FDA’s CBD public meeting: The NDI/GRAS question, gaps in the safety data, and more

By Stephen Daniells contact

- Last updated on GMT

© Getty Images / Aleksandr_Kravtsov
© Getty Images / Aleksandr_Kravtsov
Friday’s public meeting was an illuminating day of presentations, with multiple viewpoints and interests being aired. On the dietary supplements side, there were strong calls for companies to take the front door with the Agency.

The US Food and Drug Administration (FDA) held a public meeting Friday (May 31) to discuss the “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds”. About 140 people lined up to make statements, including dietary supplements trade associations, brands, and ingredient suppliers.

Messages that kept being raised included:

-        There are significant gaps in the safety data

-        Several stakeholders struggled to clarify safe dosage ranges

-        There are thousands of CBD-containing products on the market labeled as dietary supplements with quality standards all over the place. FDA must act quickly to clarify the regulatory status of the ingredient

“Time is of the essence,”​ said Daniel Fabricant, PhD, president and CEO of the Natural Products Association. “It may be a confusing issue but it’s not an impossible issue. We’re talking about food toxicology.”

Dr Fabricant pointed out that the FDA could stabilize and effectively regulate the market an HHE-precedent (Health Hazard Evaluation) on red yeast rice and monacolin-K.

Greenwich Biosciences: “There is still so much we do not know about CBD”

Multiple presentations hit upon the vast range of product quality in the market. Professor Bill Gurley from the University of Arkansas for Medical Sciences presented data from an analysis of 25 CBD products purchased in Mississippi, which showed that some products contained no CBD, while others contain significantly more than claimed on the label. One products contained only THC, added Prof Gurley.

“Clearly, many ‘CBD products’ have little or no relation to any potential benefits of CBD itself, and pose a range of risks to consumers, from fraud to serious health dangers,” ​he stated.

Alice Mead from Greenwich  Biosciences (the US subsidiary of GW Pharmaceuticals, developer of Epidiolex), stated: “There is still so much we do not know about CBD. It has not been tested in a number of vulnerable patient populations, such as pregnant women and patients over 55. In fact, concerns about fetal toxicity in lab rats prompted FDA to require us to do more studies in fetal toxicity.”

Mead added that her company’s research showed that negative side effects from CBD begin to appear at one milligram per kilogram of body weight, or about 70 milligrams per day for an average adult.

NOW Health Group: Either enforce the current statutes or make CBD legal

Aaron Secrist, vice president of quality and regulatory affairs for NOW Health Group, said the FDA’s current approach, which he described as unofficial enforcement discretion​, does little to promote and protect the public health, the primary mission of the agency.

“We respectfully ask the FDA to do one of two things,”​ said Secrist. “Either enforce the current statutes and hold the company responsible for manufacturing and marketing these illegal products, or we urge the secretary to exercise his authority under current statute to allow hemp derived products, such as CBD, to be recognized as legal dietary ingredients, provided the NDIN is submitted and all applicable federal laws are met.

“This 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 a NDIN for agency review to ensure safe and effective products are available to the American public.”

NOW also asked the Agency to ensure the rule of law is upheld by barring any company illegally marketing CBD or other hemp derived dietary supplements from submitting a NDIN 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 secretaries authority without such provision, then it effectually encourages companies to flout the law in the future,” ​he said. “As the only consequence would seem to be a 3 to 5 year head start in the marketplace over companies who choose to follow the law.”

Secrist also echoed comments made at the NDI public meeting earlier this month​ by calling for FDA to continue to explore the idea of master files relative to the NDIN  process.

“We do not believe the agency should accept self-affirmed GRAS to subvert the process as it relates to CBD and other hemp derived ingredients,” ​he added.

GRAS and NDI

A couple of companies – notably CV Sciences and Manitoba Harvest – have self-affirmed the GRAS (Generally Recognized As Safe) status of their ingredients, but no company to date has actually taken the front door with FDA and filed either a GRAS notification or a New Dietary Ingredient Notification (NDIN) with the Agency.

Dr Douglas MacKay, senior vice president of scientific and regulatory affairs for CV Sciences said that new FDA rulemaking is not required, “if FDA provides clear industry guidance to the type of ingredients allowed in each FDA-regulated category [ie. drugs, food, supplements].”

However, given the FDA’s stance that CBD was the subject of an investigational new drug, if a company submitted an NDI notification today the FDA complete with all that safety data it would have the notification returned because the ingredient isn't recognized as a legitimate dietary ingredient, said Steve Mister, president and CEO of the Council for Responsible Nutrition.

“If the FDA creates a predictable path to market then the safety research that the agency craves will materialize,” ​he said.

Key comments from AHPA and UNPA

Michael McGuffin, president of the American Herbal Products Association (AHPA), urged the FDA to promptly take one of the two following actions:

- Use its authority under the 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. AHPA would support conditioning this exercise of enforcement discretion on full compliance with all other regulations applicable to these categories.

In comments submitted to the public record, Loren Israelsen, president and founder of the United Natural Products Alliance (UNPA), urged the Agency to rely on the framework of DSHEA.

“Once the major challenges are resolved with the Section 201ff exclusionary rule and an appropriate safe total daily consumption level for CBD is worked out, all other consumer safeguards in DSHEA and ensuing amendments should apply, including New Dietary Ingredient Notifications (NDINs), 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,” ​he stated.

Israelsen also noted that there is little relevant safety data available about total CBD consumption levels, which given its incorporation in food and beverage products raise concerns for consumption levels beyond manageable levels.

UNPA also noted the following concerns:

1. The presence of synthetic CBD and the attendant problems of misleading labeling, unknown safety issues, losses to farmers planting hemp as a new cash crop, and spiking of natural hemp extracts with synthetic CBD require an FDA policy decision. While UNPA disagrees with FDA’s guidance on synthetic copies of botanicals (not allowed to file NDINs), the alliance believes synthetic CBD should not be a dietary ingredient for the reasons noted.

2. The 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,”​ stated Israelsen.

3. CBD is a recently FDA approved drug. The new drug holder’s investments are based on an expectation of an ROI and a fair profit. They also seek to help very sick kids and their families. That said, a vast number of consumers now seek CBD for various reasons, including cost, personal choice and preference, and satisfaction with non-FDA approved CBD products.

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