FDA Sends Warnings To Three Companies Selling CBD Products

At the same time that the Food and Drug Administration (FDA) is working to create a regulatory framework for hemp-derived CBD, it’s also cracking down on companies that are in its view irresponsibly marketing CBD products and making unsanctioned claims about their medical benefits.

FDA announced on Tuesday that it and the Federal Trade Commission sent warning letters to three such companies last month: PotNetwork Holdings in Florida, Nutra Pure in Washington state and Advanced Spine and Pain in New Jersey. The letters were sent “in response to their making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites,” FDA Commissioner Scott Gottlieb said in a press release.

In a Twitter thread, the commissioner added that he was “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 and that the agency will “be contacting them to remind them of #FDA obligations and our commitment to protect consumers against products that can put them at risk.”

CVS and Walgreens both recently announced they will begin selling CBD-infused products.

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.

— Scott Gottlieb, M.D. (@SGottliebFDA) April 2, 2019

In the press release about the warning letters his agency has already sent to CBD companies, Gottlieb asserted that they used their websites to “make unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.”

At the same time, the warning letters announced today make clear that #FDA has and will continue to monitor the marketplace and use our authorities to take action against companies illegally selling these types of products when they are putting consumers at risk

— Scott Gottlieb, M.D. (@SGottliebFDA) April 2, 2019

FDA is hustling to provide manufacturers guidelines on marketing cannabidiol following the federal legalization of hemp last last year, but the process is complicated by the fact that CBD is the active ingredient in an FDA-approved drug, Epidiolex, and remains the subject of intensive clinical testing. Gottlieb has indicated that it will take years to develop a regulatory plan for CBD without further congressional action.

In the meantime, companies that continue to choose to engage in CBD commerce should be wary about making health claims about their products. The commissioner said FDA has “limited resources” for enforcement operations, but it would take action against companies that make “over-the-line” statements.

In the press announcement, FDA listed some of the unauthorized claims that the three companies made. For example, the products were touted as being able to treat cervical cancer, Alzheimer’s disease and substance use disorder.

“I believe these are egregious, over-the-line claims and we won’t tolerate this kind of deceptive marketing to vulnerable patients,” Gottlieb said. “The FDA continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain CBD that haven’t been approved by the FDA, such as the products and companies receiving warning letters today.”

“Selling unapproved products with unsubstantiated therapeutic claims can put patients and consumers at risk,” he said. “These products have not been shown to be safe or effective, and deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Questions about what constitutes an unauthorized claim that would put a company at risk of enforcement action will likely come up at the agency’s just-announced public hearing CBD issues on May 31. Stakeholders are invited to submit information about the public safety impacts of CBD and how to manufacture and market products that contain the cannabis compound.

FDA Announces Details On CBD Public Hearing

This piece was updated to include Gottlieb’s tweets about national pharmacy chains.

Photo courtesy of Nicholas C. Morton.

FDA Is Exploring ‘Alternative Approaches’ To CBD Regulation, Commissioner Says

The Food and Drug Administration (FDA) is investigating “possible alternative approaches” to regulating CBD products, Commissioner Scott Gottlieb said on Tuesday.

During a speech at a conference hosted by the National Association of State Departments of Agriculture, Gottlieb recognized that many members of the organization were interested in the “regulatory framework for products derived from cannabis.”

He started by reiterating that the 2018 Farm Bill, which federally legalized industrial hemp, “specifically preserved” the FDA’s regulatory authority over products that contain cannabis or cannabis-derived compounds. The agency will continue to take action against companies that make unsanctioned claims about the therapeutic benefits of CBD products, engage in interstate commerce of foods containing cannabis compounds or market such products, he said.

But the commissioner also made a point of emphasizing that the FDA is open to exploring other options when it comes to regulating CBD.

“We’re planning to seek broad public input on this pathway, including information on the science and safety behind CBD. But we know that this process could take time,” Gottlieb said. “So we’re also interested in hearing from stakeholders and talking to Congress on possible alternative approaches to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products.”

Pleased to address #FDA’s state ag partners @NASDAnews on our recent steps to advance safety of produce, imported food, animal food, cell-cultured food, cannabis-derived products, use of terms like milk/cheese on plant-based products https://t.co/n5kx8S08wY and our share goals pic.twitter.com/I8DCIhobCg

— Scott Gottlieb, M.D. (@SGottliebFDA) February 26, 2019

That’s similar to comments he made shortly after the Farm Bill was signed into law in December. Gottlieb said at the time that “pathways remain available for the FDA” in terms of permitting cannabis compounds in food and dietary supplements and also to lawfully market and sell products containing CBD across state lines.

But prospective hemp manufacturers are eager to get the ball rolling, and recent state- and local-led crackdowns on foods and drinks containing CBD have prompted federal lawmakers to pressure the FDA for clarification. A bipartisan group of members of Congress sent a letter to the commissioner earlier this month, imploring him to “provide guidance on lawful pathways for food products with CBD.”

Later in his speech, Gottlieb said “it’s important to note that CBD isn’t risk free” and that “there are potential risks associated with its use.”

Companies can continue to “seek approval from the FDA to market human or animal drugs derived from cannabis,” he said, pointing to the cannabis-derived anticonvulsant Epidiolex. And Gottlieb also mentioned that “hulled hemp seeds, hemp seed protein and hemp seed oil” can currently be marketed in human food.

Lawmakers Push FDA To Allow CBD-Infused Food Products

Photo courtesy of Pixabay.

FDA To Take Steps Toward Allowing CBD Products Following Hemp Legalization

Just after President Donald Trump signed the 2018 Farm Bill into law on Thursday, legalizing industrial hemp, the Food and Drug Administration (FDA) published a lengthy press release responding to the legislative development—including a pledge to pursue pathways that would allow businesses to legally market products containing cannabis or cannabis-derived compounds.

The federal agency stressed that it retains the right to regulate products containing cannabis and would take enforcement action against businesses that make unsanctioned claims about the therapeutic potential of cannabidiol (CBD) products, including those derived from hemp, or attempt to introduce such products into interstate commerce.

“In view of the proliferation of products containing cannabis or cannabis-derived substances, the FDA will advance new steps to better define our public health obligations in this area,” FDA Commissioner Scott Gottlieb said. “We’ll also continue to closely scrutinize products that could pose risks to consumers.”

My statement on the signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds and new steps we plan to take: https://t.co/mDsLqGGM0s

— Scott Gottlieb, M.D. (@SGottliebFDA) December 20, 2018

Specifically, Gottlieb emphasized that, because components of marijuana such as THC and CBD are “active ingredients in FDA-approved drugs” such as the epilepsy medication Epidiolex, it remains illegal to “introduce drug ingredients like these into the food supply, or to market them as dietary supplements.”

In preserving these authorities, Congress recognized #FDA’s important public health role for products it regulates & allows us to continue enforcing the law to protect patients and the public while also providing potential pathways for cannabis and cannabis-derived products.

— Scott Gottlieb, M.D. (@SGottliebFDA) December 20, 2018

But the commissioner also said the agency nonetheless has the authority to grant businesses the ability to legally market cannabis-derived products under certain circumstances, and it is actively exploring those options.

“In addition, pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement. Although such products are generally prohibited to be introduced in interstate commerce, the FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process.”

Gottlieb also recognized that certain foods derived from the hemp plant don’t contain regulated cannabinoids (or contain just trace amounts), and the FDA used the press release to announce that it’s completed evaluations of “hulled hemp seeds, hemp seed protein and hemp seed oil” and determined that the products are safe based on “generally recognized as safe,” or GRAS, standards.

“Therefore, these products can be legally marketed in human foods for these uses without food additive approval, provided they comply with all other requirements and do not make disease treatment claims,” he wrote.

In a separate press release, the agency expanded on that determination: 

“The GRAS notices are for three different hemp seed-derived ingredients. The GRAS conclusions can apply to ingredients from other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Some of the intended uses for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars. Products that contain any of these hemp seed-derived ingredients must declare them by name on the ingredient list.”

The FDA said it will be holding a public meeting soon, soliciting input from stakeholders, to “gather additional input relevant to the lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed, and how we can make these legal pathways more predictable and efficient.”

While it might seem at first that the FDA is establishing its dominance in what many consider a potential multi-billion dollar industry, the press release signals some interest within the agency to create pathways for businesses to market hemp-based products. The FDA is “committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products,” Gottlieb said.

Hemp Is Officially Legalized With President Trump’s Signature On The Farm Bill