Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Because 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)].
Passage 2ADIPROPEN 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.
Passage 3SUPERJOINTS 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.
Passage 4Conjugated linoleum Acid (CLA): is a potent . . . anti-carcinogen, and anti-catabolic . . . Some of the common accolades of CLA are . . . is a cancer fighter.
Passage 5Accordingly, OPTIMUM-CLA fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. 352(f)(1)].
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 190.6
- 21 CFR 201.5