2ENGLISH PAU EXAM

ENGLISH PAU EXAM

• ISMAEL SGHIR
• MARC CHALMETA
• IKER ROIG
• VICENT ROCA

GROUP:

TEXT:

"FOR COSMETICS, LET THE BUYER BEWARE"

When you wash your hair, clean or moisturize your skin, polish your nails, or put on makeup, deodorant or sunscreen, do you ever think about whether the products you’re using may do more harm than good? To be sure, these products are not nearly as worrisome as drugs, which require extensive testing and premarket approval by the Food and Drug Administration (F.D.A.). In a recent editorial in JAMA Internal Medicine, Dr. Robert M. Califf, who served as F.D.A. chief under President Obama, noted, “The cosmetic industry remains largely self-regulated. History has repeatedly shown that when there is insufficient regulatory oversight, a few unscrupulous people or companies will exploit the vulnerable public for profit.” Even when a hazard comes to light, a product can remain on the market for years until negotiations make their way through the legal system or the company decides to halt sales. A current case is a classic example. When in 2013 the agency received 127 reports of adverse effects from a single line of hair-care products called WEN, it discovered that the manufacturer, Chaz Dean, Inc., had received more than 21,000 complaints of hair loss and scalp damage associated with the products’ use. A lawsuit filed by more than 200 women against the company was settled last year for $26.3 million. Yet the company claims that WEN hair care products are “totally safe” and continues to sell them. Unlike drugs, cosmetics can be sold based solely on manufacturers’ tests (or no tests at all) and claims for effectiveness and safety. Even the ingredients don’t have to be filed with the government. (Only color additives require premarket approval.) Asked in an interview whether more can be done to protect the public, Dr. Califf said, “It’s highly unlikely in the current administration. There’s a tiny work force at the F.D.A. to deal with an enormous industry that’s currently selfpolicing. Voluntary reporting of adverse events linked to cosmetics and personal care products is a lot better than nothing, but it’s way inadequate for the job. There’s no legal requirement for manufacturers to submit reports of adverse events to the F.D.A.” Dr. Califf’s editorial accompanied a rather startling report in the journal by Dr. Shuai Xu,a dermatologist. On the heels of the thousands of complaints uncovered about WEN products, the F.D.A. made publicly available its Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System, a repository of adverse events related to foods, dietary supplements and cosmetics. This enabled Dr. Xu to analyze all the adverse events associated with cosmetics and personal care products voluntarily submitted from 2004 through 2016 by consumers and health care professionals. Through 2014, he averaged 396 a year. There was a 78 percent increase in reports in 2015 and a 300 percent rise in 2016, largely driven by complaints about WEN products. Dr. Xu said, “As a dermatologist, I live and breathe personal care products day and night. Patients ask me about them all the time. I warn patients that labeling can be very tricky. One needs a Ph.D. in chemistry to be able to interpret all the terms. What does it mean for a product to be labeled ‘natural’? That doesn’t make it safe. Poison ivy is perfectly natural.”

Parts of the exam

PART I- READING COMPREHENSION

PART II- WRITING COMPOSITION

• True / False
• Open questions
• Synonyms
• Multiple choice

• Opinion essay
• For and Against essay

Part I- Reading comprehension

1. Decide if each statement is true (T) or false (F) based on the text. Copy the exact words from the text that support your answer.

QUESTION 1

1. All cosmetics require F.D.A. premarket testing and approval prior to public sale.

2. WEN resolved most of its 21,000 consumer complaints through F.D.A.-mediated settlements exceeding $2 million.

3. 2016 saw a surge to over 500 adverse event reports due to WEN, surpassing prior years despite self-regulation.

4. No legal mandate forces cosmetic firms to report safety issues to the F.D.A., even amid widespread complaints.

SOLUTIONS:

1. (F) "F.D.A. doesn't require premarket proof of safety for cosmetics sold."

2. (F)"company had received more than 21,000 complaints" but no settlements mentioned.

3. (F) "207 reports [...] against [...] WEN" but "more than 21,000 complaints" to company.

4. (T) "no legal requirement" and products persist despite complaints.

Part I- Reading comprehension

2. Answer the following questions using your own words but taking into account the information in the text. (2.5 points: 1.25 each)

QUESTION 2

a. Why can dangerous cosmetic products remain on the market for years?

b. What did Dr. Xu discover when he analysed the reports of adverse events?

SOLUTIONS:

"The cosmetic industry remains largely self-regulated. History has repeatedly shown that when there is insufficient regulatory oversight, a few unscrupulous people or companies will exploit the vulnerable public for profit." Even when a hazard comes to light, a product can remain on the market for years until negotiations make their way through the legal system or the company decides to halt sales.

a.

Through 2014, he averaged 396 a year. There was a 78 percent increase in reports in 2015 and a 300 percent rise in 2016, largely driven by complaints about WEN products.

b.

Part I- Reading comprehension

3. Find a synonym for each of the four words below from these six options. All the words are underlined in the text (1 point: 0.25 each)

QUESTION 3

Harm Hazard Settled Effectiveness Accompanied Associated

a. Attended: b. Performance: c. Resoluted: d. Threat:

SOLUTIONS:

c. Resoluted: settled

a. Attended: accompanied

d. Threat: hazard

b. Performance: effectiveness

Part I- Reading comprehension

QUESTION 4

4. Choose a, b, c or d in each question below. Only one choiceis correct. (1.5 points: 0.5 each)

1. According to the text, why is the cosmetic industry self-regulated?

2. According to the text, why is it inefficient to report events related to the cosmetic industry?

3. According to the text, why aren't all the natural labels safe?

SOLUTIONS:

d. To prevent companies from taking advantage of consumers

b. Because the producers don’t have an obligation to send these reports to the F.D.A

b. Because elements in the nature can be harmful for health too

Part 2- Writing composition

QUESTION 5

5. Choose one of these two topics and write a composition about it.

1. Do you think all products should go through official security tests? Write about 130-150 words.

• Opinion essay

2. Are natural products always better than non-natural ones? Contrast both. Write about 130-150 words.

• For and against essay

THANK YOU!

According to the text, why is it inefficient to report events related to the cosmetic industry?

a. Because the percentage of complains is much more less than the percentage of flattery b. Because the producers don’t have an obligation to send these reports to the F.D.A c. Because it is beneficial for the F.D.A that there are bad quality products in stock d. Because the products don’t need to be tested in any case, and therefore the companies aren’t responsible for the effects

According to the text, why aren't all the natural labels safe?

a. Because the products can’t be 100% natural in any way b. Because elements in the nature can be harmful for health too c. Because the mix of different nature elements can produce different effects d. Because the products that have natural labels are composed primarily by poisonous plants

According to the text, why is the cosmetic industry self-regulated?

a. To reduce the possibilities of scams on consumers b. To help the companies create better products for less money c. To ban companies who make bad quality products d. To prevent companies from taking advantage of consumers