White Paper-Brett Lang

Topic Background: Dietary supplements are created and made to help better the users health in either muscle growth, weight loss, and many other different ways to better their health. The FDA doesn’t classify these dietary supplements as a drug, but as a special category in food. It’s manly its own actual category as a supplement For a supplement to be a supplement it must include certain characteristics. Based on the information given to me from the website from the National Institute of Health on their background information on Dietary Supplements and streetdrugs.org, A dietary supplement is intended to supplement the diet, includes one or more vitamins, minerals, herbs or other botanicals, amino acids, and other substances including enzymes, organ tissues, glandulars, and metabolites, or their constituents. They must also be taken by mouth as a pill, capsule, tablet, or liquid and be labeled as a dietary supplement on the bottle.

Since dietary supplements aren’t included as a drug then they don’t have to be tested before sale for safety. They can be produced and put on the market saying it helps in a certain way, but the manufacturers do not have to give actual evidence of this claim that the product makes. These rules give a very loose restriction to the manufacturers and can ultimately cause many problems to occur and for there to be hidden information about the product and its side effects. An example of one of these instances was the problem with the supplement Ephedra.

The Ephedra supplement was produced and sold to be a weight loss dietary supplement. It was very effective and caused great weight loss in the users at the cost of very severe side effects. The drug caused very damaging side effects such as strokes, heart attacks, high blood pressure, seizures, and has even caused many deaths. This drug was then completely banned in 2004 for its terrible side effects and dangerous consequences of use.

Counterituitive Note: Ephedra being a supplement that is suppose to help with weight loss and make people healthier is causing severe health issues and death to the users of the product. The health dangers of a product that is suppose to help make you healthier is quite head scratching.

Classifications and Labeling of A Dietary Supplements: Dietary supplements can be classified as including the characteristics I named before that must be included in its ingredients, labeling, or make, but there are some more rules to this classification. There are only three types of claims that a dietary supplement can make such as a health claim, nutrition content claim, or a structure/function claim. The labels on the dietary products must include the following information. They need to have its name stating it’s a supplement along with it, its quantity in the container, manufacturers name, and directions of use.  It must also label the serving size, if it has a botanical property, proprietary blend, and other ingredients that are non dietary ones such as fillers and sweeteners.

Ephedra Ingredients: Epehdra comes from the plant Ephedra which is a shrub found in desert regions such as central Asia. Ephedra contains the herbal form of Ephedrine which is a drug used in asthma medicine. It contains the alkaloids ephedrine and psuedoephedrine which are amphetamines-like compounds. This causes the severe stimulant effect of the Ephedra. A supplement with Ephedra in it called 3-Andro Xtreme follows these ingredients: Serving size: 1 cap 2-3 times daily 100 milligrams 4-Androstenediol 100 mg 5-Androstenediol 100 mg 19-Norandrostenedione 200 mg Caffeine 400 mg Ephedra Extract 8% 100 mg L-Phenylalanine 100 mg L-Tyrosine. When checked it does meet the minimum requirements to be classified a supplement. If you notice though it contains Ephedra a high stimulation component along with caffeine another high stimulant.

Dangers of Ephedra: The high stimulant effect of Ephedra causes many dangers with the heart. the side effects including high blood pressure, irregularities in heart rate, insomnia, nervousness, tremors and headaches, seizures, heart attacks, strokes and even death. The mixture of this high stimulant product with such things as caffeine can also cause these same problems to occur because of the high stimulant effectiveness from it. Also mixtures with certain drugs can cause terrible problems that lead to death in the users. The over stimulation of the product leading to death is not worth the fifteen or twenty pounds you’ll lose. As in the product I used above 3-Andro Xtreme, it has been proven and stated that Ephedra alone is a dangerous stimulant and mixed with more stimulation is dangerous, this product has both caffeine and the Ephedra which is a heart attack or death just waiting to happen.

Helpful uses of Ephedra product: Ephedra may be a terrible product for weight loss, but it does have some pros. It is used in asthma medicine to help patients with breathing problems. It also can help with major weight loss. Those are the only two pluses to the use of Ephedra in any products, but it’s many harmful side effects aren’t worth it.

Loose Regulations of Dietary Supplements: The FDA doesn’t regulate the supplements and check them for safety before sale. They can be put out on the market without being tested for harmful side effects. The supplement manufacturers have to make sure what they say their product does actually does follow that claim, but there doesn’t have to be shown evidence of this. In this case it sounds like you could just lie about what your product does and not have to give visual tested evidence of your claim. The checking for safety after sales have been made is very hard when it was proven that manufacturers were hiding some of their reports of unwanted side effects from their supplements. also the loose regulation on labeling allows manufacturers to hide contents to their ingredients, and even some supplements have been confused to what is exactly in them based on multiple different ingredient labels.

Current State of Research Paper: Based on my research and findings on the dietary supplements I have found a couple of interesting points. The first being the loose regulations allows for a wide range of loop holes to be taken by the manufacturer to sell a possibly dangerous supplement. It can cause ingredients to be hidden from some users, by not exactly labeling all that is in the product. I have also found that from the banned supplement Ephedra, the products it was contained in met the loose qualifications and labeling that supplements have to meet.

The only problem is it doesn’t explain the dangers of how Ephedra is a very highly stimulant supplement and contains a strong amphetamine component. This amphetamine causes the high stimulation of Epehdra which makes the heart race and causes all the high blood pressure and heart attack problems. I can also see how the lack of warning about this high stimulation can be mixed with caffeine from drinks or other sources causing the heart to race faster and causing more drastic problems that have been seen. The high stimulation can be a cause for the insomnia, racing heart beat and eventual death from the heart being worked to hard and too fast especially when mixed with high caffeine or other high stimulated products, or even over the counter drugs.

i have overall found the source to the problem with the ephedra supplement, and even though met the requirements of a supplement when the manufacturers used it in their product, the amphetamine component in it caused the severe side effects. the amphetamine component along with the loose regulations of supplements made it easy for such a product to be out on the market and sold. Many Deaths and terrible heart problems along with other side effects were allowed to happen until later investigation of the supplement, due to these flaws in how supplements are created by the manufacturers and regulated by the FDA.

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1 Response to White Paper-Brett Lang

  1. davidbdale says:

    Good to see you’re early, Brett. This looks quite comprehensive from my first quick scan. I have classes this afternoon and evening, but I’ll give this another read tonight. If you’re looking for advance feedback, let me know. (I tossed a couple of paragraph breaks into your Current State section but made no other changes.)

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