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).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm325553.htm
