Banned Appetite Suppressant Found in Three Weight Loss Supplements, FDA Warns
The drug sibutramine, which raises the risk of heart attack and stroke among cardiovascular patients, is present in some dietary supplements marketed in the U.S.
-- by Heather Kathryn Ross
Until 2010, the chemical sibutramine, which is similar in composition to amphetamines, was prescribed to obese patients under the brand name Meridia. Following a study demonstrating that the drug increases the risk of heart attack, stroke, high blood pressure, and cardiac arrest in patients with heart disease or type 2 diabetes, it was withdrawn from the U.S. market.
However, some manufacturers of dietary supplements for weight loss are attempting to skirt the ban by sneaking sibutramine into their products and selling them to American consumers desperate to shed excess pounds.
This month, the FDA issued stern warnings about Japan Hokkaido Slimming Weight Loss Pills, Beautiful Slim Body, and Best Share Green Coffee: Brazilian Slimming Coffee. The agency says patients using these supplements should stop immediately and report any adverse health effects of the diet drugs through its website.
“The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke,” one FDA notification reads. “This product may also interact, in life-threatening ways, with other medications.”
The FDA Regulatory Structure
These three diet products are a small part of an ever-expanding market in “all natural” remedies for everything from weight loss to sexual enhancement to muscle building, many of which contain hidden compounds that often go untested by regulatory agencies.
“Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide the FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products,” said Stephen King, Public Affairs Specialist for the FDA’s Center for Drug Evaluation and Research in an email to Healthline. “However, manufacturers and distributors of dietary supplements must record, investigate and forward to FDA any reports they receive of serious adverse events associated with the use of their products. The FDA is able to evaluate these reports and any other adverse event information reported directly to us... to identify early signals that a product may present safety risks to consumers.”
Linda Bacon, Ph.D., an author and professor of nutrition at City College of San Francisco, explained that drugs marketed as supplements are loosely regulated largely because of the 1994 Dietary Supplement Health and Education Act (DSHEA), signed into law by President Clinton.
The DSHEA transferred responsibility for ensuring that a supplement and the ingredients in it are effective and safe for consumption to the manufacturers themselves. Supplement producers need not get the FDA’s approval before selling their products. If the agency later discovers that a supplement is unsafe, it typically issues an advisory, like the ones discussed above, but does not remove the item from the market.
“At the core of FDA’s dietary supplement enforcement efforts is the agency’s commitment to protect the public health by removing unsafe products from the market,” King said. “Generally, the FDA works with manufacturers to voluntarily recall their products when problems or issues are identified; however, the FDA does have other enforcement actions that can be pursued if necessary.”
Under the Bioterrorism Act of 2002, manufacturers must register the factories and businesses through which they produce and import supplements with the FDA. And in June 2007, the FDA published guidelines for supplement manufacturing best practices. According to King, “these regulations focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements.”
Unsubstantiated Claims from Supplement Manufacturers
Clearly, however, some foreign and domestically produced supplements have slipped through the FDA safety net. Now that the onus is on producers and distributors to prove that their products are safe and actually initiate weight loss, Bacon worries that they’ve been given carte blanche to peddle false hope to their clientele.
“No appetite suppressant has been demonstrated to produce lasting weight loss," said Bacon. "The false promises make people believe that they are failures in the long run, rather than recognize that it’s the product that failed. There is substantial research to support that any attempt to manipulate our internal weight regulation system meets up with resistance, so I think it’s safer to go with the assumption that nothing is effective until proven otherwise.”
If a weight loss product works to suppress your appetite, as those containing sibutramine do, Bacon says the body will likely overcompensate for the lack of calories you eat by storing more of the food’s energy content and slowing your metabolism. Conversely, diet pills that claim to increase your metabolism eventually cause your brain to ratchet up the hunger signals it sends your body. You simply can’t trick your system in the long run.
“Yes, you can temporarily curb your appetite or boost your metabolism with an amphetamine or similar supplements, but you may also be nervous, jumpy, and subject to insomnia and addiction and a host of other problems,” said Bacon. “Plus, once you stop taking the supplement, your lost weight comes right back, if not higher.”
Bacon’s bottom line on all weight loss drugs is the same, whether they contain harmful substances or not: “Don’t fall for the hype,” she advises. “There is no ‘magic pill’ that will melt the pounds away. It is unlikely that thin bodies will ever come from a bottle.”