FDA rejects three CBD petitions, proposes new regulatory path forward

27 Jan 2023 --- The US Food and Drug Administration (FDA) has said no to three different citizen petitions requesting that cannabidiol (CBD) products be marketed as dietary supplements. The groups behind the requests are the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA).

The latest rejection builds upon the FDA’s consistent stance that CBD be excluded from the dietary supplement definition. Over the years, it issued numerous warning letters, posted statements on its website and communicated its position with individual firms.

The agency cites safety as its primary concern, especially for long-term use and unknown interactions between CBD and other drugs.

“Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive,” says Janet Woodcock, principal deputy commissioner at the FDA.

However, Organizations like CRN warn that further delay [in regulation] from FDA’s part continues to harm both consumers and the industry.

Delay in regulation has also led to uncertainty in the supplement industry about where companies should make investments in the compound.

The agency will work with Congress to establish risk management tactics, such as the minimum age to purchase CBD.Blazing a new path
The lack of lawful marketing rules has yet to take CBD products off the shelves. Faced with strong consumer demand, the FDA convened a high-level internal working group to explore regulatory pathways for CBD products.

The agency concluded that existing frameworks were not appropriate for CBD and that it was “prepared to work with Congress” to establish a new regulatory pathway.

“The FDA’s existing foods and dietary supplement authorities provide limited tools for managing many of the risks associated with CBD products,” says Woodcock.

“A new pathway is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”

Protecting the public right away
She envisions that the new cross-agency strategy would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products.

“Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.”

In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals. This needs to be considered as people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD.

An exceptional ingredient
As a relatively new ingredient, CBD does not fall within the list of acceptable ingredients that define supplements according to the Federal Food, Drug and Cosmetic Act (FD&C Act).

Exceptions to the rule can only be given to new dietary ingredients that have been well-established as safe through sufficient clinical trials.

Although CBD’s safety has been demonstrated in some situations, it still falls short of being declared safe generally.

For example, the FDA has approved Epidiolex, a drug containing CBD as safe. But the approval of this drug does not answer the question of whether CBD is safe or not in other marketing contexts, such as in dietary supplements.

The FDA is concerned over the safety of CBD as a supplement, especially in vulnerable populations like pregnant women.Safety first
One of the biggest hurdles to defining CBD as a supplement is establishing its safety.

“The use of CBD raises various safety concerns, especially with long-term use,” explains Woodcock.

“Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.”

Furthermore, it’s “not apparent” how CBD products might meet safety standards for dietary supplements or food additives, she adds.

“For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.”

Wonders or blunders?
CBD has been praised by its advocates for imparting multiple health benefits, such as relaxation, anti-inflammation and pain management.

The ingredient continues to be the subject of clinical trials to examine how effective it is in various contexts. One study, for example, found that sleep quality improves when combining CBD and melatonin. CBD has also been explored for areas like sports nutrition and even sun care.

Its acclaimed benefits have led to companies recreating the cannabidiol molecule without the use of hemp, providing high standardization and a guaranteed THC-free formulation.

Alternatives to CBD have also sprung onto the market, such as Gencor’s PEA ingredient, which claims to influence the endocannabinoid system.

Current R&D into CBD is tackling aspects like low and variable bioavailability, which poses a significant challenge in CBD-based formulations.

By Missy Green

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