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

High Protein Diets and Weight Loss

Posted October 16, 2018 by Dr. Steve Chaney

Do High Protein Diets Reduce Fat And Preserve Muscle?

Author: Dr. Stephen Chaney

Healthy Diet food group, proteins, include meat (chicken or turkAre high protein diets your secret to healthy weight loss? There are lots of diets out there – high fat, low fat, Paleolithic, blood type, exotic juices, magic pills and potions. But recently, high protein diets are getting a lot of press. The word is that they preserve muscle mass and preferentially decrease fat mass.

If high protein diets actually did that, it would be huge because:

  • It’s the fat – not the pounds – that causes most of the health problems.
  • Muscle burns more calories than fat, so preserving muscle mass helps keep your metabolic rate high without dangerous herbs or stimulants – and keeping your metabolic rate high helps prevent both the plateau and yo-yo (weight regain) characteristic of so many diets.
  • When you lose fat and retain muscle you are reshaping your body – and that’s why most people are dieting to begin with.

So let’s look more carefully at the recent study that has been generating all the headlines (Pasiakos et al, The FASEB Journal, 27: 3837-3847, 2013).

The Study Design:

This was a randomized control study with 39 young (21), healthy and fit men and women who were only borderline overweight (BMI = 25). These volunteers were put on a 21 day weight loss program in which calories were reduced by 30% and exercise was increased by 10%. They were divided into 3 groups:

  • One group was assigned a diet containing the RDA for protein (about 14% of calories in this study design).
  • The second group’s diet contained 2X the RDA for protein (28% of calories)
  • The third group’s diet contained 3X the RDA for protein (42% of calories)

In the RDA protein group carbohydrate was 56% of calories, and fat was 30% of calories. In the other two groups the carbohydrate and fat content of the diets was decreased proportionally.

Feet_On_ScaleWhat Did The Study Show?

  • Weight loss (7 pounds in 21 days) was the same on all 3 diets.
  • The high protein (28% and 42%) diets caused almost 2X more fat loss (5 pounds versus 2.8 pounds) than the diet supplying the RDA amount of protein.
  • The high protein (28% and 42%) diets caused 2X less muscle loss (2.1 pounds versus 4.2 pounds) than the diet supplying the RDA amount of protein.
  • In case you didn’t notice, there was no difference in overall results between the 28% (2X the RDA) and 42% (3X the RDA) diets.

Pros And Cons Of The Study:

  • The con is fairly obvious. The participants in this study were all young, healthy and were not seriously overweight. If this were the only study of this type one might seriously question whether the results were applicable to middle aged, overweight coach potatoes. However, there have been several other studies with older, more overweight volunteers that have come to the same conclusion – namely that high protein diets preserve muscle mass and enhance fat loss.
  • The value of this study is that it defines for the first time the upper limit for how much protein is required to preserve muscle mass in a weight loss regimen. 28% of calories is sufficient, and there appear to be no benefit from increasing protein further. I would add the caveat that there are studies suggesting that protein requirements for preserving muscle mass may be greater in adults 50 and older.

The Bottom Line:

1)    Forget the high fat diets, low fat diets, pills and potions. High protein diets (~2X the RDA or 28% of calories) do appear to be the safest, most effective way to preserve muscle mass and enhance fat loss in a weight loss regimen.

2)     That’s not a lot of protein, by the way. The average American consumes almost 2X the RDA for protein on a daily basis. However, it is significantly more protein than the average American consumes when they are trying to lose weight. Salads and carrot sticks are great diet foods, but they don’t contain much protein.

3)     Higher protein intake does not appear to offer any additional benefit – at least in young adults.

4)     Not all high protein diets are created equal. What some people call high protein diets are laden with saturated fats or devoid of carbohydrate. The diet in this study, which is what I recommend, had 43% healthy carbohydrates and 30% healthy fats.

5)    These diets were designed to give 7 pounds of weight loss in 21 days – which is what the experts recommend. There are diets out there promising faster weight loss but they severely restrict calories and/or rely heavily on stimulants, they do not preserve muscle mass, and they often are not safe. In addition they are usually temporary.  I do not recommend them.

6)    This level of protein intake is safe for almost everyone. The major exception would be people with kidney disease, who should always check with their doctor before increasing protein intake. The only other caveat is that protein metabolism creates a lot of nitrogenous waste, so you should drink plenty of water to flush that waste out of your system. But, water is always a good idea.

7)     The high protein diets minimized, but did not completely prevent, muscle loss. Other studies suggest that adding the amino acid leucine to a high protein diet can give 100% retention of muscle mass in a weight loss regimen – but that’s another story for another day.

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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