What happened
Original notice title
Dominant Nutrition LLC formerly 8 Weeks Out Labs MARCS-CMS 613688, October 21, 2021
From the archived source record
Based on a review of your website, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and applicable regulations. Adulterated Dietary Supplement Labeling on your website at [see original source] establishes that you offer for sale your product LipogenX as a dietary supplement and that the product’s Supplement Facts panel declares Hordenine as a dietary ingredient in this product. Under section 413 of the FD&C Act [21 U.S.C. § 350b], a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402(f) of the FD&C Act [21 U.S.C. § 342(f)] unless it meets one of two requirements: 1. Because the required notification has not been submitted, your product is adulterated under sections 402(f)(1)(B) and 413(a) of the FD&C Act [21 U.S.C. §§ 342(f)(1)(B) and 350b(a)]. Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that Hordenine, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, dietary supplements containing Hordenine as a new dietary ingredient are adulterated under sections 402(f)(1)(B) and 413(a) of the FD&C Act [21 U.S.C. §§ 342(f)(1)(B) and 350b(a)] because there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Unapproved New Drugs The claims on your website establish that your products ADIPROPEN ULTRA, SUPERJOINTS, and OPTIMUM-CLA are drugs under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.
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
- 88b58d789dec
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.
Sources, dates, and coverage →