FDA Issues Warning Letters to 15 CBD Companies: What Does This Mean?

The Food and Drug Administration (FDA) has taken a profound interest in the chemical CBD, its long-term effects, and how it impacts special populations (such as pregnant women, young children, and animals).

The agency also seeks to address false advertising involved in the marketing of CBD products as a result of many brands making false and unsubstantiated claims about what CBD can do.

Although no formal review process has taken place for CBD products, the FDA’s recent decision to target 15 CBD suppliers demonstrates that this is an important issue that they are watching closely.

What Are the Circumstances of the Warnings?

It’s clear that CBD is on the FDA’s radar. Recently, the FDA warned 15 companies for illegally selling various products containing CBD.

FDA Principal Deputy Commissioner Amy Abernethy has stated in regard to CBD, “We’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns.”

“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’”

CBD’s safety is currently questionable, as reports indicate CBD products often contain contaminants such as pesticides and heavy metals.

The FDA seeks to work with industry stakeholders to further study the science and safety behind CBD products. While the enactment of formal policy is still years away, the agency is already addressing the issue to the public.

Who Are the 15 Companies?

• Koi CBD LLC, of Norwalk, California
• Pink Collections Inc., of Beverly Hills, California
• Noli Oil, of Southlake, Texas
• Natural Native LLC, of Norman, Oklahoma
• Whole Leaf Organics LLC, of Sherman Oaks, California
• Infinite Product Company LLLP, doing business as Infinite CBD, of Lakewood, Colorado
• Apex Hemp Oil LLC, of Redmond, Oregon
• Bella Rose Labs, of Brooklyn, New York
• Sunflora Inc., of Tampa, Florida/Your CBD Store, of Bradenton, Florida
• Healthy Hemp Strategies LLC, doing business as Curapure, of Concord, California
• Private I Salon LLC, of Charlotte, North Carolina
• Organix Industries Inc., doing business as Plant Organix, of San Bernardino, California
• Red Pill Medical Inc., of Phoenix, Arizona
• Sabai Ventures Ltd., of Los Angeles, California
• Daddy Burt LLC, doing business as Daddy Burt Hemp Co., of Lexington, Kentucky 

What Is the Content of the Warnings?

The warning condemned many companies’ unbacked claims that their drugs treated serious diseases such as cancer. It also pinpointed businesses that otherwise violated the FD&C Act.

There is limited research on the actual medical benefits and safe dosage levels of CBD. Thus, products containing the chemical are not yet subject to an FDA review process.

The agency also pointed out that companies were marketing these products towards infants and children even though CBD’s effects on those populations is not yet fully understood. CBD has also been found in animal food, which can cause problems when those animals are prepared for human consumption.

These companies also implemented the chemical into dietary supplements, even though CBD is not considered one under the definition by the FD&C Act.

What These Warnings Could Mean for Your Company

The companies named in these warnings have 15 business days to correct these violations. During this time, they must figure out a framework for legitimizing these processes.

If your organization works with CBD or other CBD-related products, it is in your best interest to plan out compliance protocols for future FDA regulations. While the agency has not issued official guidance on this topic yet, these warnings indicate that CBD is a priority for them.

Industry stakeholders should sign up for classes in pharmaceutical training. The Center for Professional Innovation & Education (CfPIE) has created courses such as “Regulated Medical Marijuana Business - Concept to Product Sale.” While there is no current date for this course, future sessions will become available soon.

Other courses we offer include: “Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products,” which aims to help your staff get up to speed with current industry activities.

Are you looking to improve your compliance with the FDA? Contact CfPIE today at 1-610-648-7550 or [email protected] to learn more.