Supplement industry to FDA on CBD regulations: “We can’t wait years”

May 31, 2019

At FDA’s highly anticipated public hearing on hemp cannabidiol (CBD) today, May 31, the message from dietary supplement industry representatives was clear: The supplement industry needs a regulatory pathway for CBD-and needs it now.

At FDA’s highly anticipated public hearing on hemp cannabidiol (CBD) today, May 31, the message from dietary supplement industry representatives was clear: The supplement industry needs a regulatory pathway for CBD-and needs it now.

FDA called the meeting, titled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds,” in an effort to gain more information on safety, manufacturing, and market concerns around cannabis and cannabis-derived compounds. More than 100 speakers representing a broad range of entities with concerns or business related to cannabis and cannabis-related compounds like CBD delivered short speeches outlining their biggest concerns. Speakers ranged from members of health-advocate groups, academia, analytical labs, and legal groups to representatives from the dietary supplement industry.

The overarching concern among all parties is the lack of regulatory oversight, and the lack of a clear legal pathway, concerning CBD and hemp extracts, especially in light of the fact that the consumer market for these products has grown astronomically-and, it seems, uncontrolled.

At the meeting, speaker Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA; Washington, DC), shared NPA’s market analysis estimating that in the last three years alone, approximately 1500 new products containing CBD have entered the market. He noted that the skyrocketing CBD market is “completely new territory for the agency.”

Although the passage of the 2018 Farm Bill de-scheduled industrial hemp and its constituents such as CBD as a Schedule I drugs under the Controlled Substances Act, FDA has still maintained that CBD products cannot be sold as dietary supplements. Even as CBD and hemp-extract supplement and food products continue to flood the market, their legality remains gray area that, many argue, puts public health at risk.

“FDA’s position on CBD has resulted in significant marketplace confusion,” said Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD), at the FDA public hearing. “Many companies now selling foods and supplements containing CBD have the mistaken impression that FDA does not currently regulate them; others have chosen to stay out of the market based on FDA’s position.”


Wide Usage

Speaker Megan Olsen, assistant general counsel for the Council for Responsible Nutrition (CRN; Washington, DC), said: “Despite FDA’s current position on the legality of CBD, the CBD food and supplement marketplace is exploding. For dietary supplements alone, hemp-derived CBD sales were over $200 million in 2018 and are expected to grow to over $300 million by the end of 2019. Driving these sales is an intense consumer demand of hemp-derived CBD. Research suggests that a third of U.S. adults are current CBD users; nearly half of all U.S. adults have used CBD at some point. Lack of FDA oversight of these products leaves this growing consumer base vulnerable. Without FDA oversight, consumers lack assurance that products labeled as CBD are safe. Consumers cannot trust that the products are manufactured in an appropriate manner or actually contain the amount of CBD listed on the label or any CBD at all.”

 

Market Run Amuck

Many speakers at the FDA hearing expressed concerns about lack of quality and safety control in the CBD manufacturing space. Speaker Stephen Mueller, founder of CBD manufacturer Mile High Labs (Boulder, CO), called out many of the biggest problems currently in the CBD market, including mislabeled products and a lack of compliance with Good Manufacturing Practices (GMPs). “This is one of the biggest issues we see out there,” he said. “If you don’t have the proper controls in place for the GMP guidelines, you are really at risk of shipping unsafe product to the consumer.”

Then there are problems with testing and a lack of appropriate standards and standardized language when dealing with CBD and hemp extracts.

Loren Israelsen, president of the United Natural Products Alliance (UNPA; Washington, DC), who was scheduled to speak at the event but who instead released his official comments via a UNPA bulletin, pointed out that there is “lack of a cannabis lexicon to facilitate clear communication between policy makers, regulators, academia, and industry. The language of cannabis is new to most of us, which stands as an impediment to clarity of our communications and public discourse on this subject.”

Mueller said that “many manufacturers don’t have access to accurate test methods, either in house or through contract labs. The level of inconsistency we’ve seen at contract labs is really astounding.”

The bottom line, Mueller said, is that there is a severe lack of general quality control in the market. “One of the problems today is that a lot of the manufacturers don’t understand what they need to do to make a safe and consistent product for the consumer. Consumers also don’t have confidence in the product themselves and don’t understand which manufacturers they can look to buy a safe product.”

Need to Act Now

As a result of these unsafe market conditions, FDA needs to act now to enact a clear, intelligent regulatory framework for CBD and hemp extracts and to protect the public.

“FDA does not have the luxury of time,” CRN's Olsen said. “We must act quickly to address the market that is out of control. Three to five years at a minimum for rulemaking is too long. In fact, CRN was alarmed by this suggested time frame in comments by FDA leadership, including former FDA commissioner Dr. [Scott] Gottlieb.”

UNPA's Israelsen said, “We call on FDA to create a legal pathway, and if that can’t reasonably be expected to be done in the next six months, FDA must provide Congress the technical assistance it needs to statutorily create the pathway. It should make that determination in the next 30 days so that if Congress needs to act, it has the time to do so this year. We can’t wait three years for action. Inaction is the worst outcome for all involved.”

 

Regulatory Pathways, Enforcement

AHPA’s McGuffin outlined two regulatory pathways FDA can take on CBD and hemp-extract regulation. McGuffin outlined both in his speech.

  • “FDA should use its authority under the [Food, Drug, and Cosmetic Act; FD&C Act] to issue a regulation-possibly as an interim final rule with an accelerated effective date-permitting CBD as a lawful ingredient in supplements and foods. Of course, this regulation would still requirement compliance with all other applicable federal regulations.”

  • “Alternately, and especially if FDA cannot issue this requested regulation promptly, FDA should issue guidance to state the agency’s intent to exercise formal enforcement discretion with respect to the provisions of the FD&C Act on which FDA bases its position that CBD-containing supplements and foods are unlawful.”

Industry leaders also pointed out that once CBD and hemp-derived products do have a regulatory pathway, they should be held to the same legal requirements of all food and supplement products. Israelsen said these include: “New Dietary Ingredient (NDI) notifications, adherence to current Good Manufacturing Practices (cGMPs), product labeling, serious adverse event reporting, and structure/function claims. Likewise, relevant FSMA requirements should be fully observed.”

Speaker Aaron Secrist, vice president of regulatory affairs for supplement brand NOW Foods, said, “By not enforcing the current statutes, the agency is [allowing] irresponsible, uninformed companies to manufacture CBD and hemp-derived products without understanding, in many instances, the identity of the CBD ingredients or hemp-derived ingredients they are putting in products and without any safety studies performed on these ingredients that they use in products that varies widely in the marketplace as we have seen today.”

Secrist said that a legal pathway “will encourage responsible companies who follow the law, such as NOW Health Group, to potentially enter the market through the front door and perform the requisite safety studies, method validation, clinical studies, and submit an NDI notification for agency review to ensure safe and effective products are available to the American public. This is in keeping with the FDA’s mission and our company’s mission and values.”

And what of companies on the market already operating in gray area? Secrist said that NOW Foods “respectfully ask[s] the FDA to ensure the rule of law is upheld by barring any company illegally marketing CBD or other hemp-derived dietary supplements from submitting an NDI notification for a period of time equal to the time that their products have been illegally marketed. If the FDA simply opens the door to hemp-derived ingredients and products containing CBD by exercising the [U.S. Department of Health and Human Services] Secretary’s authority without such provision, then it effectually encourages companies to flout the law in the future.”

Both Secrist and Israelsen also discussed whether the Generally Recognized as Safe (GRAS) process is appropriate for CBD and hemp extracts. Secrist said that NOW Foods does not believe that GRAS self-affirmations should be accepted by the agency in lieu of NDI notifications. Israelsen said: “The agency should also consider carefully whether self-affirmed GRAS without notification is an appropriate means of safety assessment for CBD/hemp extracts.”


IND Exclusion

There was also some discussion about whether CBD drugs and supplements should both be allowed in the market. FDA has said that CBD supplements are not allowed by law under Investigational New Drug (IND) policy that states that ingredients first investigated publicly for drug purposes cannot be later brought to market as dietary supplements.

Speaker Duffy MacKay, ND, senior vice president of scientific and regulatory affairs for CV Sciences (Las Vegas), said his company sees legal pathways for both CBD drugs and supplements. (CV Sciences operates both a consumer division with its CBD oil products, and also runs a pharmaceutical division pursuing an FDA-approved drug.)

Israelsen said: “We believe, in this unusual case, a CBD-approved drug and general consumer–oriented CBD/hemp extract products can coexist in the market. The goal, we believe, is to ‘fence out’ claims that exceed DSHEA”-Dietary Supplement Health and Education Act-“standards and establish a CBD dosage upper limit that takes into account safety as well as the Rx therapeutic dosage required by the patient.”

 

Safety

At the heart of CBD regulatory discussions is the question of safety. Simply put, there is not a large amount of data available yet on whether-and how much-CBD and hemp-derived extracts are safe for human use.

CRN’s president and CEO, Steve Mister, said that FDA’s ability to quickly establish a legal pathway for CBD should be a commercial decision alone. “[T]he initial determination of whether CBD is a dietary ingredient isn’t a safety question,” he said. “It’s a commercial one.” And, he said, FDA “need[s] to trust its own processes for examining safety.”

He rightly pointed out that more science on the safety and efficacy of CBD and hemp-derived ingredients will organically develop once more companies have a legal pathway to put these products on the market and see investing in studies worth the cost. “If the FDA creates a predictable path to market, then the safety research that the agency craves will materialize,” Mister said.

NPA’s Fabricant noted that official exposure levels need to be set with regard to safe human use of these ingredients. He also added that more studies in healthy populations are needed.

 

Chance to Comment

In alignment with the public hearing, FDA opened a docket for the public to submit comments. Comments can be submitted to the agency here.