Pharmaceutical

FDA cites company for marketing dangerous dietary supplements

dietary supplements pills probiotics FDA cites company for marketing dangerous dietary supplementsX2 Zero Corporation was slapped with a Food and Drug Administration (FDA) warning letter for marketing dietary supplements that contain undeclared and potentially dangerous drug ingredients and making claims that the products can cure, treat or prevent diseases.

The FDA conducted laboratory analyses of several of the company’s diet pills and sexual enhancement products, and found that many contain the active drug ingredients sibutramine, desmethyisibutramine, phenolphthalein, thiosildenafil and sildenafil. The company sells the supplements under the brand names Dynamism, Eradicate, Xerophagy, Salute, ZimXter, Exhilarate, and Natural Eruption. The products are sold on the company’s websites, www.x2zero.com and www.361weightloss.com.

Sibutramine is a stimulant used for weight loss that was sold in the U.S. under the brand name Meridia but pulled from the market in October 2010 after studies linked the drug to serious cardiovascular events such as heart attack, cardiac arrest and cardiovascular death. Desmethylsibutramine is an active metabolite of sibutramine.

Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the U.S. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

Sildenafil is the drug ingredient in the prescription erectile dysfunction medication Viagra. Sildenafil may react with some prescription drugs, like nitrates, which can lower blood pressure to dangerous levels. Thiosildenafil is a derivative of sildenafil that is not approved by any health regulation agency and the risks are unknown.

The agency also cited X2 Zero Corporation for misbranding its products Colon Relief, Woman Revived, Ketone Cleanse, Colon Wipeout, T Drive, Thyroid Support, Yacon Syrup, X Heat, Coconut Oil, and Natural Vine Multi Vitamin, because many do not include the part of the plant from which it claims to be derived, and for not listing ingredients on the label that are included in the supplements.

The company was given 15 working days to notify federal officials of steps it has taken to correct the violations, including an explanation of each step being taken to prevent the violations from reoccurring.

Source: FDA