On an all time high? Cannabis, hemp and CBD green lights fuel NPD surge

08 Jan 2019

08 Jan 2019 --- As a string of regulatory greenlights have begun to move the cannabis plant and cannabis-derived products into an increasingly mainstream track, cannabis-derived products may well be the trend to watch in 2019. The FDA has signaled a softened stance on cannabis-derived products with its most recent move which has legalized hemp and Cannabidiol (CBD) derived from hemp. Such developments are exciting for the innovation front of food and drink products that contain cannabis-derived compounds. The future, it could be said, may be green.

2018 saw huge regulatory gains for cannabis and its derived products, including hemp and CBD, with a host of US states and Canada and, very recently the UK, legalizing the use of medical marijuana in some form.

It is important to note the differences between the products that may fall under the cannabis umbrella term. The plant species Cannabis sativa has about 113 cannabinoids which are said to have a direct effect on the body through cannabinoid receptors in our cells. Perhaps the best-known cannabinoid is THC, popular for its psychotropic properties.

However, Cannabis sativa has two species; hemp and marijuana. Hemp contains a host of cannabinoids, but no THC. Meaning, hemp won't “get you high.” CBD, on the other hand, is another kind of cannabinoid that is present in both strains of Cannabis sativa. It has garnered a large amount of attention in recent times as it is thought to be responsible for many of cannabis’ therapeutic effects, which include pain relief, without the “high” associated with marijuana use.

A softening regulatory stance
The US Food and Drug Administration (FDA) has signaled that it may be softening its stance on hemp and cannabis, with a recent statement from Commissioner Scott Gottlieb noting it is considering “potential regulatory pathways.”

The FDA statement, released on December 20 last year, coincided with the signing of the Agriculture Improvement Act of 2018 into law.

Significantly, the farm bill legalizes hemp, or, cannabis and derivatives of cannabis with extremely low – less than 0.3 percent on a dry weight basis – concentrations of THC. These changes mean that hemp is removed from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law.

Hulled hemp seeds, hemp seed protein and hemp seed oil have also been certified with Generally Recognized as Safe (GRAS) status.

Gottlieb noted the “growing public interest” in cannabis and cannabis-derived products, including CBD. He reiterated that “in short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products – meaning, that they are subject to the same authorities and requirements as FDA regulated products containing any other substance.”

The FDA commissioner makes clear that the FDA is extremely concerned about the health claims that are being tagged onto products, such as those containing CBD. Any such product making health or nutrition claims in their marketing or promotional materials must go through the FDA drug approval process before being marketed in the US.

“Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they’re intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases (such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes) are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the US,” he notes.

The farm bill could, in many ways, be a step toward legalization, and is the first real step the federal government has taken in this direction in almost 50 years, Forbes reports. The move also signals to the booming cannabis-derived product industry that hemp NPD can proceed amid a friendlier regulatory environment.

It can be expected that the FDA and USDA’s oversight and regulatory enforcement of farms, laboratories and manufacturers producing these ingredients and products that contain them, will be heightened. This is particularly with regards to quality systems that lead to a safer product for the consumer, comments Tara Lin, the Senior Director of Dietary Supplement Consulting Services, EAS Consulting Group, in a statement on the FDA announcement.

However, the regulatory front remains somewhat confusing regarding CBD that is not derived from hemp. As it stands, CBD has only been approved so far as a drug and not as a dietary supplement or for use in food. The approved drug, Epidiolex from GW Pharmaceuticals, is used to treat two severe forms of epilepsy in children.

Further complicating the CBD space is the current US partial government shutdown. Gottlieb indicated in his statement that the FDA would be willing to “have a conversation about the legal path to market for cannabidiol (CBD),” but the shutdown is blocking such conversations from taking place, the Council of Responsible Nutrition (CRN) President & CEO, Steve Mister said in an interview with our sister website, FoodIngredientsFirst.

President Trump is due to visit the US-Mexico border wall this week, but talks with Democrats are still failing to produce any resolutions right now and the shutdown could even last months.

CBD and hemp in the food and nutrition industry
The FDA statement has been welcomed by Maruchy Lachance, Co-Founder and COO of Boulder Botanical & Bioscience Laboratory.

“We welcome any move from the gray into the light. Now that there is clear-cut guidance for legal sales of hemp-derived cannabidiol (CBD) products and allowing interstate commerce, American companies can move forward in confidence with domestically sourced hemp and development of cannabinoid products to help consumers seeking to enhance their natural wellness,” she tells NutritionInsight.

Boulder Botanical & Bioscience Laboratory is a Colorado-based R&D and manufacturing firm that makes hemp-derived products including contract private-label cannabinoid extract formulations, pet products and health-and-wellness products.

“For a hemp cannabinoid formulation company such as Boulder Botanical & Bioscience Laboratory, we’re setting the standard by strictly adhering to good manufacturing practices and transparent operations and this recent news will only embolden our mission of delivering carefully formulated hemp products to retailers throughout the US,” she adds.

The current environment is spawning new product innovation. According to Innova Market Insights' data, there was a 34 percent average annual growth in the number of new food & beverage launches with hemp ingredients (global, 2013-2017), with US introductions enjoying an average annual growth of 21 percent over this period. This ripe environment for NPD will be the focus of an upcoming article. Stay tuned with NutritionInsight for part two.

By Laxmi Haigh