On November 25, 2019, FDA issued Warning Letters to 15 companies for “illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act.” It also published a revised Consumer Update outlining other concerns FDA has about CBD products.

In its press release, FDA noted that it is “also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.”

Why you should care

1 First, it is illegal under federal law to market CBD by adding it to a food or labeling it as a dietary supplement. The 2018 Farm Bill removed hemp from the definition of marijuana in the Controlled Substances Act. Many companies are under the impression that the bill thus exempted hemp-derived CBD from FDA regulatory oversight, but the Farm Bill explicitly carved out FDA’s authority to regulate products containing cannabis or cannabis-derived compounds.

2 Second, because of the disconnect between state and federal laws, CBD companies must figure out how to walk this legal tightrope. FDA is trying to figure this out, too, and their enforcement actions have been mainly been concerned with the more egregious claims about the therapeutic nature of CBD.

3 Third, Warning Letters hurt. Recipients of these letters must respond to FDA within 15 working days, outlining the steps they have taken to correct the violations and how they will prevent recurrences. This means that you could end up doubling your annual advertising budget issuing re-tooled ads.

Received a Warning Letter?
Here’s what you should do

1. Create a team of key stakeholders and meet as soon as possible. Your team will include your FDA attorney, c-suite leadership, marketing and commercial leaders, and your ad agency.

2. Identify the materials referenced in the Warning Letter and review other promotional materials that could also contain violations, including social media and websites.

3. Create a plan to stop disseminating the offending materials. Don’t forget to inform sales representatives or agents working on your behalf and plan for those materials to be returned or destroyed.

4. Draft an outline of proposed corrective action, including a timeline. Your FDA attorney will communicate with FDA to work out the details.

Everyone else…

These 15 Warning Letters bring the total for CBD companies in 2019 to 22. FDA issued only one in 2018 and four in 2017. But in 2015/16, FDA issued a whopping 40 letters to CBD companies.

Clearly, FDA had hoped that the first round would get the word out. This new round of Warning Letters demonstrates FDA’s continued focus on CBD companies—including those producing pet food or supplements. It also reflects the importance of having clear company policies and procedures that govern creating and disseminating marketing materials and handling social media.

That means this is an excellent time to:

1. Conduct a risk assessment. If you don’t know what your risks are and where they lie on a risk heat map, any efforts you take to protect your company could be wasted time and money.

2. Assess your marketing materials, including social media and websites. Fixing these now is a lot less intrusive (and expensive) than responding to an FDA Warning Letter.

The market for cannabis, hemp, and cannabis-related products is growing exponentially. As the industry grows, so too does market competition and regulatory scrutiny. FDA, through its own resources and competitor reports through its Bad Ad Program, will continue to pursue companies for promoting outside the boundaries.

As always, if you have any questions, don’t hesitate to contact me.

Kim Life
Kim LifeLead Counsel, Advertising and Promotion
+1 650.619.4954