What happened
Original notice title
MusclMasster, LLC 8/30/17
From the archived source record
Based on the inspection, a review of the product labels collected during the inspection, and a review of your website at www.thegreenherb.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. The use of ephedrine alkaloids in your dietary supplement product AL-ER-G causes the product to be adulterated within the meaning of section 402(f)(1)(A)(ii) of the Act [21 U.S.C. § 342(f)(1)(A)(ii)] in that it is a dietary supplement that contains a dietary ingredient that presents a significant or unreasonable risk of illness or injury under ordinary conditions of use (see also 21 Code of Federal Regulations (CFR) 119.1). We acknowledge that you stated that you voluntarily destroyed all Ephedra-containing ingredients and dietary supplement products in your possession during the inspection and that you issued a voluntary nationwide recall for the product AL-ER-G. Unapproved New Drugs/Misbranded Drugs FDA reviewed your website at www.thegreenherb.com in July 2017 and has determined that you take orders there for the products Vas-Q-Lar, Vir-L IV, and Nu Woman. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Vas-Q-Lar and Vir-L IV fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. Dietary Supplement CGMP Violations The dietary supplement products that you manufacture, package, label, and/or hold are adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, 21 CFR Part 111.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- 0cec46ea1a91
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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