Because it was my name on the license, I chose to handle all complaints, comments, suggestions, and grievances, to keep my finger on the pulse of the company. What I discovered was incredibly inspiring, and, at the same time, terrifying. Inspiring because of the amazing success stories I was hearing daily about how much cannabis had improved people’s lives. Terrifying because I realized there were no protections for health and safety around this product that was being used as a medicine by people with compromised immune systems. Coming from a highly compliance driven background like pharma, I quickly realized there was no way for the cannabis industry to succeed without quality and safety standards to address public health and consumer safety concerns.
In most industries, agencies that control licensing for the manufacture and sale of a product recommend Good Manufacturing Practices (GMP) to ensure products are consistently produced according to quality standards. GMP provides minimum requirements that operators must meet to assure products are of good, consistent quality, and do not pose any risk to the consumer or the public. Because cannabis is federally illegal, no such guidelines exist for cannabis. State cannabis regulations only address who, what, when, where and why...
Who - can buy, sell, and grow cannabis
What - types of cannabis products that can be made
When – times cannabis is allowed to be sold
Where – location of cannabis facilities
Why - reasons (or conditions) cannabis is allowed to
be used
The only attempts to protect for quality and safety within state regulations was done through the mandate of laboratory testing. While testing is an important part of any Quality Management Program, it is only one
part of Quality Control. Testing is a reactive process, that leaves multiple opportunities for unsafe product to reach the market.
This realization, combined with my firsthand experience in the cannabis industry, compelled me to try and change things. My first step was reaching out to trade associations within the industry to assure I wasn't duplicating efforts. Once confirmed, I began my education on standards and certification. I researched existing organizations that provided these services, such as the hospital accreditation program, The Joint Commission. While that name certainly seemed applicable to the cannabis industry, the business model did not fit.
During my research, I learned of the organization Commission on Accreditation of Rehabilitation Facilities or CARF International (CARF). Established in 1966, CARF is an independent, non-profit accreditor of health and human services. The CARF business model piqued my interest because of their role in providing standards, certification, and training to methadone clinics.
During the 90's, as the heroin epidemic swept throughout the US, methadone clinics had popped up all over the country. These clinics were operating under all different state and municipal regulations, without any consistency, and no real protection for health and safety - much like the cannabis industry today.
Federal officials realized something needed to be done to protect consumers and the public. A report was put together suggesting that existing FDA process-oriented regulations should be reduced in scope to allow greater reliance on guidelines and clinical judgment. The report recommended a single inspection format, conducted by one agency, that serves all agencies (Federal, State, and local). In response, the Substance Abuse and Mental Health Services Administration (SAMHSA), proposed a certification system by a non-profit entity, requiring all dispensers of methadone to complete certification stating they meet the standards and will comply with them.
Eventually, final rule (21 CFR part 291 and 42 CFR part 8) was released, along with an RFP seeking a non-profit organization to provide these services. CARF is the organization that answered and won that RFP, and is still under contract with Health and Human Services (HHS) to provide those services today. With some small modifications to meet the needs of the cannabis industry, CARF's role with the methadone clinics became the basis of the FOCUS business model.
Founded in 2014, Foundation of Cannabis Unified Standards (FOCUS) was established as the first and only Cannabis Health & Safety Organization, to address the many shortcomings in quality, safety, and consistency that became evident with the explosive growth of the global cannabis industry. FOCUS develops international, cannabis specific, voluntary-consensus standards and third-party certification for the cannabis industry to protect public health, consumer safety, and safeguard the environment.
To eliminate any potential conflict of interest and assure impartiality, FOCUS was established as two independent organizations. The first, a federal, 501(c)(3), not-for-profit organization, is responsible for the development of cannabis specific voluntary-consensus standards and unbiased education. The second, a Delaware C Corporation, is responsible for providing third-party, certification and related services to cannabis businesses and regulatory agencies. Each organization has additional controls built into its corporate structure to abolish any suggestion of impropriety and protect the integrity of FOCUS Standards and Certification.
FOCUS is not an advocacy organization or industry trade association, nor do we accept membership dues or fees. FOCUS is not a cannabis company, and has no financial stake in the cannabis industry. To assure the protection of public health and consumer safety always remain the driving factor behind everything FOCUS does, and avoid any ethical dilemmas, I chose to fund FOCUS myself. This autonomy distinguishes FOCUS from all other organizations in the cannabis space, and fosters a principled, objective environment to develop comprehensive standards and third-party certification for the cannabis industry. FOCUS standards are GMP for the cannabis industry that cover Cultivation, Retail, Manufacturing, Laboratory, Security, Sustainability, and Packaging & Labeling. To learn more, or for certification inquiries, please visit www.focusstandards.org.
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