However, the U.S. Food and Drug Administration (FDA) continues to regulate cannabis products under the Food, Drug, and Cosmetic Act.
One of the many components of hemp and cannabis, CBD has been marketed as a panacea for modern living, in both topical and ingestible product formulations, drawing warning letters that have called out bogus health claims and the ire of more modest brands.
Given federal statute regarding investigational new drug trials that might preclude a New Dietary Ingredient (NDI) Notification, FDA has stated that CBD cannot legally be sold as a dietary supplement in the U.S. However, at the same time, it has mostly exercised enforcement discretion, except for cases of egregious health claims or serious good manufacturing practice (GMP) violations, while it explores legal pathways
The tentative regulatory status has left retailers and product developers on uneven ground as some companies have gone full-steam ahead while others await the official federal greenlight.
Meanwhile, consumers have been making their voice abundantly clear. U.S. sales of hemp-based CBD supplements grew from $148 million in 2017 to $297 million in 2018, and are projected to reach $3 billion by 2023, growing at a CAGR of 46% from 2019 to 2023, according to estimates from Nutrition Business Journal (NBJ).
Nearly two in three Americans indicated they have some familiarity with CBD oils, according to a 2019 Gallup survey, yet that includes only 14% who said they are very familiar; 33% are somewhat familiar, and 17% not too familiar.
Still, one in seven Americans (14%) use CBD products, according to Gallup. The most commonly cited reasons for taking CBD were relief from pain (40%), anxiety (20%), insomnia (11%), and arthritis (8%).
Overall, nearly four in 10 think CBD should be legally available for adults as an over-the-counter purchase, while another 21% think people should only be able to buy them with a doctor’s prescription.
Traditional capsules and tinctures, gummies and teas, lotions and creams, even pet products—creative companies have found virtually limitless potential to add hemp and CBD to their product lineups.
Charlotte’s Web, a market leader in hemp CBD extract products, recently launched a new line of CBD-infused gummies designed to support specific health concerns such as stress, sleep, and recovery.
Flavored with natural juices from fruit and vegetables, the plant-based gummies feature Charlotte’s Web proprietary “hemp genetics” that provides the foundation of its whole-plant hemp extract. The gummies come in a variety of flavors and botanical combinations. The Sleep formula combines naturally occurring phytocannabinoids with melatonin. The Calm formula mixes a botanical blend of lemon balm, L-theanine, and whole-plant hemp extract and the Recover product blends ginger, turmeric, and hemp extract to support joint health, strength, and exercise-induced inflammation.
Garden of Life debuted its THC-free whole hemp extracts formulated by David Perlmutter, MD. The company said it uses “a clean, supercritical CO2 extraction method to ensure our products are free from solvent residues, toxins and chlorophyll.”
The line includes softgel supplements like CBD+Sleep, which combines whole hemp extract with vitamin D3, lemon balm, chamomile, and valerian; CBD+Relax, which contains organic saffron and L-theanine; CBD+DHA; and CBD+Turmeric; along with varying concentrations in dropper and spray formats.
Opening the door for hemp cultivation not only benefits business, but could reap benefits for the environment too.
RE Botanicals, branded as the “Pure Organic Hemp Apothecary,” sells tinctures and capsules along with a line of body oils. The company also donates 1% of sales to regenerative agriculture to help farmers create healthier soil.
According to the company, “Regenerative agriculture describes farming and grazing practices that, among other benefits, reverse climate change by rebuilding soil organic matter and restoring degraded soil biodiversity—resulting in both carbon drawdown and improving the water cycle.”
Specifically, regenerative agriculture is a “holistic land management practice that leverages the power of photosynthesis in plants to close the carbon cycle, and build soil health, crop resilience, and nutrient density,” the company said.
A study by Rodale Institute, a leader in regenerative organic agriculture, estimated that converting the world’s croplands and pastures to regenerative organic agriculture could offset an entire year’s worth of global CO2 emissions.
Charlotte’s Web recently entered into a research initiative with Rodale and Natural Care, one of the largest regenerative organic hemp research and cultivation operations in the U.S., to pioneer regenerative organic hemp farming. In collaboration with Rodale Institute, Natural Care will oversee and host the research at a start-up regenerative organic farm in Long Pond, PA.
“We’re very proud to be an active partner supporting this research, which aims to bring regenerative agriculture to hemp in this region of the country, through our collaboration with Rodale Institute, Natural Care, and Pocono Organics,” said Deanie Elsner, CEO of Charlotte’s Web.
The company aims to raise the bar for responsible hemp farming practices, she added. “It is our intent that the data from this research will support furthering sustainability for hemp farming.”
“As hemp farming returns to the United States, we’re excited to lead the way in working with farmers to grow this crop without synthetic fertilizers and pesticides, and in a way that supports soil health and the health of people and the planet,” said Jeff Moyer, Rodale Institute executive director.
Rodale Institute’s research on hemp, now in its third year, is focusing on the crop’s ability to suppress weeds, one of the greatest challenges for organic farmers, while improving yields for subsequent crops and reducing tillage. Preliminary results are promising, showing hemp is a viable cash and cover crop option for farmers. “We’re proud to be working with industry partners who can roll out these regenerative practices at scale around the country,” said Moyer.
The expanded research at the Pocono Organics farm examines new CBD varieties that grow differently, comparing the impact on soil health, nutrient consumption, and the ability to suppress weeds.
“We know that research is a key component for transitioning conventional and organic agricultural practices to regenerative organic standards—both to promote soil sustainability and to increase hemp crop quality,” said Ashley Walsh, president and founder of Natural Care and its sister company, Pocono Organics. “So it was a priority for us to provide the financial and farm resources to not only bring this vital hemp research to life, but to also stand alongside industry leaders Rodale Institute and Charlotte’s Web in this mission.”
Science: Scratching the Surface
Understanding about the varying components of hemp and cannabis is still nascent.
CV Sciences, which markets the leading PlusCBD brand of products, recently completed a controlled clinical study that demonstrated improvements in sleep, reduction in appetite, and enhanced quality of life. The company claimed the study is the first of its kind, proving that high-quality, hemp CBD oil benefits human health.
Using a randomized, double-blind, placebo-controlled design, 65 overweight but otherwise healthy men and women ingested either one PlusCBD Oil Gold Formula softgel or a placebo containing olive oil every day for six weeks. Subjects followed their normal diet and a routine of low intensity physical activity. After six weeks of supplementation, the study found PlusCBD Oil supplementation can improve self-reported measures of sleep, quality of life, and reduce appetite, while demonstrating no adverse effects on standard biomarkers of safety.
The study was conducted by the Center for Applied Health Sciences (CAHS), a multidisciplinary contract research organization in the dietary supplement, pharmaceutical, functional food, and medical food industries.
“Collectively, these seminal findings in healthy subjects demonstrate that PlusCBD Oil supplementation can improve measures of sleep, reduce appetite, and enhance quality of life,” said Hector Lopez, MD, CMO, and co-founder of CAHS. “This study is an important contribution for all stakeholders, as it represents the first randomized clinical trial that we are aware of regarding the safety and efficacy of multi-constituent hemp CBD extract in healthy human subjects, and we hope it will serve as a template for further research into the many potential benefits of this fascinating compound.”
The research was presented at the International Society of Sports Nutrition’s 16th Annual Conference and Expo in Las Vegas in June 2019.
“According to the National Institutes of Health, more than one third of adults report daytime sleepiness so severe that it interferes with work, driving, and social functioning at least a few days each month,” said Joseph Dowling, CEO of CV Sciences. “As the industry leader, we are committed to advancing research and education to help more and more consumers realize the many benefits of hemp CBD supplementation.”
Douglas MacKay, senior vice president of scientific and regulatory affairs for CV Sciences added: “The Center for Applied Health Sciences collected additional data during the clinical trial, and we are looking forward to future analyses that explores how hemp CBD can create positive changes in human stress resilience, nervous system function, body composition, inflammation, as well as targeted gene expression.”
The hemp/cannabis and CBD market is poised for continued expansion, especially as scientific research progresses.
Gallup recently noted that, according to Forbes, retail sales for CBD products were between $600 million and $2 billion in 2018 but are expected to grow to $16 billion by 2025.
“Although medical research has a long way to go to investigate all of the claims made about CBD,” Gallup noted, “half of Americans already believe it has at least some medical value, and that percentage is likely to grow.”