Still a Long Way to Go

 

Good day everyone and we hope all is well with you and yours in spite of the recent pandemic and all the negative news that is continually bombarding us daily. Chin up, this too will pass and hopefully, we will be back to some kind of “normal” sooner rather than later.

As always, we have to add our disclaimer that we are not making any health claims regarding CBD or hemp/ marijuana products. This blog is simply to inform people about CBD and to increase awareness and caution those who are interested to fully investigate the market before making any decision that may affect their health and safety.

Each day, I search for news regarding the latest information regarding CBD/Hemp products to see if the FDA has made any headway in its lessening the controls and defining proper guidelines for the product(s) manufacture, sale and distribution. Sadly, little has been done, especially in light of the Covid-19 pandemic.

As we have noted before, the Agricultural Improvement Act of 2018 (otherwise known as the Farm Bill) which was signed in to law by President Donald J. Trump I December of 2018, made CBD obtained from hemp plants legal so long as it contained no more than 0.3% THC by weight. It also stipulated that products that contained the required level of THC, but were derived from hemp, were illegal unless grown by a licensed cultivator.

Still, marijuana is the more popular of the two and is grown to contain high levels of THC (tetrahydrocannabinol) while hemp contains high levels of CBD and few traces of THC.

Even though the government approved CBD derived from the hemp plant, individual states have laws which do not always align with federal regulations. For instance, Texas recently allowed for the growing and cultivation of industrial hemp while Idaho is still lagging behind and considering its production illegal.

The FDA released a report, on March 5, 2020, regarding the progress on creating a regulatory framework in regards to CBD products. One development mentioned in the report was that the FDA is considering regulating these products in a way similar to that of dietary supplements. That move would incline us to believe that the FDA will soon be taking steps to provide more insight and clarity to the market which should help improve the safety of the public. As we have said before, the market is still a lot like the “wild west” with many of the distributors sounding more like “snake oil salesmen” rather than true medical experts on the subject.

One of the primary functions of the FDA is to educate the public on the possible risks that are linked to the consumption of any supplement and or pharmaceutical. It is their responsibility to evaluate and report the possible risks that are linked to these products when used either with or without a prescription.

Unfortunately, this is not always the case and it often appears that those responsible for keeping us “safe and informed” are often working hand in hand with those that are positioned to profit from the sale of products that may or may not be beneficial to society. If you haven’t, take a look at our blog from 8/4/2020 to gain some insight into who is truly benefiting from the relationship between Washington and big pharma.

The numbers do not lie. Something is out of control when we find that in 2018 alone 14,975 people died, in the U.S., from prescription opioid deaths while 46,802 died in total from prescription and non-prescription opioid deaths (source: Trends and Statistics – March 10, 2020). Granted, this does not compare to those who reportedly succumbed to the Covid-19 epidemic but, where is the outrage when one came upon us through none of our own doing, while we have control over the other?

Last year, the FDA sent out several warning letters to CBD manufacturers for making unsubstantiated claims regarding the therapeutic uses of cannabidiol (CBD). While they were correct in their concern, the question remains is this the best action to take against small businesses and what guidelines need to be enacted to force these manufacturers to develop products that do as they claim?

What has happened to these companies is, if they want to continue their operations, it means they have to become quite savy at not making any potentially erroneous claims.  This becomes quite difficult when you consider that the FDA had garnered the support of several banks that supply merchant services, as well as several social media providers who have taken it upon themselves to determine what language is and is not acceptable to use when marketing their products?  

Here are some examples of what is considered non-acceptable information that can often place marketers of CBD products in hot water:

1)      Any type of claim should not be present in product reviews or tetimonials

2)      Inserting a hashtag claim (#paintreatment, #anxiety, #CBDheals) can increase the risk of a company being warned or even fined by the FDA as they are considered “claims” by the agency.

3)      The FDA also investigates popular video and social media providers for any unauthorized CBD claims

4)      A made in the U.S.A. label may result in lawsuits as this can only be applied when most of the products components come from the U.S. including the carrier oils and packaging.

5)      The agency considers infographics as a “claim”. So, the photo of someone smiling and looking healthy could result in possible discipline.

The point is, how do the marketers know what is and is not acceptable when those responsible for determining what requirements must be met to substantiate said claims have failed in their duty to test and establish the effectiveness of the products they wish to control? Confusing right?

Not to mention, as of this date, I can find no documented claims of deaths caused due to the abuse of CBD products when purchased from a reputable source and used as suggested. This does not include vaping products that may have been manufactured using potentially toxic chemicals. That is a subject for another day and I will admit I feel the action taken by the FDA, in this case, was fully justified.

Some of you may remember in May 2019, a Great-Grandmother was arrested at Disneyworld of all places, because she was found in possession of a bottle of CBD oil which violated local ordinances. Strangely enough, local law enforcement, at the time were taking no action against the smoke shops and convenient stores that were selling the products. It made no difference that she had a note from her Physician that suggested she try it to help her arthritis. She still spent twelve hours locked up until arrangements could be made for her release. Thankfully, they came to their senses and the charges were eventually dropped.

Not to make light of a bad situation but, I must point out, this happened over a year ago and still, little, if anything, has changed.

The only way we can effect “change” is to continue in our efforts to make those in control of resolving this issue understand that there is an increasing sense of urgency. Not only is their non-action a detriment to small business throughout our nation by the loss of jobs and tax revenue but clearly, if some of the claims can be substantiate, can help to save lives as well.  

That’s about it for now. As always, thanks for following us and we appreciate all of your efforts in putting pressure on the parties responsible that have a responsibility to us all in the development and marketing of products that are both safe and effective.  CBD Doc.