I have personal experience with regulation and deregulation of industries.  I worked in cable television for fourteen years prior to the advent of satellite consumer services. I worked with regulators at the city, state and federal levels. With the way some cable operators continually raised rates at that time, we ended up on a march to federal price regulation.  And the feds regulated following complaints from consumers.  With the launches of DirecTV and Dish Network, price deregulation took place, and consumers now determine acceptable pricing with their current choice of even more services.

In my opinion, the cannabis industry is on a march toward regulation with its unsubstantiated health claims.  Why do I say this?

Today, health claims are regulated at the Federal level. 

If you visit the Federal Trade Commission, you’ll see their byline, which is “Protecting America’s Consumers.”  Under health claims, they state, “Companies must support their advertising claims with solid proof. This is especially true for businesses that market food, over-the-counter drugs, dietary supplements, contact lenses, and other health-related products.”[1]

If you visit the Food and Drug Administration website, you’ll read:

“To be approved by the FDA as an authorized health claim, there must be significant scientific agreement (SSA) among qualified experts that the claim is supported by the totality of publicly available scientific evidence for a substance/disease relationship. The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of the substance/disease relationship.”[2]

The cannabis industry today is not meeting federal health claim standards.

Licensed producers and dispensaries are making myriad health claims about products which haven’t been proven by research.  Consumers are buying these products with the expectations that the claims are valid – “I hope my pain will be reduced”, “I hope I will sleep better”, “I hope my tremors are improved.” 

When these hopes are not met, and consumers get frustrated with experimenting with multiple products and feel they are wasting money, they will start complaining.  Who the complaints go to will be regulatory authorities (State or Federal), who will be forced to act when news stories, calls and letters mount.

How can the cannabis industry self-regulate for health claims?The FDA and FTC are already slapping warnings on CBD companies for making health claims that are not proven by evidence, and are marketed or labeled incorrectly.[3]

We need cannabis industry self-regulation.

The day will come in the near future when consumer spending on medical marijuana based on unproven medical claims will produce consumer complaints.  It’s just the way the world works.  Anything associated with a medical claim must be tested.

Medical cannabis licensed producers and marijuana dispensaries need to begin self-regulating by making medical claims based on research and scientific evidence.  Unsubstantiated claims fly in the face of federal law, and simply urge States to respond with unfortunate regulations in the face of consumer dissatisfaction.

An April 2019 article entitled “Why Self-Regulation Can Pay Off[4],” compiling research by two Stanford professors, warns that when industries don’t self-regulate, they create conditions that lead to regulation – conditions driven by consumer complaints in mounting numbers.

They argue that anticipatory self-regulation can forestall or even prevent authorities from demanding practices that industries should have put in place proactively.  This is achieved by businesses sending public messages to consumers, activists and politicians that the industry is doing what it needs to do without oversight.

Further, what is even of more consequence than standards and action, “is the percentage of an industry that is involved in self-regulation (perhaps because then it is a true substitute for public regulation) rather than what the companies are actually doing. This may make it more important for third-party bodies to monitor and audit the activities of companies and communicate this information to the mass public.”[5]

We need the industry in general making this an initiative.

So where does the “solid proof” or “scientific evidence” come from?

In my opinion, it comes from cannabis producers funding research about their products to determine what aspects of the thc or cbd composition, terpene profile, and delivery methods are most effective in relieving specific health symptoms.

The National Academies of Science released a comprehensive 2017 report on the status of marijuana research and what is known.  They called for a national research program to begin collecting evidence of what kinds of cannabis work for medical conditions and their mechanisms of action.  You can read the full report here.

Our company, CannaTrials, has the unique set of skills and experience to

  1. design this research and organize funding,
  2. recruit and retain both medical investigators and trial participants,
  3. facilitate study participation with our proprietary diary application,
  4. analyze and report results,
  5. certify a product so that both producers and dispensaries can make valid health claims.

Let’s work together to get the cannabis industry in compliance with national health claim standards now, so that we self-regulate and establish our own standards, and avoid the inevitable and painful process of government regulation.

Please!

Contact us at info@cannatrials.com if you are interested in knowing more.

_________________________________________________________________

[1]  Health Claims. Federal Trade Commission. https://www.ftc.gov/tips-advice/business-center/advertising-and-marketing/health-claims. Accessed May 10, 2019.

[2] Center for Food Safety and Applied Nutrition. Authorized Health Claims That Meet Significant Scientific Agreement. Authorized Health Claims That Meet the Significant Scientific Agreement (SSA) Standard. https://www.fda.gov/food/food-labeling-nutrition/authorized-health-claims-meet-significant-scientific-agreement-ssa-standard. Accessed May 10, 2019.

 

[3] “FTC Joins FDA in Sending Warning Letters to Companies Advertising and Selling Products Containing Cannabidiol (CBD) Claiming to Treat Alzheimer’s, Cancer, and Other Diseases.” Federal Trade Commission, 2 Apr. 2019, www.ftc.gov/news-events/press-releases/2019/04/ftc-joins-fda-sending-warning-letters-companies-advertising.

 

[4] Why Self-Regulation Can Pay Off. Stanford Graduate School of Business. https://www.gsb.stanford.edu/insights/why-self-regulation-can-pay. Accessed May 10, 2019.

[5] Ibid.

About Jonathan Marx, MBA

Jonathan Marx, MBA, is CannaTrials Co-Founder and Chief Marketing Officer. His expertise is in online medical and health education as well as dissemination. He has helped train more than 15,000 medical professionals online. His orientation to evidence-based medicine drives his interest in developing evidence for cannabis and health, so that patients can use cannabis most effectively, and so that producers can craft the best products to address diseases and symptoms.