As of May 31, the most awaited hemp cannabidiol (CBD) public hearing at the FDA was disseminated to public that guidelines and regulations on CBD use is highly needed and that this current time and it must be implemented now. This message was given by the dietary supplement industry representatives.
The meeting was titled by the FDA as “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds,”.
The aim of this meeting is to gain information on manufacturing, safety, and marketing issued covering cannabis and cannabis-derived compounds. The event was participated by more than 100 speakers who shared their entities and concerns about cannabis-related compounds such as CBD. Various speeches were delivered airing all sorts of issues and information related to CBD as given by the academia, health advocates, legal groups to representatives from the dietary supplement industry and analytical labs.
The most predominant concern in this meeting is the lack of a clear pathway and regulatory oversight concerning hemp extracts and CBD, particularly in the fact that the consumer market has reflected a huge growth which seems to be uncontrolled at this current time.
During the meeting, one of the speakers Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA; Washington, DC), provided some figures covering the NPA’s market analysis which estimated 1500 new products comprising CBD which penetrated the market in the last three years. He also specified that the rise of CBD market is “completely new territory for the agency.”
Even if the passage of the 2018 Farm Bill de-scheduled industrial hemp and its elements such as CBD as a Schedule I drugs under the Controlled Substances Act, FDA stood strong with their regulation that CBD products cannot be easily sold to the public as dietary supplements. Legality remains a gray area despite the fact that food products, hemp-extract and CBD continue to saturate the market as many arguments prevailed explaining public health risks.
Michael McGuffin, president of the American Herbal Products Association (AHPA; Silver Spring, MD), at the FDA public hearing stated “FDA’s position on CBD has resulted in significant marketplace confusion,” He added, “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.”
Usage is Widespread
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
Several speakers at the FDA hearing session voiced out their concerns about safety control and lack of quality in the CBD manufacturing industry. In fact, Speaker Stephen Mueller, founder of CBD manufacturer Mile High Labs (Boulder, CO), specified a number of the problems being practiced in the CBD market particularly lack of compliance with Good Manufacturing Practices (GMPs) and mislabeled products.
“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.”
In addition, there are also issues concerning lack of appropriate standards and standardized language and testing when dealing with hemp extracts and CBD.
Loren Israelsen, president of the United Natural Products Alliance (UNPA; Washington, DC), who was actually one of the speakers during the event, presented her official comments through a UNPA bulletin, stating 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 for Immediate Action
Due to the occurrence of dangerous market conditions, FDA must initiate all possible measures to clear out a clean and accurate framework on the regulation of hemp extracts and CBD in order to the preserve public’s protection and safety.
“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 Guidelines and Implementation
AHPA’s McGuffin said that the FDA can take two regulatory pathways on regulating hemp-extract and CBD use. McGuffin explained 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 require 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.”
Leaders in the industry pointed out that as soon as CBD and hemp-derived products obtain pertinent regulation, they too must hold the same legitimate 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 Israelsen and Secrist discussed whether the Generally Recognized as Safe (GRAS) process is suitable for CBD and hem extracts. Secrist pointed out 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.”
Part of the discussion concerns whether or not CBD drugs and supplements should be permitted in the market. FDA explained that CBD supplements are not permissible by law under the IND policy which states that ingredients first investigated publicly for drug purposes cannot enter market and be labeled as dietary supplements.
Speaker Duffy MacKay, ND, senior vice president of scientific and regulatory affairs for CV Sciences (Las Vegas), stated that his company is studying legal measures for both CBD 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.)
“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.”
The gist of the CBD regulatory discussion is a question of safety. The answer is simple – no amount of data is available yet as to the quantity of CBD and hemp-derived which can be safe for human use.
CRN’s president and CEO, Steve Mister, stated that the FDA’s capacity to easily create a legitimate direction for CBD should be a commercial verdict 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 strongly explained that scientific investigation pertaining to the efficacy and safety of CBD and hemp-derived ingredients shall naturally grow once a greater number of companies carry a legal method to settle situate these products on the market and determine if investing in more studies is worth the cost.
“If the FDA creates a predictable path to market, then the safety research that the agency craves will materialize,” Mister said.
Also, NPA’s Fabricant pointed out that appropriate levels of exposure must be carried out in accordance with the safety use of these ingredients as consumed by the public. In addition, further studies in healthy populations are necessary.