The Food and Drug Administration (FDA) has recently identified two more fake weight loss products. In a consumer update, the FDA has advised users not to purchase these weight loss products: Ultimate Lean and Slim Fit X, which were being sold as all natural supplements. According to the FDA, both of the products were identified as fraudulent when it examined records of international mail shipments and subsequently conducted laboratory analysis, which confirmed the products contained banned chemical substances (sibutramine).
“These products are masquerading as dietary supplements—they may look like dietary supplements but they are not legal dietary supplements,” says Michael Levy, Director of FDA’s Division of New Drugs and Labeling Compliance.
With the obesity epidemic in full swing in the US in 2012, it was estimated Americans have spent more than $65 billion on trying to lose weight, out of which $2.69 billion were spent on diet pills, without knowing such products can be more harmful than helpful for the health.
Both of the products contain banned chemical substances known as ‘sibutramine’ and ‘desmethylsibutramine’ which were labeled as controlled substances back in October 2010 when they were found to be responsible for causing adverse health effects.
Sibutramine was banned from market while desmethylsibutramine is a structurally similar derivative of the harmful chemical. The presence of both substances poses safety concerns for users, especially those with heart problems.
Sibutramine leads to a substantial increase in blood pressure or pulse rate and may be harmful or even fatal in some patients, especially people suffering from coronary heart diseases or having suffered from a stroke, heart attack or arrhythmias before. The chemical compounds may also interact with other medication in a dangerous way and can even lead to heart failure.
“Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous,” says Levy.
In addition to the consumer update specifically about the two products, the FDA also advised the readers to keep in mind the increasing frequency of such counterfeit and fraudulent products.
According to the FDA, the trend of using dietary supplements for various health enhancements is growing but many of the consumers don’t know that such products contain hidden banned substances. Even conventional foods posing as health promoters like sexual enhancement, weight loss and body building can contain toxic drugs and chemicals. Such products are usually cited as being ‘All Natural’ but that is far from truth.
Also bear in mind the FDA does not have the power to regulate these products under law as part of the Dietary Supplement Health and Education Act of 1994, and can only test products when reports against the products have been filed. Therefore it falls on the consumers to take precaution while buying any such products. The FDA has also warned if a product is found on the shelves of a health store or pharmacy, it does not mean federal agencies allowed the product to be placed there.
“We need consumers to be aware of these dangerous products and to learn how to identify and avoid them,” says Levy.
The FDA also regularly issues public consumer updates, notifications and recall details so the consumers can stay updated. To date more than 300 fraudulent products posing as all natural supplements have been caught by FDA to contain deceptively labeled harmful ingredients. To prevent detection, dietary supplement companies often use ingredients which are close analogs of the controlled chemicals but they fail to mention such compounds can also have adverse outcomes on health. Besides, such compounds do not qualify as natural dietary supplements and do not meet the official criteria of legal ‘all natural’ supplements. These drugs are actually prescription drugs, anabolic steroids, new drugs analogs or untested chemical compounds. Instances of harmful health effects reported to the FDA include high blood pressure, heart palpitations, stroke, liver injury, kidney failure and even death.
The FDA also advises that those using these products should consult their professional healthcare providers before consuming these products. If it is a nutrient a consumer is looking for to add in their diet, they should consult a dietitian which is the best way to go about making up for lack of nutrient deficiency.
A healthcare provider can also be consulted to learn to distinguish between real and fake health enhancement products. When products have labels which claim to ‘cure’, it is sure to be fraudulent because dietary supplements do not have the ability to cure as they can just help in promoting health. Consumers can also check the official FDA site to gain more information and to see if any product is listed as banned. Similarly, if a consumer believes a product they have encountered posing as dietary supplement is fake, they can contact the FDA on their website or simply call 1-800-FDA-1088 to report the product.