FDA Holds CBD Public Hearing
The U.S. Food and Drug Administration (FDA) held a public hearing on cannabidiol, also known as CBD, at its Silver Spring, MD headquarters on Friday, May 31.
The New York Times(NYT), called the hearing “the hottest ticket in the capital.” More than 400 applicants, from the U.S. Hemp Roundtable to blue chip law firms, had petitioned the agency for a chance to testify. The agency had to create a complex lottery system to whittle down the list to a lucky 120.
Each speaker was given either two or five minutes to make a case to the presiding panel of top FDA officials, with cases for both sides.
Topics brought up during the hearing included CBD’s lack of sound research, use in foods, labeling and dosing and the current patchwork of laws.
From Susan Cromer, of Virginia-based LilyHemp (Infused Herbal Goodness): “I have been privileged, awed and at times brought to tears by the positive changes CBD has brought to my customers’ lives.”
From Michelle Peace, an assistant professor of forensic science at Virginia Commonwealth University, “We have seen a rash of reports nationwide from people being poisoned from taking CBD products.”
“Although the occurrence of this meeting is a milestone of sorts, we don’t anticipate much being accomplished or decisions being made,” said Andrew Shao, interim senior vice president, scientific & regulatory affairs for the Council for Responsible Nutrition (CRN), who was interviewed by Vitamin Retailerprior to the hearing. “This meeting is an opportunity for FDA to hear from a range of stakeholders and possibly obtain help in answering some of the questions it has about cannabis and CBD. CRN would advise retailers to continue to perform due diligence on vendors looking to sell CBD products on their shelves. Many retailers hold their manufacturer vendors to very high standards for GMP [good manufacturing practice] and labeling. CRN advises the same due diligence for CBD companies.”
The FDA has been skeptical of the rapidly growing cannabis industry, but it is under increasing pressure from Congress to ease the path to market for cannabis-derived products. These products are different from medical marijuana, which a growing number of states allow for treating severe pain, nausea and other ailments. Conservative estimates predict that sales of CBD in the United States could be $16 billion by 2025.
Many cannabis companies are already selling cannabis products, ranging from soft drinks to bath salts in stores and online, but the FDA will eventually decide whether they can continue to do so. Though CBD is not currently allowed in dietary supplements or foods, the FDA had tended to overlook these infractions.
Most of the academic researchers who spoke at the hearing agreed that CBD had potential health benefits, but many also argued that more clinical trials were needed before a sound decision could be made on whether to let CBD get further into the food supply. Numerous speakers cited problems with adulterated CBD products, found to include pesticides, lead or other metals; inconsistent CBD levels leading customers to take too high a dose and get sick; and research indicating a potential for liver problems and other adverse events when taking CBD. The potential for addiction was also raised.
The 2018 Farm Bill removed hemp and derivatives like CBD from the controlled substance list, as long as products containing them didn’t have more than 0.3 percent THC. But the law preserved the FDA’s authority to regulate cannabis compounds.
The World Health Organization said last year that CBD is generally well tolerated, with a good safety profile and no addictive effects. It also noted the potential for adverse effects caused by interactions between CBD and medications people may be taking.
In the United States, health agencies have called for more research into potential therapeutic uses, as well as into health risks. The FDA has taken a harder line, pointing out the lack of quality control in the field and stressing the absence of data proving that CBD products are safe, whether they work and what the proper dosages may be if they do work.
“I don’t think that CBD is doing anything approximating what people are purporting is its magic quality,” Scott Gottlieb, MD who stepped down as FDA commissioner in April, said in an interview to NYT. “It’s a real safety issue here. There are risks of accumulated effects. It’s not a completely benign compound.”
Michael McGuffin, president of the American Herbal Products Association (AHPA) who testified at the Friday hearing, said that FDA’s current stated position that provisions of the Food Drug and Cosmetic Act (FD&C Act) prohibit marketing CBD dietary supplements and adding CBD to conventional foods has resulted in significant marketplace confusion for companies working to meet consumer demand for CBD products. He recommended FDA either use its authority under the FD&C Act to issue a regulation permitting CBD as a lawful ingredient in supplements and foods, or issue guidance to state the Agency’s intent to exercise formal enforcement discretion with respect to the provisions of the FD&C Act on which FDA bases its position that CBD-containing supplements and foods are unlawful.
“To fully implement Congress’s intent to allow access to products that contain hemp-derived CBD, and to further AHPA’s and FDA’s shared goal of ensuring safe and well-manufactured supplements and foods, AHPA requests that FDA promptly take one of [these] two … actions,” McGuffin said.
As for natural product retailers, “CRN’s recommendation would be for retailers to advise their customers that it should be a matter of time until a legitimate legal pathway for CBD-containing foods and supplements is established,” said Shao. “There is too much momentum and too many products already on the market to not progress to this. There may be some changes in how the products are formulated and labeled, depending on the specifics of the regulation FDA develops. But CBD is here to stay.”
