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FDA Provides Plan of Action for Evaluating CBD Products

April 8, 2019

Earlier this week, the Food and Drug Administration’s retiring Commissioner Scott Gottlieb penned a comprehensive press release pertaining to CBD products. Gottlieb laid out a plan of action for the coming months that will help them evaluate safety concerns while finding a way for CBD products to be marketed accurately.

FDA Holds Public Hearing

The outgoing FDA Commissioner reinforced the stance that it is unlawful to make and sell food with added CBD or THC, or to market CBD and THC dietary supplements. There has been an explosion of CBD products in the past few years, but the FDA warns that there are still potential health risks that need to be researched. One of the primary concerns is that extended use of a wide variety of CBD products could cause liver injury.

Basically the FDA will be taking several steps in the coming months to directly address the sales and marketing of CBD products. Below is a list of steps that the FDA will take or has already taken.

  • The FDA scheduled a public hearing on May 31st to allow stakeholders to share experiences and challenges with CBD products. This will included hearing public safety concerns.

  • Announced the formation of an internal agency to “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed.”

  • Overhauled its FAQ webpage, providing answers and new guidance for CBD products.

  • Issued three warning letters to companies marketing CBD products using “egregious and unfounded claims aimed at vulnerable populations.”

National Pharmacy Chains

One of the biggest concerns that the FDA has is that the widespread availability of CBD products could negatively impact research that would otherwise be performed to support regulatory approval. Additionally, the FDA does not want to incentivize patients to choose CBD products over traditional methods of medical treatment by substituting unapproved products for FDA-approved medicines.

The FDA’s position on CBD products hasn’t slowed the demand and recently a few national retailers announced they will start selling CBD-infused products. Gottlieb responded on twitter by saying, “I was also concerned to hear recently that several national pharmacy chains and other major retailers have begun to sell or will soon begin to sell CBD products in several states. We’ll be contacting them to remind them of FDA obligations and our commitment to protect consumers against products that can put them at risk.”

Warning Letters from FDA

In an attempt to protect consumers from misleading CBD product marketing, the FDA in collaboration with the Federal Trade Commission sent warning letters to three manufacturers who were making “egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune disease, opioid disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.”

Gottlieb is sending a clear message to these companies and want them to understand that “egregious, over-the-line claims won’t be tolerated.” Their false claims pertaining to their CBD products disqualified them from being sold to the public without the FDA first approving each product.