SunWay Biotech announced that its best-selling probiotic strain, Lactobacillus paracasei NTU 101, has received the U.S. Food and Drug Administration (FDA) “Generally Recognized As Safe” (GRAS, GRN001232) certification. This milestone not only paves the way for SunWay to expand its export opportunities but also marks the first Lactobacillus paracasei strain in Taiwan to obtain this recognition, underscoring the company’s strong research capabilities and strategic business vision.

The GRAS certification is a critical entry requirement for the U.S. food and dietary supplements market, representing that the ingredient has passed rigorous toxicological evaluation and safety validation. Lactobacillus paracasei (commonly referred to as LP), naturally found in the human gut and dairy products, helps regulate physical constitution and supports digestive health.

According to SunWay, NTU 101 is the result of over 20 years of research by National Taiwan University Honorary Professor Tzu-Ming Pan, who selected the strain for its resistance to gastric acid and bile salts. The strain was identified as Lactobacillus paracasei subsp. paracasei and was isolated and purified at National Taiwan University. More than 40 studies on its efficacy have been published in international SCI journals. In 2024, SunWay completed four human clinical trials, further confirming its strong performance. Currently, only about 30% of health supplements in Taiwan have human clinical trial data. SunWay, committed to scientific validation, applies the same rigorous standard across its ingredients, including the NTU 568 red yeast rice strain and the ExoBDNF probiotic powder.

SunWay stated that obtaining GRAS certification not only strengthens NTU 101’s position as Taiwan’s “flagship probiotic” in the domestic market but also serves as a milestone for the company’s global expansion. Backed by this authoritative safety recognition, SunWay can formally enter the North American food and dietary supplement market, accelerating collaborations with international brands and distributors while advancing both technology licensing and brand exports. Looking ahead, the company plans to expand NTU 101’s applications across a wider range of health products, building differentiated competitiveness in the global market under the concept of “light healthcare.”

Resource: 晨暉益生菌種獲美FDA GRAS認證，開啟外銷商機