HeinOnline’s Journal called, “Beauty Is Pain: An Analytical View Of The American Beauty Industry And The Effects Of Regulation On Consumers” Started off in 1989 discussing the lack of legislation granting the FDA power to execute and enforce stricter regulations on cosmetic manufacturers. Morgan G. Egeberg the writer delves deeper into the cosmetic industry and how out of the “thirteen thousand chemicals that are used in cosmetics only 10%” are tested for safety before being placed onto selves. The FDA regulates the ingredients used but has minimal say in the safety of the products leading to dangerous products being up for sale on the market even today. Since the regulations are so minimal there are high chances that consumers are being exposed to chemicals that can cause disease and even cancer. The HeinOnline’s Journal goes into more detail about how women were producing skin care products in their house with “hazardous ingredients such as lead, mercury, copper, tin, arsenic and bismuth” which are still used in today’s skincare products. There was such a big trend for skincare that started up the industry and soon became unregulated due to the fact that women at the time were not able to vote meaning their voice was ignored. The Fair Packaging and Labeling Act of 1973 were passed which seemed like a sign of hope yet since the FDA does not hold enough power all it can do is place a label on a product that most people do not even understand or know effects of. “An Analytical View Of The American Beauty Industry And The Effects Of Regulation On Consumers” continues to explain that the FDA can not “deny a product from being placed on the market” which is very concerning to users. They can create labels on “potentially dangerous products to warn consumers of the effects” which shows how little to no power the FDA holds on the skincare industry. This issue in the regulation of cosmetics is due to the idea that there is a distinction between drugs and cosmetics even today. The definitions of both vary, “The FDCA defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body.” The statement is not only unprofessional but also makes skincare products seem safe and nonhazardous which is the opposite of what these ingredients’ effects can really have on the skin. The author of this journal Morgan G. Egebers writes how the FDCA, on the other hand, defines drugs as, “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” This problem of differentiating drugs and cosmetics is very serious since some of these ingredients used in cosmetics can lead to horrible skin reactions and even more damaging effects with consistent use. A company named Lash Lure was becoming popular in the mid-1920s but became harmful to its users quickly after women started to realize eye injuries, blindness, and even in one case death since the product was made up of coal tar-based eyelash dye.
The article, “Dermatological and environmental toxicological impact of the sunscreen ingredient oxybenzone/benzophenone-3” from the Wiley Online Library discusses the concern that, “Personal care products containing oxybenzone must be raised and compared with the potential negative health and environmental effects.” This ingredient is known to protect the skin from the harmful effects of ultraviolet radiation. Oxybenzone is a chemical used in sunscreens, moisturizers, lip gloss, face oil, and more personal care products that are on the market at this moment. Joseph C DiNardo and Craig A Downs write more on the statics that the Center of Disease Control states, “97% of the people tested have oxybenzone present in their urine.” This shocking statement proves how ingredients used in our everyday life absorb so deeply into our skin that it starts to affect our body internally. Not only is this ingredient affecting humans but wildlife as well, especially marine life. Another statement made in the article is that “Oxybenzone can also react with chlorine, producing hazardous by-products that can concentrate in swimming pools and wastewater treatment plants.” This horrifying claim gives a clear idea of how strong oxybenzone as an ingredient alone is, even thinking of the concept that people are still applying this harmful ingredient onto their skin without care. The Wiley Online Library article by authors Joseph C DiNardo and Craig A Downs state that oxybenzone is, “reported produce contact and photocontact allergy reactions,” which are the reactions to the human skin that have even been linked to “Hirschsprung’s disease.” Since there is an increase in the use of sunscreen, especially with the rise in skin cancer there is a demand for protection. People who do not seek interest in their skincare products are unknowingly applying countless products onto their skin containing harmful chemicals like oxybenzone and other commonly used ingredients in sunscreen lotion such as zinc oxide and titanium dioxide.
3. Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.
In the article, “Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.” from the MDPI website I quickly realized how intricate and precise regulations are placed on the production and testing of nasal sprays and drops. Not only did the Food and Drug Admission create a guideline for the production of nasal drops but it also collaborated with the European Medicines agency to do so. Things to take into consideration include, “droplet size distribution (DSD), plume geometry, spray pattern and shot weights of solution nasal sprays.” A complex since the regulations have to be met by quality of product have to be met with an accurate formulation but the device used to deliver the product itself is also taken into consideration. The strict regulations do not compare to the skincare industry in any way shape or form. In order to determine droplet size distribution (DSD), there has to be testing done using, “laser diffraction” which has been known to be a technique used to determine the “geometric size of droplets and particles,” inside the nasal spray. This article showed how the FDA regulations are so much stricter towards products that are considered drugs versus those that are not considered to be a drug. This shows how much power the FDA can have and can lack at the same time.
4. Regulation of skin lightening agents in the United States and implications for public health
As discussed in the Journal of the American Academy of Dermatology the research article called, “Regulation of skin lightening agents in the United States and implications for public health” talks about skin bleaching and lighting as a tested and documented ingredient list of harmful ingredients. These ingredients are causing effects such as “exogenous ochronosis, irritant dermatitis, elastosis, sunburn, acne, hypertrichosis, and fragile skin.” Not only are these reactions harmful with continuous use of these products that are labeled as, “cosmetics.” The authors Yuangoa Liu, Loren D. Krueger, and Harrison P. Nguyen state that, “ toxic levels of mercury are found in many skin lightening products.” This being said, users of these products are an extreme health concern due to the never-ending list of negatively affecting symptoms due to these ingredients that are used inside the products. The Journal of the American Academy of Dermatology stated, that both over-the-counter skin lightening products as well as those that are prescribed by dermatologists,” do not undergo any degree of United States Food and Drug Administration (FDA) premarket approval.” Even with advanced technology as a society, we think everything is regulated, tested, and triple-checked which is not the reality in many cases, especially with skincare.
5. COSMETICS: A Dermatologist Looks to the Future: Promises and Problems
On the website Science Direct the article, “COSMETICS: A Dermatologist Looks to the Future: Promises and Problems” gives a good perspective of the cosmetic industry from someone in the field with hands-on experience. The article starts off by discussing baby boomers and how they have high expectations to look youthful and glowing as they age by sending money a huge industry of cosmetics. Albert M. Kilgman explains how people using these cosmetics have no education on the fact that FDA approval is not shown and,” No premarketing proof of efficacy or safety is required.” This being said manufacturers can make any claims they desire and still be placed on the market. He goes into more detail on how companies producing these cosmetics are using “exotic ingredients” that are applied to the face with no real evidence showing “proof of efficacy or safety” in topical products that are said to be antiaging and brightening. What we read and see in commercials is not the reality for cosmetics and will not be for decades to come due to the lack of regulations placed on cosmetics by the FDA.
The popularity of cosmetics has grown worldwide. As discussed on the website ScienceDirect the article called, “Consumers’ lack of understanding of customized cosmetics made on the spot and implications for regulations and controls.” there are three categories that customized cosmetics fall into. They stated that the first category is when customized products are “Previously made by manufacturers.” If there are similar ingredients used in the base of some customized cosmetics there will be some level of safety taken into account. The second category is a “do-it-yourself (DIY) kit” this category is when customers can make their own beauty products at home. Letting the customer have total control of what is being put into their products limits the manufacturer’s ability to prevent any unneeded side effects or chemical reactions that can damage the skin and even lead to an allergic reaction. The third category is, “made on the spot by sellers or customers.” Many customers see this category in specific as a way to avoid harsh chemicals and help out the environment. This may be true to a certain extent yet, the lack of knowledge of the enormous number of ingredient combinations makes both the sellers and customers blind to the possible side effects and contamination. A study was made on 1084 consumers of cosmetics from Korea and they were given a survey to fill out. The results showed that “teens and 20s showed high interest” in cosmetics. It is clear that the target audience for manufacturers is young girls who are trapped in the high beauty standards of today’s world. The results of the survey state that most of the customers buy from “Drug store 18.7%” and the second most popular place to buy cosmetics are, “retail stores (17.8%).” This information is useful to understand what brands are most commonly used by customers. Most of the cosmetics sold in these stores are still not regulated which can make harmful ingredients easily sold on the market to the youth.
South Korea created the Piolet Project which is the first chnage for those who love cosmetics to be able to create skincare products on the spot. According to the Scientific Reports website, these customized cosmetics do have, “potential risks for cross-contamination from the surrounding environment.” Cross-contamination to cosmetic products can cause bacteria growth as well as not safely regulated products that are being made on the spot. These customized cosmetics, “can be made by untrained customers or sellers in shops with no specialized facilities for the manufacture of cosmetics.” The FDA has no intentions to help change these standards but instead believes that, “cosmetics need not be sterile.” These high powers that can make regulations and changes in the cosmetic industry cover up the lack of safety measures taken which still has not made customers stop buying cosmetics. The article mentions another study that states, “most frequently found microorganisms in cosmetics are P. aeruginosa, S. aureus, E. coli, and Bacillus species, as well as other bacteria, mold, and yeasts.” The high levels of microorganisms in customized cosmetics are not controlled by any regulation since all these products are final sales and do not have time for a safety process. This article proves that cosmetics are not safely made even when they are marketed as improving skin with no unneeded ingredients.
8. The regulation of personalized cosmetics in the EU.
It is well known that Europe has stricter regulations on cosmetics compared to the United States. Most customized cosmetics are bought online after answering a questionnaire about skin type and shipped to the buyer. According to the article published by MDPI, Europeans have to follow the “good manufacturing practice (GMP)” which is a way to make sure products have quality standards to achieve. There are regulations placed on equipment, testing, safety, domestic equipment use, and following other guidelines. As stated in the article “A safety assessment must be performed prior to placing a cosmetic product on the market.” Europe has no comparison to the lack of interest in the cosmetic industry from stronger powers in the United States. There is a lot more to take into consideration when it comes to customized products and Europe has tried its best to prevent contaminating skincare products that will be on the market.
9. Knowledge and behavior regarding cosmetics in Koreans visiting dermatology clinics.
There is a lack of knowledge when it comes to cosmetics in general. There was a survey given to patients who came to a Korean clinic. They were asked 43 questions about their knowledge of cosmetics. In the National Library of Medicine stated that “Thirty-one percent had been diagnosed with a skin disorder, atopic dermatitis, and seborrheic dermatitis.” This example shows how much cosmetics’ negative effects catch up to those who choose to purchase any cosmetics. There are not only short-term side effects such as irritation but long-term effects such as disorders, organ failure, and even horrible diseases. When these patients were asked about the most used functional cosmetics, “whitening products were used most frequently.” Skin whitening products have been very popular in Asia since they bleach the skin to become a lighter shade. In today’s society having lighter skin is a beauty standard that still exists in Asia specifically in the Philippines. Not only are people buying these nonregulated lighteners on the streets but also using IVs. The main ingredient in these bleaching creams is glutathione which bleaches the skin inside and out and a poison known as Mercury is also an ingredient that has led to hospitalization. Not only are these lighteners sold in Asia they are also sold in the US but are usually labeled as brightening cosmetics. Out of the pacients survey, “79.2% purchased cosmetics without checking ingredients” which is a big concern since the FDA does not regulate cosmetics to the same level as foods. People have knowledge of cosmetics themselves but not about the harmful side effects that are caused by the ingredients that are inside these cosmetics.
This Journal goes into a study that surveys 34 college girls in Chitwan, Nepal. As stated in the Journal of Chitwan Medical College, “ 98.6% got information about cosmetic products from television.” A majority of the girls that were randomly selected were influenced by television ads to buy the skincare products they use. What is frightening is that the FDA does not have regulations on what claims manufacturers have about their products. Cosmetics such as sunscreen, lotion, nail polish, and makeup are used to enhance our appearance. Not only is the United States allowing for harmful ingredients to be used in cosmetics, “ Saudi Arabia found that lead contents were determined in 26 and eight different brands of lipsticks and eye shadows.” As discussed in the paragraphs before the United States also struggles with the problem. The cosmetic industry is lacking any transparency to their customers and this is all due to the fact that the FDA requires any laws or regulations for cosmetics. These college students were also asked about the long-term side effects of skin lightening, “97.1% had knowledge that skin lightening cream and sunscreen cause skin cancer.” These girls had knowledge about the harmful side effects of many cosmetics they were asked about but it does not seem to face them. The problem is that young girls are going to the extreme by using cosmetics that contain harmful ingredients to keep up with the beauty standards. Young girls are not making any steps to urge the FDA to regulate the cosmetics they are using on a daily bases to be safe to use.
11. Substance abuse and addiction statistics
Drugs have been a big problem in the United States for decades. The federal government is investing billions of dollars to help control drugs. The US is in a drug pandemic where people are barely keeping their jobs, using unsanitary supplies, and getting laced drugs to satisfy their cravings. Some of the most commonly used drugs according to the NCDAS include, “Marijuana, prescription stimulants, Opioids, Methamphetamines, prescription pain medicine, heroin, cocaine, and prescription seductive.” Many of these drugs are used by people ages 18 – 29 years old who become addicted easily and struggle to recover. Many young people are dying from overdoses, “Over 70,000 drug overdose deaths occur in the US annually.” This proves that drug use is an issue we face on a national level. Investing more to provide recovery and sanitary supplies to users is the key to preventing more overdoses. Cosmetics do not have mind-altering side effects like hard drugs do which should not classify them as drugs. Not only are drugs transported from different countries they are also laced, “28,466 deaths were fentanyl-related” these numbers are rising and the urge for regulations and strict laws is needed now. Cosmetics will never have the same effects as hard drugs do which will prevent them from being classified as drugs and regulated strictly by the FDA.
12. Human drugs overview for imported products.
According to the FDA article, “Human Drugs,” the real definition of a drug is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” Drugs have been a great advancement in the medical field to help people stay healthy. This definition has no similarities to the benefits of cosmetics themselves which should not make cosmetics classified under the definition of what drugs are meant to do. Drugs are strictly regulated and require accurate labeling, good manufacturing practices (GMP), drug application, registration, and listing to be excepted by the FDA to be sold on the market. This process is time-consuming but has to be completed before being sold on shelves since these are very powerful doses that have nothing to do with the idea of cosmetics which relate to beauty and having the ability to choose to use.
In the article “Effects of the virtual makeup beauty makeup applications on mood, body satisfaction, and self-esteem among female university students” by the KoreaScience website there was a study conducted on a group of “114 undergraduate students.” These students were separated and placed into two categories which included taking selfies. The first group took selfies with makeup while the second group was not able to put any beauty products on their face. The test results showed that “The level of body satisfaction significantly decreased only for women who took selfies without the use of a beauty makeup application.” Beauty standards are at an all-time high and women feel obligated to wear makeup and look youthful. Women are trapped in the idea that cosmetics are their only way to reach those beauty standards. Most women who use makeup products use a couple of different products which in many cases have harmful ingredients that can lead to long-term side effects such as cancer, inability to reproduce, and other diseases.
14. Cosmetics, skincare, and appearance in teenagers.
As mentioned on the Pubmed website, “The cosmetic industry has identified teenagers as “powerful” consumers, and offers them various toiletry and skincare products that should fulfill their needs.” The target market for these cosmetics is females specifically teenagers and young adults. Since social media has been such a hit for years it has become easy to be convinced by our favorite influencers to buy cosmetics without future research. In today’s society beauty is taught especially to young girls they were born. There are cosmetics for children that have shown to have Talc which is a powder that is grown next to asbestos which is contaminated every time. These harmful ingredients are not only harming teenagers but even younger girls to a level that their development process can be affected in negative ways.
15. Drug use and aggression: How to protect yourself.
Drugs in some cases lead to aggression due to the change behavior and lack of control drug abusers under go. In the Positive Choices website article called, “Drug use and agreesion: How to proect yourself” there was a stament on how drug useer “increases the risk of harm to themselves and others.” This is not shocking since drugs are such mind altering substances that have been a problem nation wide. There does need to be protection for those who have loved ones addicted to substances but there also has to be proetcion for users of cosmetics. Cosmetics may not be mind altering yet, they have a large list of both short and long term side effects that do negetivly effect users health. This source in specific shows how much research there has been on drug users and how to deal with chnages in behavior but it seems that there is a lack of interest to discuss the side effects of cosmtics and how to aviod putting people’s health at risk.
16. Treatment for common illnesses.
As mentioned in the CDC article, “Treatment for common illnesses” the common cold has, “More than 200 viruses.” The common cold has been an illness that for many years has killed thousands but because of the advancements in medicine, there are treatments to help people survey. This form of treatment is known as over-the-counter medications or antibiotics which are usually prescribed by a medical professional. Medicine has advanced in many ways and so have cosmetics and for that reason, they should be considered to be in the same category. Drugs used to treat the common cold lead to many side effects that cosmetic products can also lead to.
17. EGW
As stated by the EGW website article, “Our personal care products are out dated and dangerous” other countries are moving towards improvements but, “the Food and Drug Administration doesn’t even require the basic safety testing of ingredients in personal care products before they’re used.” This website is run by an enciornmental group and knowing that there is no saftey testing og ingreinets in cosmetics make the US seem less advanced with technology as it portrays itself to be. This website has been been a relable source that is ranking personal care products such as sunscreen, lotions, deodorant, shampoo, makeup and more. These ranks are based on a level from verified being not toxic at all and 10 being the worst products to purchase. The ranks show the levels of irritation and allergies, possibility of cancer causation, a list of all the ingreinets in that products and what their rating is aswell. This is a great source to help educate people on the harmful ingreinets in their daily cosmtics.
Hypothesis 1: Skincare products should be identified as drugs that are regulated by the FDA.
Hypothesis 2: The harmful ingredients used in skincare are ignored by the FDA and the lack of regulations needed to protect society.
White paper experience paragraph: I think that overall I am doing well on the white paper. It is taking me a lot longer than expected to find topics that are related to my hypothesis and can back it up with evidence. I have learned a lot of new information I did not know about the skincare industry before reading the articles and writing in-depth summaries on each of them.
Before I look at your summaries, Cookie, I want to suggest that your two hypotheses are clearly at odds, which is fine if you’re aware of it.
I doubt you’d want the FDA to have to regulate every skincare product. Maybe you do, but can they all be identified as drugs? You’re going to need a VERY inclusive definition of drug to include sponges as a drug. They are a skin-care product, but they probably don’t require drug labeling. I’m sure you must mean something more specific by drug than that.
Harmful ingredients are something else again and most likely will contribute more persuasively to your thesis. Even so, some specificity in your hypothesis would make it more immediately compelling. Harmful ingredients absorbed through the skin or taken by mouth are more likely to be recognized as falling under the FDA’s jurisdiction. Now that I think about it, chemical peels probably present dangers even though they’re not likely absorbed. So maybe the category harmful ingredients needs some clarification as well.
Yeah. Scanning your summaries looking for clarity on definitions was an eye-opener! You’re definitely going to have to devote a lot of study to teasing out the differences BOTH in what the laws and regulations actually say AND how YOU believe the terms NEED TO BE DEFINED in order to provide the protections you seek from the FDA.
This is going to turn out to be a HUGE topic if you don’t work hard to narrow it. Skin lighteners! How could that process not be considered hazardous? Skin darkeners too, for that matter.
The disparity you’ve found in the skin care vs. nasal spray regulations is brilliant, Cookie! It’s a really good example of what appears to be a prejudice in the science to consider anything that goes INTO the body as a potential drug, but not something that gets applied ONTO the body. You know better, but readers will not have considered this important difference until you reveal it to them.
I do agree that my hypothesis is not clear enough and is very and it should be even more revised to be narrowed down. Thank you for bringing up the point that not every skincare product has to be regulated by the FDA which I did not think of before. I do see your point that the most dangerous ingredients used in these products should be regulated. Also, it has been hard finding any articles on regulations specifically on skincare on google scholar but I see your vision when you say that I should look into the actual regulations that are already in place today and how I could change their definitions to fit the hazardous ingredients being applied to our faces quite possibly every day.
I just made some adjustments to my hypothesis so I was wondering if you could look over it to see if I narrowed down my argument a bit more. I am also looking on google scholar for regulations that the FDA has already on cosmetics and which ones are not even talked about. Thank you for your feedback it will be especially helpful when I start writing my essays.
To clarify your statement for me, Cookie, when you say
do you mean you HAVE FOUND some FDA regulations on cosmetics?
Cookie, I think the incongruence between the two definitions you identify in your first source are worse than you even suggest.
Cosmetics are: “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body.” You call that “defined by their intended use,” but the list doesn’t mention WHY the articles are rubbed, poured, etc. I suspect, though, that if you looked hard at the entire article, you wouldn’t find any mention of “healing or mitigating a disease.”
And Drugs are: “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”
So, unless cosmetics or beauty products cure disease, they’re not drugs and that’s why the FDA has no jurisdiction over them. That just seems SO wrong, doesn’t it? They can regulate toothpaste that goes in your mouth until you spit it out, but they can’t regulate a cream that you spread on your face that gets absorbed into your body and stays there forever?
Your hypotheses are more specific, but alone they don’t make as compelling an argument as the Proposal Argument: BECAUSE skincare products contain dangerous, even toxic, ingredients, they should be regulated as least as strictly by the FDA as drugs that have NOT been proven to cause disease.