Weight Loss

Over-The-Counter Weight Loss Supplements Are Tainted

We all want a quick fix. Something that will correct whatever is ailing us without effort. We’ve all heard the ads that claim weight loss without dieting or exercising. It sounds great but as the adage goes- if it sounds too good to be true, it probably is!

We all agree that making healthy lifestyle changes- eating healthier foods, reducing calories, and increasing physical activity- is the only way to lose weight and keep it off. But these changes aren’t easy. Many people turn to dietary supplements promoted by weight loss companies as a cure-all in the hopes they will help them achieve their goals. The U.S. Government Accountability Office concluded that “little is known about whether weight loss supplements are effective, but some supplements have been associated with the potential for physical harm”. Many weight-loss supplements are costly, and some of the ingredients in these products can interact or interfere with certain medications. So it is important to consider what is known, and not known, about each ingredient in any dietary supplement before using it.

In the United States, more than 50% of adults consume dietary supplements, fueling a $35 billion industry. Dietary supplements include vitamins, minerals, botanicals, amino acids, and enzymes, that according to the US Food and Drug Administration (FDA), are not intended to treat or prevent disease. Controversy over adulterated supplements stretches back decades. Under a 1994 law, the Dietary Supplement Health and Education Act, the products are regulated as food and therefore not subject to premarket safety and effectiveness testing imposed on medications.

To identify products that are unsafe or contain unapproved ingredients, the FDA relies on postmarket surveillance efforts. These include review of adverse event reports and consumer complaints, inspection of dietary supplement firms, and screening of imported products. Additionally, a dietary supplement firm is obligated to report to the FDA events that require medical intervention to prevent death, hospitalization, or birth defect. When a product has the potential to cause serious adverse health consequences, the FDA can issue a Class 1 recall and take it off the market. Unless something catastrophic occurs, it’s a voluntary process left up to the sole discretion of the company! And we all know how well that works. New information now shows that many manufacturers do not modify their products to follow the FDA guidelines– with roughly 30% of products that were issued a warning letter by the FDA still being available online for sale over 6 years after the letters were issued!

A new paper written by a team from the California Department of Public Health found that dietary supplement use has been associated with 23,000 emergency department visits and 2,000 hospitalizations in the United States each year. Serious adverse events reported with the use of dietary supplements include stroke, acute liver injury, kidney failure, pulmonary embolisms, and death. Identifying adverse events through post-market surveillance efforts poses some challenges, mainly owing to difficulties in asserting causality and under reporting. A U.S. Government Accountability Office report found that, of adverse event reports received by the FDA, most do not initiate consumer protection actions like inspections or warning letters. Additionally, many consumers and physicians may not attribute symptoms to use of a dietary supplement or know to report to the FDA or the associated dietary supplement firm. In fact, poison control centers received over 1,000 more reports of adverse events associated with dietary supplement use than the FDA did over a 3-year period.

To increase transparency and public knowledge, the FDA’s Center for Drug Evaluation and Research maintains the “Tainted Products Marketed as Dietary Supplements_CDER database” (Tainted Supplements database) as a resource to lower risk to consumers. They study analyzes data from the Tainted Supplements database for adulterated dietary supplements associated with a warning by the FDA over the last decade in order to summarize trends.

About 80 percent of the supplements were contaminated by pharmaceuticals that should not have been in the product. Despite these contaminants, fewer than half the products were recalled. The presence of unknown drugs in supplements “poses a serious public health risk,” the researchers wrote. Unfortunately the vast majority of consumers know nothing about this and mistakenly believe the products are carefully regulated and accurately labeled.

The drugs found in the supplements have “the potential to cause serious adverse health effects owing to accidental misuse, overuse or interaction with other medications, underlying health conditions or other pharmaceuticals,” the researchers wrote. The most common drug ingredients detected in adulterated dietary supplements marketed for weight loss were sibutramine, sibutramine- like products, and the laxative phenolphthalein. Sibutramine has the potential to substantially increase blood pressure or pulse rate in some patients. This presents a risk to patients with a history of heart disease or stroke. Studies indicate that phenolphthalein presents a potential carcinogenic risk and may also lead to gastrointestinal disturbances or irregular heartbeat. Both sibutramine and phenolphthalein were removed from the U.S. market by the FDA in 2010 and 1999, respectively. Fluoxetine (Prozac) and Sildenafil (Viagra) or 1 of its analogues was also identified. Others were found to contain ephedrine, a stimulant that increases blood pressure and was banned from use in dietary supplements by the FDA in 2004.

The presence of pharmaceutically active ingredients in dietary supplements makes them unapproved drugs and represents an important public health concern. Of products that were found to be adulterated, more than once, 19 (67.9%) had new drug ingredients reported in their second or third warning. This indicates that these products continue to be sold and are potentially dangerous even after FDA warnings. This is alarming, especially considering that the FDA is only able to test a portion of products available on the market.

In an editorial to the research published, Pieter Cohen, an associate professor at Harvard Medical School who conducts research into the safety of dietary supplements, called on the FDA to more aggressively act against companies that produce adulterated supplements and urged an overhaul of the 1994 law. He suggested that companies be required to register the products with the FDA before sale. He said many tainted supplements come from well-known manufacturers based in the United States. He cited a 2014 study that he and others conducted that found 20 of 27 supplements were still adulterated with drugs and available for purchase between eight and 52 months after they were recalled by the FDA. As the dietary supplement industry continues to grow in the United States, it is essential to further address this significant public health hazard.

People who are considering using weight-loss supplements should talk with their healthcare provider to discuss these products potential benefits and risks. This is especially important for those who have medical conditions, including high blood pressure, diabetes, and liver or heart disease. Yet, according to a large national survey, less than one-third of U.S. adults who use weight-loss dietary supplements discuss them with a healthcare professional. We all know the only way to lose weight is through hard work, time and persistence. None of this other stuff works. If there was a magic pill, I promise you, we’d be prescribing it.










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