“The market has been dominated by ‘energy’ for nearly 15 years. Think Red Bull and Monster,” Compound Solutions CEO Matt Titlow told NutraIngredients-USA. “But the next 15 years will be dominated by ‘energy and focus.’ TeaCrine plays a major role in both energy and focus, so it will have a major impact on the energy drink category and the new attention placed on focus.”
It announced its self-affirmed GRAS status last week for its nature identical version of theacrine, an alkaloid structurally similar to caffeine which is found in some tea leaf varieties. The announcement comes after years of independent assessments. In a press release, the company confirmed 68 new products featuring TeaCrine will be added to distribution so far in 2016, bringing the total product count to 124.
Back in 2014, Titlow shared multiple studies, both animal and human, that the company was working on to reach self-affirmed GRAS status. The most recent, and what the company called “pivotal” study for the ingredient was accepted for publication last month, a pre-clinical 90-day safety study, due to be published in the Journal of Toxicology.
A comment on the new NDI draft guidance
According to Titlow, the studies conducted on the ingredient so far have accumulated into “a higher standard of safety and reasonable certainty of no harm than is even required for NDI.”
He argued that the burden of safety is equal to a no objection letter from the FDA for GRAS status. “After more than a year of research and hundreds of thousands of dollars, we clinically proved that our TeaCrine is even safer than caffeine on a one-time or daily-use basis. Our approved daily limit includes a 100x safety factor, which means TeaCrine will not cause harm at 100x the approved limit,” he said.
Examples include one comparing TeaCrine with caffeine or placebo for energy and mood published in Nutrients, one that suggests its safety and efficacy to reduce cholesterol published in the Journal of the International Society of Sports Nutrition, and another one vetting the dose required for positive energy, focus, and mood, published in the Journal of Dietary Supplements.
So even though the specific languages “self-affirmed” GRAS was left off the most recent NDI draft guidance, Titlow said that the company still has “the confidence to proceed judiciously despite the modified language.”
The future of TeaCrine with its new self-affirmed status
Titlow said that the GRAS status “dramatically increases the potential market size and potential for TeaCrine,” as all major food and beverage companies require GRAS-affirmation.
“We are about two months away from completing a fifth clinical study, and we plan to continue researching TeaCrine well beyond that point,” he added. “When our pharmacokinetic data is published before year-end, it will add to the inevitability of TeaCrine making it into the cognitive energy and clean energy markets on a mass scale.”
Sports Nutrition forum
Want to hear directly from sports nutrition experts on the category’s latest market and science trends? An panel of experts from Douglas Labs, Mintel, Bodybuilding.com, and the International Society of Sports Nutrition will share their insight at NutraIngredients-USA’s free online Sports Nutrition Forum on Sept. 13. To register click HERE