Wednesday, November 28, 2012

FDA Issues Warning Letter to Mushroom Supplements Company

Here's the warning letter to this company:

The products are labeled for conditions that cause them to be drugs. Also the dietary supplements have been prepared, packed, or held under conditions that do not meet the CGMP in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation. Although the firm sent out samples of finished product lots to outside laboratories for testing, the laboratories only tested for heavy metals (mercury, lead, arsenic, and cadmium) and food chemistry (ash, total calories, total carbohydrates, fat, moisture, and protein); instead of conducting assay tests to determine that the components were consistent with your firm’s established specifications, etc. (Amyloban 3399 From Lion’s Mane, Grifron Maitake, and Super Shiitake); FDCA 505(a), 21 CFR 111.75, 111.560(a)(2), 111.325(b)(1), 111.535(b)(2), 111.160(d)(1), 111.160(c)(3), 111.35(b)(4).