WAshington – Major food makers are ready to cash in on the sale of CBD-infused foods and drinks. But the Food and Drug Administration doesn’t have it.
Technically, all products that contain CBD, or cannabidiol, are illegal under FDA rules — regardless of whether they’re a dietary supplement sold at The Vitamin Shoppe or Whole Foods’ CBD seltzer. But the Food and Drug Administration is showing itself particularly concerned about the latter.
The agency recently warned Congress that any attempts to legalize CBD foods would jeopardize public health. The Food and Drug Administration has been so dismissive of the idea that a group of lawmakers is now accusing the agency of being uncooperative.
This tough stance is in stark contrast to the Food and Drug Administration’s approach to CBD supplements. While the agency says these products are technically illegal, it is actively considering regulatory reforms that would allow companies to legally sell these products.
“They seem to acknowledge that there should be a path to supplements, but they seem to be against foods and drinks,” said Jonathan Miller, general counsel for Hemp Roundtable, which has been lobbying companies that produce CBD products.
The FDA’s final stance on allowing CBD in foods and beverages could have massive commercial implications for the trillion-dollar market — much larger than any decision on the relatively meager nutritional supplement market.
Already, a few major food and beverage makers, such as Molson Coors, have launched their own lines of CBD-infused products. said Roberta Wagner, vice president of regulatory and technical affairs for the Consumer Brands Association, which represents more food makers such as General Mills, Hostess and Campbell’s Soup.
“Our members want a regulatory pathway established for CBD … before they start bringing these products to market,” Wagner said. “They won’t take a risk when the FDA comes out right away and says CBD is not allowed for use in conventional foods.”
The decision to allow CBD in foods and beverages is likely to have much greater public health implications than its decisions about dietary supplements because the products are more widely available.
“The stakes are greater then.” [CBD is added to] Stephen Ostroff, a former FDA deputy commissioner for foods and veterinary medicine, said he sees no reason to add CBD to foods. “They’ll show up in places where someone might not necessarily think about the fact that there’s CBD in the product. It’s hard to get supplements — you really, really have to want it.”
There is little research on the actual health effects of adding CBD to food, although the US Food and Drug Administration has raised concerns that high levels of CBD consumption may lead to liver damage.
It may not ultimately end up being the FDA’s decision at all. A bipartisan group of House members has drafted legislation that would legalize CBD food and beverage products, although it’s not clear if it has the support or impetus to become law.
The Food and Drug Administration has already raised concerns about this bill. Last month, the agency warned lawmakers pushing the bill that allowing CBD in the food supply would put consumers, including vulnerable populations such as children, the elderly, pregnant and breastfeeding women, and the chronically ill… at risk.
It’s a point the FDA has made previously — in fact, they’ve made many of the exact same comments to authors of an earlier bill with the same emphasis.
But lawmakers are resisting. In a strongly worded letter sent late last month to Commissioner Robert Califf, the bill’s sponsors wrote that the FDA’s response was “a completely inadequate response at this moment when CBD products are rampant across the country.” They noted that the bill would give the agency explicit authority to set ground rules around the labeling, packaging, and serving of any CBD-infused food or beverage.
“Under our legislation, it would be up to the FDA to regulate how products are packaged and labeled – so consumers know a product contains CBD just by looking at it on the store shelf,” the lawmakers wrote.
One of the bill’s sponsors, Representative Morgan Griffiths (R-Va), sent a second letter to the Food and Drug Administration on September 19 requesting a slew of information about the agency’s approach to CBD, including how it collects scientific data on CBD. level.
“Instead of preventing new products from reaching the market, the FDA should take action and establish a clear set of standards that companies must adhere to, especially since these products are already sold in states across the country,” Griffiths and Representative Brett Guthrie wrote ( R-Ky.).
The FDA’s brief response was particularly surprising because the agency has been deeply involved in helping craft legislation intended to allow the sale of CBD supplements. In an eight-page letter last August, the FDA provided lawmakers with legal language that would, in the words of the FDA, “create a path for hemp-derived CBD to be legally marketed as a dietary supplement while also alleviating public health and operational concerns.” The FDA has not technically endorsed this law, but provided the comments as “technical assistance” to lawmakers. This document also urges lawmakers to provide the agency with an additional $37.6 million to help fund the Food and Drug Administration’s CBD work.
Congress’ control of the FDA’s approach is just the latest example of its struggle to regulate this market. The working group that then-Commissioner Scott Gottlieb set up in 2018 to determine a path forward failed even to come up with a plan. The agency’s long-awaited policy outlining how rules regarding the Convention on Biological Diversity will be implemented was presented to the White House at the end of the Trump administration but has not been publicly disclosed.
Wagner, of the Consumer Products Association, said its members are so frustrated with the pace of the FDA that some seem to lose faith that the agency will ever find out about the problem.
“It’s as if they’ve given up,” Wagner said of her companies. “The FDA can’t work together on this.”
Califf, who also served as the commissioner of the Food and Drug Administration under President Obama, told lawmakers that the FDA will need to find a way out of the regulatory impasse.
“When you come back six years later to the job you were working at before and nothing really changed, that tells you that you can’t keep trying to do the same thing over and over,” Califf said.
The agency took a small step toward that goal earlier this year when it appointed a new leader for the Long-Term Cannabis Products Committee, which deals with the issue of CBD and other regulatory challenges related to hemp-derived products. Patrick Cornuer now serves as the leader of that group and reports to longtime regulator Janet Woodcock, who serves as “CEO,” according to a spokesperson.
Cournoyer is not very well known in the CBD world. He has not worked on cannabis issues in the past, according to LinkedIn and STAT conversations with people in the industry. His expertise is primarily in the field of biotechnology. Previously, he was the acting chair of the US Food and Drug Administration (FDA) committee that evaluates the “food safety of new plant varieties”.
This story was supported by a grant from Bloomberg Philanthropies.
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