Legislating Hemp As Dietary Ingredient: Wrapping US Market In A Bow, Or Tying DSHEA In Knots?

House legislation to exempt hemp-derived cannabinoids from FDA rule that an “article” previously studied or approved for use as drugs is not allowed for use in dietary supplements either resolves a conundrum or raises additional questions for the agency and the industry.

Legislation to lift a prohibition against using hemp-derived cannabinoids as dietary ingredients could untie a regulatory knot around their production and sales in the US but also could tie the supplement industry into knots about other regulatory changes that could be proposed.

That’s how food and drug regulation attorneys and other industry stakeholders see legislation introduced in the House that would make hemp-derived cannabinoids, with cannabidiols the most common type, exempt from the Food and Drug Administration rule that an “article” previously studied or approved for use as drugs is not allowed for use in dietary supplements.

The 2018 farm bill de-scheduled hemp – defined as cannabis or any part of the cannabis plant containing no more than 0.3% concentration, on a dry weight basis, of tetrahydrocannabinol – as a controlled substance but it maintained the FDA’s oversight of the use of ingredients derived from the plant in products subject to its regulation.

That meant with the FDA previously approving synthetic cannabidiol ingredients as a drug as well as several cannabis-based drugs, its rules prohibited use of the “article,” hemp, in non-drug products even though hemp no longer was an illegal substance.

"My concern is if we start making special carve outs for CBD, that points to a flaw in DSHEA.” –  attorney Robert Durkin, Arnall Golden Gregory

The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act, H.R. 841, introduced in February by Energy and Commerce members Kurt Schrader, D-OR, and Morgan Griffiths, R-VA, would exempt hemp from the FDA’s drug preclusion provision, making lawful its use in supplements. (Also see "CBD Regulation Bill Filed In US House Again; VMS In Pre-Tax Savings Accounts In First Senate Vote" - HBW Insight, 5 Feb, 2021.)

With the legislation, said Council for Responsible Nutrition president and CEO Steve Mister, Congress would say to the supplement industry: “Your shoes were tied together in that race to market. So we’re going to let you have a free pass here and we’re going to give you an exemption to the drug preclusion language.”

Why ‘Special Carve Out' For CBD?

It’s up to the FDA to act on its own, not at Congress’ direction through legislation, to untie the regulatory knot it’s allowed to develop around the production and sales of cannabinoid-containing supplements, says Robert Durkin, a food and drug attorney of counsel at Arnall Golden Gregory LLP in Washington.

“There’s an answer in DSHEA already for how this should be handled. For whatever reason, FDA is not availing themselves of it. My concern is if we start making special carve outs for CBD, that points to a flaw in DSHEA,” Durkin said.

“Why would they have to legislate a special position for CBD relative to all other dietary ingredients?” he added.

DSHEA authorizes the FDA to use notice-and-comment rulemakings to propose making eligible for use as dietary ingredients substances that might be otherwise not be considered dietary ingredients.

Additionally, DSHEA requires that substances recognized as dietary ingredients but not in use in the US food supply before passage of the act in 1994 must be notified to the FDA with proof of reasonable expectation of safety for their intended uses before being offered in products for sale; however, notifiers aren’t required to wait for answers from the FDA before marketing those products.

There’s no reason that cannabinoids’ use in dietary supplements couldn’t be made lawful through an FDA rulemaking combined with new dietary ingredient notifications submitted to the agency, Durkin says.

“All of a sudden CBD comes in and folks want to rewrite the rules for CBD,” he said, adding, “Either there is a fundamental flaw that needs to addressed in DSHEA or CBD needs to play by the same rules as everyone else.”

Many consumer health product firms, particularly larger companies, have not entered the cannabinoid supplement market because the ingredients are unlawful. Those businesses have been waiting for the FDA to open a regulatory pathway.

FDA Looks To Congress

Since Congress passed the 2018 farm bill, the FDA has allowed sales of the products that are manufactured and marketed in compliance with its regulations while still deeming the ingredients unlawful.

The FDA opened a docket in April 2019 on considering a pathway that could be adopted through a rulemaking process that would make cannabinoids lawful as dietary ingredients under its regulatory framework for manufacturing and marketing dietary supplements established by the Dietary Supplement and Health Education Act, Public Law 103-417.

The docket was re-opened more than once before the FDA opened it indefinitely because little information was being submitted on the agency’s primary question, safety of hemp-derived cannabinoids used as ingredients in non-drug products. (Also see "FDA ISO Data On CBD Safety In Supplements, Sees Potential As Well As Risks " - HBW Insight, 20 Nov, 2019.)

As well, multiple agency officials have said that a change in its policy for the ingredients could be more quickly established by Congress than by rulemaking. (Also see "Lawful Use Of Cannabidiols In Supplements ‘Different Than The Rest’ Of US FDA Regulations?" - HBW Insight, 7 Oct, 2020.)

“Since FDA seems to be slow doing something like that, we will continue to ask Congress to do it directly,” said David Spangler, the Consumer Healthcare Products Association’s senior vice president for legal, government and regulatory affairs.

“It’s just not equitable to the folks in the industry who have been supporting industry by putting good products on the market for the last 25 years, to come in and just change the rules,” Durkin said.

As for Schrader and Griffiths’ H.R. 841, or other legislation that would exempt cannabinoids specifically from the FDA’s drug preclusion provision for dietary ingredients, “That’s changing DSHEA just for CBD,” he added.

The Natural Products Association also contends that the FDA should resolve its conundrum around hemp by rulemaking, and not by direction from Congress. (Also see "Legislating CBD As Lawful Supplement Ingredient: A Threatening Precedent For US Industry?" - HBW Insight, 18 Feb, 2021.)

NDI A Thorn In Hemp’s Use?

The FDA isn’t entirely satisfied with the Energy and Commerce members’ existing legislation. In “technical comments” it submitted to the committee following introduction of the legislation in 2019, the agency suggested adding language to the bill that specify that any hemp-derived cannabinoid is an NDI when used in a supplement. (Also see "US FDA Showed ‘Several’ Cards In CBD Bill Comments – CV Sciences’ Duffy MacKay" - HBW Insight, 14 Dec, 2020.)

CRN’s position is that H.R. 841 doesn’t relieve the ingredients of being subject to all other requirements and restrictions the FDA imposes, including the NDI notification requirement. However, the trade group supports adding language to the bill specifically including the requirement along with allowing firms already marketing cannabinoid supplements a period of 90 days to submit notifications to the FDA. (Also see "Unprecedented To Lawful: Regulatory Precedent Needed For Cannabinoids’ Use In Supplements?" - HBW Insight, 5 Mar, 2021.)

Theoretically, businesses already making cannabinoid-containing supplements that fail to submit NDI notifications within the 90 days could be required to pull their products from the market, an approach firms that have remained out of the market have suggested to the agency since early in the cannabinoid market boom. (Also see "VMS Industry Wants Into CBD Market, Plus Enforcement On Firms Already There" - HBW Insight, 4 Jun, 2019.)  

Three months is a tight schedule for preparing and submitting an NDI notification to the FDA, say Durkin and Kevin Bell, a colleague at Arnall Golden Gregory.

“I think a timeframe that short would be unfair,” Bell said.

That’s partly because the agency’s NDI program doesn’t instill confidence in the industry, and it won’t be any easier to navigate when manufacturers, marketers and other businesses potentially submit NDI notifications for cannabinoids. The FDA currently isn't accepting notifications for cannabinoids because the agency's official position is that they're not dietary ingredients. 

After a 2011 draft guidance that was withdrawn and a 2014 revision that garnered slightly fewer questions, the industry and the FDA are far from agreeing on what DSHEA requires on which ingredients should be notified to the agency; for proof of reasonable expectation of safety; and whether the act entitles the sources of NDI notifications filed by the FDA to some periods of market exclusivity for their ingredients. (Also see "In US, Market Exclusivity For NDI Notifications ‘Just Not There’ In DSHEA Regulation" - HBW Insight, 25 Sep, 2020.)

“If there was timeframe that short it would almost be insulting to industry who has spent quite a bit of time asking, begging for guidance in this area. If they got cut short like that, I think that would be very unfair to industry stakeholders who really are wanting FDA to clarify what it will allow,” Bell said.

The same results the industry and the FDA have seen from NDI notifications for other ingredients will surface for cannabinoids, he added. Businesses that haven’t submitted notifications will continue selling products alongside those offered by businesses with NDI notifications for cannabinoids filed by the FDA.

“At the end of the day, lets say that they come out with some kind of NDI guidance, what do you get from that? How many companies are going to do that unless they know that there is a compliance component and a benefit to spending the kind of money it takes to do the right kind of work scientifically?” Bell said

“Now what? Is this going to garner me the befit that I’m supposed to receive under existing law? Until there is enforcement, FDA has got a real problem with compliance.”

Short of Congress passing legislation or the FDA conducting a rulemaking, the US hemp-derived cannabinoids market most likely will be impacted by a draft guidance on the agency’s its enforcement over the ingredients’ use in dietary supplements submitted in July 2020 for the Office of Management and Budget’s review.

However, the draft remained at OMB through the end of the Trump administration and was returned to the FDA in January after President Biden ordered the White House office to withdraw from its review any pending rule or other regulatory item, including guidance documents, submitted by all federal agencies. (Also see "Biden Administration Pause On Pending Trump-Era Rules Stalls FDA Cannabinoids Guidance Progress" - HBW Insight, 27 Jan, 2021.)

Whether by guidance or rulemaking, Durkin says, it’s up to the FDA to act. “Are they deliberately waiting for congress to fix their problem? I think they’re waiting for somebody else to solve the problem they allowed to happen. I think they’re waiting for the legislators to do it.”