FDA issues warning letter to CBD product manufacturer Curaleaf Inc.

July 23, 2019

As FDA considers a potential regulatory pathway for hemp-derived CBD products, the agency continues to take action against firms making unsubstantiated claims.

FDA has issued a warning letter to Curaleaf Inc. (Wakefield, MA) for selling products containing cannabidiol (CBD) online, alongside unsubstantiated claims. In a press release, FDA characterized the products as illegal and unapproved. This is the fourth warning letter to be sent to a CBD manufacturer in 2019. The previous three were issued simultaneously on March 28, 2019, coinciding with the announcement from former FDA Commissioner Scott Gottlieb, MD of an internal agency working group tasked with exploring the potential regulatory pathways for cannabis-derived products, and a public hearing to collect information and testimony on the subject of cannabis and cannabis-derived products. The meeting was held on May 31, 2019, and the public comment period closed on July 16, 2019.

“As we examine potential regulatory pathways for the lawful marketing of products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority. Selling unapproved products with unsubstantiated therapeutic claims - such as claims that CBD products can treat serious diseases and conditions - can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” said Acting FDA Commissioner Ned Sharpless, MD, in a press release. “Today’s action demonstrates that the agency stands firm in its commitment to continue monitoring the marketplace and protecting the public health by taking action as needed against companies that deceive consumers and put them at risk by illegally selling products marketed for therapeutic uses for which they are not approved, such as those claiming to treat cancer or Alzheimer’s disease.”

FDA specifically called out Curaleaf’s “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” as unapproved drugs in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d), as well as misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). The firm’s “Bido CBD for Pets” products, said FDA, are also unapproved new animal drugs under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).

The agency cited product web pages that stated that Curaleaf’s “CBD Disposable Vape Pen” was “for chronic pain,” and the “CBD Tincture” was a “soothing tincture for chronic pain.” FDA also took issue with educational web pages on the company’s site which made statements about the benefits of CBD for specific conditions like ADHD, anxiety, Parkinson’s Disease, Alzheimer’s disease, and depression.

FDA quoted a number of statements found on these web pages that the agency considers unsubstantiated claims, including:

• “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety . . . ADHD.”

• “CBD has also been shown to be effective in treating Parkinson’s disease.”

• “CBD has been linked to the effective treatment of Alzheimer’s disease . . ..”

• “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”

• “CBD was effective in killing human breast cancer cells.”

• “A 2018 study showed that CBD offers quick relief of depression and anxiety symptoms and that the residual effects can last up to seven days.”

“We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in a press release. “The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency’s regulatory policies related to other types of CBD products. We plan to report our progress by early this fall as we expedite our work to address the many questions about CBD. The step-wise, science-based approach we’re taking protects patients and the public health, fosters innovation for safe and appropriate products, and promotes consumer confidence.”

Abernathy is co-chair of FDA’s internal agency working group for cannabis-derived products, along with principal associate commissioner for policy Lowell Schiller.

In a statement, Curaleaf stated: "Curaleaf is committed to the highest standards of quality and compliance, and will work collaboratively with the FDA to resolve all issues addressed in the agency's letter. The Company will respond to the FDA letter within the required 15 working days. Compliance is a top priority for Curaleaf and the Company is fully committed to complying with FDA requirements for all of the products that it markets. We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the Company's cultivation and manufacturing processes. Curaleaf CBD products are all derived from hemp and meet the requirements of the Farm Bill."

 

UPDATED July 24, 2019 at 3:48 PM: A previous version of this article did not contain Curaleaf's statement.