Are Food Supplements Safe?

Written by Dr. Steve Chaney on . Posted in current health articles, Health Current Events, Supplements and Health

Author: Dr. Stephen Chaney

 

are food supplements safeIf you saw the recent headlines proclaiming that dietary supplements were responsible for 23,000 emergency room visits and 2,100 hospitalizations every year, you are probably wondering are food supplements safe to use at all. The study behind these headlines (Geller et al, New England Journal of Medicine, 373: 1531-1540, 2015) was based on an extrapolation from 63 hospitals to every hospital in the United States.

Some experts consider this to be an overestimation since it is almost 8 times higher than the 3,200 cases/year in the official FDA’s Serious Adverse Event Reporting database. However, for the purposes of this article I will accept the 23,000 numbers.

Let me start by putting the 23,000 number into perspective.

  • It represents about 0.015% of the 150 million people in the US who use supplements.
  • It represents about 1% of the emergency room admissions caused by side effects of properly prescribed medications.

In short, the headlines are over-dramatizing the dangers of dietary supplements. Dietary supplements are actually quite safe. However, even one emergency room visit due to a dietary supplement is too many – especially if it were to happen to you or a loved one. Consequently, I will analyze the study in more detail so that I can show you how to recognize and avoid those few supplements that are truly dangerous.

Are Supplements Dangerous?

Here is a breakdown of the data:

  • 13% of the ER visits were due to allergic reactions. These were seldom serious enough to require hospitalization. This is also a type of problem that is probably unavoidable. Since many food supplements use natural ingredients, some degree of food allergies are to be expected.
  • 13% of the ER visits were due to swallowing problems, primarily in people over the age of 65. The preventative measure here is also pretty simple. If you or a loved one has difficulty swallowing, choose pills that are small and slick, chewable, powder or liquid supplements.
  • 20% of the ER visits were due to adverse effects caused by unsupervised ingestion of the supplements by children. The preventative measure here is pretty simple. Keep your supplements out of reach of small children – especially if they are chewable or have attractive colors. While the supplements may be perfectly safe when taken as recommended, the unsupervised ingestion of a whole bottle of almost any supplement by a small child is problematic.
  • 41% of the ER visits were due to weight loss products (25.5%), energy products (10%), sexual enhancement products (3.4%) and bodybuilding products (2.2%). The most common adverse effect for these products were heart palpitations, chest pain, and irregular heartbeat. These are the kinds of supplements you really need to be most careful about.

Why Are Dangerous Supplements Even On The Market?

are supplements dangerousLet’s start with the obvious question: Why are weight loss, energy, sexual enhancement and bodybuilding products the ones most likely to be dangerous? To quote Pogo (now I’m really dating myself): “We have met the enemy, and he is us”

  • Weight Loss Products: We can listen all day long to experts tell us that we need to make lifestyle changes, and we should aim for no more than one or two pounds of weight loss per week. However, for most of us that advice goes in one ear and out the other. We want to lose weight fast, and we want it to be easy.
  • Energy Products: Many of us are just plain exhausted because our diets are terrible; we are under stress; and we are burning the candle at both ends. We don’t want to eat better and change our lifestyle. We want high octane energy, and we want it now.
  • Body Building Products: The story is similar, especially for males in the 20-34 age range. We want big muscles, and we don’t want to wait for the years of workouts it will take to build that kind of physique naturally. We want it now.
  • Sexual Enhancement Products: ER admissions for sexual enhancement products were 100% male. What does that say about us guys? I won’t even go there.

Most supplement manufacturers are ethical and don’t make supplements that could harm us. However, there are a few unscrupulous sports supplements companies that misleadmanufacturers who are only too happy to exploit our human weaknesses if they can make a buck in the process. They will give us exactly what we want, even if it kills us in the process.

I’ve warned about these unscrupulous manufacturers in the past. The easiest way to create products that will burn off weight effortlessly, build muscle rapidly, and give you energy are to add chemically synthesized stimulants in the amphetamine family. For example, I’ve warned you about products containing stimulants such as DMAA and  DEPEA  in Are Dietary Supplements Safe and BMPEA in Are Sports Supplements Safe. They all work, but they also cause heart palpitations, chest pain, and irregular heartbeat. They can land you in the emergency room, and sometimes they can kill you.

In addition to stimulants, some weight loss products use diuretics, and some energy products use dangerous levels of caffeine, both of which can cause problems. Sexual enhancement products often use herbal ingredients like yohimbe bark that can be quite dangerous

Don’t Count On The FDA To Protect You

Unfortunately, you can’t count on the FDA to protect you. For example, in the case of the DMAA scandal, the FDA did not act until the day before a big expose was to air on 60 Minutes about the deaths caused by DMAA. They were shamed into taking strong action and removing DMAA from the shelves of retailers.

Case closed, you might think, but the truth is a bit scarier. That action was back in 2013. Since then, the FDA has ignored DMAA-containing products. The Human Performance Resource Center, an initiative of the Department of Defense, recently listed 39 products containing DMAA  that are readily available, either online or from retail stores. Even though the FDA has classified DMAA as an illegal ingredient, it is still readily available, and they don’t act.

This is just one of many examples I could cite. It’s not clear whether the FDA is unwilling to protect us, or if it is overwhelmed. However, it is clear that if we want to avoid dangerous supplements, it is up to us.

How Can You Protect Yourself From Dangerous Supplements?

protect yourself against dangerous supplementsIf the FDA isn’t going to protect you, what can you do to protect yourself from dangerous supplements? There are threesimple things that you can do to protect yourself;

#1: Use common sense.

  • Don’t even consider those weight loss supplements that promise you’ll lose 5-10 pounds/week, or that they will make the fat melt away effortlessly.
  • Walk away from those bodybuilding supplements that promise to make your muscles “explode” or give you “insane energy”.
  • Put those energy supplements that promise a jolt of energy back on the shelf.
  • As for sexual enhancement products, consult your doctor before you reach for a magic pill. Your problems in the bedroom may be caused by a treatable medical condition.

#2: Make the Commitment. A holistic lifestyle change that includes weight control, exercise, diet and supplementation may be more work, but it is so much safer and more beneficial in the long run.

#3: Choose wisely. Look for a supplement company with integrity.

  • A company that is committed to only making products that are both safe and effective.
  • A company that does clinical studies to make sure their products are safe and effective and publishes those studies in peer-reviewed scientific journals.

Are food supplements safe?

The Bottom Line

  • A recent study reported that 23,000 emergency visits and 2,100 hospital admissions each year were caused by dietary supplements. Some experts consider this to be an overestimate. It is an extrapolation from 63 hospitals to every hospital in the United States, and it is approximately 8-fold higher than the FDAs Adverse Events database.
  • While the headlines sound scary, when you put the data into perspective it is clear that dietary supplements are actually quite safe. Even if we accept the 23,000 ER visits/year as accurate, this represents:
  • 015% of the supplement users in the US.
  • Approximately 1% of the annual ER admissions due to side effects of properly prescribed medications.
  • The main value of this study is that it allows us to identify what the dangers are and what strategies can help us avoid those dangers.
  • 13% of the ER visits were due to allergic reactions. This is probably unavoidable. Since many food supplements use natural ingredients, some degree of food allergies are to be expected.
  • 13% of the ER visits were due to swallowing problems, primarily in people over the age of 65. If you or a loved one has difficulty swallowing, the solution is pretty simple. Choose pills that are small and slick, chewable, powder or liquid supplements.
  • 20% of the ER visits were due to adverse effects caused by unsupervised ingestion of the supplements by children. The preventative measure here is also pretty simple. Keep your supplements out of reach of small children.
  • 41% of the ER visits were due to weight loss products (25.5%), energy products (10%), sexual enhancement products (3.4%) and bodybuilding products (2.2%). These are the kinds of supplements you really need to be most careful about. Some supplements in this category are truly dangerous.
  • If we ask why these dangerous supplements exist, the answers are pretty simple.
  • Many Americans are looking for quick and easy solutions. They want a magic pill or powder.
  • A few unscrupulous supplement companies are only too happy to give them exactly what they want, even if it kills them in the process.
  • Unfortunately, the FDA is not doing a good enough job of protecting us from the truly dangerous supplements on the market, so we need to protect ourselves.
  • To protect ourselves from the dangerous supplements on the market we need to take 3 simple steps:
  • Use common sense. Don’t fall for the advertising hype promising quick and easy solutions.
  • Commit to true lifestyle change. Adopt a holistic lifestyle that includes weight control, diet, exercise, and supplementation.
  • Choose your supplement manufacturer wisely. Choose one with integrity – one that is committed to making supplements that are both safe and effective.

 

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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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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