By Lezli Engelking
Hearing about the lack of standards in the cannabis industry comes as quite a surprise to most. After all, cannabis is one of the most highly regulated industries in existence today. Complicated terminology and varied definitions, however, often confuse the difference between standards and regulations.
While more than half of the United States currently permits cannabis for medical or adult use, it continues to remain illegal under federal law. This regulatory contradiction creates a significant problem: inconsistent and disjointed cannabis regulations that severely increases risk to the health and safety of consumers.
Regulations are detailed instructions issued by regulatory bodies or public authorities on how laws are to be carried out or enforced. Regulations are sometimes referred to as “rules” or “administrative laws.” They carry the force of law – their application is mandatory.
Standards are an agreed upon way of doing things. A standard is pre-determined criteria for a given situation. Standards make things work by providing guidelines or requirements for products, services and systems. They are not good or bad, but provide a basis to measure and assess activities and things.
Standards guide our daily lives and help us make informed decisions. For example, standards ensure that film can be purchased anywhere in the world to fit our cameras, a light bulb will fit a socket, banks can read our ATM cards all around the world, and plugs for electrical appliances fit into outlets. With standards, our homes, workplaces and public buildings are safer from collapse, fire and explosion.
“The U.S. Department of Commerce estimates that standards and conformity assessment impact more than 80% of global commodity trade.” United States Department of Commerce, Standards and Competitiveness – Coordinating for Results. Washington, DC May 2004
Most people are accustomed to the use of “safety” standards, especially in consumer products. These guidelines provide assistance in evaluating and using products. When we know that an item complies with normal safety standards, we accept the product has been objectively measured according to agreed upon safety criteria. We are then assured in our use of the product that we are not put at unusual risk.
In other industries, agencies that control licensing for the manufacture and sale of a product recommend Good Manufacturing Practices (GMP). These guidelines provide minimum requirements that a manufacturer must be certified as meeting, to assure that products are of high quality and do not pose any risk to the consumer or public. GMP guidelines generally become the basis of regulations. In the United States, Food and Drug Administration (FDA) mandates any food, drug or pharmaceutical related business receives annual certification by a third-party to confirm conformance with GMP guidelines and assure the production of safe, consistent, quality products.
According to the World Health Organization, Good Manufacturing Practices (GMP) is a system for ensuring that products are consistently produced according to quality standards. GMP is the proactive part of quality assurance, designed to minimize the risks involved in all steps of the manufacturing process. A basic tenet of GMP is that quality cannot be tested into a product. It must be built into each batch of product during all stages of the manufacturing process. GMP involves much more than most people think. A common misconception is that GMP only covers the process of manufacturing itself. GMP actually covers all aspects of the production process.
- Record Keeping
- Staff Training
- How Complaints Are Handled
- Product Development
Because cannabis remains illegal at the national level, none of the federal agencies that would normally develop Good Manufacturing Practice guidelines have done so. Forcing state lawmakers and business owners to navigate this new, rapidly developing industry without uniform guidance. The result is U.S. cannabis regulations that attempt to protect health and safety, and control for product quality in a reactive manner through the mandate of laboratory testing.
While testing is an important part of any quality management program, it is only one aspect of quality assurance. Testing is a reactive process, leaving multiple opportunities for unsafe products to reach the market. Quality control through testing alone also has the potential to dramatically drive up costs and increase liability, which can be catastrophic to small business owners. The implementation of comprehensive cannabis-specific GMP Guidelines, like FOCUS Standards, across all aspects of the industry will assist business owners and regulators alike in proactively addressing quality at every step in the process. This is critical to protecting consumer safety and public heath – and the overall success of a nascent industry like cannabis.
FOCUS is a non-profit, 501(c)(3) organization that develops international, cannabis-specific standards and third-party certification for the cannabis industry to protect public health, consumer safety, and safeguard the environment. FOCUS is the only organization to create voluntary-consensus standards suitable for accreditation and adoption into regulations by assuring impartiality, balance and transparency in the development process. Unlike most standards-setting organizations, FOCUS does not accept dues or fees for standards development. FOCUS is not a regulatory agency or industry trade association. This autonomy fosters a principled, objective environment in which comprehensive standards can be developed. FOCUS Standards provide current good manufacturing practice (CGM) guidelines for all key areas of the cannabis industry including Cultivation, Retail, Extraction, Infused Products, Laboratory, Security, Sustainability, and Packaging & Labeling.