“Whatever its health benefits turn out to be, CBD could well prove to have beneficial effects for the safety of all supplements and foods in the United States,” they wrote in The New England Journal of Medicine. Dr Cohen is affiliated with Harvard Medical School, while former FDA official Dr Sharfstein is affiliated with the Johns Hopkins Bloomberg School of Public Health.
Hemp-derived CBD has rarely been far from the headlines in 2019. While the 2018 Farm Act did remove hemp from the definition of marijuana under the Controlled Substances Act, the FDA has consistently stated that CBD is not a legal ingredient for use in dietary supplements, foods and beverage.
Despite this stance, there are an estimated 1,500 CBD products in the marketplace.
The FDA is exploring how to create an appropriately efficient and predictable regulatory framework for regulating CBD products, and held a public meeting on May 31 to discuss the “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds”.
HHE
One proposal to quickly address the issue involves a Health Hazard Evaluation (HHE), similar to the approach taken for red yeast rice and monacolin-K.
A proposed amendment to modify the House Agriculture appropriations bill focuses on this approach. The amendment essentially earmarks $100,000 for the “FDA to undertake a process to make lawful a safe level for conventional foods and dietary supplements containing Cannabidiol (CBD) so long as the products are compliant with all other FDA rules and regulations.”
The amendment was introduced by Californian member of the US House of Representatives Jerry McNerney (CA-09), who worked with the Natural Products Association (NPA).
Commenting on the HHE approach, Dr Daniel Fabricant, NPA’s president and CEO, told us that there is “not another process at the FDA to do this. You have got to set a level.”
Drs Cohen and Sharfstein acknowledge this as one approach. But they tress that if this were followed that FDA, not Congress, should make the decision as “the scientific agency whose job it is to protect the public from unacceptable risks”.
“A more responsible approach…”
However, they state that, “a more responsible approach would be for Congress to pass a law that both waives the prohibition created by CBD’s prior approval as a drug and creates clear, reasonable pathways for low-dose CBD and other new substances to be safely introduced into supplements and food.
“A new CBD law could require the FDA to strengthen its approach to safety requirements for new dietary ingredients, prohibit the risky practice of concentrating ingredients in supplements at levels much higher than those traditionally found in food or botanicals, and create an effective mandatory product listing for all dietary supplements,” wrote Drs Cohen and Sharfstein. “A listing requirement is especially important in cases of newly introduced substances, such as CBD, for which safety issues may not be fully understood until there is broader public exposure.”
Such changes are needed, they argue, because the current NDI process is “broken”.
This refers to perceived weaknesses in the current law that do “not require that firms submit studies conducted in humans, and firms may use weak evidence, such as historical use in foreign countries, to support conclusions about an ingredient’s safety,” wrote Drs Cohen and Sharfstein.
“In addition, some companies attempt to cite the natural presence of trace amounts in food to claim that ingredients can bypass the premarket notification altogether. Others simply sell products with questionable ingredients without informing the FDA.”
The authors also question the GRAS (generally recognized as safe) process, noting that companies may self-determine the safety of an ingredient, and incorporate the substance into food “before the FDA was even aware of what was happening.
“A CBD law could ensure that, moving forward, the GRAS determination would be made only by independent experts and that manufacturers would inform the FDA of all GRAS determinations before marketing,” wrote Drs Cohen and Sharfstein.
In response to the perspective in NEJM, NPA’s Dr Fabricant noted that creating something new like this proposed CBD law could take two to three years. “We don’t have that kind of time,” he said. “The consumer demand, the consumer access, the consumer safety piece is now.”
Source: The New England Journal of Medicine
Published online ahead of print, doi: 10.1056/NEJMp1906409
“The Opportunity of CBD – Reforming the Law”
Authors: P.A. Cohen, J. Sharfstein
