The FDA has issued warnings about five weight loss products including dietary supplements that have been found to contain banned synthetic drugs as ingredients. FDA is advising people not to buy any of the products, namely Dream Body Extreme Gold, Dream Body Advanced + Acai Weight Loss & Cleanse, Extra Slim Plus Acai Berry Weight Loss Formula, Dream Body Original Formula and SBF Bee Pollen. Laboratory analysis by the FDA confirmed that the products contain hidden substances which can cause serious harm to health resulting in injury or even death.
“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.
Laboratory analysis confirmed Dream Body Extreme Gold and Dream Body Advanced + Acai Weight Loss & Cleanse both contain the forbidden ingredients sibutramine, fluoxetine and sildenafil. Meanwhile, Extra Slim Plus Acai Berry Weight Loss Formula, Dream Body Original Formula and SBF Bee Pollen were found to contain sibutramine. These products do not qualify as dietary supplements since they contain synthetic compounds and are falsely labeled as such.
Counterfeit Products Are Not Included In Dietary Supplements
More and more people are concerned about their wellbeing and turning to the internet for medical consultation. A majority of them are trying to find natural alternatives to synthetic medicines. Needless to say dietary supplement makers have taken advantage of the situation and currently the US supplement industry is considered to be worth more than $36.7 billion.
Although the FDA continuously warns the masses about the potential dangers of such fraudulent products and has even unearthed 300 false dietary products to date, under federal law (Dietary Supplement Health and Education Act of 1994), the agency is not allowed to regulate the production and distribution of these dangerous products.
Such products posing as dietary supplements are marketed for weight loss, sexual enhancement and bodybuilding. They can be labeled falsely while containing many harmful ingredients. The ingredients can be active compounds either banned by the FDA or their closely related analogs e.g., steroids, adverse drugs etc. Consumption or use of such products has been shown to cause high blood pressure, stroke, liver failure, kidney failure, heart palpitations and even death in some cases. The agency continuously warns they do not have the resources to test or identify all supplemental products on the market which may potentially contain harmful hidden ingredients.
“Some of these products contain hidden prescription ingredients at levels much higher than those found in an approved drug product and are dangerous,” said Levy.
Sibutramine, which is a banned substance, was found in all five of the weight loss products. Sibutramine was taken off the market by the FDA in October 2010 after it showed adverse effects on health. It was found to increase the pulse rate or blood pressure and therefore deemed dangerous for patients with a history of heart diseases, since it could interact with other medications in life-threatening ways.
On the other hand, Fluoxetine is a prescription drug used for treating serious neurological disorders. Although Fluoxetine was an FDA-approved drug and is a selective serotonin reuptake inhibitors (SSRIs) drug, it cannot be consumed without physician consultation. Fluoxetine is prescribed to treat depression, bulimia, obsessive-compulsive disorder (OCD), panic disorder, and premenstrual dysphoric disorder (PMDD), therefore unnecessary use of the drug can lead to suicidal thinking, abnormal bleeding, or seizures. Fluoxetine can also interact with other common drugs such as aspirin or ibuprofen leading to sudden death.
Likewise, sildenafil is one of the active ingredients found in the prescription drug Viagra, which is used to treat erectile dysfunction. Sildenafil can cause adverse effects in the body if consumed along with other prescription drugs such as nitroglycerin. The controlled substance lowers the blood pressure to a dangerous degree and is especially dangerous for people with diabetes, high blood pressure, high cholesterol, or other heart diseases, since they take nitrate drugs.
According to the FDA, the fact a dietary supplement can be found on the shelves of grocery stores does not make them safe for consumption. The FDA can only investigate a dietary supplement or related products if safety concerns are raised. The agency needs to prove the products being inquired about is adulterated i.e., unsafe or misbranded i.e., has false labels. In the past the FDA has recalled more than 40 products directed at weight loss, 70 products claiming to provide sexual enhancement and 80 products used for body building from the market due to the presence of potentially harmful ingredients.
According to the Federal Food, Drug, and Cosmetic Act, a dietary ingredient can be vitamin, mineral, herbs, amino acids, enzymes or any other botanical extract in any concentration. In the same way, dietary supplements cannot claim to treat, diagnose, prevent, or cure serious chronic diseases and labeling them as such is wrong.