Regulating Dietary Supplements Essay

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

The Food and Drug Administration, also known as the FDA or USFDA, is responsible for protecting and advocating public health. They are the official government agency that ensures our drug supply is safe and effective. This is achieved through the regulation and supervision of food safety, dietary supplements, veterinary products, cosmetics, vaccines, biopharmaceuticals, medical devices, prescription and pharmaceutical drugs that can be purchased over- the- counter.

In our experience with Pharmasim we learned that Marketing decision making must be very sensitive and responsive to everything going on in the industry which is very complex. Consumer responses to marketing tactics can be volatile and unpredictable and no idea is guaranteed to work well. Marketing is a matter of meticulous research, assumptions, planning, and volatility at times. Overall we took away two major points: 1) that it is important to consider the product lifecycle in evaluating how to promote businesses and, 2) that the “Sweet Spot” as a competitive advantage should be the greatest point of consideration when evaluating how to best gain leverage to beat the competition in the minds of

FDA’s Center for Drug Evaluation and Research (CDER) works to ensure that the drugs release in the market are safe to be used by general public. They evaluate prescription as well as non-prescription drugs for their safety effectiveness and quality. They review the drug before being marketed to improve overall health

An increasing number of people are using products to enhance their diets. A recent estimate indicates, “Americans are spending some $6 billion annually on nutritional supplements, and the market is growing by 20% every year” (Zahn, 1997). Of these supplements, the increase in herbal remedy use is most dramatic. Zahn holds that the increase can be attributed to the widely held belief that herbal substances are healthy and harmless because of their natural origins (1997). Unfortunately, research on these supplements, herbal or otherwise, has not transmitted to the public as quickly as the diet enhancers themselves. The phenomenon leaves many consumers misguided by skewed advertising and

Specify the types of country risks that pharmaceutical firms face in international business. How do the political and legal systems of countries affect the global pharmaceutical industry?

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

A new escalating drug abuse epidemic has come about in the recent years; people are now choosing prescription pills as their new drug of choice. The use, abuse and death caused by prescription drugs has increased significantly within the past couple years. All types of prescription pills are more easily accessible from their doctors, family members or off the street. Doctors are handing out prescriptions for pills, such as pain management pills, muscle relaxers, and anti-anxiety, like they are candy and not potentially dangerous to the consumers. In today’s society doctors are over prescribing pills to Americans and the prescription pill distribution should be more closely monitored and controlled. Although there are people who benefit

As children, we rarely look at the back of our chocolate bar or care what elements are in the french fries we indulge in. Whilst getting older, we become more conscious of what is going into our food, and what we put in our bodies. We are more aware of the places that we go to eat, and are constantly looking at reviews. The Food and Drug Administration (FDA) is a government federal agency whose purpose is to ensure our safety as consumers. There are various factors that the FDA oversees, thus requiring a substantial budget. Last year, the over-all spent was 4.8 billion dollars, which is generally made from taxes and user fees from the drug industry. They regulate food consumption,

Introduction: Since 2001, compounded drugs have caused more than 1,000 illnesses, and 87 deaths in the United States (cite 1). All of these unfortunate incidents were caused by errors during the manufacturing of compounded drugs, and in most cases, because of contamination. On the 25th of September 2013, the Drug Quality and Security Act, also known as H.R. 3204, was introduced, and three days later, was passed by the House of Representatives. On the 18th of November, this Act cleared the Senate. On the 27th of September, 2013, President Barack Obama signed the Drug Quality and Security Act into law (cite 2).

Magnesium in normal does of ~350mg per day (MAGNESIUM.n.d.) is considered safe with only minor reported side effects such as:

Some other type of testing is required by the FDA when human subjects are need to prove the liability of a product. The FDA divides unapproved

While health foods stores attract consumers to purchase health supplements, many manufacturers use health food stores to promote their bogus products. In March 1999, the FTC filed a complaint in federal court against the makers of Vitamin O. The company ran false ads claiming the Vitamin O supplement prevents cancer, heart, and lung disease by adding an extra oxygen supplement to the bloodstream. With no scientific evidence to prove the benefits of Vitamin O, the two companies from Washington agreed to a settlement of $375,000 for consumer compensation. The settlement prohibited the Vitamin O manufacturers from making claims that were unsupported about the Vitamin O health benefits. Testimonials and endorsements of product represented through previous experience from members of the public who used the product were also prohibited in the settlement. In conclusion, marketing agents with false science beliefs have one common goal: To sell! We as consumers must be aware and informed of unknown supplements that claims to have a great deal of impact to your life. These products are known for its testimonials by doctors and actors that make claims of using the product. Pseudoscience supplements have caused serious illnesses and even death due to consumers lack of knowledge when purchasing these products. It is strongly recommended that consumers research the companies and the product that advertise false products very carefully before purchasing a supplement that claims to

Miracle Mineral Supplement, frequently alluded to as Miracle Mineral Solution, Master Mineral Solution, or MMS, is a poisonous arrangement of 28% sodium chlorite in refined water. The item contains basically the same fixing as modern quality blanches before "actuation" with a sustenance grade corrosive. The name was instituted by Jim Humble in his 2006 independently published book, The Marvel Mineral Arrangement of the 21st Century. A more weaken rendition is promoted as Chlorine Dioxide Solution (CDS).

Okay, so there really is no mystery about weight loss supplements. In this day and age, anyone of average intelligence or better knows that weight loss supplements are worthless. Sadly, it does not seem to be so. Suppliers of weight loss supplements are still making millions of unethical dollars, and purchasers of these products are still waddling away disappointed with the results. Hope springs eternal, I guess. When it comes to losing weight, we all want to take that magic pill that will shed those unwanted pounds without having to sacrifice our beloved food or having to suffer through the rigors of consistent exercise. And there is always someone trying to tell you that that magic pill actually does exist, and that for a few measly dollars they will be happy to sell it to you. It doesn 't exist, so save your money. If you still believe in those magic pills, check the instructions of any weight loss supplement on the market. Each and every one of them that I have seen has listed as the most important part of the instructions to eat less and exercise more in combination with the miracle drug. Um ... if you eat less and exercise more, is it really necessary to put some foreign substance in your body? Won 't you simply lose weight from eating less and exercising more? Sure you will. If it were easy to eat less and exercise more, nobody would be looking for that magic pill. But that magic pill can 't even pretend to work if you don 't eat less and exercise more. Hmm. Some