08 January 2022 |

Warning Letters To U.S CBD Companies

By Matthew O'Brien

U.S POLICIES

Warning Letters To U.S CBD Companies

Examining The Food and Drug Administration’s Warnings to CBD Companies…

THC and CBD produce very different effects when consumed, which is why they answer to different regulating authorities.

Medical or adult cannabis companies currently work with with their state and local government, whereas CBD companies have to answer to federal regulators. 

The Letters

The FDA has been sending letters to hemp companies who make medical claims since as far back as 2015. All of them are published on the FDA’s website

In 2020, the FDA sent warning letters to 19 companies about COVID-19 specifically. 

With COVID-19, there has been a lot of hype about cannabis/CBD and whether or not it can help eradicate coronavirus. 

Especially as more studies continue to emerge, this one indicating CBD inhibited infection of SARS-CoV-2 in cells and mice. 

Does that mean cannabis cures coronavirus? It certainty does not, as we don’t have nearly enough data to make such a conclusion today.

The Examples

Wisconsin-based Native Roots Hemp, wrote about CBD and COVID-19: 

“Cannabis Indica speeds up Recovery from Coronavirus” “Don’t Fear the #CoronaVirus FIGHT it with us!

Soap, immune boosting oils & more!”

Noetic Nutraceuticals was hit with a warning letter from the FDA following this post the company made online.

“We are getting a lot of questions about whether CBD (Hemp Extract) can help with the Coronavirus (COVID-19). 

The short answer is YES, it certainly can help. 

Now, let’s be clear, it is not seen as a cure, but CBD has properties (anti-bacterial, anti-viral, and anti-inflammatory) that can aid with symptoms and help a person stay healthy to fight off illness.”

And in 2021, CBD company, Cannafy, was hit with a letter reprimanding them for making medical claims about cancer. 

Like CBD and COVID, there are positive studies about CBD and cancer, too. But that doesn’t mean CBD = a cure for cancer. 

Cannafy’s website said: 

“How CBD helps manage Cancer Growth…

One of the many reasons Cannafy decided to make a full spectrum CBD product is the research shown that having all of the cannabinoids working together synergistically provides that extra component that cancer patients fear the most, will my cancer return?”

Looking Forward

Each company has since remedied the problem and are now in compliance with the FDA’s guidelines, as far as we can tell. 

And while we mentioned smaller CBD companies today, Charlotte’s Web, Green Roads CBD, and Curaleaf’s hemp line have all received similar letters since 2015.

The FDA doesn’t play favorites. If you are non-compliant: sooner or later, you are going to receive a strongly worded letter form the FDA.

Our Take

While there are things CBD companies can’t say, there are many things that they can say, while remaining compliant such as –

  1. Revitalize your wellness.
  2. Supercharge your focus.
  3. Enhance your well being.

As such, hemp-derived CBD companies should focus on sharing a lifestyle change and enhanced state of mind when marketing CBD products, instead of presenting them as a silver bullet that solves all problems.

EUROPEAN POLICIES

Regulating CBD In Europe

Breaking Down The Current Regulations For CBD Companies in the UK & EU…

The European Food Standards Agency (FSA) classified hemp-derived CBD as a “novel food” in February 2019. 

novel food is a food that hasn’t been consumed to a significant degree by humans in the European Union before May 15th, 1997.

CBD was recently added to the list.

Here’s a few more examples of a novel food, according to the European Food Standards Agency (FSA): 

  • Chia seeds.
  • Noni fruit juice.
  • New sources of vitamin K.
  • Food derived from new production processes, like milk, bread, and mushrooms.

CBD In The U.K

As far as the U.K. is concerned, who officially left the EU in 2020, the UK Food Safety Authority set a March 31st, 2021 deadline for CBD companies already on store shelves to prove their products are safe.

CBD Companies were provided 13 months to complete this process, with those failing to meet this deadline unable to sell their CBD products in the U.K.

The application included information about:

  • Nutritional data.
  • The production process.
  • Compositional information.
  • The novel food’s history of use. 
  • Information about its absorption.

This information is required for every single product the company carries.

The European Industrial Hemp Association (EIHA) estimated a single product’s registration under these new guidelines would cost between $420,000 and $600,000. That’s why hemp-derived CBD companies in the UK began to join forces and split the costs

Looking Forward

The EU’s decision to classify CBD as a novel food is still under review, with a dossier having been reviewed on January 4th, 2022 and a recent statement indicated a final decision would be made by January 31st, 2022. 

However, certain CBD products have been validated to continue through the novel foods process and operate in the U.K.

Many haven’t, though, and are considered an “on hold” product by the U.K’s Food Safety Authority – the organization responsible for protecting consumers in the U.K.

If the proper information is not supplied within an acceptable time frame, they will be removed from the list completely and will be unable to remain in the U.K. market. 

Our Take

Standard regulations are needed for hemp derived CBD products in the U.K and in Europe, but the road to regulatory oversight shouldn’t constrain the success of companies operating in these regions.

In a world where the United States has federally legalized cannabis, it remains unclear what this will mean for both cannabis and CBD companies operating in the United States from a regulatory standpoint.

Nonetheless, we will keep you updated with any changes that arise.

TOP OF MIND

Top Cannabis Articles: The Senate Minority Leader Mitch McConnell is not one bit happy with the Democrats for including a provision protecting banks that work cannabis companies in an upcoming bill focused on trade competition with China.

Super Bowl Sunday: Cannabis technology company Weedmaps ​​​​​​created a very interesting ad that was meant to air during the Super Bowl. Unfortunately the Super Bowl rejected Weedmaps efforts to have this cannabis focused ad air this Sunday.

Congrats To Leafly: Congratulations to everyone at Leafly who has helped build the business since it was founded in 2010, with the company going public yesterday on the NYSE with a $105 million USD market cap.