‘Demonstrating efficacy through clinical trials will drive future marketing’: JBSL-USA President


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JBSL's NSK-SD ingredient is fermented from the original Bacillus subtilis natto strain. Image: © iStockPhoto / yumehana
JBSL's NSK-SD ingredient is fermented from the original Bacillus subtilis natto strain. Image: © iStockPhoto / yumehana
Nattokinase, an enzyme extracted from fermented soy, has seen tremendous growth in recent years, with its foundation of science key to driving future marketing and consumer understanding, says Vincent Hackel, President of JBSL-USA, Inc.

“There are now more than 50 SKU’s in the US that include our NSK-SD; we now sell NSK-SD in more than eight countries worldwide, and sales volume has tripled since that of 2008,”​ Hackel told NutraIngredients-USA. “This success comes down to our relentless commitment to the science behind our product.

“We firmly believe that demonstrating efficacy through clinical trials will drive marketing in the future,” ​he added. “We are eager to partner with brands that do not yet have NSK-SD in their formulas and share in the cost of producing clinical work on their proprietary formulas.”

NSF Certification

Japan Bio Science Laboratory (JBSL) recently received NSF Certification for its NSK-SD ingredient, which is fermented from the original Bacillus subtilis​ natto strain. The registration by NSF International states JBSL is in compliance with Good Manufacturing Practices (GMP), as set forth in NSF International Certification Guideline 229, Functional Foods. These GMP are consistent with Food & Drug Administration (FDA) cGMP for food products (21 CFR 110.3).

Numerous clinical studies have reported that nattokinase may help dissolve excess fibrin, reduce blood platelet aggregation, decrease blood pressure and improve circulation.

“We still feel products directed to reducing hypertension, reducing inflammation, and improving circulation, with the clinical science evidence to back them up, are underrepresented in the professional, retail, and multi-level marketing channels and hope to forge new partnerships in these important areas,”​ said Hackel.

Currently, JBSL has two Japanese patents and three U.S. patents for its technology in producing NSK-SD, he added.

RCTs conducted in the US

Image: © iStockPhoto

“Japan Bio Science Lab is far more than ‘just’ the first company to manufacturer and produce nattokinase,”​ said Hackel. “We were also the first to develop four different identification assays, including DNA sequencing. Additionally, we were the first -and only- company to demonstrate bioavailability in humans, and we are the company with the most science demonstrating safety and efficacy. We were the first and only company to demonstrate the effectiveness of protein peptide in reducing hypertension in animals.”

Hackel said the company expects to publish three different randomized placebo controlled human studies, all conducted in the US, this year.

Healthy blood circulation, the direct healthful benefits of reduced inflammation and less stress on the heart muscle, and the positive influence on potentially reduced  thrombosis continues to be of keen interest with consumers including, extreme athletes, women on birth control pills, and men and women reaching the age where strokes, heart attacks and the onset of Alzheimer’s become of concern, he said.

Building consumer awareness in the US

JBSL is a member of the Japan Natto Kinase Association​, an industry association in Japan, which is committed to increasing awareness with consumers on the healthful benefits of nattokinase and validating products that claim to contain nattokinase, explained Hackel. “Although this organization presently is primarily based in Japan, they encourage membership from the US, which would provide them with the resources to undertake marketing in the US to consumers.

“In Japan, they recently launched a television ad, hold press conferences, and actively advertise in newspapers to promote education and drive awareness.

“Presently there are three members in the US; HORN, our US distributor, Jarrow Formulas, and JBSL-USA.”

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