Are Dietary Supplements Safe?

Written by Dr. Steve Chaney on . Posted in Issues, Supplements and Health

It’s a Jungle Out There

Author: Dr. Stephen Chaney

JungleIt’s a jungle out there. You probably already know that there are some bad players in the food supplement industry. There are companies that make products that don’t work, products that haven’t been tested for safety and efficacy, products are contaminated, and even products that are dangerous. There are some companies that even make products that contain dangerous drugs – drugs that can kill you.

Are Dietary Supplements Safe?

A recent report (Harel et al, JAMA Internal Medicine, doi: 10.1001/jamaintermed.2013.379) states that between January of 2004 and December of 2012 there were 465 drugs that were subject to a class I recall by the FDA. A class I recall is for cases in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.

Now here’s the scary part: 98% of those recalls were for dietary supplements. The worst offenders were sexual enhancement products (40%), bodybuilding products (31%) and weight loss products (27%). And these weren’t all foreign-made products. 74% were manufactured in the United States.

[Note: If you are good at math, you will have noticed that leaves 0% for recalls of all other dietary supplements].

It’s A Jungle Out There

A perfect example of this scandalous behavior in certain segments of the food supplement industry is the DMAA saga. You may recall that I mentioned this in a recent “Health Tips From the Professor” titled “Are Fat Burning Supplements Safe?”  Let me give you a very brief overview of that report, followed by the latest developments.

DMAA is short for dimethylamylamine. It is a stimulant that is chemically very similar to the ephedrine class of chemicals. The less reputable supplement manufacturers often add stimulants to their weight loss and bodybuilding products.

Stimulants do raise metabolic rate so they help with weight loss. They have no effect on athletic performance, but the athletes often feel like they have more energy – so they are popular in bodybuilding products. The problem is that many stimulants are dangerous. They can increase heart rate, cause arrhythmia, and they can kill people.

Because supplements with ephedra, another close realative of ephedrine, killed a bunch of people, the FDA forced supplement manufacturers to remove it from their products a number of years ago. You might have thought that the manufacturers would decide that adding stimulants to their products wasn’t a good idea. But no, they just substituted DMAA for ephedra. And guess what? The inevitable happened again. Two US soldiers died following DMAA usage in 2012.

The DMAA Scandal

The story really gets scandalous from here. The military ordered the removal of all DMAA containing products from U.S. Army and Air Force exchanges, but the FDA did not act. So what happened? Just about what you’d expect. Companies like GNC pulled their DMAA containing products from military bases, but continued to sell them from all their other stores.

Several months later the FDA finally acted. It sent a warning letter to all US manufacturers of DMAA containing products asking them to stop using DMAA as an ingredient in their supplements. All of the companies agreed to stop using it except one – USPLabs.

USPLabs claimed that DMAA could be found in geranium, which is an approved herbal ingredient, so they continued to use it. And GNC continued to sell their DMAA containing products in all its nonmilitary stores.

Finally, on April 11, 2013 the FDA issued a strongly worded warning about DMAA. The FDA warning said that by then there had been 86 reports of illnesses and deaths associated with supplements containing DMAA, and the preponderance of scientific evidence showed that DMAA was not a natural constituent of geranium.

The FDA said that they would take all possible means to get DMAA containing products off the market. A cynic might point out that the FDA did not act until the night before a high profile exposé on DMAA was scheduled to appear on NBC.

Finally, USPLabs threw in the towel and said that they would reformulate their DMAA containing products. A cynic might suspect that they will just substitute yet another stimulant for DMAA.

And, what about GNC? They said “It [DMAA] will be positioned out of stores, probably over the next five or six months as we sell existing inventory”. You don’t need a cynic to interpret that statement.

It wasn’t until the FDA raided their warehouses and removed all remaining DMAA-containing products that the DMAA story was over.

So what’s the bottom line for you? It is a jungle out there. Don’t fall for the hype and fancy claims. Do your homework, and stick with a company you can trust.

The Bottom Line:

1)     When you hear headlines about dietary supplements killing people, you should realize that the bad players are found in only 3 types of dietary supplements – sexual enhancement products, bodybuilding products and weight loss products.

2)     Just for perspective you should contrast any concerns about the safety of dietary supplements with:

    • The more than 35,000 deaths/year from properly prescribed medications…and…
    • The 8,000 deaths/year in US hospitals due to medication errors (Journal of General Internal Medicine, 25: 774-779, 2010)

3)     When choosing supplements in that class use your common sense. Avoid those supplements promising magical gains in sexual prowess, increased muscle mass or weight loss.

4)     Stick with a supplement company you can trust – one that is committed to only making supplements of proven benefit, and never making supplements that could cause any harm.

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

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Comments (2)

  • Victoria Chase

    |

    Dr. Chaney,
    Thank you so much for these informative newsletters!
    What do you know about Plexus? I know Australia banned it for a while last summer because it contained DMAA.

    Reply

    • Dr. Steve Chaney

      |

      Dear Victoria,
      I believe that Plexus has been reformulated. Of course, they most likely simply added another stimulant – which may or may not be safe. Only time will tell.
      Dr. Chaney

      Reply

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Latest Article

A Low Carb Diet and Weight Loss

Posted January 15, 2019 by Dr. Steve Chaney

Do Low-Carb Diets Help Maintain Weight Loss?

Author: Dr. Stephen Chaney

 

low carb dietTraditional diets have been based on counting calories, but are all calories equal? Low-carb enthusiasts have long claimed that diets high in sugar and refined carbs cause obesity. Their hypothesis is based on the fact that high blood sugar levels cause a spike in insulin levels, and insulin promotes fat storage.

The problem is that there has been scant evidence to support that hypothesis. In fact, a recent meta-analysis of 32 published clinical studies (KD Hall and J Guo, Gastroenterology, 152: 1718-1727, 2017 ) concluded that low-fat diets resulted in a higher metabolic rate and greater fat loss than isocaloric low-carbohydrate diets.

However, low-carb enthusiasts persisted. They argued that the studies included in the meta-analysis were too short to adequately measure the metabolic effects of a low-carb diet. Recently, a study has been published in the British Medical Journal (CB Ebbeling et al, BMJ 2018, 363:k4583 ) that appears to vindicate their position.

Are low carb diets best for long term weight loss?

Low-carb enthusiasts claim the study conclusively shows that low-carb diets are best for losing weight and for keeping it off once you have lost it. They are saying that it is time to shift away from counting calories and from promoting low-fat diets and focus on low-carb diets instead if we wish to solve the obesity epidemic. In this article I will focus on three issues:

  • How good was the study?
  • What were its limitations?
  • Are the claims justified?

 

How Was The Study Designed?

low carb diet studyThe investigators started with 234 overweight adults (30% male, 78% white, average age 40, BMI 32) recruited from the campus of Framingham State University in Massachusetts. All participants were put on a diet that restricted calories to 60% of estimated needs for 10 weeks. The diet consisted of 45% of calories from carbohydrate, 30% from fat, and 25% from protein. [So much for the claim that the study showed low-carb diets were more effective for weight loss. The diet used for the weight loss portion of the diet was not low-carb.]

During the initial phase of the study 161 of the participants achieved 10% weight loss. These participants were randomly divided into 3 groups for the weight maintenance phase of the study.

  • The diet composition of the high-carb group was 60% carbohydrate, 20% fat, and 20% protein.
  • The diet composition of the moderate-carb group was 40% carbohydrate, 40% fat, and 20% protein.
  • The diet composition of the low-carb group was 20% carbohydrate, 60% fat, and 20% protein.

Other important characteristics of the study were:

  • The weight maintenance portion of the study lasted 5 months – much longer than any previous study.
  • All meals were designed by dietitians and prepared by a commercial food service. The meals were either served in a cafeteria or packaged to be taken home by the participants.
  • The caloric content of the meals was individually adjusted on a weekly basis so that weight was kept within a ± 4-pound range during the 5-month maintenance phase.
  • Sugar, saturated fat, and sodium were limited and kept relatively constant among the 3 diets.

120 participants made it through the 5-month maintenance phase.

 

Do Low-Carb Diets Help Maintain Weight Loss?

low carb diet maintain weight lossThe results were striking:

  • The low-carb group burned an additional 278 calories/day compared to the high-carb group and 131 calories/day more than the moderate-carbohydrate group.
  • These differences were even higher for those individuals with higher insulin secretion at the beginning of the maintenance phase of the study.
  • These differences lead the authors to hypothesize that low-carb diets might be more effective for weight maintenance than other diets.

 

What Are The Pros And Cons Of This Study?

low carb diet pros and consThis was a very well-done study. In fact, it is the most ambitious and well-controlled study of its kind. However, like any other clinical study, it has its limitations. It also needs to be repeated.

The pros of the study are obvious. It was a long study and the dietary intake of the participants was tightly controlled.

As for cons, here are the three limitations of the study listed by the authors:

#1: Potential Measurement Error: This section of the paper was a highly technical consideration of the method used to measure energy expenditure. Suffice it to say that the method they used to measure calories burned per day may overestimate calories burned in the low-carb group. That, of course, would invalidate the major findings of the study. It is unlikely, but it is why the study needs to be repeated using a different measure of energy expenditure.

#2: Compliance: Although the participants were provided with all their meals, there was no way of being sure they ate them. There was also no way of knowing whether they may have eaten other foods in addition to the food they were provided. Again, this is unlikely, but cannot be eliminated from consideration.

#3: Generalizability: This is simply an acknowledgement that the greatest strength of this study is also its greatest weakness. The authors acknowledged that their study was conducted in such a tightly controlled manner it is difficult to translate their findings to the real world. For example:

  • Sugar and saturated fat were restricted and were at very similar levels in all 3 diets. In the real world, people consuming a high-carb diet are likely to consume more sugar than people in the other diet groups. Similarly, people consuming the low-carb diet are likely to consume more saturated fat than people in the other diet groups.
  • Weight was kept constant in the weight maintenance phase by constantly adjusting caloric intake. Unfortunately, this seldom happens in the real world. Most people gain weight once they go off their diet – and this is just as true with low-carb diets as with other diets.
  • The participants had access to dietitian-designed prepared meals 3 times a day for 5 months. This almost never happens in the real world. The authors said “…these results [their data] must be reconciled with the long-term weight loss trials relying on nutrition education and behavioral counseling that find only a small advantage for low carbohydrate compared with low fat diets according to several recent meta-analyses.” [I would add that in the real world, people do not even have access to nutritional education and behavioral modification.]

 

low carb diet and youWhat Does This Study Mean For You?

  • This study shows that under very tightly controlled conditions (dietitian-prepared meals, sugar and saturated fat limited to healthy levels, calories continually adjusted so that weight remains constant) a low-carb diet burns more calories per day than a moderate-carb or high-carb diet. These findings show that it is theoretically possible to increase your metabolic weight and successfully maintain a healthy weight on a low-carb diet. These are the headlines you probably saw. However, a careful reading of the study provides a much more nuanced viewpoint. For example, the fact that the study conditions were so tightly controlled makes it difficult to translate these findings to the real world.
  • In fact, the authors of the study acknowledged that multiple clinical studies show this almost never happens in the real world. These studies show that most people regain the weight they have lost on low-carb diets. More importantly, the rate of weight regain is virtually identical on low-carb and low-fat diets. Consequently, the authors of the current study concluded “…translation [of their results to the real world] requires exploration in future mechanistic oriented research.” Simply put, the authors are saying that more research is needed to provide a mechanistic explanation for this discrepancy before one can make recommendations that are relevant to weight loss and weight maintenance in the real world.
  • The authors also discussed the results of their study in light of a recent, well-designed 12-month study (CD Gardener et al, JAMA, 319: 667-669, 2018 ) that showed no difference in weight change between a healthy low-fat versus a healthy low-carbohydrate diet. That study also reported that the results were unaffected by insulin secretion at baseline. The authors of the current study noted that “…[in the previous study] participants were instructed to minimize or eliminate refined grains and added sugars and maximize intake of vegetables. Probably for this reason, the reported glycemic load [effect of the diet on blood sugar levels] of the low-fat diet was very low…and similar to [the low-carb diet].” In short, the authors of the current study were acknowledging that diets which focus on healthy, plant-based carbohydrates and eliminate sugar, refined grains, and processed foods may be as effective as low-carb diets for helping maintain a healthy weight.
  • This would also be consistent with previous studies showing that primarily plant-based, low-carb diets are more effective at maintaining a healthy weight and better health outcomes long-term than the typical American version of the low-fat diet, which is high in sugar and refined grains. In contrast, meat-based, low-carb diets are no more effective than the American version of the low-fat diet at preventing weight gain and poor health outcomes. I have covered these studies in detail in my book “Slaying The Food Myths.”

Consequently, the lead author of the most recent study has said: “The findings [of this study] do not impugn whole fruits, beans and other unprocessed carbohydrates. Rather, the study suggests that reducing foods with added sugar, flour, and other refined carbohydrates could help people maintain weight loss….” This is something we all can agree on, but strangely this is not reflected in the headlines you may have seen in the media.

The Bottom Line

 

  • A recent study compared the calories burned per day on a low-carb, moderate-carb, and high-carb diet. The study concluded that the low-carb diet burned significantly more calories per day than the other two diets and might be suitable for long-term weight control. If confirmed by subsequent studies, this would be the first real evidence that low-carb diets are superior for maintaining a healthy weight.
  • However, the study has some major limitations. For example, it used a methodology that may overestimate the benefits of a low-carb diet, and it was performed under tightly controlled conditions that can never be duplicated in the real world. As acknowledged by the authors, this study is also contradicted by multiple previous studies. Further studies will be required to confirm the results of this study and show how it can be applied in the real world.
  • In addition, the kind of carbohydrate in the diet is every bit as important as the amount of carbohydrate. The authors acknowledge that the differences seen in their study apply mainly to carbohydrates from sugar, refined grains, and processed foods. They advocate diets with low glycemic load (small effects on blood sugar and insulin levels) and acknowledge this can also be achieved by incorporating low-glycemic load, plant-based carbohydrates into your diet. This is something we all can agree on, but strangely this is not reflected in the headlines you may have seen in the media.
  • Finally, clinical studies report averages, but none of us are average. When you examine the data from the current study, it is evident that some participants burned more calories per hour on the high-carb diet than other participants did on the low carb diet. That reinforces the observation that some people lose weight more effectively on low-carb diets while others lose weight more effectively on low-fat diets. If you are someone who does better on a low-carb diet, the best available evidence suggests you will have better long-term health outcomes on a primarily plant-based, low-carb diet such as the low-carb version of the Mediterranean diet.

For more details read the article above.

 

 

These statements have not been evaluated by the Food and Drug Administration. This information is not intended to diagnose, treat, cure or prevent any disease.

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