The Act (HR 8179) directs the US Food and Drug Administration (FDA) to use its authority and resources to set a clear regulatory framework for hemp and hemp derived CBD and assure consumer protection.
The legislation would allow hemp and hemp-derived CBD to be legally marketed in dietary supplements so long as manufacturers comply with new dietary ingredient requirements and other Food and Drug Act dietary supplement policies.
The announcement was welcomed by the dietary supplement and hemp industries. In a joint statement, the American Herbal Products Association (AHPA), Consumer Healthcare Products Association (CHPA), Council for Responsible Nutrition (CRN), and United Natural Products Alliance (UNPA) noted: “While the 2018 Farm Bill changed the law to allow hemp farming, regulatory uncertainty remains about the inclusion of hemp and hemp derived CBD in dietary supplements. This lack of regulatory clarity along with insufficient oversight around hemp and hemp derived CBD exposes consumers to potentially unsafe products and lack of consistency in product quality.
“Recognizing the urgent need to address confusion around the legal status of hemp and hemp derived CBD, [we] have been calling on Congress to provide FDA statutory authority and additional resources to regulate hemp and hemp derived CBD as a dietary supplement.
“Today’s legislation would allow hemp and hemp derived CBD to be legally marketed in dietary supplements so long as manufacturers comply with new dietary ingredient requirements and other Food and Drug Act dietary supplement policies. This pathway for hemp and hemp derived CBD products to be legally marketed, would put in place necessary safeguards to protect public health. A legal hemp and hemp derived CBD pathway would also provide much needed certainty to hemp farmers.”
CRN: Action is critical
In separate comments, Julia Gustafson, CRN’s VP of government relations, said it is critical that FDA allows a legal pathway to market for CBD dietary supplements for the benefit of the agency, industry, retailers, and ultimately, consumers.
“Over one year has passed since FDA held its public meeting to better understand hemp-derived substances, and almost two years have passed since the Farm Bill was enacted, legalizing hemp-derived CBD,” said Gustafson.
“During this time, the agency has taken no action to legalize this ingredient, facilitating an unregulated marketplace. CRN urges Congress to pass this critical legislation and open the marketplace to CBD dietary supplements, providing FDA enforcement authority over the category to assure consumers have access to safe and beneficial products to support their health and wellness.”
AHPA: “The bill aligns with the position we adopted over a year ago”
In an email to NutraIngredients-USA, Michael McGuffin, AHPA president, said, “There is at this time an absence of any visible progress on FDA’s reported attention to creating a lawful pathway for CBD, and a similar lack of clarification from the agency that simple hemp products, such as tinctures and extracts, should be regulated the same as other herbal supplements. This legislation will fill those gaps, and we see it as important for ensuring that consumers will be able to find hemp and CBD products that are clearly subject to FDA’s enforcement of the robust regulations that apply to all other herbal supplements.
“The bill is also aligned with the position AHPA first adopted over a year ago to recommend that manufacturers and marketers of hemp and CBD dietary supplements comply with all of the federal regulations that apply to such operations for other supplement products.”
Building bipartisan support
According to the American Botanical Council’s annual Herbal Supplements Market report, sales of herbal supplements made with derivatives of Cannabis sativa totaled $35.9 million in 2019 in the mainstream channel and $90.7 million in the natural and health food store channel. (Herbalgram #127)
So, what are the chances of relatively quick passage of a bill introduced in September of an election year? Jonathan Miller, general counsel for the US Hemp Roundtable, told us that his organization is realistic about the bill’s prospects, and intends to use the coming months to build additional bipartisan support and attract more sponsors to the bill. There is also the possibility a hemp-CBD bill will be attached to must-pass legislation later in the year, he said.
“We see a Senate bill in the next few months, and we believe that will include food and beverage,” he added.
Ben Witte, founder and CEO of hemp-infused beverage brand Recess, called the announcement a “monumental day for the hemp industry capped off by over a year of intense advocacy efforts by the entire hemp industry.
“This legislation demonstrates that there is significant bi-partisan support in Congress to formally regulate the use of hemp CBD in various products to protect consumers from bad actors and unsafe products currently on the market, while enabling the hemp farming and processing industry to thrive.”
Witte added that the Schrader-Griffith bill is “just the beginning of the process and we will now be advocating over the coming weeks for the addition of food and beverage as the process matures, which is ultimately where the largest opportunity lies for the Hemp and CPG industries,” Witte told us.
“Given that the CBD beverage category is already established, it’s critical that we now formally regulate the category in order to protect consumers.”
NPA: “The bill fails to set a safe level”
Not everyone is supportive of the bill, however, with the Natural Products Association (NPA) rejecting the legislation, stating that it fails to set a safe level of daily consumption and would do more to undermine public trust in the safety of supplement products and do nothing to promote public health.
“We support a science-based pathway to allowing CBD in food products, but this is not the right approach and will do more to undermine public trust in the safety of dietary supplements without promoting public health,” said Daniel Fabricant, Ph.D., President and CEO of NPA.
“The FDA already has the authority to regulate CBD products by setting a safe level of daily consumption. Setting a safe level of daily consumption is a better pathway and will do much more than introducing legislation to appease special interests,”
The association added that it had previously also helped craft legislation passed by the U.S. House of Representatives that provides resources so the FDA can perform a Health Hazard Evaluation (HHE) and set a safe level of CBD for consumers to use each day.
“The process would follow the same precedent as red yeast rice, which allows a natural product to contain a level of a drug ingredient that the FDA has determined to be safe. With the exception of Epidiolex, all CBD products in the U.S. are considered illegal by the federal government,” stated NPA.