Korean-based company Naturalendo Tech Co. applied for novel food approval for its extract EstroG-100. The product contains botanical roots Phlomis umbrosa, Cynanchum wilfordii, and Angelica gigas Nakai (Korean Angelica) extracted using hot water.
The ingredients are not listed on the BELFRIT list of about 1000 botanicals deemed safe by scientitis in Belgium, France and Italy.
The company said the herbals had more than 400 years of documented use in Korea and China.
On its website it claimed the product could be used to combat menopause symptoms like hot flushes, night sweats, vaginal dryness, insomnia, nervousness, mood swings, dizziness and fatigue within 7-10 days. It said the product was backed by four clinical studies.
This product was already on the market in the US, available online and in stores at Walgreens, CVS Pharmacy, Whole Foods Market, Sprouts Farmers Market, Amazon and iHerb.com.
The claims on the site had not been evaluated by the US Food and Drug Administration (FDA) and the company highlighted that product was not intended to “diagnose, treat, cure, or prevent and disease”.
According to the European Food Safety Authority’s (EFSA) register of questions, the application was now under consideration with a deadline to be negotiated.