Chr. Hansen says the process was more complicated because this was the first time the company had filed for a vaginal health claim.
Earlier this month, we reported that Chr. Hansen (Horsholm, Denmark) was granted South Korea’s first probiotic health claim, for the company’s Urex RC-14 and GR-1 Probio-Tech bacterial strains for women’s vaginal health. The company spoke to us about the process of preparing the claims petition, which was submitted in January of this year. The process was made more complicated by the fact that this was the first time the company had filed for a vaginal health claim. (RC-14 and GR-1 may help lower the risk of vaginal infection and yeast infection, as well as lower the risk of recurrent urinary tract infections.)
“As it was the first time that we-or to our knowledge, any company-tried to apply for a vaginal health claim, it was perhaps a slightly longer and more explorative process,” says Charlotte Hemmingsen, senior manager, human health and nutrition, product registration and documentation. “We did provide a lot of documentation on our manufacturing process, quality of raw materials, and procedures to ensure that we met the high-quality requirements of South Korea’s Ministry of Food & Drug Safety (MFDS). Likewise, documented safety of the strains according to the WHO guidance on probiotics contributed to the successful outcome.”
“We believe that it is our high-quality manufacturing and documentation standards, above the general food GMP requirements, combined with strong clinical documentations that secured this claim,” she says.
Chr. Hansen’s Urex claim, “Urex can help vaginal health by increasing lactic acid bacteria,” is unique in Asia Pacific. Other companies' health claims approvals focus primarily on gastrointestinal claims, Hemmingsen points out. In its addition to its Korea health claim, Urex has a vaginal health claim in Canada and also has a New Dietary Ingredient notification filed with U.S. FDA.
In June, DuPont announced it became the first company to win a probiotic claim in Europe-Switzerland, specifically-for its DuPont Danisco Howaru Bifidobacterium lactis HN019 strain for digestive health. With the Chr. Hansen and DuPont claims now in hand, could this signal that probiotic health claims are finally beginning to gain traction with regulatory authorities? And which areas of the world are still deemed toughest for getting a probiotic claim approved?
Without surprise, the toughest continues to be the EU, Hemmingsen says, where the claims process has been likened to drug approval. The EU still stands as probiotic claims’ biggest stumbling block. The FDA is similarly strict, but at least the United States permits structure/function claims that have allowed probiotic marketers to convey the benefits of their products. “The EU, on the other hand, does not allow for structure/function claims,” Hemmingsen says. “All claims are handled as health claims, and all claims require the same level of documentation. Other national authorities have very different requirements.”
In general, those requirements are likely to get tougher, Hemmingsen says. “It is our experience that the requirements for approval of probiotic products as food/dietary supplements are increasing. The food/health authorities are focusing more and more on the quality of the product in the form of robust manufacturing processes, well-controlled raw materials, stability of the product, safety documentation of the strains in question-especially antibiotic susceptibility-and, of course, that any claim is clinically substantiated.”
“We do expect that more and more countries will establish procedures for centralized health claims in the future,” she adds.
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