Nutraceuticals World (NW): Please introduce Japan Bio Science Laboratory (JBSL) and its Nattokinase research.
 
Vincent Hackel, President and CEO, JBSL-USA: JBSL started in 1974 and is based in Osaka, Japan. The company has approximately 50 employees and a manufacturing facility in Kyushu, Japan. JBSL has nine different ingredients, but our flagship is NSK-SD^®, a patented, branded, highly-researched enzyme called nattokinase. There are about 35 published studies on NSK-SD — 25 of which are human studies. We generate about two new clinical studies per year to keep moving that science forward. All of our safety data has been published as well.
 
NW: Tell us more about NSK-SD and how it’s manufactured?
 
Hackel: NSK-SD is a serine protease enzyme that has anti-thrombotic properties and a host of other benefits. We manufacture it by fermenting soybeans with Bacillus subtilis, natto. Bacteria digests the protein in the beans and generates this enzyme, nattokinase.

About 70% of Japanese people eat natto, but 30% don’t care for it. We started developing NSK-SD to offer the healthful benefits of natto to that 30% of the population. We quickly discovered there was an appetite for this product and its health benefits in the U.S., Europe and other places. We started exporting it outside of Japan in 1998.
 
NW: What differentiates NSK-SD from its Nattokinase competitors?
 
Hackel: There are two ways we differentiate ourselves in the marketplace. First, there are competitors that make an enzyme they claim is nattokinase, but it isn’t the same enzyme. We have five different identity test methods that we use to identify this enzyme as nattokinase. Some of the products in the market that claim to be this enzyme are not.
 
The second manner in which we differentiate is with our science. We have a large body of science currently demonstrating the efficacy and safety of our enzyme. Every year we generate 2-3 more studies, and we keep moving that science forward. Those are the two primary differentiators between us and our competitors in the marketplace.
 
NW: What are some possible formulation opportunities as well as the most common applications?
 
Hackel: The most common applications are tablets, capsules, and soft gels. We’ve also developed a lozenge, a gum, and an instant powder that dissolves on the tongue instantly. NSK-SD also works well in formulations with other ingredients like garlic, ginkgo, fish oil, L-arginine, pine bark extract, and other ingredients.
 
NW: What is the regulatory status of NSK-SD in the U.S. and around the world?
 
Hackel: In the U.S., we have self-affirmed GRAS (Generally Recognized As Safe) status. In Europe, we have novel food approval. We’re also approved in Russia, most Southeast Asian countries, Japan obviously, Taiwan, Korea, and we’re working on a few other countries.
 
NW: JBSL will celebrate 50 years in 2025. What can we expect from the company in the future? 
 
Hackel: We’re always working to push the science forward. We’re also working to get approval for health claims in the EU and some other markets. Additionally, we’re developing alternative delivery forms so that companies can use NSK-SD in applications other than standard pills and capsules.