The Supplement Sleuth Analysis

The FDA has come a long way since 1906, but in my opinion, I believe that the FDA should do more to protect our health and have stricter laws in place concerning our food and medicines. The FDA allows products to be on the market without prior approval; for the FDA to take action and recall a product something awful like multiple deaths have to happen for them to realize that the product is harmful. Prime example, Red #3 is food coloring that FDA permits in our food to make the food look appealing. However, studies done on animals have proven to show that Red #3 causes cancer. According to an article published in 1990 in the New York Times states that "Red Dye No. 3 still has some approved uses in foods and drugs, but the F.D.A. said it is

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

14. Dietary supplements do not require government approval before entering the market, and manufacturers alone decide whether their products are safe and effective.

In the first of two court cases between 1950 and 1962, the courts ordered Mytinger & Casselberry, Inc. to change their claims of Nutrilite vitamins positively aeffecting diseases like cancer, arthritis, asthma, heart trouble and tuberculosis. They changed their sales booklet, but most of the claims in the booklet was were still very misleading. After the FDA went on a rampage to seize as many of Nutrilite’s products as possible to force them to correct their misleading info or face going to court, Mytinger & Casselberry filed suit against the FDA, stating through the seizures they are trying to run them out of business, before they could make the necessary corrections, i. In a fairly lucky twist theirir the Judge in their case Judge Goldsborough, who was very much against the FDA, found in favor of Mytinger & Casselberry and issued a restraining order against the FDA, they went to trial and on

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.

Many Americans continue to believe that if a medication has been approved by the FDA it is safe for us to use, but the facts are many times they are not. You only have to look at all the medications that have been pulled from the market after many people lost their lives or had their health decay from these medications to know that nothing could be further from the truth. It helps to find a physician who will tell you to change your lifestyle rather than prescribe a pill that might have harmful side effects.

The next level of concern arises with what exactly is being given out. While many pharmaceutical companies swear by their products, it is easy to forget that at the end of the day they are

There was a time where there was no limits to what substances were in products we humans consume or use everyday. It is alarming to think that there could be items in our food or medicine that are potentially dangerous and deadly. It is for these reasons that the Food and Drug Administration came to be. It all started in a time where companies could say anything they wanted about a product without any scientific validation or proof. The government stepped in and established the Pure Food and Drugs Act of 1906 along with a new agency: the FDA. This act's purpose was to protect the public against dangerous substances in food and from products identified as healthy without scientific support. This law was an accumulation of many bills and ideas that aimed to protect consumers from contaminated products. (The Pure Food and Drug Act) Now, the FDA conducts recalls, market withdraws, and safety alerts in order to protect the citizens.

Also, the FDA has found 300 products that are frauds. These products are usually in dietary supplements, sexual enhancement supplements, and bodybuilding products. These products contained unapproved stimulants (Starling 1). Michael Levy, the FDA’s director in its Division of New Drugs and Labeling Compliance said, “These products are masquerading as dietary supplements- they may look like dietary supplements but they are not legal dietary supplements” (Starling 1). Most adverse reports consist of liver damage, strokes, heart attacks, kidney failures, and death. “The Federal Food and Drug Administration noted that it had, 'worked with industry' to to recall

This article fits nicely with our current topic, The Bureaucracy, because it demonstrates the power of the Executive Cabinet. The FDA, which resides under the Health and Human Services department, has the ability to discern between what products can be released for general consumption and, as a brief analysis of its role, ultimately determines whether a product can be sold.

In the United States, a drug can only be advertised legally after being approved by the Food and Drug Administration (FDA). Once attaining at least one FDA-approved use, physicians can prescribe a drug for other unapproved uses, based on their clinical judgment; this is referred to as “off-label use” (McCambridge, 2008). In general, marketing drugs for off-label uses is illegal; however, pharmaceutical companies have gone to various lengths within their legal rights to accomplish exactly that.

They are not required to test their supplements before the product is released. Many consumers assume that supplements have undergone inspections and have been declared to be safe, however, that is untrue. The FDA does not have the authority or power to inspect the mass quantity of supplements released to the market and they are not treated as drugs. As long as consumers are informed, Congress believed that, that was enough. Therefore, unlike drugs “dietary supplements are considered safe until proven unsafe” (FDA regulation of drugs versus dietary supplements). There have been many incidents where supplements have caused adverse or undesirable side effects due to one of the ingredients in the supplements. One of the most well-known cases was featured in the article “Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident” by the Carol Ballentine. A Dr. Calhoun has prescribed a supplement for several of his patients which ultimately led to their death. The supplement that was prescribed was Elixir Sulfanimide and was responsible for the deaths of “more than 100 people in 15 states”. Had there been supplement regulations put in place for proper testing, these deaths could have been avoided. Other cases include ““weight loss supplements” contained the weight loss drug sibutramine, which was banned in the United States because of the risk of heart attack and stroke” (FDA regulation of drugs versus dietary

As an investigator for the Food and Drug Administration (FDA), there are several stakeholders to take in consideration when considering the approval of various products, including the product originator, the product consumers, and the local environment. The overarching mission for the FDA is encourage public health by certifying the quality and safety of products traded in the United States (Levy, 2011). Therefore, the function of and FDA investigator is to appropriately balance the potential negative effects and the positive outcomes of releasing newly technologically advanced products into the US market. A pivotal problem is the time constraints allowed for studying and understanding these products. The corporations continue to push for

The FDA requires that companies test the product they sell to make sure that they are safe. But because the system essentially operates on the honor code. Unlike prescription drugs, supplements are generally considered safe until proved otherwise. Proving something wrong take lots of time which is why they are able to get away with it for a long time, and some people are too lazy or it takes lots of resources to prove it wrong so they just leave it. The alternative medications are only pulled from the shelf only after the complaints of serious injury.

Excellent job on the discussion! Like you mentioned, the Dietary Supplement Health and Education Act of 1994 (DSHEA) was enacted by Congress following the public concern for consumers to have access to current and accurate information about supplements. As a result, President Clinton signed the DSHEA law on October 25, 1994. The DSHEA amends the Federal Food, Drug, and Cosmetic Act of 1938 to alter the way dietary supplements are labeled and regulated. This law defines dietary supplements, provides regulations for good manufacturing practices, specifies certain labeling requirements or specifies types of statements of nutritional support that may be made on