Building on a regulatory foundation already laid for hemp ingredients, Rep. Collin Peterson (D-MN) has proposed a bill that would include CBD under the definition of dietary supplements found in DSHEA.
Representative Collin Peterson, the chairman of the House Agriculture Committee, introduced legislation yesterday to include hemp derived CBD in the definition of dietary supplements under the Federal Food, Drug and Cosmetic Act (FD&C Act). The bill, designated at HR5587, enjoys bipartisan support, with Rep. Thomas Massie (R-KY), Rep. James Comer (R-KY) and Rep. Chellie Pingree (D-ME) signing on as cosponsors.
Providing Legal Pathway
“The last two Farm Bills were landmark successes for hemp, but we are still very early in this process, and growers need regulatory certainty,” said Peterson. “This bill will allow FDA to regulate CBD that comes from hemp as a dietary supplement, providing a pathway forward for hemp-derived products. It would also identify barriers to success for hemp farmers, informing growers and policy makers of the challenges facing this new industry.”
The bill would also require a study and report from the US Department of Agriculture, which oversees the production of hemp, on the regulatory and market barriers for farmers engaged in hemp production.
Peterson represents a rural district that covers most of western Minnesota and is a farmer himself. As one of the movers and shakers behind the 2018 Farm Bill, he said at the time he was interested in provided new markets and commodities for hard pressed farmers.
“I may grow some hemp on my farm. I'm looking at it," Peterson told Minnesota Public Radio in late 2018. "There's a big market for this stuff that we've been ceding to Canada and other places.”
The bill amends the Dietary Supplement Health and Education Act by carving out a specific exemption for hemp-derived CBD in the so-called ‘exclusionary clause’ found in that legislation. This portion of DSHEA states that if “an article” was investigated as a drug prior to coming to market as a dietary supplement or as part of a food, then a drug it must remain and the other uses are precluded. Rep. Petersen’s bill adds the phrase ‘“(other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance)” after “an article” in this portion of the legislation.
Collaborators on Bill
Attorney Tami Wahl and consultant Mike Greene collaborated with Rep. Peterson’s office in work on the legislation. Greene, who prior to starting his own consulting firm spent almost 20 years at the Council for Responsible Nutrition, where he was senior vice president for government relations, said the bill would help make good on the promise that seemed to have been implied in the 2018 Farm Bill.
“I think the sponsors of that legislation thought CBD would be legal after the Farm Bill passed. My reading of this new bill is that it is making good on that promise,” Greene told NutraIngredients-USA.
Wahl, who runs her own law firm in Washington, DC and who previously was special counsel to the American Herbal Products Association, said the legislation will help provide clarity for the many stakeholders in the market.
“I come from a rural community in Minnesota, so I understand the potential for this crop and the excitement around it,” she said.
“The purpose of this legislation was to be true to the intent of the Farm Bill and to provide the regulatory certainty that everyone who has an interest in this ingredient needs. Looking back over the last growth cycle there was concern expressed by some of the farmers about whether they’d have end markets for their crop,” Wahl added.
FDA Would be Free to Regulate ‘Chaotic’ Market
Greene said that while the new bill would obviate the exclusionary clause, it wouldn’t prevent FDA from doing the other things that might be necessary, such as requiring New Dietary Ingredient Notifications where appropriate. And Wahl said it could help FDA to start doing some of the things that aren’t getting done now.
“We’ve had a handful of warning letters on CBD that pertain to things like egregious claims. But with regulatory certainty FDA could enforce on a lot of other things, like GMP compliance, facility registrations, labeling issues and so forth,” she said.
“What this would help do is to resolve some of the chaos in the market,” Greene said. “CBD is everywhere.”
The following is an explanation on what DSHEA is and why this is a huge step in the right direction for US consumers of CBD products:
Dietary Supplement Health & Education Act (DSHEA)
DSHEA is the acronym for the Dietary Supplement Health and Education Act of 1994. The law provides FDA with appropriate regulatory authority and ample enforcement tools to protect consumers while still allowing them the desired access to a wide variety of affordable, high quality, safe and beneficial dietary supplement products. CRN supports strong enforcement of DSHEA and continues to urge for full enactment of the law.
DSHEA specifically reaffirmed the status of dietary supplements as a category of food and created a specific definition for dietary supplements.
DSHEA made it clear that ingredients of dietary supplements could not be regulated as food additives. Instead, the legislation created two categories of dietary supplement ingredients—“old” or “grandfathered” ingredients and “new dietary ingredients.” DSHEA grandfathered all dietary supplement ingredients marketed in the United States before October 15, 1994. These are considered safe for continued consumer use. Before marketing a “new dietary ingredient” manufacturers must submit a New Dietary Ingredient Notification to FDA to providing their basis for judging that the ingredient “is reasonably expected to be safe.” This information must be provided at least 75 days before marketing a new ingredient.
DSHEA confirmed that dietary supplements must comply with current Good Manufacturing Practices (cGMPs) and also authorized FDA to establish separate GMPs for dietary supplements. The supplement-specific GMP rules were released in June 2007 with a three-year “phase in” compliance period. By June 2010, all manufacturers were expected to fully comply with the new rules. Responsible companies in the industry have fully supported the need for dietary supplements GMPs in order to create a level playing field for companies across the board and help increase consumer confidence in the quality and safety of these products.
DSHEA provided FDA with additional enforcement authority, including the ability to remove from the market products the agency deems unsafe through: 1) an “imminent hazard” clause which permits FDA to immediately remove a product it considers to present an immediate safety concern and 2) a “significant or unreasonable risk” clause that allows removal of a product considered to pose an unacceptable risk of illness or injury.
Historical Background: What Findings Did Congress Emphasize in Passing DSHEA by Unanimous Consent?
In passing this landmark legislation, Congress set forth a number of "findings" which emphasize the importance of communicating the positive benefits of supplements to the American public. Congress found that:
The importance of nutrition and the benefits of dietary supplements in health promotion and disease prevention have been documented increasingly in scientific studies;
There is a link between ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis;
Preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases and reduce long-term health care expenditures;
Consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements;
There is a growing need for emphasis on the dissemination of information linking nutrition and long-term good health;
National surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals or herbs as a means of improving their nutrition;
Legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness;
Dietary supplements are safe within a broad range of intake, and safety problems with supplements are relatively rare;
Although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;
A rational Federal framework must be established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements.
Written By: Hank Schultz
Additional Information: https://bogartx.com/home/bill-introduced-to-add-cbd-to-dsheas-supplement-definitions