Legal Recommendation On Drugs Production And Marketing (Essay Sample)
Instructions to the assignment
Recently, a product developer approached you for some advice about a new dietary supplement she wants to bring to market. Because of COVID, the product developer fled the U.S. to a remote village in Belize where she has been living for the past several months. While there, she discovered a botanical ingredient derived from a native plant only found and used in this region of Belize, which the village has been using for centuries as a hangover cure. Because the village has high cancer rates, there are some who question whether the substance may be carcinogenic.
Realizing the enormous value of such a product in the U.S. and beyond, the product developer created a product in capsule form that includes the “hangover cure” botanical, in addition to vitamins, C, E, and B12, all of which are alleged to be helpful in protecting the body against the impacts from too much alcohol consumption. The product developer wants to call this supplement, “Naturally Hangover Free” and to include the claim “Prevent Hangovers Before They Start with our unique and time-tested powerful vitamin, mineral, and botanical blend.”
Additionally, she drafted promotional materials for the product, stating, “I struggled with hangovers while working as bartender for over a decade. Striving to find a hangover cure, I hired a PhD chemist and consulted medical professionals to create hangover vitamins. Now the hangover cure allows me to avoid my hangovers.” The materials also include the following information: “Hangovers are much more than just dehydration. Headache often occurs when alcohol in the bloodstream absorbs all the vitamins and nutrients from the body’s organs. The shortage of vitamins and nutrients leads to organ dehydration, after which the organs begin to steal hydration from the brain. When this happens, the brain actually shrinks and the blood vessels become inflamed, making it harder for blood to flow through the brain and causing immense pressure. Solution: Take in a healthy dose of vitamins & nutrients prior to drinking.” Another statement says: “Diarrhea, Nausea, and Vomiting all go hand in hand. For some, simply binge eating while drinking lots of alcohol causes an awful upset stomach. The body’s reaction to all the toxins from alcohol coupled with dehydration amplifies these symptoms as well. Acute or chronic binge drinkers can develop normal bouts of diarrhea from chronic ethanol ingestion. While vomiting is very unpleasant, it is the body’s natural defenses in action. So, for many, vomiting may help ease symptoms of hangover to an extent. These are truly the hangover vitamins you need.”
According to FDA in previously issued statements, “a hangover is a sign or symptom of alcohol intoxication, which the agency considers a disease.” However, studies demonstrate that some individuals experience hangovers in the absence of intoxication due to other factors like dehydration, drinking on an empty stomach, etc.
The product developer is eager to begin marketing her product but wants to ensure she is in compliance with any applicable statutory provisions or regulations. Please advise her on all legal issues you identify.
LEGAL RECOMMENDATION ON APPLICABLE STATUTORY PROVISIONS AND REGULATIONS ON DRUGS PRODUCTION AND MARKETING
Legal Recommendation on Drugs Production and Marketing
Drug production is one area that is very sensitive as it directly deals with the health of people. Several regulations and by-laws provided by the Foods, Drugs, and Cosmetics act helps to safeguard what humans consume. FDA's Center for Drugs Evaluation and Research (CDER) acts as the consumer watchdog in the United States of America. This centre's job is to evaluate any drug developed before introducing it into the market.
Since the native plant the developer uses to produce the' hangover cure' medicine found in the town's outcast, there is a need to examine the product's contents scientifically. The main reason for this research to be carried out is that the product does not contain any harmful substances that may harm the consumer. Therefore, the FDA needs to evaluate any new drug in the market to prevent quackery and provide doctors and patients with information on the use of the medicine (FD&C Act, 2007). This centre also ensures that both brand-named and generic work correctly, and the benefits of the drug should always outweigh their known risks.
Drug companies seeking to sell new drugs must therefore comply with regulations of testing the product. After trying the product, the developer should send the report to CDER for valuation and analysis to ensure that it is safe for consumption and meets its intended purpose. After that, the developer should expect a team of CDER medical personnel, statisticians, and pharmacologists to review the company's data and its capability to produce the drugs and check its proposed labelling and branding.
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