FDA, brands caught in the middle of CBD legalization – Regulatory – MM&M – Medical Marketing and Media

CBD is illegal, a fact the average consumer might not realize considering a booming industry putting the compound in everything from lotion to beer. 

CBD, or cannabidiol, is a non-psychoactive compound in cannabis. Some claim it has health benefits from easing pain to controlling anxiety, and many Americans are already using it.

Yet until the Food and Drug Administration decides how to regulate the cannabis-derived compound, most CBD added to coffee or put into creams is not permitted. Meanwhile, the brands making the products are caught in the middle. 

The 2018 Farm Bill opened up CBD to the market by removing some cannabis compounds from the Controlled Substances Act. It also upheld the FDA’s authority to regulate these cannabis products. That bill was signed into law in December 2018, giving the FDA less than a year to grapple with the emerging market. The FDA has held hearings and put out calls for comments and data on CBD this year, but experts don’t believe there will be meaningful regulations in the next few months.

“The FDA has been kind of left in the middle of this,” said Dan Doherty, head of BCW’s cannabis strategic consulting unit. “They’re in this situation where there’s a ton of consumer demand for this, and Congress wants FDA to move on this, but FDA has its processes and requires data to classify ingredients.”

In the meantime, CBD companies, and the agencies supporting them, are plowing ahead. Jenn Michelle Pedini, development director for cannabis advocacy group NORML, says these companies are simply taking advantage of the period before FDA finalizes regulations.

However, that doesn’t mean CBD companies have free rein while the FDA figures it out, Pedini adds.

[The FDA] is in this situation where there’s a ton of consumer demand for this, and Congress wants FDA to move on this, but FDA has its processes and requires data to classify ingredients.

Dan Doherty, BCW

“We certainly see enforcement from the FDA,” Pedini says. “They have been clear the FDA intends to issue warning letters to those companies making health claims, but outside of that, there’s little legal enforcement unless it’s done at the state level.”

In July, the FDA issued a warning letter to Curaleaf for making health claims about CBD. The company said CBD could treat pain, depression, anxiety, cancer, Parkinson’s, Alzheimer’s, ADHD and even diseases in animals. Curaleaf had to scrub its website and social media accounts of anything that implied CBD could treat, prevent or cure health conditions.

Rob Dhoble, managing director of Havas’ endocannabinoid agency Havas ECS, says the FDA “painted itself into a corner” with CBD regulation and enforcement.

The issue intensified when the FDA in June 2018 approved CBD drug Epidiolex to treat seizures in patients with two rare forms of epilepsy. Once CBD was approved in a prescription drug, its use and sale over-the-counter became even more complicated.

Pedini notes there’s one other ingredient in a similar situation: fish oil. There are both prescription fish oil drugs and fish oil sold over-the-counter as a dietary supplement. The regulations of OTC fish oil may be a blueprint for how FDA will regulate CBD.  

For example, dietary supplement fish oil must contain at least 0.8 grams of the active ingredient per serving and have a disclaimer on the packaging that describes the level of scientific evidence supporting the claim that it helps lower blood pressure, according to the FDA. These measures are meant to prevent consumer deception, the agency says.

Many CBD makers support similar regulations, including NORML. “Part of our mission statement is to ensure that Americans have access to safe, affordable and convenient marijuana products and safe is generally achieved through regulation,” says Pedini.

Rep. Tulsi Gabbard (D-HI) and Rep. Don Young (R-AK) Marijuana Legalization
Rep. Tulsi Gabbard (D-HI) and Rep. Don Young (R-AK) have introduced the Ending Federal Marijuana Prohibition Act that would legalize and end the prohibition of marijuana at the federal level. The bill is supported by cannabis advocacy group NORML.

For agencies working with CBD clients, such as BCW, supporting clients while advocating for regulations is part of the job.

Doherty says his teams have public affairs clients conducting advocacy on both the federal and state levels. Many states, such as North Carolina, are also wrestling with standards for CBD and other cannabis substances that have been opened up to the market because of the Farm Bill.

The goal of part of that advocacy is to find and remove the “bad actors” in the marketplace. Companies that sell sham CBD or don’t verify the purity of the product are not helping other companies educate people about the benefits of CBD, say experts. 

“They’re really trying to shape those regulations to remove that uncertainty to help create confidence in the CBD market,” Doherty explains. “They really want a marketplace that recognizes the validity of the product and is regulated in a way that gives consumers confidence in what they’re consuming.”

In the meantime, brands have to walk a fine line while the FDA sorts out potential regulation. While in limbo, the name of the game for CBD clients is education. 

Havas ECS is named after its focus on endocannabinoid science, shortened to ECS. The agency is working to educate doctors and those in the pharma industry about the science behind cannabinoids, Dhoble says. The agency is running education modules at physician meetings, like one at the International Cannabinoid-Derived Pharmaceuticals Summit in September.

“We have a few programs underway that are training the doctors just on the science and promoting zero products, because only 13% of the medical schools have anything on the endocannabinoid system,” Dhoble says. “The same way [a patient] can seek out an allergist for their allergies, what if they could seek out a doctor that’s trained in, certified in endocannabinoid science?”

Havas is also helping doctors navigate the legal gray area around CBD. Doctors who want to urge patients to try something such as CBD for pain instead of something addictive such as opioids need guidance.

Aside from public affairs and advocacy work, Doherty’s team at BCW is also focused on education. Before the Farm Bill removed CBD from the controlled substances list, many platforms did not even allow CBD advertisements. Since then, platforms such as Facebook and Google have begun to relax those standards, while other channels such as radio are still wary of CBD ads, Doherty notes.

The same way [a patient] can seek out an allergist for their allergies, what if they could seek out a doctor that’s trained in, certified in endocannabinoid science?

Rob Dhoble, Havas ECS

“Mostly what we focus on is education, and most of the advertising platforms are open to that,” he says. “So if you’re focused on educating the consumer or the patient on CBD, that seems to be a safe space to be in. Then, you get into the debate of what’s educating and what’s promotional, so different brands will take their own perspective on that risk and, for our clients, we help them quantify that.”

The FDA warning letters can actually be helpful to marketers. When the FDA notified Curaleaf in July, marketers could see exactly where the FDA is drawing a line when it comes to health claims and CBD.

Because CBD is being sold without regulations, making sure patients, consumers, doctors and even pharma companies know the rules is the best way to keep people away from bad products.

“You need [CBD] in the hands of clinicians that are the ones in the know, and that’s why we’re focused on training them so they can be smart with their patients no matter which way the laws go,” Dhoble says. “If you’re a pharma client that is entering this space, they want to be up to speed and be able to really converse. Learning the entire endocannabinoid system makes them a much better resource to the health community.”

Source: https://www.mmm-online.com/home/channel/regulatory/fda-brands-caught-in-the-middle-of-cannabis-legalization/