What happened
Original notice title
Genetic Edge Compounds LLC 4/14/17
From the archived source record
During the inspection, our investigator found a number of violations of the current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplements to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under insanitary conditions that do not meet cGMP regulations for dietary supplements. Based on our review, we have concluded that certain products are in violation of sections 403, 505(a), and 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and 352(f)(1)] and regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). Unapproved New Drugs and Misbranded Drugs FDA reviewed your websites at the Internet addresses www.geneticedgecompounds.net and www.gecdirect.com in December 2016 and has determined that you take orders there for the products “Innersteel NST,” “Revitastane PCT,” “NG Nitroglide,” “Test MD,” “LX Laxoplex Figure,” “LX Laxoplex,” and “XR Neurospike.” The claims on your websites establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of some of the website claims that provide evidence that your products are intended for use as drugs include: Innersteel NST “Milk thistle – used as a natural treatment for liver problems….helps repair liver cells damaged by alcohol and other toxic substances.” “N-acetyl L-cysteine…plays a role in white cell production which may help repair damaged tissue.” “Alpha Lipoic Acid…may also be helpful in certain liver diseases.” “Chinese skullcap…helpful in preventing heart disease and limiting the damage to the heart following a heart attack.
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
- 6577c99a5cd3
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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