CBD

CBD In Supplements Dietary Products: What’s FDA’s Recent Verdict?

The signing of the 2018 Farm Bill by President Trump suddenly saw hemp and its derivatives—containing no more than 0.3% of THC, redefined and reclassified as an agricultural product.

And, with hemp no longer being governed by the same regulations which apply to substances on the Controlled Substances Act, CBD containing products started exploding in popularity.

So much so that the recent years have shown CBD containing products to be readily available just about anywhere. Think CVS or your local pet store. CBD-infused gummies, anyone?

However, this legalization of status hasn’t been without its own set of confusion and misinformation. If you’re someone who’s considering buying CBD containing supplements or dietary products, FDA’s verdict can have a significant bearing on your decision.   

So, let’s look at whether the FDA considers allowing CBD in dietary supplements to companies operating in the CBD industry.

Hemp As No Longer Being A Controlled Substance & FDA’s Regulation: Clarifying the Confusion First

The fact that the FDA claims it’s against the law to market and sell dietary products or supplements with CBD or THC can be confusing.

Why? Because in 2018 alone, hemp and its derivatives are no more on the Controlled Substances Act. All of which makes the regulation by the FDA all the more difficult to understand.

However, what’s often overlooked while talking about the reclassification and redefinition of the 2018 Farm Bill reclassified hemp as an agricultural product. Although, it still persevered FDA’s authority as a regulatory body in charge of putting public health before everything else.

Therefore, any dietary product or supplement containing CBD or THC is bound to like any other FDA-regulated product.

Understanding FDA’s Current Stance

Now that the confusion has been cleared up let’s delve into what stance FDA has taken and why. As of March 2020, regarding the selling and marketing of dietary products or supplements containing hemp and its derivatives.

According to the FDA, any CBD containing a dietary product marketed as having some therapeutic benefits must first be FDA-approved.

Additionally, it’s unlawful to market and sells dietary products or supplements containing CBD, as was mentioned above. These ingredients were initially part of clinical investigations where the trials and their results were made available to the public.

Therefore, it makes it against the law to introduce and then market CBD-containing products as dietary supplements after such clinical trials have taken place.

To further explain what FDA means, it gives the example of Epidiolex—a form of CBD approved in 2018 to treat two rare seizure disorders in pediatric patients.

Consequently, it takes the position that any products containing CBD are not to be taken lightly as they are, in fact, drugs.  And thereby, require FDA approval before being marketed.

Safety Concerns Drive The Narrative

It’s important to understand that throughout the discussion, FDA keeps on stressing about the potential risks and side effects of using dietary products or supplements containing CBD.

For example, if you were to look at the FDA’s website, you’ll notice a list of potential side effects and unknowns that might arise from the usage of CBD-containing products. Some of which are:

  • Liver injury.
  • Dangerous interactions with other medicines and drugs. One may experience increased side effects of CBD is used along with these medications:
  • Antidepressants (such as fluoxetine or Prozac)
  • Drugs that can cause drowsiness (antipsychotics, benzodiazepines)
  • Macrolide antibiotics (erythromycin, clarithromycin)
  • Heart medications (some calcium channel blockers
  • Mood swings.
  • Fertility issues.

However, what’s more concerning for the FDA is that there are still so many questions about CBD that it hasn’t been able to answer.

Such as, what would be the effect of taking CBD daily over some time? What impact would CBD have on the developing fetus’s brain if a pregnant woman is taking CBD supplements? Can CBD cause issues in conceiving? So, on and so forth.

Therefore, these unanswered questions, lack of research, and definitive evidence make it all the riskier for the FDA to put a blanket stamp of approval on the marketing of CBD-containing dietary supplements.

Emphasis On Creating A Viable Regulatory Pathway

While the FDA understands the risks and side effects of using CBD-containing dietary products and supplements to the public because of the huge knowledge gap, it also recognizes and understands the high public demand for such products.

Therefore, it has emphasized the importance of working closely with all the industry’s key stakeholders to bridge the knowledge gap regarding such products’ safety and science.

However, such a stance is the FDA’s lack of action for many. But let’s not forget that the March 2020 report lists solid and tangible steps on allowing selling the CBD products as dietary products and supplements.

For example, some of these steps focus on how various sampling studies can be undertaken on CBD-containing products to eliminate impurity or mislabeling.

Similarly, there’s also an emphasis on generating high-quality data through research to make an informed decision regarding such products. The report states several research studies that the agency has undertaken to do just that.

To give the example of one such study, the FDA is currently conducting a study to understand better the effects of using CBD while pregnant.

The Bottom Line

Therefore, all of this discussion brings us to the initial question that we set out to answer: is the FDA considering CBD’s use in supplements and dietary products? Or is it against this idea as a whole? What exactly is the bottom line?

To answer that simply, the FDA is trying to pave the way for the marketing and selling CBD-containing supplements and dietary products.

After all, if it weren’t so keen, it would not have listed concrete steps in the reports, neither would it have invested in several research studies to gather high-quality and meaningful research data. It seems that CBD is gaining favor in the eyes of the FDA.

However, let’s not forget that bridging this glaring “knowledge gap” can take years to achieve.

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