Kim Stuck

Articles

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.

Update from the FDA: Not Adopting Existing Regulations for the CBD Industry

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.

Creating a Culture of Compliance in the 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. 

Psilocybin Rule Update: Oregon’s Newly Released Regulations

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. 

Entheogens and What Future Compliance May Look Like

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.

Cannabinoid Isomers Such as Delta-8: Navigating Regulations and Safety Concerns

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 to Expect with Product Recalls 

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?

Why cGMP Certification Matters in the Cannabis Industry

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. 