Tim McDonnell recently produced an article titled ‘The FDA Is About to Crack Down on Shady CBD Products”.
Tim’s article looks at the FDA’s interest in the exploding CBD market and associated industry, and this comes at a coincidental and ironic timing with of the recent Blumenauer amendment passing through Congress on June 20th which seeks to limit the Department of Justice’s powers to override state laws legalizing access to Cannabis for recreation and medical use. You may not beware that the same amendment serves in directing the FDA to come up with new regulations for the industry.
Congress Seeks to Change Federal Laws on Cannabis While the FDA Seeks to Bring in Controls
While the Congress and later the Senate is being tested on its willingness to curb federal powers to override new state laws giving access to cannabis and marijuana, the FDA is swinging into gear to regulate and control the CBD market. Is this something to panic about? Well, we had to expect this was coming and in some respects, it can be a good thing, as long as the FDA does not go too far or use its muscle to give ‘Big Pharma’ an unfair monopoly over smaller producers and minorities in a new industry being encouraged by various states.
So what is going on with the FDA, cannabis, and CBD?
According to Tim McDonnell’s article, the FDA is seeking greater oversight of the industry to impose standards and control misinformation stemming from wild claims. Fair enough.
What has alarmed the FDA is that, with the loosening of state laws, and a new federal law last December that legalized hemp, there has been a proliferation of all sorts of products containing CBD at all sorts of strengths and a loose purity and regulation framework.
The new industry had been relying on producers to self-regulate to this point; on things like source, purity, THC levels, and labeling to show correct strength and contents. Products include vape oil, drops, topical creams, cosmetic lotions, drinks, gummies, foods, pet treats, and pet medicines.
The FDA held a hearing this past May to grill experts on the claims being made about CBD and the science behind the claims that are being used to support them. The FDA specifically wanted to know what claims were backed by research and what assurances consumers had about what they were getting in a bottle and other product forms concerning strength, purity, and additives. Fair enough.
What was the outcome of the FDA hearing?
As a result of the hearing, the FDA issued a number of warning letters to some producers instructing them to withdraw some claims about CBD, to avoid violating marketing laws and prosecution.
The FDA also asked the public for submissions about the use and effectiveness of CBD and received thousands of submissions in response, many of which were positive. The reason public opinion input has been sort and is so important is that the previous restriction on access for CBD for medical research meant that medical scientific research on CBD had been limited, so data is scarce. But there are a variety of illnesses it has gained listing approval for in various states. In looking at every state individually, we counted nearly 100 conditions that are on the approval list collectively, even though research to this point is less than the FDA is looking for due to previous heavy federal restrictions on obtaining CBD for research.
So Where Are We Now With the FDA, Cannabis, and CBD?
It won’t be long before new FDA rules will appear, and some CBD products will disappear from supplier’s shelves and shop sites.
There will probably be federal control on strength maximums as well as limits placed on what products may be permitted to contain CBD. My prediction is that CBD being added to drinks and candy will undergo the heaviest regulatory intervention. CBD purity, primarily concerning THC content, will also come under the spotlight.
The problem for CBD, as distinct from marijuana or other THC containing products, has been the inconsistent patchwork of state laws as legalization has been progressively moving across the country. There does need to be a better, more helpful federal position with a matched legal approach inline with state changes, and especially changes in federal regulations governing CBD produced from legal hemp production being permitted but while marijuana still remains classified as a schedule 1 narcotic under current FDA rules.
From the FDA’s position now, it is not legal to market CBD as a dietary supplement or food additive, and only one product (Epilox) for a rare form of childhood epilepsy has FDA approval as prescription medicine.
Is the FDA Seriously Going to Limit My Access to CBD Products If the They are Legal in my State?
The enforcement of the FDA’s position on CBD has been scarce as state legal changes have rolled through, with relatively minor attention on a burgeoning industry – until now.
If you are panicking about your favorite CBD oil or gummy products being ripped off the shelves soon, bear in mind that there is a strong public push to legalize and allow the use of marijuana and CBD that is growing. Evidence the recent success of the amendment that has just past congress to protect new state laws from federal overreach.
What’s the Upside of Increased FDA Control?
There is a silver lining to the FDA intervention. Greater control over purity and a push for better understanding and research will be a win for the consumer, in that the consumer will have more assurance of what they are getting in a product.
At the moment, what is in your bottle or gummy may not be quite what you think in terms of additives that are safe, strength level, THC content, or purity.
FDA rules will force the industry to improve its act on these points…as long as new rules governing production do not become draconian and stifle consumer access and stall a new industry offering jobs, new business opportunities to small players, new tax revenues for the states and hope to marijuana and CBD users – both medical and recreational.
America desperately needs all these advantages from the new cannabis industry at the moment, but more can be expected with the export potential for American made products in this potentially massive emerging market as other countries start to discuss legalization, as has recently been the case in France which highlights the growing global phenomenon. Washington cannot afford to ignore the global potential of being a world leader in seeking new international markets with export potential.
What about the medical value of CBD according to research?
Cannabis is still undergoing study, and there needs to be much more. Cannabis is far from being fully understood for all its health benefits recognized now.
Medical research is understandably conservative and can be slow in this area, but there is evidence from medical studies that show the value of CBD for epilepsy and seizure control, and that it aids in the control of anxiety, depression, and other psychological disorders, including schizophrenia. There are research indications that CBD is an anti-inflammatory applied to the skin.
There is not yet enough evidence yet collected to reliably support claims from a research basis for disorders such as Alzheimer’s and Parkinson’s, slowing the growth of cancerous tumors, as an aid to stop addictions, and to relieve rheumatoid arthritis (though its noted effect as an anti-inflammatory would logically seem to indicate a helpful application with arthritic conditions). Claims for its effectiveness with these disorders may need to be considered from anecdotal evidence at this stage, but that won’t fully cut it for the FDA. We do need Federal backing for more medical research.
Another issue needs recognition in that there is not enough clear understanding of dosages and best delivery mechanisms for CBD for various disorders. This area of information remains a bit vague and would benefit greatly from medical studies to streamline the understanding of the best effective dosing and delivery of a CBD treatment for particular disorders.
What’s the FDA’s Problem?
So what’s the FDA’s problem? Summing it up, they want to know if the CBD products now out there are safe, effective and whether they are addictive for the consumer; and there is also a major FDA focus being placed on inflated marketing claims where research guidance to back the claims is not there or hard to find.
The FDA was also alarmed by recent tests of some products that found the concentrations stated were inaccurate (some were higher by 42%, some lower by 26%), and that there were additives such as synthetic cannabinoids and dextromethorphan along with THC being present in some products, making them illegal products under current FDA regulation.
So what will the FDA do Next?
The FDA will probably start at the manufacturing end and seek to put into place regulations, and standards covering purity and origin of the CBD produced (and it is still illegal to produce from marijuana).
They will likely set national standards on allowed strength and limit the addition of CBD to foods as an additive. They will likely lend new support to CBD for medical research to help deepen the understanding of how CBD can be used for various medical conditions, and they will likely get very tough on producers and marketers that break the new rules.
Hopefully, the outcome of the FDA’s intensified interest and involvement will mean a better standard of product available to consumers who can have complete confidence in what they are buying, according to the claims and labeling and an increase in research to better understand the benefits and uses of CBD.
This is not a bad thing……as long as the FDA powers are used to help the market to grow and mature in a positive way, and at the same time helping the public confidence in CBD.
What we must be cautious about is that the FDA does not use its powers to throttle the market and responsible business entrepreneurs who are seeking to help the public gain access to one of nature’s great medical gifts.
Stop Press Final Words!
If you are worried about the FDA over-flexing its muscle, then take heart in the fact that the Blumenauer amendment made it through Congress last month and that the FDA is being directed to supply guidelines to protect consumers and control shady practices, not shut down the industry.
To further reinforce this new positive approach in Washington with the Blumenauer amendment, Marijuana Moment broke the news last week that a major congressional subcommittee will hold a hearing on marijuana policy on July 10th.
The House Judiciary Crime, Terrorism, and Homeland Security Subcommittee is expected to discuss various legislative proposals to allow states to set their own cannabis policies without fear of federal intervention. This hearing will be focused on how to end federal cannabis prohibition.
Further to this, Rep. Ilhan Omar (D-MN) has called for nationwide marijuana legalization to ensure social equity for all people. She said that marijuana legalization must happen at the federal level to prevent discrimination disadvantaging some groups in society. This will ensure that individual states that are falling behind in law reform aren’t able to continue to disproportionately enforce a prohibition against communities of color.
Omar is a co-sponsor of legislation to de-schedule cannabis and penalize states that carry out prohibition in a discriminatory way, as well as a separate bill that would mandate the U.S. Department of Veterans Affairs study the therapeutic potential of cannabis for veterans
A note of thanks…
A very special thanks to Tim McDonnell for his excellent article for inspiring this article and being the source of much of the information.
You can follow Tim here: http://www.timmcdonnell.org/
And his article link is here: The FDA Is About to Crack Down on Shady CBD Products