Cannabis laws and the resulting policies across the United States are changing rapidly. As of June 2021, 36 states and 4 territories have legalized cannabis for medical use. 18 states, two territories and the District of Columbia have legalized cannabis for adult use. Yet cannabis remains illegal under federal law. This regulatory contradiction creates a significant problem: inconsistent, disjointed, and absent cannabis regulations that severely increase the risks to the health and safety of patients and consumers. Regulators need solutions to resolve this contradiction.
The Regulatory Reality
- Public acceptance of cannabis has forced legislators and regulators to play catch up as one of America’s fastest growing industries innovates and adapts faster than first-generation regulations.
- The absence of standards in any other industry such as pharmaceutical, automobile, tobacco, alcohol, agriculture is unacceptable. Cannabis is no different.
- Inconsistent and often disjointed cannabis regulations pose clear health and safety risks to the entire cannabis supply chain.
- Policymakers and agencies responsible for regulating the new cannabis industry are faced with creating a comprehensive regulatory structure and assuring the compliance of an increasing number of entities and products
- Those same policymakers and agencies do not have corresponding growth in agency resources.
- Consensus standards, in any industry, typically come before regulation and serve as a guide for regulatory policies.
FOCUS provides comprehensive cannabis-specific voluntary consensus standards that cover the entire supply chain.
Since 2016, FOCUS has worked with the Association of Food and Drug Officials (AFDO) to provide regulatory and industry solutions based on our voluntary consensus standards. FOCUS standards, which span the entire spectrum of the cannabis industry supply chain – cultivation, manufacturing, laboratory, and retail – were developed using existing international quality and safety guidelines, and US Code of Federal Regulations requirements for pharmaceuticals, nutraceuticals, food safety, and agriculture.
FOCUS Standards for cannabis are comprehensive, complete, and available to incorporate into your regulatory framework today. If you are interested in obtaining a full copy of FOCUS Standards, please email Lezli@focusstandards.org. We are proud to provide them for your use at no cost.
Regulatory leadership in cannabis is a global necessity that FOCUS has been filling for years. The domestic cannabis industry is significantly more advanced in terms of production, supply chain, and product availability than any foreign industry. All areas of the industry have been hampered by the lack of American regulatory development, but foreign jurisdictions are emerging with regulations to meet local needs. Most would prefer to follow US standards and regulatory leadership, especially with respect to the perceptions of compliance with international treaties. Regulatory leadership is a clear benefit to the entire domestic and international cannabis supply chain.
FOCUS works with the Association of Food and Drug Officials (AFDO) to provide regulatory and industry training on the cannabis supply chain, quality, and safety. Now, with clear national public support for cannabis consumption, we are proactively supporting the efforts of regulators and policymakers by providing you with our voluntary consensus standards to use as a development tool for your jurisdictional needs.
How FOCUS Standards Can Be Utilized
- Relieve regulatory authorities of the need to devise new, detailed, or complex requirements relating to materials, processes, design considerations and criteria, technical procedures, test methods, etc.
- Permit detailed technical requirements to be embodied into the text of a regulation simply by referencing a standard or the relevant parts of a standard
- Simplify and accelerate legislative work and lower costs to government in developing and enforcing regulations
- Reduce the number of pages of regulations and make them more manageable
- Promote uniformity of technical requirements – as standards that provide the basis for certification, technical requirements can be equitably applied
- Improve responsiveness of regulators to public concerns
- Avoid duplication of efforts and optimize the use of scarce standards resources by taking into consideration the results of international standardization work
- Facilitate elimination of barriers to trade by referring to recognized national standards which have been harmonized internationally
- Improve public acceptance of regulations when there is endorsement of existing voluntary standards.
Foundation of Cannabis Unified Standards | Established 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 is a federal 501c3 not-for-profit organization that develops international, cannabis-specific, voluntary-consensus standards and provides third-party certification for cannabis industry operators and regulators alike; ensuring only safe, consistent, quality cannabis products are available in the marketplace.
FOCUS Regulatory Services
FOCUS works with the public sector to provide dynamic, customized solutions that meet clients where they are and prepares them for the future. As an unbiased, third-party Cannabis Health and Safety Organization, FOCUS has been defining the role of regulatory leadership in cannabis for years.
Agencies responsible for regulating cannabis are faced with assuring the compliance of an increasing number of entities and products, often without a corresponding growth in agency resources. Standards-based regulations and third-party certification are a proactive approach to regulations that improve the efficiency and resiliency of a regulatory system. They help establish a new regulatory program quickly, lowering costs for developing and enforcing regulations. Inspection and monitoring strain agency budgets. Third-party certification leverages private resources and expertise to improve inspection. Standards-based certification also provides more complete and reliable health, safety, and compliance data collection reducing the regulatory burden. By integrating third-party assessments, regulators can be confident that claims of conformance are legitimate in relation to products, processes, services, management, and personnel.
FOCUS offers services to assist public agencies with cannabis program development, implementation, ongoing management, and program evaluation. FOCUS provides audit training, research, communication, and planning support for agency staff, regulators, legislators, and non-governmental groups.
Among our strengths:
- Program Management – FOCUS partners with government agencies to develop, implement, and manage cannabis safety and quality programs at the federal, state, county, and local levels. Program options range from statewide management of cannabis safety and quality programs or certification programs to specialized workshops, custom research, and third-party inspections. Our solutions include systems, processes, and people to ensure stable, compliant cannabis programs.
- Process Design – Standards enhance license application processes, add value to agency audits, investigations, and corrective action management, build staff skills and knowledge, and keep staff current on regulatory changes. FOCUS designs processes to help manage cannabis requirements and build credibility for agency programs.
- Training Programs – FOCUS provides on-site and electronic training programs to support standards implementation and stakeholder commitment. FOCUS delivers standard programs or will customize a program for your requirement.
- Auditor Training – FOCUS auditor training and certification gives auditors or contractors the required cannabis safety, quality, regulatory, and operations knowledge to conduct effective onsite audits. Our process supports all phases of the audit process including pre-reviews, licensing audits, annual renewal audits, for-cause audits, and corrective action management.
- Risk Assessment – Certified auditors work with your team to develop and conduct an intensive assessment of all risks to your agency, organization, or public constituents. The outcome provides valuable information and direction for planning, response, and prevention.
- First Responder Training – Public safety, paramedic, medical and hazardous materials teams learn how to respond to emergencies involving cannabis operations including cultivation facilities, high-pressure processing equipment, chemicals, security protocols, and property protection.
- Consulting – The FOCUS team includes a range of versatile professionals experienced in all aspects of the cannabis business including management, regulatory, cultivation, production operations, laboratory and testing, product management, packaging and labeling, worker safety, security, and sustainability. We bring immediate value to any project and will customize a work plan that meets your objectives.
- Standards Licensing – Certified standards improve the quality and safety of products and services, and licensing the FOCUS standards demonstrates a commitment to a safe, quality cannabis program. Licensing includes management training, technology systems tools, auditor certification, process implementation, and ongoing support.
- Legislative Briefings – Cannabis laws are changing rapidly, and our extensive network of legislative, agency, legal, medical, lobby, research, and industry experts maintains a database of the latest cannabis legislative action. We provide legislative overviews, conduct focused research, or host forum events to ensure your organization is fully informed of the current and anticipated state of cannabis.
- Facilitated Workshops – In this emerging industry, groups constantly need information, education, planning, and networking to meet increasing legislative, regulatory, and public demand. Our dynamic facilitators design and facilitate seminars, workshops, and other events to meet organization goals and leave lasting value with stakeholders.
The combination of government regulation with standards and third-party certification achieves the needs of both industry and regulators by protecting public health and establishing a strong foundation for industry growth.
FOCUS GMP Certification
Certification in any industry provides stakeholders with information essential to maintain regulatory compliance, ensure manufacturing specifications, effectively apply risk management principles, and objectively assess a company’s products, systems, and processes. Certification is a confirmation from an independent, competent, and accredited agency that an organization meets and adheres to the requirements of an internationally recognized quality management system standard. A management system is a systematic framework designed to manage an organization’s policies, procedures, and processes and promote continuous internal improvement. Management systems enable organizations to meet challenges by implementing standards and validating, through certification, that they are appropriately established and followed throughout all aspects of a business. In other industries, companies like NSF, SQF, and BSI offer management system certification. FOCUS is the first cannabis-specific organization to provide a cannabis-specific management certification.
FOCUS Certification is a partnership designed to build confidence in the competence of a cannabis business to produce safe, high-quality, consistent products. Certification provides all stakeholders – industry, regulators, law enforcement, patients, consumers, and the general public – the assurance that a cannabis business complies with the technical requirements within FOCUS Standards. Certification involves the successful implementation of preventative steps throughout a cannabis organization to help assure operations run as efficiently as possible while minimizing costs and reducing liability. Certification is a proactive way for cannabis businesses to meet legal and regulatory obligations, as well as the needs of customers.
FOCUS Standards Update
We will be conducting a comprehensive update to FOCUS standards, as well as developing additional standards, beginning Q4 2021. If you are interested in participating in the standards update or development, please email firstname.lastname@example.org. All email inquiries will be contacted as the project launch date gets closer.