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Hey guys.. here's my paper I had to write bashing the usefulness of the FDA.. sorta.... has to be turned in on Monday.. just wanted a critique or 2.. thanks for your help.. 
The Food and Drug Administration by name came about in 1930. However, it had been around for many years in one form or another constantly evolving and changing as needed. The first organization formed in the United States was U.S. Pharmacopeia in 1820. The American people have always been concerned with the safety of food and pharmaceuticals. From 1820 to present, the FDA has continued to evolve and take on what they consider to be hazards to consumers. The question is, has the FDA overstepped their ability to regulate industries by getting involved in the natural dietary supplement industry?
As determined by the FDA, a dietary supplement is a product taken orally that contains “dietary ingredients” intended to supplement the diet. In all due respect, this definition is extremely vague and would have left open the thought that anything ingested by mouth, other than food, would be considered a dietary supplement. Therefore, the following list of “dietary ingredients” was created. In order for something to qualify, it must meet one or more of the following criteria:
• a vitamin,
• a mineral,
• an herb or other botanical,
• an amino acid,
• a dietary substance for use by man to supplement the diet by increasing the total dietary intake (i.e. Enzymes, or tissues from organs or glands) or
• a concentrate, metabolite, constituent or extract 1
On October 25, 1994, President Bill Clinton signed The Dietary Supplement Health and Education Act (DSHEA) into law. This was the first regulatory structure on dietary supplements in the United States. It became effective December 31, 1996.
The basic idea behind the DSHEA was to enable the FDA to remove supplements from the marketplace that were considered to be adulterated or posed “a significant risk or unreasonable risk of illness or injury”. 2 It also required that all ingredients in a supplement be listed with accurate amounts on all the labels.
The DSHEA came into being after the FDA had found supplements that were not living up to the ingredient amounts on the labels, some had too much, and others had too little. Some firms had recalled dietary supplements found to be contaminated by high amounts of lead or were labeled incorrectly and contained as much as ten times the amount of an ingredient than stated on the label. This could be potentially dangerous.
This regulation was designed to prevent consumers from injury or illness due to supplement consumption.
With the recent FDA ban on ephedra and androstenedione, have they overstepped the boundary? Have they truly determined that these substances are detrimental for human consumption or is the FDA simply trying to make a statement?
“The difference between a policy and a crusade is that a policy is judged by its results while a crusade is judged by how good it makes its crusaders feel.” Thomas Sowell
In 1999 alone, there were approximately 110,000 deaths linked to alcohol related incidents; 400,000 linked to tobacco use; 100,000 linked to prescription medications; and 7,600 linked to aspirin and other related pain relievers. However, throughout all the years of ephedra use in the United States only 155 deaths 3 could be linked to its use and androstenedione only has suspicions to have “potential” long term side effects. 4 Strangely enough, both ephedra and androstenedione were pulled from the shelf following FDA ruling and alcohol and tobacco remain readily available for consumption.
On September 17, 2001, The Department of Health and Human Services, a division of the FDA, issued a warning letter to Merck & Co., Inc. due to fraudulent promotional and marketing materials for their Vioxx (rofecoxib) tablets. “Patients on Vioxx were observed to have a four to five fold increase in Myocardial Infarctions (MI’s) than compared to other anti-inflammatory drugs.” 5 In studies done, “101 patients (2.5%) taking Vioxx compared to 46 (1.1%) taking other anti-inflammatory drugs, reported serious cardiovascular events”. 6 The study findings were reported to the FDA, yet the only action taken was to demand that Merck cease fraudulent promotions.
With this in mind, just who is the FDA out to protect, the rights of the pharmaceutical companies or the rights of the consumers? In the early 1990’s, Darvon (trade name Darvocet) was cited in 589 overdose deaths in the US. 7 There have been groups lobbying for the ban of these propoxyphene drugs, calling them “the deadliest prescription drugs in the US”. These drugs are not only dangerous and highly addictive, 8 but there is “no substantial evidence to demonstrate that 65mg of Darvon is more effective than 650mg of aspirin (two standard tablets)”. 9 How does the FDA justify the 6,449 emergency room visits in 1996? How can they rationalize that medical examiners cite these drugs as the twelfth-leading cause of drug fatalities in 1995? 10
The Center for Disease Control (CDC) reports that Sudden Cardiac Death (SCD), the nations’ number one killer, prematurely ended the lives of 460,000 Americans in 1999 alone. SCD causes the heart to stop abruptly. This leads to death in 95% of its victims, most of them never making it to the hospital. SCD is not caused by clogged arteries, but by electrical interruptions in the cardiac system that regulates heart beat. Much of the research into SCD has lead back to one thing, aspartame consumption. Aspartame triggers an irregular heart rhythm and interacts with cardiac medications. 11 Yet, with all of this knowledge, the FDA allows thousands of products to be produced with aspartame and sold daily in the United States.
The US Food and Drug Administration is touted as being the protector to the consumer. After all of the information provided, the same question keeps coming up, “is it the consumer or the pharmaceutical companies that they are protecting?”
The FDA banned ephedra products based on reports done by the RAND Corporation. It’s funny how the reports came from a scientific company that does work for the pharmaceutical companies. Even more strange, “the ban (on ephedra products) does not affect decongestants and other medicines containing ephedrine, a synthetic version of ephedra. Drugs containing ephedrine and a chemical cousin, pseudo-ephedrine are regulated and approved by the FDA and are safe”. 12 How is it that the natural form of ephedra is not safe for consumption and the ones made by pharmaceutical companies are? (Some of the approved drugs actually have a higher dose of “ephedra” than the natural weight loss supplements had.)
Unfortunately, as you can see, the FDA is in control of what we can and cannot ingest. It seems as if the FDA is under the control of the pharmaceutical companies. What does this mean for the future of the supplement industry? Only time will tell what the future holds for those that want to stay healthy in a natural way.
The Food and Drug Administration by name came about in 1930. However, it had been around for many years in one form or another constantly evolving and changing as needed. The first organization formed in the United States was U.S. Pharmacopeia in 1820. The American people have always been concerned with the safety of food and pharmaceuticals. From 1820 to present, the FDA has continued to evolve and take on what they consider to be hazards to consumers. The question is, has the FDA overstepped their ability to regulate industries by getting involved in the natural dietary supplement industry?
As determined by the FDA, a dietary supplement is a product taken orally that contains “dietary ingredients” intended to supplement the diet. In all due respect, this definition is extremely vague and would have left open the thought that anything ingested by mouth, other than food, would be considered a dietary supplement. Therefore, the following list of “dietary ingredients” was created. In order for something to qualify, it must meet one or more of the following criteria:
• a vitamin,
• a mineral,
• an herb or other botanical,
• an amino acid,
• a dietary substance for use by man to supplement the diet by increasing the total dietary intake (i.e. Enzymes, or tissues from organs or glands) or
• a concentrate, metabolite, constituent or extract 1
On October 25, 1994, President Bill Clinton signed The Dietary Supplement Health and Education Act (DSHEA) into law. This was the first regulatory structure on dietary supplements in the United States. It became effective December 31, 1996.
The basic idea behind the DSHEA was to enable the FDA to remove supplements from the marketplace that were considered to be adulterated or posed “a significant risk or unreasonable risk of illness or injury”. 2 It also required that all ingredients in a supplement be listed with accurate amounts on all the labels.
The DSHEA came into being after the FDA had found supplements that were not living up to the ingredient amounts on the labels, some had too much, and others had too little. Some firms had recalled dietary supplements found to be contaminated by high amounts of lead or were labeled incorrectly and contained as much as ten times the amount of an ingredient than stated on the label. This could be potentially dangerous.
This regulation was designed to prevent consumers from injury or illness due to supplement consumption.
With the recent FDA ban on ephedra and androstenedione, have they overstepped the boundary? Have they truly determined that these substances are detrimental for human consumption or is the FDA simply trying to make a statement?
“The difference between a policy and a crusade is that a policy is judged by its results while a crusade is judged by how good it makes its crusaders feel.” Thomas Sowell
In 1999 alone, there were approximately 110,000 deaths linked to alcohol related incidents; 400,000 linked to tobacco use; 100,000 linked to prescription medications; and 7,600 linked to aspirin and other related pain relievers. However, throughout all the years of ephedra use in the United States only 155 deaths 3 could be linked to its use and androstenedione only has suspicions to have “potential” long term side effects. 4 Strangely enough, both ephedra and androstenedione were pulled from the shelf following FDA ruling and alcohol and tobacco remain readily available for consumption.
On September 17, 2001, The Department of Health and Human Services, a division of the FDA, issued a warning letter to Merck & Co., Inc. due to fraudulent promotional and marketing materials for their Vioxx (rofecoxib) tablets. “Patients on Vioxx were observed to have a four to five fold increase in Myocardial Infarctions (MI’s) than compared to other anti-inflammatory drugs.” 5 In studies done, “101 patients (2.5%) taking Vioxx compared to 46 (1.1%) taking other anti-inflammatory drugs, reported serious cardiovascular events”. 6 The study findings were reported to the FDA, yet the only action taken was to demand that Merck cease fraudulent promotions.
With this in mind, just who is the FDA out to protect, the rights of the pharmaceutical companies or the rights of the consumers? In the early 1990’s, Darvon (trade name Darvocet) was cited in 589 overdose deaths in the US. 7 There have been groups lobbying for the ban of these propoxyphene drugs, calling them “the deadliest prescription drugs in the US”. These drugs are not only dangerous and highly addictive, 8 but there is “no substantial evidence to demonstrate that 65mg of Darvon is more effective than 650mg of aspirin (two standard tablets)”. 9 How does the FDA justify the 6,449 emergency room visits in 1996? How can they rationalize that medical examiners cite these drugs as the twelfth-leading cause of drug fatalities in 1995? 10
The Center for Disease Control (CDC) reports that Sudden Cardiac Death (SCD), the nations’ number one killer, prematurely ended the lives of 460,000 Americans in 1999 alone. SCD causes the heart to stop abruptly. This leads to death in 95% of its victims, most of them never making it to the hospital. SCD is not caused by clogged arteries, but by electrical interruptions in the cardiac system that regulates heart beat. Much of the research into SCD has lead back to one thing, aspartame consumption. Aspartame triggers an irregular heart rhythm and interacts with cardiac medications. 11 Yet, with all of this knowledge, the FDA allows thousands of products to be produced with aspartame and sold daily in the United States.
The US Food and Drug Administration is touted as being the protector to the consumer. After all of the information provided, the same question keeps coming up, “is it the consumer or the pharmaceutical companies that they are protecting?”
The FDA banned ephedra products based on reports done by the RAND Corporation. It’s funny how the reports came from a scientific company that does work for the pharmaceutical companies. Even more strange, “the ban (on ephedra products) does not affect decongestants and other medicines containing ephedrine, a synthetic version of ephedra. Drugs containing ephedrine and a chemical cousin, pseudo-ephedrine are regulated and approved by the FDA and are safe”. 12 How is it that the natural form of ephedra is not safe for consumption and the ones made by pharmaceutical companies are? (Some of the approved drugs actually have a higher dose of “ephedra” than the natural weight loss supplements had.)
Unfortunately, as you can see, the FDA is in control of what we can and cannot ingest. It seems as if the FDA is under the control of the pharmaceutical companies. What does this mean for the future of the supplement industry? Only time will tell what the future holds for those that want to stay healthy in a natural way.
