WASHINGTON — Major food makers are ready to cash in on selling CBD-filled foods and drinks. But the Food and Drug Administration isn’t having it.
Technically all products containing CBD, or cannabidiol, are illegal under FDA’s rules — regardless of whether they’re a dietary supplement sold at the Vitamin Shoppe or a CBD seltzer from Whole Foods. But the FDA is showing itself particularly concerned about the latter.
The agency recently warned Congress that any attempts to legalize CBD foods would put the public health at risk. The FDA has been so dismissive of the idea that a group of lawmakers is now accusing the agency of being uncooperative.
That hardline position is a stark contrast to the FDA’s approach toward CBD dietary supplements. While the agency says those products are technically illegal, it has been actively considering regulatory fixes that would let companies sell those products legally.
“They seem to concede that there should be a pathway for dietary supplements, but they seem opposed to food and beverages,” said Jonathan Miller, the general counsel of the Hemp Roundtable, which lobbies for companies that produce CBD products.
The FDA’s ultimate stance on whether to allow CBD in foods and beverages could have massive business implications for that $1 trillion market — far greater than any decision on the comparably puny dietary supplement market.
Already, a handful of major food and drink makers, like Molson Coors, have launched their own lines of CBD-infused products. Countless more, from Anheuser-Busch to Mondelez International have expressed an interest in the market, but most food companies are waiting for more clarity from the FDA, said Roberta Wagner, vice president of regulatory and technical affairs for the Consumer Brands Association, which represents food makers like General Mills, Hostess, and Campbell’s Soup.
“Our members want a regulatory pathway established for CBD … before they’re ever going to start introducing those products to the marketplace,” Wagner said. “They’re just not going to take the risks when the FDA has come straight out and said CBD is not allowed for use in conventional foods.”
The decision on whether to allow CBD in foods and beverages is likely to have much bigger public health implications than its decisions on dietary supplements because the products are so much more widely available.
“The risks are greater if [CBD is added to] conventional food,” argued Stephen Ostroff, the former FDA deputy commissioner for foods and veterinary medicine, who said he didn’t see a reason to add CBD to foods. “They’ll show up in places where somebody may not necessarily be thinking about the fact that there’s CBD in the product. It’s harder to get dietary supplements — you have to really, really want them.”
There’s little research on the actual health impacts of adding CBD to food, though the FDA has raised concerns that high levels of CBD consumption could lead to liver damage.
It might not eventually end up being the FDA’s decision at all. A bipartisan group of House lawmakers has penned legislation that would legalize CBD food and drink products, though it isn’t clear if it has the support or momentum to become law.
The FDA has already raised concerns with that bill. Last month, the agency warned the lawmakers pushing the bill that allowing CBD in the food supply would put “consumers, including vulnerable populations such as children, the elderly, those who are pregnant and lactating, and those with chronic illnesses … at risk.”
It’s a point the FDA has made previously — in fact, they provided many of the exact same comments to the authors of a previous bill with the same focus.
But the lawmakers are pushing back. In a sharply worded letter sent late last month to Commissioner Robert Califf, the sponsors of the bill wrote that the FDA’s reply was “a completely insufficient response at this moment when cannabidiol (CBD) products are proliferating around the country.” They noted that the bill would give the agency explicit authority to set ground rules around labeling, packaging, and serving for any CBD-infused food or beverage.
“Under our legislation, it would be in FDA’s clear purview to regulate how the products are packaged and labeled — so consumers would know a product contains CBD just by looking at it on the store shelf,” the lawmakers wrote.
One of bill’s co-sponsors, Rep. Morgan Griffith (R-Va.), sent a second letter to the FDA on Sept. 19 requesting a slew of information about the agency’s approach toward CBD, including how it is gathering scientific data about the substance.
“Rather than denying new products from coming to market, the FDA must take action and establish a clear set of standards for companies to adhere by, especially since these products are already being sold in states across the nation,” Griffith and Rep. Brett Guthrie (R-Ky.) wrote.
The FDA’s terse response was especially surprising because the agency has been so heavily involved in helping to craft legislation meant to allow the sale of CBD supplements. In an eight page letter from last August, the FDA provided lawmakers legal language that, in the FDA’s own words, would “create a pathway for hemp-derived CBD to be legally marketed as a dietary supplement while also mitigating the public health and operational concerns.” The FDA technically has not endorsed that bill, but rather provided the comments as “technical assistance” to the lawmakers. That document also pitches lawmakers on providing the agency an additional $37.6 million to help fund the FDA’s CBD work.
Congress’ gripes with the FDA’s approach are just the latest example of its struggles to regulate this market. A working group set up by then-commissioner Scott Gottlieb in 2018 to figure out a path forward failed to ever even come up with a plan. And a long-awaited agency policy outlining how it would enforce the rules around CBD was submitted to the White House at the tail end of the Trump administration but never was released publicly.
Wagner, of the Consumer Products Association, said her members are so frustrated by the FDA’s pace that some seem to be losing faith the agency will ever figure this issue out.
“It’s almost like they’ve given up,” Wagner said about her companies. “The FDA just can’t get their act together on this.”
Califf, who also served as FDA commissioner under President Obama, recently told lawmakers the FDA will need to figure a way out of the regulatory logjam.
“When you come back six years later to the job you had before and nothing has really changed, that is telling you that you can’t just keep trying to do the same thing over and over,” Califf said.
The agency took a minor step toward that goal earlier this year when it appointed a new leader of its long-standing Cannabis Product Committee, which deals with the CBD issue and other regulatory challenges around cannabis-derived products. Patrick Cournoyer now serves as the lead of that group and reports to longtime regulator Janet Woodcock, who serves as the “executive lead,” according to a spokesperson.
Cournoyer is not well known in the CBD world. He hasn’t worked on cannabis issues in the past, according to his LinkedIn and STAT’s conversations with people in the industry. His experience is primarily in the biotechnology space; he was previously the acting lead of an FDA committee that evaluates “the safety of food from new plant varieties.”
This story was supported by a grant from Bloomberg Philanthropies.
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