Food and Drug Administration (FDA) issued a public warning yesterday cautioning people about the mislabeled and illegal chemicals present in the weight loss medication advertised as a dietary supplement: Propell Platinum. The warning comes following a series of steps taken by the FDA, starting with sending an open letter to the companies in December 2010, to regulate the dietary supplements industry so that no adverse public health incident takes place in the United States.
Weight Loss Supplements Receive Warning
Propell Platinum is being sold and advertised as a supplement which claims that it decreases belly fat, increases energy, and suppresses appetite, at zxtbeepollenpills.com by Ultimate WeightLoss Corporation.
Propell Platinum currently makes $50 per every single bottle of the supplement.
The warning issued by the FDA states that the product is tainted with two chemicals. First, with sibutramine that can cause increased blood pressure and pulse rate and may affect people adversely with history of coronary artery disease, congestive heart failure, arrhythmias, and stroke. Sibutramine can also counteract with your medication and affect your health. This chemical was removed from the market by the FDA in 2010 and is classified as a controlled substance.
Second, a chemical named phenolphthalein (a laxative) was present which has shown cancer causing risk in several studies and is not part of any drug as an active ingredient in the United States.
FDA procedures, according to the above mentioned letter, dictate that after it issues the public warning, it will contact the responsible company about the product that is already in the market or in the consumers’ hand. When the company will be contacted was not included in the warning issued to the public. FDA can prosecute anyone who has violated the Federal Food, Drug, and Cosmetic Act and endangered the public under section 21 U.S.C. 331. Whether an investigation would be carried out to determine incompetence or fraudulence was also not made clear.
Similar drugs containing such chemicals have been indicated as tainted by the FDA through this warning system. The list includes almost 300 supplements, like Solo Slim, Slim-30, ArimaDex, Vigor-25 and others.
The dietary supplements industry in United States is worth $36.7 billion. But the regulation of the industry is not similar to how drugs or pharmaceutical industry is kept in tight check. FDA has stated that “with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time”.
The 1994 law, the Dietary Supplement Health and Education Act, classifies these supplements as food and not drugs. The manufacturers do not have to prove that their product is safe or that it actually works nor do they have to get approval from FDA, but the packaging must include the product name, manufacturer’s name and address, along with nutrient list, identity and quantity of its ingredients.
In 2013, Senator Dick Durbin reintroduced a law, The Dietary Supplemental Labeling Act, after a previous failed attempt to try and get the manufacturers of dietary supplements to provide a list of ingredients to the FDA and label the bottles with possible adverse effects, but it saw a serious opposition from the industry and was never approved.
“My goal is to take the decision about how a product will be regulated out of the hands of the manufacturer and put it in the hands of the FDA where it belongs. Consumers who don’t scour the fine print on the back of products may never know the difference, but they will be safer as a result of this bill,” said Senator Durbin when he proposed it.
In 2014, the Senate hearing on consumer protection reprimanded the famous Dr Mehmet Oz for promoting products such as Green Coffee Bean extract for weight loss (for which conducted research study was retracted later on), and showed resolve for better future supervision of the dietary supplement industry and protection of consumer rights.