THC level certification program set for global launch amid blooming CBD and hemp applications

19 Jun 2019 --- Set to be launched in September, the International Cannabinoid Analysis Program (ICAP) is a new third-party certification program for manufacturers and brands in the hemp and cannabidiol (CBD) products market. ICAP tests cannabis, hemp and their extracts or derivative products with appropriate methods to ensure they contain less than 0.20 percent delta-9-tetrahydrocannabinol (THC) – the legal US limit laid out in the December 2018 Farm Bill. The limit is also in alignment with the European regulations. NutritionInsight speaks to the companies behind the program and the blooming CBD and hemp market.

The program seeks to appeal to players operating in the growing CBD and hemp space. The hemp CBD market totaled US$190 million in 2018 – an astounding rate of growth for a category that didn’t even exist five years ago, according to The Hemp Business Journal estimates. By 2022, sales are projected to reach US$22 billion, notes the Brightfield Group, a cannabis and CBD market research firm.

The program has been developed by Alkemist Labs, a contract testing lab specializing in botanical identity and potency testing for dietary supplements, and Nutrasource, a Canadian contract research organization that helps health companies bring products to market. The companies note that accurate testing in this product category is a prominent concern, as evidenced by several comments at the recent May 31 US Food and Drug Administration (FDA) public hearing on CBD regulation.

The hearing will reportedly be the first of many, as many questions have been raised, yet have largely remained unanswered. Dr. Ned Sharpless, acting FDA Commissioner, reiterated the gaps in FDA knowledge around CBD use, inquiring in his opening remarks, “How much CBD is safe to consume in a day? What if someone applies a topical CBD lotion, consumes a CBD beverage or candy, and also consumes some CBD oil? How much is too much? How will it interact with other drugs the person might be taking?” 

Now, the industry continues to wait with bated breath for US regulators to provide some solid legal pathways for the inclusion of CBD in food and beverage products.CBD and hemp are increasinly appearing in a range of NPD.

A booming market despite legal uncertainty 
Despite the fact that adding CBD to food and beverage products, as well as supplements, is still not technically legal, it has not deterred companies infusing a whole host of products with it – from gummy bears to beer. However, this lack of regulation only strengthens the need for a verification program, Elan Sudberg, CEO, Alkemist Labs, tells NutritionInsight.

“In the US, regulations are still lacking clarity, but the industry is surprisingly fast-moving, and now there is CBD in just about everything. That makes this program ensuring only legal limits are present even more important. The FDA is clearly watching and if companies push boundaries too far they can and will certainly take action,” he explains.

Indeed, CBD products which are derived from hemp are certainly at risk for contamination with THC and other cannabinoids that may not be present on the label – such as whether they are psychoactive components. 

What the regulations are clear on, however, are the levels of THC that are allowed in hemp, as elucidated in the December 2018 Farm Bill. This motion legalized low THC hemp (<0.3 percent Δ9-THC) and stripped hemp of its illegal substance status under federal law as it was removed from the Controlled Substances Act (CSA). The FDA also certified hulled hemp seeds, hemp seed protein and hemp seed oil with Generally Recognized as Safe (GRAS) status.

Staying under the specified THC level is imperative, notes William Rowe, President and CEO of Nutrasource.

“It’s imperative to meet the THC standards to ensure compliance and brand longevity. The Farm Bill set a clear standard for hemp parameters, including a maximum THC concentration for hemp-derived products of 0.3 percent. Adhering to the regulations will minimize legal risk, whether it’s a warning letter from the FDA or a lawsuit,” he says.

He adds that products that don’t comply with regulations are at risk for many repercussions including stop sale, recall, warning letters from FDA, and lawsuits.

Global reach
The program has been designed to be applicable to all countries who are selling CBD products and want to ensure their products meet the appropriate THC concentration standard. The sale of CBD infused products, in particular, has proliferated globally. As an increasing number of consumers incorporate CBD into their daily wellness regimes, an analysis of buyers’ preferences by cannabis industry specialist High Yield Insights reveals that the most common delivery methods of CBD are “edibles” such as baked goods, gummies; oils; vapes and topical beauty skincare products. 

Rowe explains that the program validates < 0.20 percent THC, which is compliant with European (0.2 percent) and US standards (0.3 percent). However, he adds, the global regulatory landscape is constantly changing, and “we are not providing regulatory advice or guidance with this certification program.”

However, the regulatory status of CBD is somewhat complicated in the EU as it has recently been categorized as an unauthorized novel food. 

“It is difficult to navigate the regulatory space in the US due to conflicting federal and state positions, however, the standards for hemp-derived CBD products are clear. Any CBD product that enters the US market must comply with the < 0.2 percent THC concentration levels. For the UK, CBD oil is legal as long as it is THC-free,” he explains.

“The regulatory landscapes are constantly changing and we will be monitoring the global conversation surrounding cannabinoid product standards and modifying ICAP appropriately. This is a lab-based certification to prove bioactive concentration levels to help adhere to regulations,” he adds.

At this point in time, the cannabis derivative space has been largely dominated by smaller companies. However, a range of larger players are certainly eyeing the space. 

Mondelēz is reportedly considering CBD as an ingredient to infuse into its snacking portfolio. Meanwhile, Unilever’s Ben & Jerry’s ice cream brand has announced plans to develop a CBD-infused ice cream, and Monster Beverage is also reportedly eyeing the cannabis-infused drinks market. However, all companies highlight that they want to stay well within the lines of legality – meaning a wait for clearer instructions from federal regulators. It seems clear that if an FMCG giant like Mondelēz, or indeed Unilever, were to infuse its treats with CBD, the compounds’ hop into the mainstream would be well and truly cemented. For the time being, smaller companies may continue to test the waters.

A detailed article on the current CBD market opportunities for suppliers and ingredients companies will appear in the July/August issue of The World of Food Ingredients.

By Laxmi Haigh