It’s a Jungle Out There

Author: Dr. Stephen Chaney

It’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.

It’s Buyer Beware in the Sports Supplement Market

Author: Dr. Stephen Chaney

For many athletes it’s all about being bigger, faster, stronger. That’s what makes the fat burning sports supplements so appealing. If you believe the ads, they will burn fat, increase muscle mass and give you an energy boost. But, are fat burning sports supplements safe? Are they effective?

What Are Fat Burning Sports Supplements?

Simply put, most of the fat burning sports supplements contain metabolic stimulants of some kind. That’s where the energy and fat burning claims come from. The stimulants range from clearly ineffective to downright dangerous.

Are Fat Burning Sports Supplements Effective?

Because sports supplements are considered to be foods rather than drugs, the FDA cannot require sport supplements manufacture to prove that their products are either safe or effective. As a consequence, most sports supplement manufacturers don’t conduct clinical trials to prove the effectiveness of their products. Their claims are based on animal studies and testimonials. However, in most cases there is no objective evidence that their supplements actually work.

Are Fat Burning Sports Supplements Safe?

All stimulants carry some risk. Even small amounts of caffeine can be problematic for some individuals, and many sports supplements contain massive amounts of caffeine. But, it is not caffeine containing sports products that are the most worrisome.

Many sports supplement manufacturers are firm believers in the “better living through chemistry” motto.

They start with an herbal ingredient that has stimulant properties
They synthesize what they think is the active ingredient
Perhaps they chemically modify it a bit….
..and, Voila! They have a proprietary new sports supplement
They label it a fat burner, prepare their claims and they’re ready to go to market

And, why bother testing it? Unless the product kills or seriously harms people, the FDA can’t step in and tell a manufacturer to take their product off the market.

And, if you think that the manufacturers and sellers of the product are looking after your best interests, think again.

Case Study #1: Jack3D and DMAA

I told you about this story last year, so I’ll just give you a brief recap here.

After a couple of marines died after using Jack3D prior to a workout, the US military ordered that the product not be sold on their bases. The manufacturer continued to make the product. GNC stopped selling it on military bases, but continued to sell it in all its other stores.
Eventually the FDA stepped in and recommended that Jack3D not be sold. The manufacturer claimed that the active ingredient, DMAA, was found in the geranium extract they used in their product. Since that was a food ingredient, they claimed the FDA did not have jurisdiction.
The FDA denied that claim based an extensive testing of geranium extract. At that point the manufacturer stopped making it (They have since resuming making the product with yet another poorly tested stimulant). GNC said they would stop selling Jack3D “as soon as their inventory was used up”.
The FDA finally had to raid the GNC warehouses to get the product off the market.

Case Study #2: OxyElite Pro and Aegeline

In case you thought that was an isolated case, the same sports supplement manufacturer has recently been involved in a second case that sounds all too familiar.

The FDA recently advised consumers to stop using OxyElite Pro after reports of 24 cases of acute non-viral hepatitis (a very rare disease) in users of that sports supplement in Hawaii. Two of those patients required liver transplants, and one of them died.
In this case the manufacturer stopped domestic distribution of the product, but argued that the product is safe. They claimed that counterfeit versions of OxyElite Pro were being sold in the US market.
On October 11, 2013 the FDA sent a warning letter to the manufacturer stating that the active ingredient, aegeline, was not a lawful dietary ingredient. The manufacturer replied that it was a natural constituent of the citrus fruit tree Bael. (I’m not sure why that makes it safe. I don’t know about you, but I don’t eat a lot of Bael fruit.)
As of a few days ago England, Denmark, Spain, Australia & New Zealand have warned consumers in those countries not to use OxyElite Pro.

It’s too early to tell how this story is going to turn out, but my money is with the FDA.

Case Study #3: Craze and DEPEA

And, in case you thought the problem was with a single rogue manufacturer, there is a developing story around yet another popular sports supplement, Craze, made by a different manufacturer.

Researchers from the NSF, Harvard and the National Institute for Public Health in the Netherlands recently published a paper claiming that Craze contained DEPEA, a methamphetamine-like compound.
The manufacturers claimed that the researchers did the chemical analysis incorrectly and their product actually contained a close analog of DEPEA that is found in dendrobium orchids. (Again I’m not sure why that makes it OK. I don’t think people eat a lot of dendrobium orchids either).

Stay tuned. I’m sure this story will have some interesting twists before it’s finished.

The Bottom Line:

1) In the sports nutrition industry, it is buyer beware. There are lots of rogue manufacturers out there who care more for their bottom line than your well being. Do your homework and search for reputable companies with a long track record of product quality and ethical standards. There are some out there.

2) Ignore the outlandish claims, no matter how appealing. Once again, stick with establishing companies with a track record of product integrity. Only use sports supplements that are backed by clinical studies showing that they are both safe and effective.

3) Be particularly cautious about sports supplements that claim to burn fat or give you energy. They generally contain metabolic stimulants, and often those stimulants are poorly characterized. Most have not been proven to be effective, and some have the potential to do more harm than good.

4) Fat burning supplements are often cross marketed as weight loss supplements. They are just as dangerous for dieters as they are for athletes.

5) Don’t assume that just because the ingredients supposedly come from a natural source (geraniums, Bael trees or dendrobium orchids, for example) they are safe.

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.