Opinion | The Cannabis Industry is Rife with Fraudsters. The FDA is AWOL.

Over the past 30 years, the $ 6 billion agency has grown to become the world’s leading prescription drug regulator, with hundreds of scientists and experts focused on getting safe and effective therapeutics approved quickly and efficiently. But when it comes to the nonprescription products that tens of millions of Americans buy every day – and which underpin a huge and growing industry – the agency is far less focused and effective, and in some cases completely absent. I should know

I work in an industry where consumers are deeply affected by the FDA’s reluctance to regulate. My company, Caliper Holdings, has been making Ripple, a brand of THC-infused marijuana products, and Caliper, a brand of CBD-infused hemp products, for years without FDA guidance, supervision, or interest. Neither in the seven years since Colorado and Washington legalized recreational marijuana, nor in the three years since Congress legalized the production of cannabinoid products from hemp, the FDA has taken action to protect consumers from bad actors protect, or those who so wish, offered instructions to please the consumers.

In fact, due to loopholes and quirks in the underlying laws, the cannabis industry isn’t even subject to the minimal regulation that governed Sarah Brown’s homemade root powder.

It’s not every day that a businessman in the United States asks more – for everything, in fact! – Regulation of their industry. But the FDA’s inaction is not only dangerous to consumers; it is deeply detrimental to the legitimate businesses forced to compete with those who are ruthless or worse.

The FDA will tell you their hands are tied that federal food, drug, and cosmetic law clearly states that a substance that was once studied as a drug (like THC in 1985 and CBD in 2018) should do so later can no longer be regulated as a food or dietary supplement. It is less inclined to mention that the same law also gives HHS Secretary Xavier Becerra the power to exempt products from the limitations of the law’s so-called disclaimer. And like it or not, these products are already on the market and consumers are using them.

Ultimately, the FDA’s first duty is to protect consumers, and their decision not to regulate consumer cannabinoid products or provide guidance puts us all at risk. Those who support lax enforcement and a weak FDA like to suggest that these industries will self-regulate as if bad actors – the charlatans and scammers Woodcock warns of – had an incentive to do so. Twenty-two boys who meet in a field do not spontaneously develop into an orderly soccer game.

Rules and penalties are just as important to a functioning sport as rules and enforcement are to a functioning market. I know this personally because my company puts safety and honesty first, even though there is absolutely no market incentive for it. As things stand today, companies that invest in food safety programs, accurate labeling and substantiation of claims are at a significant disadvantage compared to lying liars. Consumers cannot tell at a glance whether a product contains the CBD it contains, is high in salmonella, or has drawn its “fast-acting” claim out of nowhere. Test results are often forged, corners are often cut off, and everyone knows the FDA won’t do anything about it. If quality is expensive and lies are free, we shouldn’t be surprised if charlatanism thrives.

In fact, the evidence of consumer fraud in cannabinoid products is widespread, persistent, and known to the FDA. In July 2020, the agency presented a study to Congress in which it detailed the rampant fraud on the CBD market for consumers: 55 percent of the products tested did not meet the information on the label for the CBD content. To claim that your product contains something it doesn’t contain is not cute, it is a scam. And every consumer who buys a fraudulent product suffers harm. Multiply the FDA’s results by 20 million consumers and you will begin to understand the extent of the fraud that is being committed in public while the FDA sits idle.

The consequences of fraud also lead to physical harm. Just last month, a cannabis brand called Select (owned by Curaleaf, one of the country’s largest marijuana operators in several states) mixed batches of their THC and CBD products, causing consumers to accidentally get high on several occasions. This is, of course, terrible, and a direct result of the FDA’s failure to make consumer safety a priority in its policy making. Think about what happened next. While the Oregon Liquor and Cannabis Commission immediately recalled the state-approved THC products that actually did not contain THC, the FDA has still not recalled any of the nationally sold CBD products that actually contained THC.

Sometimes the FDA hides behind the need for more data by refusing to intervene and regulate these products. “We continue to emphasize the need for scientific evidence to support the safety profile of CBD,” Woodcock said recently. “We remain steadfast in our efforts to obtain research data and other safe public health contributions to inform our approach and shape consumer access to protect public health and to incentivize cannabis drug development through established regulatory pathways remain.”

That’s all well and good, but how is that helping consumers today? Companies sell products. Consumers consume them. The FDA can either ensure a safe, regulated marketplace or tolerate an unsafe, unregulated marketplace. There is no third option. The world is not waiting.

To be clear, I fully support more research on cannabinoids. My company helped fund the only peer-reviewed, published clinical research on commercially available CBD and THC consumer products. But that research was done in spite of the FDA, not because of it. The FDA has failed to provide or support the development of common identity standards, a necessary requirement for the “real world data” that the agency claims to need. Unless manufacturers adhere to a common standard for labeling and content, it is impossible to make real comparisons between products. Likewise, the FDA has failed to provide or support the development of common analytical standards for laboratory testing. Until we can be sure that laboratories in different states are getting the same results with the same products, reliable real-world data will remain inaccessible.

You cannot have an intellectually honest discussion of cannabinoid regulation that doesn’t start with accepting that cannabinoids are widespread. According to the Consumer Brands Association, 28 percent of Americans have tried CBD and “74% either mistakenly believe that CBD is government regulated or have no idea whether it is regulated”. When products are widely and openly available in a modern society, it is no surprise that people assume that they are just as regulated as the products around them. And if a public health regulator cannot or does not want to take a product off the shelf, then it has a moral obligation to establish and enforce rules that will ensure that the product is as safe as possible when it is sold. If Acting Commissioner Woodcock believes the FDCA’s disclaimer is preventing the agency from protecting consumers, she should either fight to lift that restriction or step aside and let someone else carry the public health and safety banner.

It is important to understand that all of this can be fixed quickly. The FDA could issue clear enforcement guidelines that prioritize label accuracy, good manufacturing practices, and batch traceability for cannabinoid products for consumers, and step up their enforcement efforts. Minister Becerra could enact a rule exempting all herbal cannabinoids from the disclaimer, forcing the FDA to regulate these products as consumers find them on the market. Alternatively, Congress could amend the FDCA to remove or limit the scope of the exclusion clause, as provided in the bipartisan hemp and hemp-derived CBD Consumer Protection and Market Stabilization Act (HR 841).

And if resources are an issue, Congress could increase the FDA’s funding. About half of the FDA’s budget currently comes from prescription drug use fees, a dynamic that creates clear and obvious incentives for FDA leadership to prioritize pharmaceutical industry desires over broad-based consumer protection. But if it’s really about money, Congress could also bill the industry for food and dietary supplement usage fees. (For the record, I think this is a really terrible idea, and yet it would still be an improvement on our current situation). In the extreme, we could officially cede the FDA to the pharmaceutical industry and outsource the agency’s consumer protection functions to a new agency that is fully publicly funded and solely charged with regulating products that consumers find on the market. In other words, create an agency that actually puts consumer safety first, which the public already believes, despite all the evidence to the contrary.

The idea of ​​a public health agency working solely in the public interest is radical, I’ll admit, but we started building one with the passage of the Pure Food and Drug Act in 1906. It is time to finish what we started.