Several sources, including the office of one Senator, have confirmed the reports. While the language of the bill has yet to be revealed, it reportedly will mirror to a large extent that of the House measure HR 841, which was introduced by Rep. Ken Schrader, D-OR. Titled the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021, the bill would allow “the use of hemp, cannabidiol (i.e., CBD) derived from hemp, or any other ingredient derived from hemp in a dietary supplement, provided that the supplement meets other applicable requirements.”
Market far too big for FDA to shut down now
The CBD/hemp extract marketplace started to warm up after the 2014 Farm Bill and really hit high gear after the 2018 version, which removed the cannabis plant entire from the Schedule One list of controlled substances. THC, the psychoactive fraction of the plant, remains on the list, however.
FDA subsequently ruled that CBD was not a legal dietary ingredient for use in supplements because of its prior investigation for use as a drug by English company GW Pharmaceuticals. That company’s drug, Epidiolex, has been approved to treat seizures in two forms of childhood epilepsy that are not easily treated with other medications.
Despite FDA’s determination, the market for CBD/hemp extract products has exploded, with thousands of products for sale online and in an increasingly broad array of brick and mortar outlets. Many of these are marketed and packaged in a manner similar to fully compliant dietary supplements.
More than a year ago, then FDA Commission Dr Stephen Hahn, MD, said FDA did not intend to try to curtail the CBD market based on the ingredient’s regulatory impairments.
“People are using these products. We are not going to be able to say you can’t use these products. It’s a fool’s game to even approach that,” Hahn said during a speech in Washington, DC.
While FDA has held discussions with industry stakeholders on ways to resolve the regulatory limbo the ingredient finds itself in, nothing has come of that effort so far. So the attention has turned to a legislative solution. HR 841 is reprise of HR 8179, which Rep. Schrader introduced in 2020.
Hemp group pushing hard for Senate bill
Jonathan Miller, general counsel of the US Hemp Roundtable, said his organization has been pushing hard for a Senate bill introduction. Attacking the issue in both Houses holds the best chance for a quick legislative solution, he said.
“There have definitely been a lot of meetings we’ve had with our hemp champions in the Senate, encouraging them to sponsor a bill,” Miller told NutraIngredients-USA. “We are hopeful to see something introduced in the near future. It’s helpful to have bills moving in separate bodies. In a dream scenario each bill would pass in its respective House and then they’d go into a conference committee.”
NPA: Foods should be included in solution
The Natural Products Association has been an outlier among industry stakeholders in regard to the effort to come up with a legislative solution. Daniel Fabricant, PhD, NPA’s CEO and executive director, has long advocated that the determination of CBD’s rightful place in the regulatory framework should come from within the Agency itself. Fabricant says FDA should begin by deciding what is the safe level for daily CBD exposure, which would include any foods that contain CBD and/or full or broad spectrum hemp extracts.
“We are only going to do this for supplements and not foods? That doesn’t make sense. Exposure is exposure. It’s true that FDA has been slow to address this issue. What we need to do is to hold FDA’s feet to the fire and make them accountable,” he said.