What happened
Original notice title
X2Zero 12/8/16
From the archived source record
Based on our inspection and review of your product labeling, including your firm’s websites, FDA has determined that certain products you offer for sale, including but not limited to “Dynamizm,” “Eradicate,” “Xerophagy,” “Salute,” “ZlimXter,” “Exhilarate,” “Natural Eruption,” and “Quick Trim Slimming Gel” are unapproved new drugs under section 505(a) of the Federal Food and Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 355(a)]. These products also are misbranded drugs under sections 502 and/or 503 of the FD&C Act [21 U.S.C. §§ 352 and 353]. In addition, your dietary supplement products including, but not limited to “Colon Relief,” “Woman Revived,” “Ketone Cleanse,” “Colon Wipeout,” “T Drive,” “Thyroid Support,” “Yacon Syrup,” “X Heat,” “Coconut Oil” and “Natural Vine Multi Vitamin” are adulterated dietary supplements within the meaning of section 402 of the FD&C Act [21 U.S.C. § 342] and/or misbranded dietary supplements within the meaning of section 403 of the FD&C Act [21 U.S.C. § 343], as detailed below. Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. Sildenafil is the active pharmaceutical ingredient in the FDA-approved drug Viagra. You will lose weight without the use of dangerous chemicals, stimulants and/or additives.” Exhilarate On the website, [see original source] “This supplement may assist with suppression of appetite, boost of energy, and works as a thermogenic.” “Function: Fat Burner” “Unique formula may assist you lose weight, shape your body from leg, belly, buttocks, arm and face where easy to have more fat.” Natural Eruption On the website, [see original source] “Natural Eruption Capsules . . . rid the body of fat, free radicals and harmful toxins.
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
- cd99ce274296
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 →