The U.S. Food and Drug Administration (FDA) issued a warning letter to Texas-based dietary supplement distributor Lucy’s Weight Loss System, d/b/a Waisted with Lucy, on February 17, 2016. According to the letter, FDA investigated the company’s label distribution facility, website and social media pages and conducted laboratory tests before concluding that four of the company’s products contained undeclared pharmaceutical ingredients.
Specifically, FDA found sibutramine—the active ingredient in Meridia®, which was approved by FDA in 1997 for the prescription treatment of obesity but withdrawn in 2010 after clinical data revealed the ingredient increased the risk of heart attack and stroke—in the company’s Pink Bikini and Shorts on the Beach supplements. The agency also uncovered diclofenac—a nonsteroidal anti-inflammatory drug (NSAID), which, although currently available by prescription, may dangerously interact with other drugs and cause serious harm—in another version of the company’s Pink Bikini product. FDA also confirmed that a variation of the company’s Shorts on the Beach product contained sibutramine and phenolphthalein, which have allegedly been linked to cancer. According to the warning letter, the manufacturer had already initiated product recalls based on FDA’s investigation. For example, it stated that in the company’s “483 response dated February 2, 2016, [the company] would cease package[ing] and/or label[ing] of any and all products that are considered a dietary supplement.”