Je Dois Lavoir LLC
FDA issued a warning letter to Je Dois Lavoir LLC (CEO Sandra Orozco) regarding its '365 Skinny High Intensity' weight-loss product, which laboratory analysis confirmed contained undeclared sibutramine — a withdrawn prescription drug linked to increased risk of heart attack and stroke. The product was marketed as a natural dietary supplement but was deemed an unapproved new drug and misbranded drug under the FD&C Act due to drug-intent claims on the company's website and social media. FDA warned that failure to address violations could result in seizure and/or injunction, and the firm had already voluntarily recalled the product prior to the letter's issuance.
Flagged claims (6)
It is a totally natural herbal supplement for anti obesity that controls anxiety, inhibits appetite, burns fat, high cholesterol, helps with sugar levels, accelerates metabolism, eliminates toxins, reduce swelling and increase your energy.
How does this capsule work? . . . Appetite Control . . . Accelerates metabolism . . . Increase your energy . . . Causes satiety . . . Burn fat through the urine . . . Eliminates toxins in the skin . . . Regenerates muscle mass . . . Reduces fat deposits and cellulite . . . Increases libido . . . Balances insulin and blood sugar levels
365 Skinny High Intensity new silver label Strong Formula 2020 are [sic] giving excellent results in the loss of weight with a single capsule a day!
Bitter orange extract: reduces 'bad' cholesterol prevents digestive disorders and regulates bowel movement
Cassia seed: combat constipation
Alism: eliminates fluid retention, reduces appetite
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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