The cannabidiol (CBD) industry is quite novel. The chemical, extracted from hemp, became legal in 2018 when the Farm Bill legalized the cultivation and sale of industrial hemp and its extracts. Just a year later, the sector is worth millions in sales, and experts predict it will hit $20 billion by 2024.
However, the industry’s monumental growth has also been its biggest weakness. Normally, new products have to go through a rigorous testing process before hitting the shelves, but CBD skipped that step. By the time the sector was filled with thousands of products, regulatory authorities were scrambling to catch up.
Now, the U.S. Food and Drug Administration (FDA) is actively taking steps to regulate the runaway industry. The agency has collaborated with a health and wellness research company to help collect consumer data on CBD use.
ValidCare, a centennial, Colorado-based cannabis-focused health and wellness company will lead an industry-sponsored liver toxicity study to deliver aggregated real-world experience data that will help answer federal health officials’ safety concerns about cannabidiol.
The company developed a consumer app, CBD+me to collect consumer experiences with CBD, and presented the initial data to federal authorities responsible for regulating CBD in December. ValidCare is now partnering with 10 CBD companies for the next phase whose results will be delivered to the FDA in the coming months.
The ten brands will sponsor the study at a cost of $150, 000 each, making it much more affordable than it would have been. “No one has $50 million to do a study. It’s not realistic,” says ValidCare CEO Patrick McCarthy. He says that the FDA has indicated that it needs liver toxicity data to move forward on regulating CBD.
The study will run from the end of March through June, and it will aggregate data from roughly 1,000 people over a 4-8 week period. Every participant will take a blood test at the start and end of the test, and they will journal their experiences with CBD on the CBD+me app.
According to McCarthy, they will also collect prior use attestations from participants to help them gauge long term exposure.
The research company started its National Consumer Experience program in October 2019 after the FDA said it needed more data about CBD safety and toxicity. It asked consumers to detail their experiences with hemp-derived products on its app CBD+me.
“We saw ourselves in a very unique situation in the industry, sitting between the consumer and the product manufacturers, and we had the ability to then take all that information in aggregate, blind it and present it to the FDA, so we decided to do just that, “says McCarthy.
Experts believe that sector players like ChineseInvestors.com (OTCQB: CIIX) and Dama Financial are hoping that the data collected is enough to show regulators that CBD doesn’t pose any safety or toxicity risks to users.
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