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Possibility of FDA Regulation of Tobacco Products

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Chapter 10

Question: The possibility of FDA regulation of tobacco products has been an ongoing topic since at least the early 1990s. Why do some think the FDA should regulate tobacco products and what have been some of the issues that complicate how they might do this?

Answer 1: “If somebody invented cigarettes today, the government would not legalize them.” ~Loni Anderson Unfortunately, cigarettes have been making a mark in the documented world as far back as 1518. More specifically, cigarettes have been impacting American society since the late 1800s (Hart and Kasir, 2011).

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Despite the negative health effects (assumed and proven), tobacco has raised years of controversial debate concerning whether or not a need for FDA regulation exists.

To start, it is controversial because tobacco has been excluded from the food genre as well as the listing of drugs. The drugs controlled by the FDA all have a therapeutic benefit. Tobacco has no such thing. The policing of tobacco use including ingredients, packaging, sales, and marketing tactics has surfaced as the alternative benefits of FDA regulation.

President Obama signed the Family Smoking Prevention and Tobacco Control Act in 2009; dealing with those same alternative benefits listed to name a few. In addition to consumers misinterpreting labels and FDA involvement to insinuate “FDA approved,” tobacco companies are fighting. Several consider the act and effects of the act to be restricting to their constitutional rights to free speech. All of these issues create complications.

Answer 2: Some think the FDA should regulate tobacco products for many different reasons. In 1604, King James of England says that tobacco is harmful to the brain and dangerous to the lungs. People see tobacco as a drug, and if they are going to regulate the drug industry, then they should also regulate the tobacco industry. The issues that complicate how the FDA should regulate tobacco products are because tobacco has been excluded as neither a drug or food. Later on, in 2000, the U.S. Supreme Court ruled that because of federal laws the FDA didn’t have the right to regulate tobacco. According to “Drugs, Society, and Human Behavior”, tobacco is a drug because it delivers nicotine. Which is a known psychoactive chemical.

The FDA needs to find a way to balance the benefits and the risks without people defining the benefits. In June 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act which gave authorization to the FDA to regulate tobacco products in a certain way. The candy and fruit-flavored cigarettes have been banned because they target children, cigarette advertising will be restricted, and the nicotine levels in cigarettes will be reduced. All of this is for the hope the cigarette dependence will be lowered.

Answer 3: The problem with the FDA regulating the tobacco industry is that it is not considered a food, or a drug. The U.S. Supreme Court ruled that because of the federal law, the FDA didn’t have the right to regulate tobacco. The problem with listing tobacco as FDA regulated is that it has no therapeutic benefits, as well. In June of 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act, which authorized the FDA to regulate tobacco products, only in certain ways. The concerns that tag along with this is that now tobacco is FDA approved, people believe that cigarettes are safe, the candy and fruit-flavored cigarettes have been bands because they target children, advertising is restricted, and the nicotine levels have and will be reduced in cigarettes. The outcome of these is the hope that cigarette dependence will be lowered.

Chapter 11

Question: Explain the effects that caffeine has on the central nervous system.

Answer 1: There are many effects that caffeine has on the central nervous system. At about 200 mg of caffeine (two cups of coffee), the cerebral cortex is activated and the EEG will show an arousal pattern. Drowsiness and fatigue typically decrease at that point. Higher dose levels at about 500 mg will affect the autonomic centers of the brain. The heart rate and respiration will increase at this dose. Caffeine will also cause dilation of the vascular muscles but the constriction of blood vessels, the constriction might be the basis for the caffeine’s ability to reduce migraines.

Answer 2: Although maximal central nervous system effects are not reached for about two hours, the onset of effects can begin within half an hour after intake. Caffeine tolerance can also occur, but there is less tolerance to the CNS stimulation effect of caffeine than to most of its other effects. With two cups of coffee taken close together, the cortex is activated, the EEG shows an arousal pattern, and drowsiness and fatigue decrease. This CNS stimulation is also the basis for coffee nerves, which can occur at low doses in sensitive individuals and in others who consume large amounts. Caffeine does not only affect the CNS but also behavioral effects, cardiovascular effects, reproductive effects and also affects your heart.

Answer 3: Caffeine on a daily basis is used by more people more than any psychoactive drug. Its effects on the human body vary depending on the quantity of consumption. Few people realize that many nonprescription drugs also include caffeine, some quite large amounts. The tolerance of caffeine on the body and the CNS and be attributed to acute withdrawal symptoms. They can include nervousness and anxiety and increased fatigue. With about 200 mg of caffeine, the cortex is activated, the Eeg shows an arousal pattern, and drowsiness and fatigue decrease.

Chapter 12

Question: Why is it important for you as a consumer to know whether a product you find on the shelf in your pharmacy is being sold as an OTC drug or as a dietary supplement?

Answer 1: It is important for consumers to know whether a product found on the shelf in a pharmacy is an OTC drug or a dietary supplement because OTC drugs have been researched and regulated by the FDA to ensure safety and efficacy. Dietary supplements have not been researched and regulated by the FDA. Dietary supplements do not require proof that the supplement is effective. An OTC drug are types that are self-prescribed and self-administered for self-diagnosed illnesses. Dietary supplements may be mainly taken for nutritional value while OTC drugs may be used to treat illnesses.

Answer 2: Technically OTC drugs are used as self-chosen medications for self-diagnosed illnesses and are also self-administered. The biggest part of the market for OTC drugs are for analgesics and cold/flu symptoms as learned from Hart and Ksir. Although it’s easy to obtain them, it’s better to be relatively cautious upon use of OTCs as I have personally witnessed due to the possible negative counter interactions with prescription drugs currently taken by the individual.

As we learn from Hart and Ksir, the FDA expects OTC drugs to have a reasonable level of effectiveness and safety when used as directed, while both dietary supplements and herbals are not regulated as drugs since they are considered to be more like food products according to the 1994 Dietary Supplement Health and Education Act (DEHSA). Dietary supplements also must be clearly labeled with “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease” as Hart and Ksir state.

Answer 3: It is important for a consumer to know whether a product on the pharmacy shelf is being sold as an OTC drug or a dietary supplement because dietary supplements are vitamins and minerals that control sufficient intake of chemicals needed if they are insufficient in the person’s diet. Although there has been some controversy about how many vitamins are needed and how much is too much.

For something to be a dietary supplement they need to be safe, pure, and they don’t have to show the FDA that they provide any benefit. These differ from Over-the-Counter (OTC) drugs because those types of drugs are self-prescribed for the relief of self-diagnosed illnesses. If people don’t know the difference between the two then they aren’t familiar with the type effects and dangers of the drug. An OTC drug can be more dangerous because if taken to much then it could harm the person. Also, since the doctor is not prescribing the drug, people make take it irresponsibly. Unlike a dietary supplement that is taken for nutrition reasons.

Chapter 13

Question: Describe the most typical pattern of opioid abuse in the early 1900s, in the middle to late 1900s, and in recent times.

Answer 1: In the early 1900s opioid use was used in everyday life for medicinal purposes as well as recreational, but the abuse was not a widely used term. With the chemical transformation into a morphine molecule, the new drug named Heroin was created and marketed as a non-habit forming substitute for codeine. The benefit originally was that it was more potent, requiring lesser amounts to achieve the medicinal effects, and therefore less harmful or addictive. In only a few years the less harmful or addictive claim was proven incorrect, in fact, it was found that heroin could produce a powerful dependence when injected.

By the second half of the 19th century, there were three forms of opioid dependence in the United States. These methods were the long useful oral intake, smoking, and the most disruptive socially was the injection of morphine. By the start of the 20th-century estimates on the number of Americans dependent on opioids were no less than one percent of the population. The typical user was a 30-50-year-old white woman. She could purchase her “family remedy” through the Sears-Roebuck mail order, sold under the name laudanum for as little as 18 cents.

Once the laws were passed that declared opioids as illegal substances, unless prescribed by a physician, the cost to maintain habits increased; creating the illegal drug dealer organization. Also as the price skyrocketed, the method delivering the drug for the user changed to injection this enabled the users to get the biggest benefit from the least amount of expense. The demographics of a visible abuser also changed, causing the population of prisons to exceed their limits, and further defeating the lower classes of our nation through harsh prison sentences, instead of treatment or education. Until 2009 and 2010 which saw sweeping reforms in the harsh sentences, giving more discretion to the judge to recommend treatment instead of imprisonment.

Answer 2: Describe the most typical pattern of opioid abuse in the early 1900s, in the middle to late 1900s, and in recent times. The early 1900s saw the highest opioid abuse. At this time it was relatively inexpensive, easily available, socially acceptable, and openly used for self-medication. a good portion smoked opioid because it took about a minute to take effect and lasted anywhere from two to three hours. Medical concern started to develop with the sight of the number of people who were dependent. Eventually, the 1906 Pure Food and Drugs Act was passed and the nation saw a decrease in use.

The Harrison Act of 1914 also helped the decreasing use as it regulated drugs prescribed by doctors. Toward the mid-1900s, heroin use slowly increased in the lower-class areas of large cities. Heroin was inexpensive and one dollar would buy enough for a good high for three to six people. At this point, opioid use was linked heavily with occurring crime. Heroin also made an appearance during the Vietnam war era, leading a good portion of United States troops to become addicted to the substance.

However, when veterans returned to the states, they did not continue to use heroin. Due to research, statistics, and a heightened understanding of the drug, substance users tend to stay away from opioids. The use of opioids is generally looked down upon when it comes to drug use aside from its role in the medical field. a National Survey in 2008 reported that only 1.5 percent of U.S. adults admitted having used heroin in their lifetimes, with 0.2 percent reporting use in the past year.

Answer 3: The use of opioids was at its highest point in the 1900s. It was a self-prescribed medicine that was very cheap, so it was easy to get. Once the Harrison Act of 1914 was passed, the number of white middle-aged people using opioids orally declined. In the middle to late 1900s, in the late 1960s, the federal government made several attempts to estimate the number of heroin users in the US. From 1970 to about the mid-1980s, the estimates ranged from between 400,000 and 500,000 users. The major source of US heroin was opium grown in Turkey and converted into heroin in southern French cities. Later, in 1972, Turkey banned all opium cultivation and production in return for $35 million from the United States. This lead to a reduction in thet supply of heroin on the streets of New York. Today, more than 90% is originated in Afghanistan. In a survey taken in 2006, only 1.6% of U.S. adults reported ever having used heroin in their life, and 0.1% reporting use in the past year.

Chapter 14

Question: Give some examples of the use of hallucinogenic plants or drugs in connection with religious practices.

Answer 1: As stated in Drugs, society and human behavior, C Hart and C Ksir, hallucinogenic plants have been used for many centuries, not only as medicines but for spiritual and recreational purposes as well. These listed below are only a small sample of hallucinogenic plants used in religious practices. Mandrake is referred to in the bible as being a love enhancing drug. Ololiuqui, seeds of the morning glory plant Rivea corymbosa, had the greatest religious significance. Peyote is the use of the hallucinogenic cactus, peyote, in the religious practice of the Native American Church of the United States. Datura metal was used to treat colds and nervous disorders and was important enough to become associated with Budda, in the Chinese religion. It has also been used in the Greek religion and has connections to the temple cravings in Delphi. Also, Datura is associated with the worship of Shiva in India.

Answer 2: Cannabis has an ancient history of ritual usage as an aid to trance and has been used in religious context throughout the Old World. Elders of the modern religious movement known as the Ethiopian Zion Coptic Church consider cannabis to be the eucharist, claiming it is an oral tradition dating back to the time of Christ. The Rastafari along with some modern Christian sects believe cannabis to be the tree of life. Other organized religions treat cannabis as a sacrament, while modern spiritual leaders have claimed cannabis gives them a more spiritual perspective and use the plant frequently for its medicinal and mind-altering properties.

Answer 3: Hallucinogenic plants have been used for spiritual and recreational purposes. Animism is the belief that animals, plants, rocks, and streams derive their special characteristics from a spirit contained within the object. This is a common theme in most of the world’s religions. Hallucinogenic plants can alter our perception of the world and can change our view of things. Some plants are believed to contain a spirit and when eaten, the spirit is transfered to that person. The spirit can then speak to the person. Shaman people use what was passed down from generations to know how to harvest plants. Their ancestors learned from the plants on how best to harvest them. Plants and their psychoactive effects are an important reason for the development of spiritual and religious traditions in many societies around the world.

Chapter 15

Question: We know that smoking tobacco cigarettes is associated with increased mortality, especially due to cardiovascular problems and cancers. Compare this situation to what we (and don’t know) about the dangers of marijuana smoke.

Answer 1: We all no that smoking tobacco cigarettes is dangerous and leads to cancer. Just like tobacco, smoking marijuana can also be dangerous. Smoking marijuana increases the chances for heart disease and increases high blood pressure. One of the physiological effects is cardiovascular which increases the heart rate. Other effects of smoking marijuana are reddening of the eyes and dryness in the mouth. The lungs of marijuana smokers are affected just like smoking cigarettes but there have been no proven deaths of smoking marijuana. Some reproductive effects of marijuana smokers are decrease in testosterone levels for men. A common risk of smoking marijuana is increasing anxiety which you feel loss of control in your body. Marijuana can impair driving skills, but not certain that it can lead to an increase in accidents.

Answer 2: Scientists searched for years for a key to help unlock the mystery of marijuana’s action on the central nervous system. THC and other cannabinoids are known to bind into two receptors, designated CB1 and CB2. Receptors are found outside the brain immune cells, suggesting that cannabinoids are known to play a role in the modulation of the immune system. Physiological effects; cardiovascular one of the most consistent acute physiological effects of both smoked marijuana oral THC is an increase in heart rate. Other consistent acute of smoked marijuana are reddening of the eyes and dryness of the mouth and throat.

Behavioral effects: marijuana is it one of the most widely used illicit drug in the world some people’s use becomes problematic. Subjective effects: some agued that before novice marijuana smokers are able to experience positive subjective effects e.g. euphoria, stoned. The cognitive effect of marijuana also is another piece that has not been concluded, as there is still confusion. Appetite: studies have shown an increase in food intake to those who smoke marijuana which shows that it stimulates appetite. Toxicity potential: Chronic lung exposure, which could be possible from long time use of marijuana. Anxiety is another behavioral problem associated with marijuana intoxication is potential.

Answer 3: Just like tobacco use, marijuana smoke also has dangers of usage. This includes high blood pressure, heart disease, and hardening of the arteries. Lung functions of those who use marijuana daily are greatly affected, but marijuana has not been proven to cause any deaths. Increased anxiety is another risk of marijuana, which is where you fear the loss of control over your own body. The immune system can also be affected. Marijuana smoke has been known to decrease testosterone levels in men as well.

Cite this Possibility of FDA Regulation of Tobacco Products

Possibility of FDA Regulation of Tobacco Products. (2016, Jun 22). Retrieved from https://graduateway.com/ada-discussion/

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