Quality work on GRAS submission boosts uptake of new tea alkaloid ingredient, company says
TeaCrine, a synthesized, nature-identical form of theacrine, a caffeine-like alkaloid, has been under development for a number of years. Compound Solutions is close to finishing its work on its self-affirmed GRAS status, Titlow said. Since Compound Solutions first began pushing the ingredient out into the market in 2014, it has grown from 53 product launches in 2015 to an additional 32 launches in the first quarter of this year.
The fact that Compound Solutions chose to work with well-regarded Seattle-based consultancy AIBMR has provided a sense of security for customers while the regulatory work is completed, Titlow said.
“For example, Glanbia has a list of only four GRAS consultants they will work with and AIBMR is one of them. That was a big selling point. We spent more than $350,000 just in compiling the GRAS data because there was confidence in their work. We are just awaiting publication of 90-day safety study. We submitted it in November of last year, and we just got questions back three weeks ago,” Titlow told NutraIngredients-USA. But by using AIBMR, Titlow said a comfort zone for customers was created, eliminating any doubts about the quality of the self affirmation process or its ultimate success. It’s an open secret in the industry that some GRAS self affirmations leave much to be desired, which can expose customers to some risks that a thorough vetting of the safety data would eliminate.
Efficacy to go with regulatory certainty
Titlow said the rapid uptake of the new ingredient is not only because of the regulatory reassurance. Rather, Teacrine offers some powerful potential benefits vs caffeine which is an ingredient with a long history of efficacy (and one that is often offered in a synthetic form). But questions swirl in the political arena around caffeine’s safety in the high doses and multiple servings that characterize the energy beverage sphere. And the ingredient itself can lead to a boom-and-bust energy cycle in the body, leading to the search among formulators for alternatives.
TeaCrine is a nature-identical version of theacrine, which can be found in kucha tea leaves (Camellia assasamica). It is an alkaloid with a similar structure to caffeine, and promotes energy in the body, but in a significantly different way to its better-known cousin, Titlow said.
“It actually activates dopamine. Unlike caffeine that is just inhibiting adenosine so you can have a big up in energy and then a crash, this actually activates your reward center so you are motivated to exercise. You have improved mood and a decrease in anxiety, multiple benefits that you don’t have with caffeine,” Titlow said.
Titlow said the ingredient does not promote an anxious, jittery feel as caffeine can in some users. The duration of action differs, too, and can be as much as six to eight hours with TeaCrine. Titlow also said that the data indicates that theacrine users do not become habituated to the ingredient as caffeine users do, so the dosage does not need to be increased over time to achieve the desired effect as is the case with caffeine.
Titlow said the ingredient comes at a propitious time in the sports nutrition sphere, with the dietary supplement industry’s supply chain now under a microscope as a result of the actions of New York Attorney General Eric Schneiderman. Customers are looking for an ingredient that won’t result in a nasty surprise such has been the case with other recent high profile ingredients such as picamilon (aka pikatropin), DMAA and AMP Citrate (DMBA), Acacia rigidula, various synthetic phenylethylamines such as BMPEA, and other ingredients.
And the company has backed the ingredient with science, Titlow said. Compound Solutions says it has spent more that $1 million on animal and human clinical data.
“In a regulatory environment where every energy ingredient is scrutinized, we are proud to say we’ve invested a large amount of money into the safety, efficacy, sensory, IP and comprehensive regulatory platforms of TeaCrine,” Titlow said. “In the next couple of months we will continue to broaden TeaCrine’s potential applications and validate new claims.”
