INSIGHTS AND PERSPECTIVES

Advocating for hemp: Industry experts share views at FDA public hearing

BY Seth Mendelson

Speakers, including manufacturers, retailers, industry experts and even patients, called on the Food and Drug Administration to provide clarity, regulations and consumer education on the fledgling CBD and hemp categories at a much-anticipated public hearing in late May.

The hearing, which attracted an overflow crowd of more than 700 people, as well as nationwide media attention, took place at the FDA’s headquarters in Silver Spring, Md. The regulator is considering what steps it may want to take with CBD and hemp after the 2018 Farm Bill essentially moved the debate on these categories into their domain. The FDA, as it normally does on such issues, is asking the public, as well as industry experts, to give their opinions on what to do with the category, which has captured the attention of many consumers and businesses in recent years.

Some industry officials have said that CBD and hemp sales could reach $22 billion annually in just two or three years. At the same time, industry officials said that more than 4,000 companies across the country already are producing CBD or hemp products, and the category needs much tighter regulations.

The mass retail industry was well-represented at the hearing, with officials from the Food Marketing Association and Consumer Healthcare Products Association, among others, speaking up on the subject.
Megan Olsen, representing the Council for Responsible Nutrition, called on fast action from the FDA, saying that without federal government oversight, CBD and hemp would be a category out of control. “We urge them to use their authority as quickly as possible,” she said.

David Spangler, senior vice president of policy and general counsel at the Consumer Healthcare Products Association, called on the FDA to increase enforcement of the category. “First, the FDA speaks frequently about three priorities for both OTC medicines and supplements: public safety; product quality; and informed consumers,” he said. “We share these priorities and agree they apply to hemp-derived and CBD products. Second, we support the status quo for medicines. The existing new drug approval process provides a pathway for sponsors to develop data to bring cannabis-derived products to market once shown safe and effective.”

He also said that he sees the intense consumer and commercial interest in CBD and hemp-derived products more broadly. “But with little regulatory oversight, the marketplace offers a vast array of products of varying degrees of quality, an array of unapproved drug claims, and, in some cases, fraudulent products,” Spangler said. “While FDA is charting a course forward, enforcement should increase. For instance, more consumer alerts, and follow-up enforcement actions would be important steps.”

Finally, Spangler said that beyond enforcement, dietary supplements need a path to bring CBD-containing products to market, and one way to do that is for FDA to exercise its authority to exempt forms of CBD from the prior-IND/prior new drug approval exception in the law’s dietary supplement definition.

CBD and hemp manufacturers also were calling on quick FDA action. For example, Maureen West, the general counsel and compliance officer at Functional Remedies, said that her company aggressively is calling for strong FDA oversight. “We want clear regulations and clarifications, so we can meet and exceed dose standards,” she told DSN during the meeting. “We want the government to provide the standards for consumer protection on everything from the manufacturing process to labeling on the package. It is a very important issue now, especially as this category gets ready to explode on the market.”

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