According to the NIH, about 15 percent of Americans have tried weight loss supplements. Supplements aret held to the same criteria as medications in terms of regulatory oversight, which means consumers arent constantly getting whats promised on the label. Pieter Cohen, MD, an associate professor of Medicine at Cambridge Health Alliance at Somerville, Mass. has been fascinated for a long time from the contents of the supplements we take. Dr. Cohen has been a outspoken critic of how dietary supplements are regulated.
Checking the label — and the contents
In a paper published March 23 at Clinical Toxicology, Dr. Cohen and his research team looked for deterenol, a beta-agonist that has not yet been approved for use in humans . A beta-agonist is a class of drugs that relaxes airway muscles, thereby helping with breathing.
Using Google to locate supplements that promoted deterenol, Dr. Cohen found 17 supplements that promoted deterenol inside them. Dr. Cohen found deterenol in 13 of the 17 brands that he tested . He believes this odd because all 17 listed deterenol as an ingredient . “It’s surprising that a banned stimulant is recorded on the label but not found in the product , ” said Dr. Cohen, “It’s difficult to divine what degree of manufacturing dysfunction could lead to this outcome . “
Deterenol wasn’t the only chemical found in those pills. And that is part of why they may be so dangerous. “ … We discovered deterenol blended with other experimental stimulants. We have no study to predict at what dose a mix of these prohibited stimulants would lead to severe health effects, said Dr. Cohen. The researchers also found 9 other experimental stimulants and 8 combinations of prohibited stimulants.
Deterenol came to Dr. Cohen’s attention when his colleague, Bastiaan Venhuis, followed on 26 cases of deterenol toxicity reported to Dutch authorities . “When our colleagues in Europe investigated the cause of several cases of serious adverse events linked to nutritional supplements – they discovered deterenol from the supplements along with other components ,” Dr. Cohen explained, “We wanted to understand if deterenol could also be available in supplements marketed in america . ”
In the Netherlands, the 26 instances of complications came from Dexaprine and Dexaprine XR, supplements targeted at athletes and others seeking to get rid of weight. People who took these supplements containing deterenol undergone a fast heartbeat , sweating, chest pain and heart palpitations. There was one reported case of cardiac arrest. Upon investigation, the researchers found deterenol, together with many other compounds, in the supplements. They were only able to test 4 of the pills, as the other 22 complainants had discarded their pills.
According to Dr. Cohen, there are no studies that show deterenol contributes to weight loss.
Seized for your safety
Blue Ice, produced by EPG, was one weight loss supplement that Dr. Cohen analyzed. He found that it contained about 15mg of deterenol each serving.
1 consumer reviewing the pills composed , “This stuff scared the heck out of me. I began breathing quickly and got really hot and felt a sudden mood shift ! I didn’t know if I should drive to the hospital or not. ” Even so, this individual persevered and claimed to have lost 6 pounds .
Consumers should not confuse these supplements, which range from “fat burners” to pre-workout beverages and weight loss pills, with prescription weight-loss pills. “To be accepted as a prescription weight-loss drug in the US you want to convince the FDA through large randomized controlled trials it’s effective and safe for weight loss, ” said Dr. Cohen.
While all medications have side effects, he explained, an FDA-approved medication must list all side effects on the packaging. Supplements aren’t required to undergo clinical trials so the agency does not have data on side effects prior to the drugs go to market.
The FDA regulates the ingredients in the supplement and requires that the manufacturers to ensure their products safety. Additionally, it requires that the labeling is accurate.
However , it only reviews supplements once they’ve made it to market. The FDA is “… accountable for taking action against any adulterated or misbranded dietary supplement product after it reaches the market. ” So consumers face a window of time between when an adulterated or misbranded product is available for purchase and any recall action.
- The FDA, which records show for the past two years or so spent a lot of its investigative time on supplements containing non-labeled erectile dysfunction medications , have recorded most, if not all, of the Cohen research chemicals on its Dietary Supplement Ingredient Advisory List.
- In 2013 the FDA released a statement about dimethylamylamine, DMAA, declaring that it was “ using all available resources at its disposal” to stop dietary supplements containing DMAA. Two of the supplements Dr. Cohen tested in the present study contained DMAA. Without testing, the FDA considers products containing DMBA “adulterated. ”
- Although not banned or considered an adulterant, BMPEA isn’t regarded as a “ nutritional ingredient” by the agency . Two of the Cohen supplements contain BMPEA.
- Higenamine, chemically akin to amphetamine, is known by at least 15 other titles .
- Oxilofrine, found in four nutritional supplements , and octodrine, found in three, are also not considered supplements . Oxilofrine, a stimulant, does not satisfy the statutory definition of a dietary ingredient and ritodrine is known as an adulterant.
- Another compound found was phenpromethamine. In exceptionally sensitive testing of its molecular weight it resembles methamphetamine and amphetamine. Once marketed as a nasal inhaler named Vonedrine, the manufacturer took Vonedrine off the market in 1960 and it dropped FDA approval in 1971.
If a number of these chemicals are known to be harmful , let alone not tested or approved for use in people , why are they weight loss supplements? Part of this comes down to the FDA’s regulatory structure, which Dr. Cohen termed as faulty .
Medication vs supplements
FDA-approved prescription medicines and over-the-counter remedies can only contain claims if the claims are backed with research . To get in front of a consumer , the manufacturer needs to have information to show that the product can do what it is purporting to do. With supplements, the FDA will review a supplement if it has a new ingredient which hasn’t been sold in a supplement prior to October 1994. This is the reason several of the chemicals were believed adulterants; their producers hadn’t submitted the compounds as fresh ingredients into the FDA.
Other institutions have banned these stimulants. For example , t he World Anti-Doping Agency has outlawed most of these . The Department of Defense has also ; it f orbids its employees from taking any dietary supplements containing certain ingredients meant to stimulate weight loss and enhance moods.
Medical Daily reached out to several companies whose goods were included in Dr. Cohen’s study ; none responded with comment.
The take home
Consumers can always look up ingredients on the FDA’s website. But keep in mind that supplement makers occasionally lie. According to the NIH, “ What’s on the label may not be what’s in the product . ” Again, consumers can also check for recalled or tainted supplements before purchasing .
The NIH warned that a producer ’s use of the words standardized, certified or verified doesn’t guarantee that the product’s quality or consistency .
Dr. Cohen believes that under present regulations, consumers are in the dark about a supplement’s components . At present , there’s no way to know if sports or weight loss supplements contain prohibited ingredients, he said, Until the laws can be reformed, my advice is to avoid all supplements sold as pre-workout or weight loss supplements. ”
Sabrina Emms is a science journalist. She got her start as an intern in a health and science podcast from Philadelphia public radio. She worked as a researcher, looking at the way bones are shaped .