CRITICALNutrition / SupplementsFDA Warning Letter · October 21, 2021

Dominant Nutrition LLC formerly 8 Weeks Out Labs

Atlas ID: 2021-10-fda-dominant-nutrition-llc-formerly-8-weeks-bg8i15

FDA issued a warning letter to Dominant Nutrition LLC (formerly 8 Weeks Out Labs) in October 2021 after reviewing their website and finding serious violations related to four products: ADIPROPEN ULTRA, SUPERJOINTS, OPTIMUM-CLA, and LipogenX. LipogenX was found to be an adulterated dietary supplement due to the inclusion of Hordenine, a new dietary ingredient lacking the required FDA safety notification. ADIPROPEN ULTRA, SUPERJOINTS, and OPTIMUM-CLA were deemed unapproved new drugs based on disease-treatment claims on the company's website, with OPTIMUM-CLA additionally cited as a misbranded drug. The company was given 15 working days to respond with corrective actions, with FDA warning that failure to comply could result in seizure or injunction.

Flagged claims (3)

Conjugated linoleum Acid (CLA): is a potent . . . anti-carcinogen, and anti-catabolic . . . Some of the common accolades of CLA are . . . is a cancer fighter.

Cure claim · unapproved-new-drug-disease-claim

ADIPROPEN ULTRA is our new and improved version of Adipropen with added Vinpocetine, commonly referred to as 'Viagra for the Brain.' [I]t is more effective than Clenbuterol.

Comparative claim w/o evidence · unapproved-new-drug-disease-claim

SUPERJOINTS contains an amazing healing extract called Cissus Quadrangularis that has the miraculous ability to relieve joint pain and heal joint damage. Used for centuries as medicine, Cissus Quadrandularis can speed joint fracture healing rates . . .. It also aids in healing tendons and ligaments in even the most stubborn cases.

Cure claim · unapproved-new-drug-disease-claim

Required actions (2)

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.

Response required · 15 days

Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Injunction

Source

www.fda.gov · FDA Warning Letter

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