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

Should We Use Supplements For Cardiovascular Health?

Posted July 10, 2018 by Dr. Steve Chaney

Are You Just Wasting Your Money On Supplements?

Author: Dr. Stephen Chaney

 

supplements for cardiovascular health wast moneyYou’ve seen the headlines. “Recent Study Finds Vitamin and Mineral Supplements Don’t Lower Heart Disease Risk.”  You are being told that supplements are of no benefit to you. They are a waste of money. You should follow a healthy diet instead. Is all of this true?

If I were like most bloggers, I would give you a simple yes or no answer that would be only partially correct. Instead, I am going to put the study behind these headlines into perspective. I am going to give you a deeper understanding of supplementation, so you can make better choices for your health.

 Should we use supplements for cardiovascular health?

In today’s article I will give you a brief overview of the subject. Here are the topics I will cover today:

  • Is this fake news?
  • Did the study ask the right questions?
  • Is this a question of “Garbage In – Garbage Out?
  • Reducing Heart Disease Risk. What you need to know.

All these topics are covered in much more detail (with references) in my book “Slaying The Supplement Myths”, which will be published this fall.

 

How Was This Study Done?

supplements for cardiovascular healthThis study (D.J.A. Jenkins et al, Journal of the American College Of Cardiology, 71: 2540-2584, 2018 ) was a meta-analysis. Simply put, that means the authors combined the results of many previous studies into a single database to increase the statistical power of their conclusions. This study included 127 randomized control trials published between 2012 and December 2017. These were all studies that included supplementation and looked at cardiovascular end points, cancer end points or overall mortality.

Before looking at the results, it is instructive to look at the strengths and weaknesses of the study. Rather than giving you my interpretation, let me summarize what the authors said about strengths and weaknesses of their own study.

The strengths are obvious. Randomized control trials are considered the gold standard of evidence-based medicine, but they have their weaknesses. Here is what the authors said about the limitations of their study:

  • “Randomized control trials are of shorter duration, whereas longer duration studies might be required to fully capture chronic disease risk.”
  • “Dose-response data were not usually available [from the randomized control studies included in their analysis]. However, larger studies would allow the effect of dose to be assessed.”

There are some other limitations of this study, which I will point out below.

Is This Fake News?

supplements for cardiovascular health fake newsWhen I talk about “fake news” I am referring to the headlines, not to the study behind the headlines. The headlines were definitive: “Vitamin and Mineral Supplements Don’t Lower Heart Disease Risk.” However, when you read the study the reality is quite different:

  • In contrast to the negative headlines, the study reported:
    • Folic acid supplementation decreased stroke risk by 20% and overall heart disease risk by 17%.
    • B complex supplements containing folic acid, B6, and B12 decreased stroke risk by 10%.
    • That’s a big deal, but somehow the headlines forgot to mention it.
  • The supplements that had no significant effect on heart disease risk (multivitamins, vitamin D, calcium, and vitamin C) were ones that would not be expected to lower heart disease risk. There was little evidence from previous studies of decreased risk. Furthermore, there is no plausible mechanism for supposing they might decrease heart disease risk.
  • The study did not include vitamin E or omega-3 supplements, which are the ones most likely to prove effective in decreasing heart disease risk when the studies are done properly (see below).

Did The Study Ask The Right Question?

Most of the studies included in this meta-analysis were asking whether a supplement decreased heart disease risk or mortality for everyone. Simply put, the studies started with a group of generally healthy Americans and asked whether supplementation had a significant effect on disease risk for everyone in that population.

That is the wrong question. We should not expect supplementation to benefit everyone equally. Instead, we should be asking who is most likely to benefit from supplementation and design our clinical studies to test whether those people benefit from supplementation.

supplements for cardiovascular health diagramI have created the graphic on the right as a guide to help answer the question of “Who is most likely to benefit from supplementation?”. Let me summarize each of the points using folic acid as the example.

 

Poor Diet: It only makes sense that those people who are deficient in folate from foods are the most likely to benefit from folic acid supplementation. Think about it for a minute. Would you really expect people who are already getting plenty of folate from their diet to obtain additional benefits from folic acid supplementation?

The NIH estimates that around 20% of US women of childbearing age are deficient in folic acid. For other segments of our population, dietary folate insufficiency ranges from 5-10%. Yet, most studies of folic acid supplementation lump everyone together – even though 80-95% of the US population is already getting enough folate through foods, food fortification, and supplementation. It is no wonder most studies fail to find a beneficial effect of folic acid supplementation.

The authors of the meta-analysis I discussed above said that the beneficial effects of folic acid they saw might have been influenced by a very large Chinese study, because a much higher percentage of Chinese are deficient in folic acid. They went on to say that the Chinese study needed to be repeated in this country.

In fact, the US study has already been done. A large study called “The Heart Outcomes Prevention Evaluation (HOPE)” study reported that folic acid supplementation did not reduce heart disease risk in the whole population. However, when the study focused on the subgroup of subjects who were folate-deficient at the beginning of the study, folic acid supplementation significantly decreased their risk of heart attack and cardiovascular death.  This would seem to suggest using supplements for cardiovascular health is a good idea.

Increased Need: There are many factors that increase the need for certain nutrients. However, for the sake of simplicity, let’s only focus on medications. Medications that interfere with folic acid metabolism include anticonvulsants, metformin (used to treat diabetes), methotrexate and sulfasalazine (used to treat severe inflammation), birth control pills, and some diuretics. Use of these medications is not a concern when the diet is adequate. However, when you combine medication use with a folate-deficient diet, health risks are increased and supplementation with folic acid is more likely to be beneficial.

Genetic Predisposition: The best known genetic defect affecting folic acid metabolism is MTHFR. MTHFR deficiency does not mean you have a specific need for methylfolate. However, it does increase your need for folic acid. Again, this is not a concern when the diet is adequate. However, when you combine MTHFR deficiency with a folate-deficient diet, health risks are increased and supplementation with folic acid is more likely to be beneficial. I cover this topic in great detail in my upcoming book, “Slaying The Supplement Myths”. In the meantime, you might wish to view my video, “The Truth About Methyl Folate.”

Diseases: An underlying disease or predisposition to disease often increases the need for one or more nutrients that help reduce disease risk. The best examples of this are two major studies on the effect of vitamin E on heart disease risk in women. Both studies found no effect of vitamin E on heart disease risk in the whole population. However, one study reported that vitamin E reduced heart disease risk in the subgroup of women who were post-menopausal (when the risk of heart disease skyrockets). The other study found that vitamin E reduced heart attack risk in the subgroup of women who had pre-existing heart disease at the beginning of the study.

Finally, if you look at the diagram closely, you will notice a red circle in the middle. When two or three of these factors overlap, that is the “sweet spot” where supplementation is almost certain to make a difference and it may be a good idea to use supplements for cardiovascular health.

Is This A Question Of “Garbage In, Garbage Out”?

supplements for cardiovascular health garbage in outUnfortunately, most clinical studies focus on the “Does everyone benefit from supplementation question?” rather than the “Who benefits from supplementation?” question.

In addition, most clinical studies of supplementation are based on the drug model. They are studying supplementation with a single vitamin or mineral, as if it were a drug. That’s unfortunate, because vitamins and minerals work together synergistically. What we need are more studies of holistic supplementation approaches.

Until these two things change, most supplement studies are doomed to failure. They are doomed to give negative results. In addition, meta-analyses based on these faulty supplement studies will fall victim to what computer programmers refer to as “Garbage In, Garbage Out”. If the data going into the analysis is faulty, the data coming out of the study will be equally faulty. It won’t be worth the paper it is written on. If you are looking for personal guidance on supplementation, this study falls into that category.

 

Should We Use Supplements For Cardiovascular Health?

 

If you want to know whether supplements decrease heart disease risk for everyone, this meta-analysis is clear. Folic acid may decrease the risk of stroke and heart disease. A B complex supplement may decrease the risk of stroke. All the other supplements they included in their analysis did not decrease heart disease risk, but the analysis did not include vitamin E and/or omega-3s.

However, if you want to know whether supplements decrease heart disease risk for you, this study provides no guidance. It did not ask the right questions.

I would be remiss, however, if I failed to point out that we know healthy diets can decrease heart disease risk. In the words of the authors: “The recent science-based report of the U.S. Dietary Guidelines Advisory Committee, also concerned with [heart disease] risk reduction, recommended 3 dietary patterns: 1) a healthy American diet low in saturated fat, trans fat, and meat, but high in fruits and vegetables; 2) a Mediterranean diet; and 3) a vegetarian diet. These diets, with their accompanying recommendations, continue the move towards more plant-based diets…” I cover the effect of diet on heart disease risk in detail in my book, “Slaying The Food Myths”.

 

The Bottom Line

 

You have probably seen the recent headlines proclaiming: “Vitamin and Mineral Supplements Don’t Lower Heart Disease Risk.” The study behind the headlines was a meta-analysis of 127 randomized control trials looking at the effect of supplementation on heart disease risk and mortality.

  • The headlines qualify as “fake news” because:
    • The study found that folic acid decreased stroke and heart disease risk, and B vitamins decreased stroke risk. Somehow the headlines forgot to mention that.
    • The study found that multivitamins, vitamin D, calcium, and vitamin C had no effect on heart disease risk. These are nutrients that were unlikely to decrease heart disease risk to begin with.
    • The study did not include vitamin E and omega-3s. These are nutrients that are likely to decrease heart disease risk when the studies are done properly.
  • The authors of the study stated that a major weakness of their study was that that randomized control studies included in their analysis were short term, whereas longer duration studies might be required to fully capture chronic disease risk.
  • The study behind the headlines is of little use for you as an individual because it asked the wrong question.
  • Most clinical studies focus on the “Does everyone benefit from supplementation question?” That is the wrong question. Instead we need more clinical studies focused on the “Who benefits from supplementation?” question. I discuss that question in more detail in the article above.
  • In addition, most clinical studies of supplementation are based on the drug model. They are studying supplementation with a single vitamin or mineral, as if it were a drug. That’s unfortunate, because vitamins and minerals work together synergistically. What we need are more studies of holistic supplementation approaches.
  • Until these two things change, most supplement studies are doomed to failure. They are doomed to give negative results. In addition, meta-analyses based on these faulty supplement studies will fall victim to what computer programmers refer to as “Garbage In, Garbage Out”. If the data going into the analysis is faulty, the data coming out of the study will be equally faulty. It won’t be worth the paper it is written on. If you are looking for personal guidance on supplementation, this study falls into that category.
  • If you want to know whether supplements decrease heart disease risk for everyone, this study is clear. Folic acid may decrease the risk of stroke and heart disease. A B-complex supplement may decrease the risk of stroke. All the other supplements they included in their analysis did not decrease heart disease risk, but they did not include vitamin E and/or omega-3s in their analysis.
  • If you want to know whether supplements decrease heart disease risk for you, this study provides no guidance. It did not ask the right questions.
  • However, we do know that healthy, plant-based diets can decrease heart disease risk. I cover heart healthy diets in detail in my book, “Slaying The Food Myths.”

 

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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