabidiol (CBD), even hemp-derived, as an ingredient on consumer product labels remains illegal under the bill. Furthermore, CBD product manufacturers are not protected under the current regulations. Since 2015 the FDA has issued warning letters to firms marketing CBD products as dietary supplements and/or foods, and in December 2018, FDA declared it illegal to introduce food containing CBD (or THC) into interstate commerce, regardless if it derived from hemp. To date, the only FDA approved CBD product is GW Pharmaceutical’s Epidiolex.

Marijuana remains classified as a Schedule I controlled substance under the CSA. 36 states have approved comprehensive, publicly available medical marijuana programs, and now 14 states have approved adult use programs, with New Jersey passing legislation on February 22, 2021. However, the industry has seen minimal movement toward mandating GMP requirements in the marijuana market. Only a handful of medical programs require manufacturers to follow GMP. Furthermore, the requirements are inconsistent between states and the language in the regulations on how to approach GMP implementation is vague and disjointed. This fragmented guidance supports the complexity and difficulty of enforcing a coherent, standardized and reliable approach to safe manufacturing practices.

What is GMP and Why Should You Care?

Good Manufacturing Practices (GMPs) are a system for ensuring that products are consistently manufactured and controlled according to quality standards and regulatory guidelines. The implementation of a GMP compliant program ensures consumer health and safety, allows manufacturers to understand the intended use of their products, allows manufacturers to defend product specifications as being appropriate, considers the risks to vulnerable populations and minimizes overall business risk. In a nutshell, GMP equals product safety and quality, and defines the responsibilities of the manufacturer to ensure consumers are protected from the distribution of unsafe and ineffective products. Currently, the GMP “landscape” in the cannabis space is complicated. The various “flavors” (food, dietary supplements, cosmetics and drugs/devices) of GMP leave many confused and frustrated when making the decision to implement GMP. Confusion is a result of unclear regulatory requirements as well as operators not fully understanding how to classify or designate the end use of their product(s). Implementing an effective GMP program requires proper planning (both short and long term), financial commitment and qualified resources.

Where Should You Start?

As the regulatory landscape continues to evolve and mature in the cannabis space, your business model must consider GMP implementation if you wish to remain successful and sustainable.

Intended Use

Before you can implement GMP you must first understand what GMP regulations apply to the intended use of your product(s). Are you manufacturing food, beverages or dietary supplements? Get acquainted with the FDA Code of Federal Regulations (CFRs) on GMP. 

Conduct a Gap Assessment

A gap assessment allows you to determine your deficiencies in relation to GMP compliance. The assessment should include, but is not limited to facility design, equipment design, supply chain, risk management and employee training.

Develop an Action Plan

Once the gap assessment is complete a comprehensive action plan will be developed to map out the steps required to achieve GMP compliance. The action plan should follow the SMART Goal principles:

• Specific (simple, well-defined)
• Measurable (meaningful)
• Attainable (achievable, agreed upon)
• Relevant (resource-based, reasonable and realistic)
• Timely (time-based, defined due dates)

The plan will include prioritized deliverables, due dates and allocated resources in order to strategically plan and execute and complete the required tasks.

Schedule a Mock GMP Inspection

A mock inspection verifies that the action plan was adequately executed. Hire an experienced resource familiar with related GMPs and QMS to conduct the inspection. A successful mock inspection is a perfect litmus test if the end goal is to achieve GMP certification.

Cannabis manufacturers that ignore the obvious progression toward an FDA-like industry will not survive the long game. Those that embrace the momentum and properly plan to mitigate product and business risk – those who demonstrate integrity and are truly in this space to ensure safe, effective and quality products to consumers will come out on top, gain credibility and secure brand recognition.

References:

• 21 CFR Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
• 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and the Food Safety Modernization Act (FSMA).
• 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General.
• 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.
• 21 CFR Part 700, Subchapter G-Cosmetics.
• 21 CFR Part 820, Subchapter H-Medical Devices; Quality System Regulation
• Congressional Research Service, FDA Regulation of Cannabidiol (CBD) Products, June 12, 2019.
• United States Food and Drug Administration-Warning Letters, Current Content as of 02/19/2021.

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