Blogs | Stuck on Compliance

The recent release of the Senate's draft for the 2024 Farm Bill could reshape how this versatile crop is cultivated, processed, and regulated.

Inconsistent testing is a significant issue in the cannabis industry, contributing to fears about potency inflation and product safety. However, adopting cGMP compliance offers a clear solution by implementing standardized testing protocols, comprehensive batch testing, and rigorous third-party verification.

As we approach a pivotal election, the cannabis industry finds itself at a crossroads. If federal legalization passes, cannabis could be reclassified from a Schedule I to a Schedule III drug. This shift would remove many barriers for businesses and consumers, opening the door to broader acceptance and regulation. However, this potential change also stirs up concerns among those opposed to cannabis, who fear its legalization could lead to unchecked risks for public health and safety.

Interstate commerce is a crucial aspect of the modern economy, allowing goods and services to move across state lines, fostering economic growth, and enabling businesses to reach wider markets. In the context of the hemp and tetrahydrocannabinol (THC) cannabis industries, interstate commerce presents unique challenges and opportunities, shaped by a complex web of federal and state regulations. This blog explores how the hemp industry handles interstate commerce from a compliance perspective and speculates on what the landscape might look like if THC cannabis becomes federally legal and interstate commerce is permitted.

The Colorado Department of Public Health and Environment (CDPHE) now regulates certain hemp manufacturers. Here’s how to prepare for compliance inspections, which may become a trend to more states beyond Colorado.

Cannabis companies can face recalls due to issues like unhealthy levels of molds, yeasts, pesticides, and heavy metals, making it crucial to minimize recall chances and follow proper protocols to prevent fines or lawsuits.

The proposed rescheduling of cannabis holds profound implications for the industry, affecting everything from research and taxation to banking and market dynamics.

There have been a few changes when it comes to Organic Certification that you might not know about, so I’ll be dedicating this month’s blog to a certification opportunity for the hemp industry.

In a big new move for Colorado, towards the end of 2023, the state approved a new set of hemp regulations that includes tighter restrictions over hemp derived cannabinoids, which were met with both pushback and acceptance from the industry.

At this moment I am in Barcelona, Spain for one of the biggest cannabis conventions in the world: Spannabis (1). I feel I would be remiss if I didn’t write my blog this month without touching on international legalization of cannabis and how that would affect the United States market.

The landscape of the cannabis industry is dynamic and continually evolving, so who is to say exactly how they will be enforcing or regulating cannabis if it does get rescheduled, but we can learn from what we have seen in the past and what we are hearing in the back rooms of regulatory agencies. This could be a significant shift that could reshape the industry. This change would signify a recognition of its medicinal value, open doors for new opportunities, and also have some consequences for companies not prepared for the shift. In this blog, we explore the potential implications of cannabis becoming a Schedule III substance and why obtaining current Good Manufacturing Practices (cGMP) 211 Certification from an accredited certifying body is crucial for ensuring the longevity and success of cannabis businesses. What we don’t know at this time is what kind of runway we have in implementing these new standards to be compliant with them. They could give 30 days or one year, but we just won’t know until it happens. The best thing you can do for your business now is become compliant with these standards before you are required to be so.

In recent years, the cannabis industry has experienced a significant shift in public perception and legal landscape. One of the key factors influencing this change is the reconsideration of the scheduling of tetrahydrocannabinol (THC), the intoxicating compound found in cannabis, by regulatory authorities. Currently classified as a Schedule I controlled substance in the United States (US), THC's rescheduling to Schedule III could have profound effects on the cannabis industry. In this blog, we analyze the many potential implications of such a change, focusing on the medical, economic, and societal aspects of the cannabis market.

The cannabis industry has experienced a paradigm shift over the past few years, with legalization sweeping across various states. As the market expands, so does the need for stringent quality control and testing measures to ensure the safety and efficacy of cannabis products. In this blog, we delve into the critical importance of quality control in the cannabis industry, focusing on testing requirements for potency, contaminants, and other quality measures. Additionally, we explore the dynamic landscape of testing standards, highlighting any recent updates or changes that businesses and consumers should be aware of.

Compliance is important, especially when incentives are involved. “Incentives” are things that motivate or encourage us to do something. We are constantly surrounded by opportunities and incentives, whether it be to enhance our personal lives or business health. Creating a vigorous and sustainable business will always include compliance nuances, especially within the cannabis and psychedelic industries.

In recent years, the cannabis industry has experienced rapid growth and legalization across various regions. With this surge in popularity comes a greater need for transparency and accountability throughout the supply chain. Traceability in cannabis facilities is not just a buzzword; it's a critical aspect that can make or break the industry's reputation and ensure consumer safety. In this blog, we'll explore the importance of traceability in cannabis facilities and why it's crucial for the industry's long-term success.

Aspergillus is a genus of mold that is commonly found in the environment, including soil, plants, and decaying organic debris. In fact, there are several hundred species of Aspergillus! Aspergillus species produce aflatoxins, which are a family of mycotoxins produced by certain fungi. These aflatoxins are known as cancer-causing substances and pose a dangerous threat to humans and livestock. Although this type of mold is commonly grown underground, the release of its spores into the air is the route of the problem in terms of contaminated product. Given there are many species of Aspergillus that are not harmful, a select few can cause life threatening issues. We aim to cover short Aspergillus topics in hopes to educate and clarify conversations surrounding this fascinating fungus. As cannabis products become increasingly popular for both medical and recreational purposes, understanding the potential health issues associated with Aspergillus contamination is crucial.

Selecting a co-manufacturer for product manufacturing can be a tough decision. Using a co-manufacturer is an interesting combination: it is your brand and reputation, yet another company makes the product. Because quality and product safety is out of your control, companies must select their co-manufacturer wisely. If you choose the wrong manufacturer and something goes wrong, it is your brand that will be affected negatively. The worst things to happen to a brand are making a consumer sick, going through a recall, or losing reputation due to poor quality assurance. Below are a few steps to help companies confidently select a co-manufacturer.

Third party certifications have become increasingly popular amongst cannabis and fungi cultivators and manufacturing companies. Receiving and maintaining certifications is a worthwhile endeavor that will set up your business for long term success, give you a competitive edge, and ensure a safe product for customers. Whether you’re seeking organic, current good manufacturing practices (cGMP), good agricultural and collection practices (GACP), International Organization for Standardization (ISO) and other certifications, you will be tasked with deciding which certifying body to work with.

Consumers want options, especially when purchasing products, and organic seems to be a popular selection. It makes sense really: people eat all organic foods, why wouldn’t you want your cannabis to be organic too? Organic items are widely available and can be purchased at any grocery store, farmers market, and online. Most people associate “organic” with healthy foods that were grown using safe and sustainable agricultural methods and fewer chemicals. Organic certified products are typically pricier compared to conventionally grown crops—this can be attributed to the cost of the organic certification from an accredited third party, required use of costly organic approved chemicals, special handling practices, potential lower yield, lack of government subsidies, and so on. With organic products being sold at a higher price than conventional products and with the high consumer demand for organic products, does this combination open the door to fraud?

The cannabis industry has experienced rapid growth over the past few years with the legalization of both medical and recreational cannabis use in numerous countries and states in the US. As the industry expands, the need for effective packaging and proper labeling has become increasingly important to ensure consumer safety, brand recognition, and compliance with regulations. Let’s explore the significance of packaging and labeling in the cannabis industry and discuss the key considerations for businesses operating in this space.

Workplace safety procedures help companies be the best they can be, especially when it comes to ensuring your staff goes home the same way they arrived. These are just a few ways to begin your safety journey!

This blog is in response to the January 26th, 2023 announcement from the Food and Drug Administration (FDA) in regards to regulatory oversight in the cannabidiol (CBD) market.

Creating a “culture of compliance” is a buzz phrase that you have probably heard before when speaking to regulators, lawmakers, auditors, and compliance consultants. At Allay Consulting, we have worked with a multitude of companies, and we have found that creating a compliance culture alone is not enough to keep your employees happy enough to follow all compliances. I would argue that creating a “culture of excellence” that includes compliance is the best way we have seen to mitigate risk and decrease revenue lost due to employee turnover and lack of employee engagement. This article is meant to encourage our industry to create a culture of excellence at the workplace. I hope our tips and hands-on experience shed light into creating the culture you want at your workplace.

The beginning of 2023 will be a huge step to the US’s legalized psilocybin industry! Oregon Psilocybin Services (OPS), a new section housed within the Oregon Health Authority (OHA), will begin accepting license applications January 2, 2023. Oregon’s legalization and implementation of regulations will take three years altogether—several years may seem too long for the legalized psilocybin roll out, but better late than never. This should give the department plenty of time to draft, edit, edit some more, then implement the nation’s first regulatory framework for psilocybin.

Psychedelics, also known as entheogens. Everyone has an opinion. From the superb kaleidoscope shapes, or making that concert even more memorable, or to digging a bit deeper within yourself for self-healing—entheogens can be a game changer. For some, these experiences are life changing, especially if it means improving well-being and life satisfaction. Thanks to many published clinical trials, the benefits of using entheogens such as psilocybin include reducing anxiety and depression, successful addiction interruption, post-traumatic stress disorder (PTSD) treatment, and many others. With increased awareness of the benefits of psilocybin and other entheogens, we are observing an acceptance of entheogens followed by decriminalization and future legalization.

Delta-8 and delta-10 have gained considerable traction over the past year. Although these cannabinoid isomers fall in an extreme grey area, consumers are driving up demand. They can be purchased in many different forms and are commonly found in vaping products, gummies, and tinctures. Since these isomers are commonly derived from hemp extract, many consumers see delta-8 and delta-10 as a lawful hemp-derived good that provides a psychoactive effect. Per a new stance from the federal government, vaping products with these isomers fall under the 2018 Farm Bill. Even with the Food and Drug Administration’s (FDA) stance regarding the 2018 Farm Bill exempting hemp from the Controlled Substances Act (CSA), the popular edible cannabinoid isomers are not automatically legal.

In the cannabis industry there seems to be a misconception that your company will never have a recall in its lifetime, or that there isn’t any possibility it will ever happen to you. In reality, all cannabis companies experience at least one or multiple recalls during their lifetime. It isn’t about if it will happen, it’s more of a when. And when it happens, how will your company handle it?

What are current good manufacturing practices (cGMP) certification and why get it? It takes a lot of time, it’s hard work, and can be expensive to become cGMP certified, so why be interested in something that isn’t yet required?

Terpenes can be tricky. Although cannabis is heavily regulated, since cannabis-derived terpenes do not contain tetrahydrocannabinol (THC) and other cannabinoids, they are not regulated in the same way that cannabis is.