What happened
Original notice title
New York Nutrition Company / American Metabolix MARCS-CMS 611994, August 31, 2021
From the archived source record
In addition, as explained further below, the Exile Euphoric Weight Loss, Exile Super Shock, Havok Hardcore, and Keto Pump in Watermelon and Grape Flavors products are adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)]. Unapproved New and Misbranded Drugs Examples of some of the website claims that provide evidence that your products are intended for use as drugs include: Muscle Test On your product page for Muscle Test at [see original source] "Avena Sativa [an ingredient in your Muscle Test product] – Considered by many to be the ‘Natural Viagra’ . . . . The high level of iodine in kelp means that it can help address thyroid disorders.” Keto Friendly Collagen On your product page for Keto Friendly Collagen at [see original source] “REPAIR JOINT, TENDONS & CARTILAGE: When we lose collagen, our cartilage, ligaments, and connective tissue start moving with less ease, leading to stiffness, swollen joints and more. 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, Muscle Test and Ketogenic Diet Aid 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)]. Adulterated Dietary Supplements Your Exile Super Shock, Havok Hardcore BombSicle, and Keto Pump in Watermelon and Grape Flavors are labeled as dietary supplements and offered for sale on your website, [see original source] As such, your Exile Super Shock, Havok Hardcore BombSicle, and Keto Pump in Watermelon and Grape Flavors products are adulterated under section 402(a)(2)(C)(i) of the Act [21 U.S.C. 342(a)(2)(C)(i)] because the ingredients Hordenine HCl and Higenamine HCl are unsafe food additives under section 409(a) of the Act [21 U.S.C. 348(a)].
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
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 49513ade3aa5
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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