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CBD & the FDA...It's complicated

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Four weeks have come and gone since the Drug Enforcement Agency announced delta-8 THCO is a Schedule I controlled substance. What is also concerning is the status of hemp-derived CBD for human consumption. Google CBD gummies and there are over 21 Illinois pages that return. If you add “unsafe” the number of hits drastically decreases to a little under 280,000.

Cannabis Corner has taken the position of level setting for readers to understand the unique nuances of the industry. The shifting regulatory status is par for the course in how rapidly government agencies can create new legal statuses for the psychoactive agricultural commodity. As of the date of this article, there are 23 states where marijuana is legal to be purchased but federally the plant is still illegal.

The Controlled Substance Act did not separate hemp from cannabis. The criminalization of a crop that has thousands of uses completely decimated the supply chain for hemp-derived products. Even though decriminalization of industrial hemp in 2018 was just five short years ago, the nascent supply chain has struggled. Albeit hemp has not struggled to the same extent as marijuana businesses have been impacted by a lack of access to banking as well as changing or confusing regulatory statuses.
When the United States Farm Bill was passed the language in regard to hemp seemed clear, first and foremost the Food and Drug Administration retained regulatory oversight of hemp production in the nation. Cannabidiol flooded the market and new businesses infused everything ingestible to topicals for humans and animals.
On July 24th of 2019 Amy Abernethy, Md, Phd. Principal Deputy Commissioner, Office of the Commissioner, Food and Drug Administration, Department of Health And Human Services testified before the Senate Committee on Agriculture, Nutrition, and Forestry;

“The passage of the 2018 Farm Bill has led to the misperception that all products made from or containing hemp, including those made with CBD, are now legal to sell in interstate commerce. The result has been that storefronts and online retailers have flooded the market with these products, many with unsubstantiated therapeutic claims.”

Four years after Dr. Abernathy testified, the Food and Drug Administration released another statement on the matter with the position that concluded: “the existing regulatory frameworks for foods and supplements are not appropriate for cannabidiol.” The statement didn’t make waves in the weed world, neither did the criminalization of delta-8 THCO. The FDA statement notes studies that have shown harm to a consumer's liver, complications with medications, and potential harm to the male reproductive system as well as sensitive populations like pregnant bodies and children.

Going back to Google, a parent can find a mix of products and brands selling tinctures for kids and mixed reviews of the safety of products from medical professionals with opinions that range. The health benefits seem to be elusive, but the federal government's line of thinking is clear. “A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”

There have been 17 statements released on CBD since 2017 on the agency's website www.fda.gov and provides an outline of resources and literacy on the regulatory framework state of science and consumer information. With so many conflicting stories it can be challenging to know who to trust and motivations. The cannabis industry has been tainted with distrust for government and regulation for decades. High taxation of the plant creates tension, leading consumers and entrepreneurs to feel preyed upon by legislation. Businesses having to operate by the rules of state and federal governments as businesses without having full access to the suite of benefits of a legally operating business doesn’t bode well.

For existing businesses operating with hemp-derived substances, the rules are still being written. Many have postured that hemp is a much safer playground than marijuana and on some levels that seem to be true. Depending upon the area of supply chain a business may do very well…that is until a change in legislation or scheduling disrupts a business model.

It is no wonder capital attainment is so challenging. If investors are watching wisely, the industries volatility is ripe for a special type of investor, likely one with some lobbying leverage to financially back a legislative approach to protect their investments.

For small businesses banking on bud be it hemp or marijuana the best investment that can be made is to be civically engaged. Industrial hemp is equally as risky as weed. We are blown away by the shifting regulations and ongoing commerce. How will states enforce federal regulations if there is money being earned? How will states be forced to participate in enforcement under new leadership? How will science be accepted or rejected and who will industry entrepreneurs believe if the results are unfavorable?

Seems like we will all have to wait and see. In the meantime do as much learning from credible sources as you can.

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About Author:

Dr. Mila Marshall is an environmental professional and journalist with a passion for advancing sustainability in all sectors. Her passion is directed towards urban food systems in segregated cities.



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