“Huge step backward”: Industry slams FDA’s extension of CBD public comment period

11 Mar 2020 --- The US Food and Drug Administration (FDA) will officially reopen the public comment window on cannabis and cannabidiol (CBD) products, “extending it indefinitely.” Although the extended comment period is to collect more scientific data on cannabis products across the supply chain, US-based Natural Products Association (NPA) has pegged the move as a “huge and surprising step backward.” Moreover, it accuses the FDA of “risking a public health crisis by delaying necessary regulatory action on CBD.” Supply chain transparency and product safety are of increasing significance as cannabis-derived NPD thrives in the blossoming CBD market.

In extending the comment period, the FDA aims to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived ingredients. Initially, the comment period closed in mid-July last year. 

“To provide a public and transparent way for stakeholders to provide new and emerging information to us in real-time as it becomes available, we are reopening and extending the comment period indefinitely to allow interested parties to continue to comment. We are particularly interested in data that may help to address uncertainties and data gaps related to the safety of CBD,” the FDA states.

Also Organics joins the CBD personal wellness market.Studies that may help to address such uncertainties and data gaps, the FDA continues, may include liver injury risk, metabolite toxicity and glaucoma. For example, a US study found last November that components of marijuana, including CBD and THC can cause brain and facial birth defects if used during the first trimester of pregnancy. Moreover, the agency is looking to understand the impact of CBD on the male reproductive system and neurological development. It also hopes to learn more about CBD’s sedative effects, general administration, bioaccumulation and cumulative exposure.

“A ticking time bomb”
The NPA has voiced its firm disapproval of reopening the comment period, stating the move will “do nothing” to protect public health. “The FDA is already sitting on a ticking time bomb: the longer it waits, the greater risk we have of seeing another public health crisis. If the FDA wants to do something constructive, then it can get to work on setting a safe level of daily consumption for CBD,” says Dr. Daniel Fabricant, President and CEO of NPA.

The FDA recently presented its CBD regulation efforts to the US Congress, which are focused on consumer education, gathering scientific evidence and addressing products that violate current regulation. However, the NPA considered this update “all words and no action” and the Council for Responsible Nutrition (CRN) equally deemed it “disheartening.”

“The report amounts to bureaucratic can-kicking and Congress should recognize it as such and take action now to declare CBD a lawful dietary supplement,” underscores CRN’s CEO and President Steve Mister. 

Lassen Labs incorporats 1000mg of CBD into its relief cream. CBD sector blooms with NPD
Amid the FDA’s scramble for additional information and data, the CBD sector continues to strengthen its position in the US supplement industry. With increasing scientific evidence for CBD’s positive health effects, health science companies are joining the ranks of cannabis-oriented businesses to tap into a growing demand for cannabis and cannabis-derived products.

Just this week, CBD newcomer Also Organics introduced its alternative personal wellness products with full-spectrum, whole-plant CBD and cannabigerol (CBG), made from 100 percent US-grown, organic hemp. Health science company Lassen Labs also launched its flagship CBD products Lassen Relief Cream, which combines a blend of CBD with the arnica, aloe and a proprietary nano-liposomal delivery system. 

The American Herbal Products Association (AHPA) is also celebrating the 10th anniversary of its Cannabis Committee, which has been actively involved in the regulatory, legislative and technical aspects of moving cannabis, hemp and CBD into the legal marketplace.

By Anni Schleicher