Is This The Initiation Of Ending Delta-8 THC Products From The Market? The FDA has issued a warning to companies that are illegally selling CBD.
CBD and Delta-8 THC products are pretty popular among marijuana enthusiasts.
However, you must know that despite the popularity of marijuana and its derivative products among cannabis users nationwide, cannabis comes under controlled substances at the federal level.
Also, various states have permitted the recreational and medicinal use of marijuana.
Still, the federal authorities have consistently been keeping an eye on the usage of marijuana and its derivatives concerning public health.
Therefore, the U.S Food and Drug Administration has issued warning letters to five companies in the country that are selling and marketing products labeled as having delta-8 THC, which violates the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Also, the FDA is seeking a written response from the companies within 15 working days responding to the action plan to avoid the violations and recurrence.
So, can this warning lead to the end of Delta-8 THC products from the market?
Or should you worry about this warning as a user?
Let’s find out who should be concerned about it and if you should stop using the Delta-8 THC product that you are using right now.
What Is The Warning About CBD And Delta-8 THC Products Against Companies?
Today, the FDA issued warning letters to five different companies selling products labeled as having Delta-8 THC in such a way that violates the FD&C Act.
These five companies are ATRLx Inc., BioMD Plus LLC, Delta-8 Hemp, Kingdom Harvest LLC, and M Six Labs Inc.
The FDA has sent warning letters to some companies even before selling illegally unapproved CBD products that claim to diagnose, cure, treat, or prevent various diseases violating the FD&C Act.
The FDA Principal Deputy Commissioner Janet Woodcock, M.D, said, “The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea, and anxiety. However, it is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. Therefore, we will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”
The FDA has started concerning CBD and Delta-8 THC products because the FDA has received several reports that the patients who have consumed these products (having Delta-8 THC) have experienced adverse events.
Some of them even needed hospitalization or emergency treatment.
Further, as the FDA has not approved any drug containing Delta-8 THC, it is potentially dangerous for the patients to consume not-approved drugs claimed by the companies to alleviate any medicinal symptom.
Moreover, the FDA has not evaluated whether these unapproved drug products are effective or beneficial for a person.
And on top of that, these products have various forms from gummies, chocolate, cookies, candies, and more varieties that can even attract children.
The letter also cites violations related to adding Delta-8 THC into foods such as cookies, gummies, chocolates, chewing gum, and more varieties.
The point to be noted here is that FDA considers delta-8 THC products not beneficial for public health yet as there is no information available about its usage as food additives or as a drug substance.
Instead, according to their consumer update report, the FDA has serious concerns about the potential health effects of delta-8 THC products.
Additionally, the adverse reports from the consumers have worked as the cherry on top.
The FDA has also mentioned violations regarding the marketing of CBD products that claim to treat medical symptoms.
Further, CBD and Delta-8 THC are unapproved food additives for use in food as the FDA is not aware that these substances are safe as additives.
Therefore, the warning has been sent to those companies that violate the FD&C Act.
What Are Delta-8 THC And CBD? Is It Legal Under Law?
Delta-8 tetrahydrocannabinol or Delta-8 THC is an intoxicating substance found in the cannabis plant.
It is one of over 100 different cannabinoids found naturally occurring in the cannabis plant.
However, the presence of Delta-8 THC is not abundant. Therefore, it is manufactured by the different companies deriving from hemp plants.
Also, Delta-8 THC is quite similar to Delta-9 THC, which is responsible for the “high” that stoners experience by smoking cannabis.
Further, there are no federal regulations concerning the “Delta-8 THC” component of the cannabis plant.
Therefore, almost every state has available the Delta-8 THC products, while some states might have few regulations.
Instead, the federal government addresses the “Delta-9 THC” component in banning, which is responsible for making people high who consume marijuana.
However, as said before, marijuana has over 100 cannabinoids, Delta-8 THC has no regulations, and companies benefit from it and make products that can give you a high similar to Delta-9 THC.
On the other hand, CBD or Cannabidiol is also a chemical compound found in hemp and marijuana.
And according to the Agriculture Improvement Act Of 2018, CBD derived from hemp containing less than 0.3 THC (the “high” making component) is legal under federal law.
However, only hemp-based CBD with less than 0.3% THC allows businesses to manufacture CBD products.
Therefore, other products or CBD derived from marijuana having more than 0.3% THC are banned federally.
Why Is FDA Concerned About CBD And Delta-8 THC Products?
Despite there being no regulations for Delta-8 THC products, which is another concern, the FDA is concerned about the companies selling and claiming its benefits for different medical symptoms.
Companies nowadays sell or market CBD or Delta-8 THC products as a drug to alleviate medical symptoms, which FDA has not approved.
No general or research-backed information could claim that those drug substances or delta-8 THC foods are safe for a specific medical condition.
Therefore, one should not use any drug from a company that claims the same.
Summing up, these are the main reasons for FDA being concerned about delta-8 THC products:
- Companies illegally sell and market unapproved CBD or delta-8 THC products claiming to diagnose, cure, or treat diseases without approval from the FDA. Also, using delta-8 THC as a food additive is another concern for public health.
- People are sending several reports to the FDA mentioning adverse events with the consumption of these products. However, some reports have serious events.
- There are no FDA-approved products containing CBD, but some companies sell on their own illegally.
- The FDA has approved only one cannabis-derived and three cannabis-related drug products (Epidiolex, Marinol, Cesamet, and Syndros). Therefore, FDA may not have approved other drug products.
- Delta-8 THC products have not been evaluated or approved by FDA for safe use, and marketing in ways claiming benefits in medicinal conditions puts public health at risk.
Should You Be Concerned About This Warning As A User?
Yes, you should also be concerned about this warning if you are concerned about your health.
Nowadays, many third parties and companies claim to alleviate some medical symptoms via their products that may have delta-8 THC or CBD.
However, FDA may not approve those products.
Therefore, they might be potentially harmful to your health because it has not been standardized and made safe for public use by the FDA.
The FDA has not evaluated or approved delta-8 THC products in any context.
And the marketing tactics claiming treatments with unproven drugs or products raise significant health concerns for the public.
Additionally, the adverse reports to the FDA contribute majorly to thinking about these products.
The authorities have sent the warning letters to the companies while asking to address the violation within 15 working days, failing, resulting in product seizure and injunction.
Frequently Asked Questions
Delta-8 THC is an intoxicating compound found in marijuana, and adding them to various edibles like gummies, candies, cookies, and other varieties led to the term delta-8 THC products.
It can make consumers high, just like smoking or vaping weed.
There is no such information about the same yet.
According to the Agriculture Improvement Act of 2018, only hemp-derived CBD is legal under federal law, containing less than 0.3% THC.
However, there is no regulation concerning delta-8 THC, but the federal government bans delta-9 THC.
Also, check if you can be allergic to weed.
It is a very right step by the FDA towards stopping companies from selling and marketing products illegally that are not good for public health, just for their profits.
Therefore, even if you are a user of delta-8 THC product for any medical condition, stop using it if the FDA has not approved it.
If you have any medical condition, always seek professional help from the doctor.
And, if a doctor prescribes you any marijuana-derived product, you can only seek the best online marijuana dispensary to get that.
At the same time, you need to consider whether the state or regional laws allow you to do so.