FDA WARNING_LETTER - Crop Pharms - April 16, 2013

The FDA inspected Crop Pharms' facility in Staatsburg, NY, on October 9-10, 2012, and April 16, 2013, collecting labels for CurrantC? Black Currant Nectar and reviewing the website www.currantc.com.

The FDA concluded that CurrantC? Black Currant Nectar, CurrantC? All Natural Black Currant Concentrate, CurrantC? Genuine Dried Black Currants, 100% Pure Black Currant leaves, and CurrantC? Black Currant Syrup are unapproved new drugs under sections 505(a) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. ?? 355(a), 321(p)]. This is due to therapeutic claims on the website promoting the products for the cure, mitigation, treatment, or prevention of diseases, such as preventing liver cancer, protecting against Alzheimer's disease, reducing cardiovascular disease risk, decreasing age-related vision problems, preventing urinary tract infections, and supporting treatment of uric acid stone disease. These products are also misbranded under section 502(f)(1) of the Act [21 U.S.C. ? 352(f)(1)] because adequate directions for use cannot be written for laypersons given the conditions are not amenable