GLG receives FDA safe letter for monk fruit extracts
2014-12-10 07:35 ET - News Release
Mr. Simon Springett reports
GLG ANNOUNCES FDA'S ISSUANCE OF LETTER OF NO OBJECTION FOR LUO HAN GUO (MONK FRUIT) EXTRACTS
The United States Food and Drug Administration has issued a generally recognized as safe letter of no objection for GLG Life Tech Corp.'s luo han guo (monk fruit) extract products (filing No. GRN 522). This letter confirms that the FDA has no questions regarding GLG's GRAS notice submitted earlier this year, which covers three distinct luo han guo extracts -- MV30, MV50 and MV60 -- each containing a minimum level of mogroside V (30 per cent, 50 per cent and 60 per cent, respectively).
Seeking and obtaining GRAS status have been among several of GLG's goals relating to its entrance this year into the luo han guo market. GLG also filed for patent protection for its luo han guo processing technology earlier this year, it has successfully implemented a large-scale agriculture program to expand the luo han guo agriculture in Guilin China, and it has successfully converted its stevia processing facility to be capable of high-volume and high-purity luo han guo extract production. GLG accomplished each of these within approximately 12 months from the company's decision to enter the luo han guo market as a vertically integrated player. GLG also announced its first major supply contract for monk fruit in July of this year with a global food industry leader.
GLG's first-year efforts were ambitious and, indeed, fruitful. Its growing operations in Guilin are substantial and the first year of GLG's monk fruit agriculture program was a big success. GLG's conversion of its Runhai stevia facility renders it capable of processing 130 metric tonnes of MV50 extract annually. GLG is on track to produce its first 10 metric tonnes of MV50 extract within December, 2014, with the first five metric tonnes recently complete and production of the second five tonnes under way. Based on these achievements, GLG believes it now has greater production capacity for luo han guo than any other company worldwide.
GLG differentiates itself from other luo han guo producers in three ways: (1) its competitive advantage in establishing agriculture systems in China, superior luo han guo seedlings and its proven methods to expand the amount of farming in other crops such as stevia; (2) its advanced processing and extraction technology; and (3) its industry-leading processing capacity, which well positions GLG for anticipated growth in the luo han guo market. GLG is currently working with a number of international customers interested in its luo han guo products and expects initial sales to be finalized prior to the start of production.
The company sees continued growth in the luo han guo market, and is encouraged by the increased market activity relating to luo han guo as a natural sweetener product. It sees continued product launches within the food and beverage space -- Mintel commented in May, 2013, that food and beverage launches using luo han guo had tripled over the prior five years -- and dietary supplement space. GLG notes that customers also recognize the value of luo han guo in conjunction with stevia; the two can be used complementarily to achieve desired sweetness and flavour profiles.
GLG has the largest number of naturally sourced sweetener products certified under the GRAS process, encompassing both stevia and now luo han guo. Stevia products for which the FDA has issued letters of no objection include rebaudioside A products ranging from purities of 50 to 97 per cent, high-purity stevioside and high-purity rebaudioside M. It has also submitted GRAS filings with the FDA for high-purity rebaudioside C and high-purity rebaudioside D. GLG remains committed to ensuring that each of its naturally sourced sweetener products is fully documented as compliant with the FDA GRAS process.
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