When it comes to food or “health” products containing cannabidiol, commonly known as CBD, the federal government is not keeping up with the marketplace, where sales of CBD products topped $500 million in 2018.
FDA has responded by promising to speed up its process for developing regulations on CBD, which can be extracted from industrial hemp, legalized last year in the 2018 farm bill. Amy Abernethy, principal deputy commissioner and acting chief information officer at FDA, said her agency would report on its progress in late summer or early fall.
FDA’s process will include poring over more than 4,000 comments received through July 16 on the question of just how FDA should regulate CBD to provide a degree of certainty to farmers and food, drug and feed manufacturers, all of whom have a keen interest in hemp.
“There is no doubt this industry is booming. However, hemp will only become economically viable to American farmers and ranchers in the United States, if a well-defined regulatory framework for its products is developed,” the National Association of State Departments of Agriculture said in its comments.
As Agri-Pulse reported last week, all but a handful of states have passed laws to set up state programs for hemp cultivation. One of those that has, Vermont, said in comments that it has received 200 applications to grow more than 2,000 acres of hemp in the state. Hemp “is critical to our state, as our primary agricultural business, dairy, decreased significantly in the same time period,” Anson Tebbetts, secretary of the state’s Agriculture, Food and Markets Agency, said in comments.
Research will be key to the continued commercialization of hemp, the American Veterinary Medical Association said. AVMA noted it is now illegal to use a product in feed for a food-producing animal “for which the scientific evidence of appropriate withdrawal times — time between when a substance can be fed to a food-producing animal and when the animal is milked or slaughtered — has not been established.”
Therefore, AVMA said, “research needs to be conducted and withdrawal times must be determined before cannabis and cannabis-derived compounds (including CBD) can be incorporated into a feed intended for livestock.”
But research has been complicated by limitations on the transport of industrial hemp in interstate commerce, the University of California System said, asking FDA to issue “clarification or guidance ... regarding the ability of researchers to obtain products containing hemp-derived CBD from a variety of sources, including via interstate commerce.”
The Hoban Law Group, which represents cannabis companies, said federal laws “have long stifled sensible research into cannabis-derived compounds.”
The Center for Science in the Public Interest said FDA should temporarily decide that CBD and THC, the psychoactive compound in cannabis, are not “generally recognized as safe” in foods while FDA evaluates how to regulate them as food additives.
"The GRAS process offers an opportunity for FDA review," CSPI said. "As the agency did with partially hydrogenated oils (artificial trans fat), FDA should issue a tentative determination that neither CBD nor THC is GRAS for use in food, and provide the cannabis industry with a specified period of time, such as 2-3 years, for comment and to submit data to the docket before finalizing that determination. As with trans fat, products could continue to be sold during that time."
The test under federal law for GRAS status is whether there is consensus among knowledgeable experts that a particular substance for a particular use is “reasonably certain to do no harm.”
CSPI emphasized the risk of allowing unfettered marketing of cannabis products, saying there are “major safety hazards related to cannabis edibles, specifically, include variable levels of THC, CBD, and other cannabinoids; aflatoxins; chemical residues; high levels of pesticide residues; heavy metals; and dangerous pathogens.”
Thirty-seven state attorneys general also highlighted health risks. “Currently, companies are creating a myriad of cannabinoid products largely unburdened by any oversight or testing requirements,” they said. “The inherent complexity of cannabinoids, combined with the danger of hazardous additives, raises serious public health concerns that absent some rules or regulations, unscrupulous companies will be able to distribute products that include illegal cannabinoid combinations or have dangerous additives.”
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