I was disappointed but not terribly surprised that at some point the FDA (Food and Drug Administration), with its cousin the FTC (Federal Trade Commission), would take some action together against CBD companies, as mentioned in Jonathan Marx’s article1 on health claims and self-regulation, as well as Steven Schain’s article2 on the FDA Cracking the Whip. Certainly not all CBD companies were targeted and not even some of the bigger ones.

FDA and FTC
The FDA is primarily concerned with health claims and food and drug safety.  The FTC is primarily concerned with interstate commerce. They have a joint memorandum that when the two intersect (health claims and interstate commerce) they will coordinate efforts and take on shared roles.

It is instructive to understand why and how, in the shadow of the recent Farm Bill, that CBD companies are on the defensive – literally.

The Farm Bill appears to lessen regulations and guarantee that hemp and hemp-derived products can be imported, exported and transported from state to state like any other crop.

Since CBD products are mostly sold over the internet and enter the “stream of interstate commerce,” making wellness and health claims, or being deemed a food or drug, makes them subject to FDA and FTC oversight.  

CBD Health ClaimsCannaTrials has solutions
What the 3 targeted firms have in common is that they promoted their products as having health claims. They advertised that their CBD-containing supplements have the ability to effectively treat diseases (including cancer, Alzheimer’s and fibromyalgia) and “neuropsychiatric disorders” in both humans and animals.

One of the warning letters apprises that it is unlawful “to advertise that a product can prevent, treat or cure human disease” unless possessing competent and reliable scientific evidence, including well-controlled human clinical studies.

At CannaTrials, we are problem solvers and solution creators.  We are solving THIS PROBLEM with clinical research on cannabis.

What the CBD Market Needs
The challenge is that health and wellness applications, and food and beverage infusions, are what makes CBD and other oil-based hemp derived products attractive to consumers.

The big concern should be that unproven advertising that makes excessive claims could lead to “snake oil-type” advertising and products too. In the 1970s as states were decriminalizing, the proliferation of head shops with their excessive and outlandish (to parents) advertising helped kill the decriminalization efforts of that decade and set back legalization by 2 decades. Is this worth the risk again?

This type of blowback could slow down the rate at which additional States a) consider legalization, b) reduce the rate of approved conditions for a medical card and c) move from “medical only” legalization to full rec use in States with an existing medical program.

CBD seems to work for so many people, myself included. There is plenty of anecdotal and testimonial evidence. I’m fairly certain the CBD producers who received visits from the FDA and FTC know from their customers that their products actually provide relief and therefore work and for which health conditions. However, this is not proof in a scientific sense.  

A multibillion dollar industry must immediately decide to:

  1. Cease operations or
  2. Carefully proceed with health claims or removing health claims, while assessing “legal versus bottom line” risks, or
  3. Get CBD product tested via clinical research with patients in order to make health claims

 

CannaTrials Supports Health Claims with Clinical Research
That’s where CannaTrials comes in. CannaTrials provides everything from consulting services to help identify a disease research target, to expertise on recruiting patients and running a study.  Our app even recruits and tracks patients once enrolled in the research and reports on study progress. Some industry professionals insist the industry needs to self police or consider closing down, I think conducting the research is just good business practice. Imagine having the ability to make the claim legitimately before anyone else can. What are the outcomes?

Let’s do the research, publish the work, sell the product without FDA and FTC prejudice. If you’re selling lots of product without the proof, just imagine how much could be sold with positive proof that the product is as advertised. We can even help you determine that as well. Of equal or greater importance, think of the people who might experience new levels of relief and greater participation in and enjoyment of life.

CannaTrials has just released its CannaTrials Calculator where producers can choose a State and health condition, and see the multiples of revenues that can potentially be earned if your product can make a health claim for a particular condition.  Play with the calculator today and let’s get you to a valid health claim.

Are you a producer or physician?  Want to discuss clinical research with us? Just email us at info@cannatrials.com.  We’ll get right back to you.

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1Marx, J. (2019, May 15). How can the cannabis industry self-regulate for health claims? Retrieved May 21, 2019, from https://cannatrials.com/how-can-the-cannabis-industry-self-regulate-for-health-claims/

2Schain, S. (2019, May 9). Cannabis and Hemp Industry Trembles After FDA Cracks the Whip. Retrieved May 21, 2019 from https://www.cannabisbusinessexecutive.com/2019/05/cannabis-and-hemp-industry-trembles-after-fda-cracks-the-whip/

About Joseph Sameh

Joseph (Joe) Sameh, President of CannaTrials, is a healthcare entrepreneur and recognized industry leader, author, and speaker.  He has more than a decade experience as medical practice manager with a previous 30 year career in computer, telephone, and communications systems. His unique contributions to better patient access in clinical trials, patient recruitment ,and enhanced management of the process, are widely recognized. Among his inventions, Sameh invented what we know of as the patient communications portal in your electronic health record that allows you to communicate with your physician.  Starting a call center for doctors in Chicago, MediConnect evolved to provide services to more than 17,000 physicians nationwide plus the majority of Chicago area hospitals.