US FDA targets “lawful pathways” for CBD marketing, warns about “unfounded” health claims

04 Apr 2019 --- The US Food and Drug Administration (FDA) has announced that it will hold a public hearing next month to discuss developing a regulatory framework for the use of cannabidiol (CBD) in foods and beverages as interest in products derived from Cannabis sativa L. continues to balloon. The move will hopefully contribute to constructing “lawful pathways by which products containing cannabis or cannabis-derived compounds can be marketed,” outgoing FDA Commissioner, Dr. Scott Gottlieb, says in a statement.

The move comes as the market for CBD products is growing exponentially and the industry has been calling for clarity. The Hemp Business Journal estimates that the hemp CBD market totaled US$190 million in 2018 – an astounding rate of growth for a category that didn’t officially exist five years ago.

The agency 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.” It issued a set of warning letters – in conjunction with the Federal Trade Commission (FTC) – to companies reportedly doing so. The claims in question included CBD products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder and other serious diseases. The three companies were Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc, who advertise a range of supplements they say contain CBD, such as “Hemp Oil,” “CBD Softgels,” “Liquid Gold Gummies” and “CBD Oil.”

Interest in these products began rising last December when Congress passed the 2018 Farm Bill. Among other things, this law established a new category of cannabis classified as “hemp” – defined as cannabis and cannabis derivatives with up to 0.3 percent concentrations of the psychoactive compound tetrahydrocannabinol (THC) on a dry weight basis. The bill also removed hemp from the Controlled Substances Act (CSA), which means that it is no longer a controlled substance under federal law.

At the same time, however, US Congress explicitly preserved the FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.

In doing so, this allows the FDA to continue enforce the law to “protect patients and the public while also providing potential regulatory pathways, to the extent permitted by law, for products containing cannabis and cannabis-derived compounds.”

Following the bill’s passing, Dr. Gottlieb issued a “cautionary” reminder, in which he reiterated the FDA’s approach to cannabis-derived products and the agency’s intended next steps. The statement released this week follows on from this, laying out new actions to “advance our consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.”

These actions include: 

• A public hearing on May 31, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety.
• The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.
• Updates to the FDA webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products.
• The issuance of multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations.

The move may bring hope to an industry that remains in legal limbo. Although hemp has been removed from the CSA, and hulled hemp seeds, hemp seed protein and hemp seed oil have been certified with Generally Recognized as Safe (GRAS) status, confusion remains. However, amid this regulatory confusion NDP has been somewhat active. Earlier this month, it was announced that Cannabidiol (CBD) infused food and beverage manufacturer Weller is set to launch its CBD Sparkling Water in April. Meanwhile, large players such as Walgreens and CVS has recently begun selling CBD products in its drugstores – a move that reportedly sparked concern from Dr. Gottlieb.  

By Laxmi Haigh