FDA issues another warning in 10-year fight against sibutramine
The latest warning letter was issued to a California company that does business under the name Je Dois L’avoir Boutique. The warning letter pertained to a product called 365 Skinny High Intensity.
“FDA confirmed through laboratory analysis that a sample of your “365 Skinny High Intensity” contains undeclared sibutramine. 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in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the United States market on December 21, 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke,” FDA wrote in the warning letter.
The Agency also cited the company over some claims it was making on the product, including that the supplement “controls anxiety, inhibits appetite, burns fat, high cholesterol, helps with sugar levels, accelerates metabolism, eliminates toxins, reduce swelling and increase your energy.”
Je Dois L’avoir did issue a voluntary recall of the products according to FDA.
Decade-long enforcement effort
Almost from the day that sibutramine was taken off the market it started showing up in products marketed as dietary supplements, and not just in the United States. In 2011 the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning about weight loss products that contained the banned ingredient.
FDA has sent a number of warning letters over the ingredient over the years. In 2018 the Agency shut down a Florida-based supplement marketer over the persistent presence of active pharmaceutical ingredients (APIs) in its products, one of which was sibutramine.
In 2019 FDA issued a consumer alert about a weight loss product called DeToxi Slim that was found to contain sibutramine. That product was uncovered during an examination of international mail shipments, and a consumer alert was a quicker way to deal with the issue than going through the drawn-out process of issuing a warning letter.
And earlier this year, the Agency sent a letter to Amazon about the sale of sexual enhancement and weight loss products on its sits that contained sibutramine as well as other APIs. The common APIs in sexual enhancement products are various analogues of popular erectile dysfunction drugs such as Viagra and Cialis.
