Research Paper- Brett Lang

The Killer Supplement

Dietary supplements kill, and you may not even know how, or be warned that the product is doing so too. People go on large diets, workout for hours, and take different supplements to get a better looking body that they prefer, and feel looks good to them. imagine a person walks into GNC looking for something to help them get thinner and lose weight. They see tons of dietary supplements that say, Huge weight loss, best weight loss supplement out there, lose weight in eight weeks on our product, and etcetera. They all sound completely wonderful and just what they need, but with further research the person finds these “amazing” supplements actually cause terrible health issues such as high blood pressure, heart attacks, seizures, death, and more. This gets them to wondering how these products get out on the market like that and causes them to ponder, what is a dietary supplement?

A dietary supplement is an herbal based product made to help one with a healthy benefit, which is followed along by a bunch of loose and seemingly dangerous regulations that causes it to be a danger to the user, but Congress defines it a little differently. According to Congress under the Dietary Supplement Health and Education Act, it says a dietary supplement is “a product (other than tobacco) that is intended to supplement the diet;contains one or more of each dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and is labeled on the front panel as being a dietary supplement,”(“Dietary Supplements”). Now according to all these rules set by the Dietary Supplement Health and Education Act, this is what you need to create a dietary supplement. The question that comes up now is how does an Ephedra based product, Ephedra being banned by the FDA for use because of its highly catastrophic side effects and cause of death, such as Metabolife356 meet these requirements?

Metabolife 356 was a very popular Ephedra based product. The ingredients of the product is as follows: Vitamin E (as di-alpha tocopheryl acetate) (6 i.u.), Magnesium (as Magnesium Chelate) (75 mg), Zinc (as Zinc Chelate) (5 mg), Chromium (as Chromium Piccolinate) (75 mcg), and a proprietary blend (728 mg total) of the following: Guarana (seed), Ephedra (Ma Huang) extract (ephedrine group alkaloids) (aerial part), Bee Pollen, Eleuthero (Siberian Ginseng) (root), Ginger (root), Lecithin, Bovine Complex, Damiana (leaf), Sarsaparilla (root), Goldenseal (aerial part), Nettle (leaf), Gotu Kola (aerial part), Spirulina, Royal Jelly. Other ingredients: Citric acid, glycine, caffeine, croscarmellose sodium, protein hydrolysate, silica, modified cellulose, magnesium stearate, dextrin, dextrose, sodium carboxymethylcellulose, sodium citrate, ascorbic acid (“Browsing Store″). Now all these ingredients are great, but what is the classification importance of some and which are just fillers and blends of components. Taking a look at each important requirement lets see how Metabolife 356 follows the Dietary Supplement Health and Education Act. Was it even a supplement, or just some hazard that fell through the cracks.

A dietary supplement is intended to supplement the diet, and this product claims to do exactly that and help with weight loss. Having vitamins in a dietary supplement is essential and we know it has at least one with Vitamin E. Along with Vitamins, minerals are just as important to be included in the product, which the Metabolife has with zinc being included in its ingredients. The main banned component of the Metabolife 356 completes the criteria for a herb or botanical component. Ephedra being a herb coming from the plant also named Ephedra is what makes this requirement met(“What is Ephedrine?”). The plant is a shrub located in desert region areas such as Asia, which they extract and create into the Ephedra component found in the Metabolife356(“What is Ephedrine?”). After that you must have an amino acid component in the mix of a dietary supplement. One of the amino acid compounds found in this product is glycine which completes the requirement of at least one amino acid being included in the dietary supplement. Based on the qualifications for ingredients the Metabolife 356 has met all the needed requirements set. When looking at the website on the product it clearly states to take the product dosage and calls the product “caplets,” which checks off another restriction on what dietary supplements must be taken as (“Browsing Store″). The product is also clearly labeled as a dietary supplement too. It was definitely a dietary supplement, but also a terrible hazard as well.

When looking over the Metabolife product, the first solution you come upon is to eliminate the Ephedra herb, so that you don’t have the terrible side effects. Add a different herb what’s the big deal with this one if it kills? The thing is it also gives everything the user wants when they buy the product. They want the loss of weight and they want it fast. That’s exactly what the Ephedra does. It highly stimulants your body and gets you going and helps burn off the fat much faster, along with giving you a huge dose of energy to use to help burn off the fat. Mixing it with the Caffeine component in the Metabolife 356 causes an even higher boost of energy along with a very dangerous health risk to the user. The combination gives too much high stimulation on your body and heart. Ephedra gives all the benefits that the user bought the product for, while killing them internally at the same time. Without the ephedra the Metabolife 356 is nothing. The ephedra makes and breaks the product into what it is, but it’s the regulations and loose qualifications that really created the dangers in this product to be out there.

It was easily shown how this dangerous life risking product became an easy to buy supplement on the shelf for anyone to purchase. This is caused by the terrible qualifications of a dietary supplement. The rules are quite easy to follow and there are no restrictions to the ingredients you can add. Where is the part that says you can’t have people’s hands as part of the ingredients in your product, or any dangerous component. Besides the Ephedra that was recently banned, I don’t see any where it says what you can’t put into a dietary supplement. There are no rules for testing for safety before the product is put on the market, or providing evidence that it does what it states. It just says it needs to do what the label says, but the manufacturer doesn’t have to show prove. That’s very contradicting because how does the user knows it does what it says without evidence? Easy answer, they don’t and they never will until it is tested. The testing for safety is done after sale, and complaints of the product. It can cause large complications and possible dangers to the user. The possibilities for the dietary supplement to cause any number of outcomes harmful or helpful is endless. they have no real tight rules or restrictions. Once you meet the very basic ingredients and claims you can do whatever to the product and sell millions of the supplement before it’s even questioned what is in the product and how safe it is? It’s a very open-ended topic with such a broad way to go with the product, that the manufacturers have gone with the leash they’ve been given so far that it’s not really certain if the FDA has any control, sight, or idea that they could pull back on the dietary supplement industry and it even be there or stopped.

The  Metabolife356 product was so easily checked out to definitely be a dietary supplement in every way and form, from ingredients, to labeling, and claims. It puts a real question mark to the regulations and requirements that are set up on supplements as to how they are manufactured, regulated, and determined a good dietary supplement. If people could easily have made products such as the Metabolife 356 with the Ephedra component being included, that had caused death to some users, then why wouldn’t someone be able to put a worse and more dangerous herb or other component in the mix. The classifications of a dietary supplement is very weak and set around many rules with loop holes in them. A dietary supplement may be what it is as the Dietary Supplement Health and Education Act defines it as, which the Ephedra product Metabolife 356 meets, but A dietary supplement is also a very poorly regulated, quite frightening, and dangerous health risk to any user that does not know what they are really paying for in the end.

This misconception that the dietary supplements aren’t that bad and the only reason people have terrible side effects is wrong usage is a very blinded view on the subject. someone looking at a substance that is a large risk factor and killer and thinking there shouldn’t be some change in the product, or the way it is handled is ridiculous.Regulation and construction of the Ephedra product has to be addressed. Some people may feel that there is no reason to waste time and money on supplement regulation, but the risk of losing one’s life seems to be a very important thing to consider when dealing with anything, let alone a dietary supplement.

The main point in the argument against improving regulation of the dietary supplements will be that the better regulation, safety precautions, and change in rules will not stop all dangerous supplements from being put on sale. That is true and I agree highly with that. There are plenty of drugs out there that have slipped through FDA regulation and been put on sale, but turned out to be very dangerous to people’s health. For example the drug Darvocet was recently banned by the FDA for causing bad heart side effects (“Pharmaceutical Industry”). Drugs just like this happen to sneak by the regulations, but the regulations have also stopped tons of terrible drugs from being put out on the shelves to be sold too. Just because better regulations won’t stop all of the terrible supplements from being sold on the market doesn’t mean they shouldn’t be fixed and tightened up. It’s like saying well people still rob banks, so lets stop having laws against it and security precautions to stop it. The security and laws clearly stop the acts from happening more frequently and lessen the number of robberies. If you tighten the regulations up on the supplements, and make the safety testing be done before and after sale, the chances that harmful supplements will be on the market will clearly become fewer in number.

The tight regulations and safety precautions would help the supplement manufactures find more issues with their product, and could cause them to be less deceitful in their claims, and ingredient information. If there are more regulations that ask for proof of safety testing before being sold, then it would create a more honest producer. If the manufacturers can’t get their product out on sale until it is proven safe with clear evidence, then they are more likely to make sure of the safety in their product, and create a better product for the user and a more honest supplier in the manufacturers. As of now they can sell a product as long as they say it does what they say their product does. They don’t have to worry about what happens to the user later because they could sell millions of their supplement before testing shows its risks, but when they must have proof of safety before sale this changes things completely. If the manufacturers are losing out on making money they will make sure their product is on the up and up with regulations. Everything changes when people’s wallets are threatened.

The combination of caffeine with the Ephedra is what causes such excessive dangers to occur to the user, not just the stimulant. This is a very misconstrued thought by some people believing the problem is not the plant being used, but the other combination of ingredients inside the product. These kind of people will feel like Metabolife 356 is dangerous because of the mixture in the caffeine, but the use of just the Ephedra in itself is safe for them. The combination of the caffeine may make the supplement more dangerous, but the key point in that is it will make it “more” dangerous. The Ephedra has been tested and proved to be a high stimulant that causes the heart to race quickly. It affects the central nervous system along with causing the heart to race because of the very lethal stimulants in Ephedra (“What is Ephedrine?”). The combination may cause a more severe effect on the user, but the mixture is not the start of the problem. The Ephedra is just a high amphetamine like stimulant that alone causes the damage to the body and heart, and is increased when the caffeine is added.

The main basis of the disagreement with the change of the regulations and dangers of such Ephedra based supplements as Metabolife 356 is quite weak. The regulatory system becoming tightly ran would create a more careful examination of supplements, and a safer way of controlling dangerous substances to be sold. It also creates a more honest and loyal manufacturer that must now follow the rules before selling his product, which hurts his profit, making him more likely to make sure his product is safe, so it will be allowed to be sold. The combination of caffeine and Ephedra does create a very dangerous concoction and increases the risk to the supplement causing damage to the heart, but it does not create this problem(“Ingredients — Ephedrine”). That is made up in the Ephedra itself with its high stimulant ingredients that just alone has been proven dangerous to someone. The tighter regulations and safety precautions that could be set up for dietary supplements may not stop all the dangerous substances that try to get sold, but as long as it catches at least one, isn’t that better than letting them be unregulated safely to prey upon uninformed users looking for a little weight loss? These regulation issues can be helped with tighter rules such as ones that drugs follow.

The FDA regulates drugs a lot and puts very specific rules and regulations on them that you don’t see on dietary supplements. They may not catch all of the problematic drugs trying to be put on the market, but they sure do catch a whole lot more than they would if they just sat there and let everything be put on the market before being checked out. “  In order to satisfy safety and benefit considerations of the FDA, pharmaceutical companies conduct on average ten to fifteen years of research on a new medication. Approval of a new drug is a rigorous process and for every 5,000 to 10,000 compounds tested, only one receives FDA approval and becomes a new or improved treatment. The entire U.S. pharmaceutical industry spent an estimated $51.3 billion on research and development in 2005″ (“Pharmaceutical Industry”). this quote gives a clear explanation as to why dietary supplements need tighter regulation. Drug companies have such a hard time passing their products that they spend ten to fifteen years on research, and for all the ones that are tested only one gets approved. If dietary supplements had to follow this kind of regulation there would be a whole lot less dangerous supplements out there. If you don’t have to pass tests before sale then you are going to get your product out there as quick as possible and test safety later. That’s what the supplement industry does, and to be honest I would to if I thought I had a good product and could make millions right away. Who wouldn’t?

A certain type of Ephedra is the main problem with the drug being so dangerous anyway. The Ma Huang form of the Ephedra causes the severe problems and is the main type banned by the FDA(“Is Ephedra Legal”). In this case the actual Ephedra drug is not as harmful as talked about. It has a bad rap as a whole because of the one type produced out there. If the benefit of Ephedra could be harnessed and used as good, not in the Ma Huang form, it could be a very beneficial product to be used. The FDA may not just want to look into better safety measures and regulations, but research and development too of the supplements. They may need to study more on them in not just safety, but more into the herbal ingredients that they allow to be put in so easily. It all comes down to better regulating and studying into the industry. They act like it’s the red-headed step child of the family the way they regulate it.

A dietary supplement is just too dangerous of a product to not have these tighter regulations on it as drugs do. If drugs and supplements can both cause severe health risks and death, then shouldn’t both have to follow strict rules of safety to be passed before sale? Of course they should, and shown above the rules and safety testing after supplements have been put on sale is too risky. Dietary supplements are just ticking time bombs ready to explode unless we get a better grip on their regulation and production. The effects of putting out the time and work to regulate these products better greatly out weigh the risk of users losing their lives. The Metabolife 356 easily met the standards set today for dietary supplements and just as easily killed while out on the market. There is no argument against this tighter regulation and better safety protocol. Drugs have been greatly affected by tight rules, and even though it doesn’t catch all of the bad ones it stops most of them. That’s all the supplements need is something trying to stop bad products before sale to make it a safer industry. Before this industry goes out of control and every product is out there hurting the user, the FDA must nip this in the bud and make it more of the industry it’s suppose to be. Dietary supplements are a healthy benefit industry, not a healthy death industry as their regulation leaves them to become today.

Work Cited 

“Browsing Store.” Netnutri.com. Netnutri, 2009. Web. 16 Apr. 2012.

“Dietary Supplements.” Background Information: — Health Professional Fact Sheet. National Institutes of Health, 24 June 2011. Web. 16 Apr. 2012.

“Ingredients — Ephedrine.” Ingredients. Web. 16 Apr. 2012.

“Is Ephedra Legal?” Ephedra Diet Pills, Ephedra Weight Loss Products, Buy Ephedrine! Web. 16 Apr. 2012.

“Pharmaceutical Industry.” International Encyclopedia of the Social Sciences. 2008. Retrieved April 16, 2012 from Encyclopedia.com:

“What Is Ephedrine?” Ephedrine (Ephedra) Legal Advice: Speak to Lawyers Handling Injuries Associated Ephedra. Web. 16 Apr. 2012.

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1 Response to Research Paper- Brett Lang

  1. davidbdale says:

    Successive versions have gotten better, but still significant language problems and too much repetition. The bold section is a good example.
    Solid ideas.

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