Genesis Nutrition Ultra Slim dba Genesis Ultra Slim
FDA issued a warning letter to Genesis Nutrition Ultra Slim dba Genesis Ultra Slim (Doral, FL) after laboratory analysis confirmed their 'Genesis Ultra Slim Gold' product contained undeclared sibutramine (a withdrawn prescription drug linked to heart attack and stroke risk) and phenolphthalein (a potential carcinogen). The product was marketed as a dietary supplement for weight loss via websites and social media, but FDA determined it constitutes an unapproved new drug and misbranded drug under the FD&C Act. FDA demanded written corrective action within 15 working days and warned that failure to comply may result in seizure and/or injunction.
Flagged claims (7)
Konjac root . . . slows the rate of digestion and the absorption of both fat and carbohydrates.
Dry Green Apple Powder . . . has detoxifying properties because of the diuretic effect and it also helps relieve constipation.
Our natural blend of ingredients can benefit you by . . . [s]uppressing your appetite . . . [b]oosts your metabolism . . . [b]urn fat & calories . . . [i]ncrease energy levels . . .
Complete blend of 100% natural ingredients formulated to help you lose weight . . .
Benefits . . . appetite suppression . . . reduce bloating . . . burns fat . . . reduce inches . . . potentiates weight loss . . . improves metabolism
[P]ineapple is anti-inflammatory . . .
Genesis UltraSlim Gold . . . Lose up to 20 pounds in just 4 weeks . . . Promotes weight loss
Required actions (2)
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.
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