The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.

The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques. (Wikipedia.org)

FEATURES:
Cover Story: Cracking Down on Health Fraud
The FDA teams up with other agencies to protect consumers from fraudulent devices and other products.

Outreach Program to Teach Safe Medicine Use to Middle School Children
A cooperative effort allows school students to take a lesson in over-the-counter medicine.

The FDA: Fresh Leafy Greens Grown in the United States Are Safe
Every year, there are many thousands of pounds of fresh leafy greens, such as lettuce and spinach, grown in the United States and eaten by the public with no consequent illness. Outbreaks, however, do occur.

Purchasing Pet Drugs Online: Buyer Beware
Pet owners need to use caution to avoid unscrupulous Internet pharmacies.

The FDA Broadens Access to Lead Screening Test
It will now be easier and faster to test children and adults for lead poisoning.

The Importance of Patient-Reported Outcomes … It’s All About the Patients
How patients feel and function has taken on new importance in clinical trials and in making claims about drugs and medical devices.

New FDA Test Detects Fake Bioterror Agents
Researchers are developing a quick way to identify suspected samples of bioterror agents.

First of a Kind in HIV Treatment
A new 3-in-1 tablet simplifies the drug regimen for adults infected with HIV-1.

Strengthening the Regulation of Clinical Trials and Bioresearch Monitoring
An FDA initiative supports the safe conduct of clinical trials

Read FDA Consumer Magazine, November/December 2007 Online

Online HTML Edition. Published by FDA.

Take the FDA Consumer Quiz

How's your knowledge of health topics such as pain control, health fraud, lead hazards, and medicines for your pets? Find out by taking our quiz.

Hint: The answers to all these questions can be found within articles in the November-December 2006 issue of FDA Consumer (and at the bottom of this page).

1. A patient-reported outcome instrument is:

a. a device that delivers a shock every time a patient forgets to take his or her medication

b. a beeping ankle device worn by patients to ensure they don’t leave the hospital until released

c. a questionnaire used to collect information about how a patient feels and functions

d. an acoustic guitar played in hospitals to entertain patients

2. In most cases, if someone has been in pain, the only way to know whether he or she is feeling better is to:

a. ask the person

b. measure his or her pain with an electronic pain assessment device found in certain hospitals and clinics

c. biopsy his or her brain

d. X-ray his or her spine

e. do an MRI

3. A broad concept referring to all aspects of a person’s well-being is called:

a. psyche

b. ego

c. psychosocial theory

d. quality of life

e. health-related quality of life

4. What is PROMIS?

a. a new health plan that ensures better coverage for patients

b. a new drug to treat colon cancer

c. a new drug to treat prostate cancer

d. Patient-Reported Outcomes Measurement Information System

e. a new, improved version of a butter substitute

5. According to the American Heartworm Society, which states have never reported heartworm in dogs?

a. Alaska and Hawaii

b. only Alaska

c. Montana, Colorado, and Wyoming

d. Alaska, Washington, and Idaho

e. all 50 states have reported heartworm

6. Which pets can be infected with heartworms?

a. dogs, cats, and ferrets

b. only dogs

c. only dogs and cats

d. dogs, cats, and fish

e. dogs, frogs, and fish

7. Since 2003, how many compliance actions has the Mexico, United States, Canada Health Fraud Working Group taken against misleading weight loss schemes?

a. 50

b. 200

c. 450

d. more than 700

8. In 2005 and 2006, the FDA’s Center for Devices and Radiological Health issued Warning Letters to firms that claimed to prevent or cure avian influenza with which type of devices?

a. an “avian influenza device kit”

b. masks

c. breathing machines

d. contact lenses

9. Which of the following are considered health fraud red flags?

a. undocumented case histories claiming amazing results

b. statements that a product can cure several diseases at once

c. promises of an “easy” fix

d. limited availability of the product and advance payment requirements

e. all of the above

10. About how many homes in the United States have significant lead-based paint hazards?

a. 4 million

b. 16 million

c. 24 million

d. 52 million

Answers to the FDA Consumer Quiz:

      1. A patient-reported outcome instrument is: c. a questionnaire used to collect information about how a patient feels and functions

      2. In most cases, if someone has been in pain, the only way to know whether he or she is feeling better is to: a. ask the person

      3. A broad concept referring to all aspects of a person’s well-being is called: d. quality of life

      4. What is PROMIS? d. Patient-Reported Outcomes Measurement Information System

      5. According to the American Heartworm Society, which states have never reported heartworm in dogs? e. all 50 states have reported heartworm

      6. Which pets can be infected with heartworms? a. dogs, cats, and ferrets

      7. Since 2003, how many compliance actions has the Mexico, United States, Canada Health Fraud Working Group taken against misleading weight loss schemes? d. more than 700

      8. In 2005 and 2006, the FDA’s Center for Devices and Radiological Health issued Warning Letters to firms that claimed to prevent or cure avian influenza with which type of devices? b. masks

      9. Which of the following are considered health fraud red flags? e. all of the above

      10. About how many homes in the United States have significant lead-based paint hazards? c. 24 million

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