FDA Pulls Maxiloss Weight Advanced Softgels From the Market

Maxiloss Weight Advanced Softgels is a dietary supplement that until last February was marketed and sold in the U.S. as a weight loss pill. The Food and Drug Administration (FDA) recalled the supplement from the market when testing showed that the pills contained an undisclosed ingredient, Sibutramine. Unlike the product’s listed ingredients such as Lotus Leaf and Ginseng, Sibutramine is not an herb; it is a chemical compound classified as a serotonin-norepinephrine reuptake inhibitor (SNRI), a class of drugs typically used to treat major depression.

Sibutramine was previously prescribed in the U.S. for the treatment of obesity, but it was pulled from the market in October 2010 due to safety risks, such as substantially increasing blood pressure. Sibutramine also posed a significant danger to patients with a history of heart disease, heart failure, arrhythmias and stroke. Maxiloss can still be found on some websites, though the FDA warns consumers to refrain from purchasing the now-illegal supplement from these sources.

Maxiloss is not the first herbal supplement found to secretly contain Sibutramine. Herbal supplements are considered “food” rather than drugs, and they are not as heavily regulated by the FDA as prescription or over the counter medicines. Under the Dietary Supplemental Health and Education Act of 1994, producers of herbal supplements do not need to prove to the FDA that their product is safe as is the case with drugs. Instead, the FDA has the burden of proving that the herbal supplements are unsafe. Herbal supplements only need to disclose on the products’ packaging that they are not FDA approved, and that they have not been approved for the treatment or cure of any disease or condition. These requirements do nothing to account for the actual substance of the herbal pills.

The FDA does not monitor the safety of herbal supplements until they are on the market, which can create a lag between the time that herbal supplements become available to the public and the time that it is discovered that they contain unlisted substances. Due to the high demand for weight loss aids in the United States, it is conceivable that herbal supplements purporting to stimulate metabolism and promote weight loss are more likely to have secret ingredients to make the product sell. The injuries that resulted from the consumption of Maxiloss are a reminder to consumers to use caution when taking weight loss supplements.