Expert: Hemp-Derived CBD Products ‘Are Simply Not Regulated, That's The Problem’

In the United States, there are still no clear regulations for managing the quality of hemp-derived cannabidiol (CBD) products, said Bharat Ayyar, CEO of Sunsoil, in an interview with Pharmacy Times.

“After 5 years of inaction, the FDA said this January that it needs the help of Congress to issue a regulatory framework for CBD products,” Ayyar said.

However, there has been no momentum from Congress since this statement.

Without regulations, CBD companies could be more likely to mislabel or put lower quality products on shelves for consumers. Yet mislabeling alone is not likely to severely impact patient health, Ayyar said. Numerous studies have identified CBD as safe, non-habit forming, and having mild adverse events—but more research is still needed, he added.

The more serious problem occurs with CBD that is mislabeled and has not been quality controlled. Ayyar explained this should be a significant concern for all hemp-based products; hemp is a strong bio-accumulator that can absorb heavy metals and toxins from the soil.

“This is great for remediating soil, but it also means that the plant (and therefore your CBD) might easily contain contaminants,” Ayyar said.

CBD is currently an active ingredient in Epidiolex, an FDA-approved drug to treat seizures, Ayyar explained. According to the Food, Drug, and Cosmetic Act, this means that CBD cannot be marketed as a dietary supplement while it is also in a drug.

Traditionally, the FDA will not regulate a drug as food or a dietary supplement unless it has been proven as safe or effective for other conditions.² The FDA stated that CBD could have dangerous effects with long-term use, such as liver damage, adverse drug interactions, or a negative impact on male reproductive health, which means they will not regulate CBD products until, or unless, proven otherwise.¹

“We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” said Janet Woodcock, MD, Principal Deputy Commissioner of the FDA, in the January statement.¹

What this ultimately means is that the responsibility to provide a quality product currently falls on the CBD company. Because of this, Ayyar is a proponent of product transparency through clear marketing. “It sounds simple, but CBD companies should be clearly marking the CBD content of their products on a total per-package and per-serving basis,” Ayyar said.

Ayyar also supports having CBD products tested and independently verified by a credible third-party source, making the results publicly available. The CBD content of each batch should also be identified in a manner that is specific to that batch and clearly marked on the product.

Ultimately, CBD products can only be guaranteed safe and effective if they are tested for potency (meaning the product contains the amount of CBD stated on the label) and purity (meaning the product is free of toxins and contaminants), according to Ayyar.

If the FDA created a new regulatory pathway for CBD products, it would provide consumers with safeguards and oversight that could reduce risk related to CBD products, according to the FDA statement. Potential risk management tools could include¹:

1. clear labels
2. contaminant prevention
3. CBD content limits
4. CBD purchasing age measures
5. oversight of CBD-containing products for animals

If a patient is interested in using a CBD product, Ayyar suggests that health care professionals guide the patient toward reputable manufacturers that use third-party testing with transparent marketing and quality control practices. Ayyar went on to provide some further guidance for health care professionals to look out for when considering CBD manufacturers to recommend to patients:

• Clear labeling including the per serving dosage of CBD (not umbrella terms such as "cannabinoids" or "hemp extract")
• Clear ingredients list
• Third-party testing results that confirm potency and purity
• USDA organic certification, or at the very least use of organic hemp
• Reasonable pricing at around 5 cents per milligram

References

1. FDA. FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward. News Release. January 26, 2023. Accessed on May 8, 2023. https://www.fda.gov/news-events/press-announcements/fda-concludes-existing-regulatory-frameworks-foods-and-supplements-are-not-appropriate-cannabidiol
2. CBS. CBD has too many safety unknowns to be regulated, FDA says. News Release. January 26, 2023. Accessed on May 8, 2023. https://www.cbsnews.com/news/cbd-fda-regulation-safety-concerns/