Issue #14 - Fall 2007

• FDA Studies Whether Photos Help Consumers Identify Recalled Food Products
• Who Knew? What food safety precautions should I take when shopping at the supermarket?
• Proposed Sunscreen Rating System May Help Consumers Make Better Informed Decisions about Sun Protection
• Learn About It Online: Tanning
• Medicines in my Home: Caffeine and Your Body
• How Much Do You Know About Hepatitis?
• Tips for Preventing Foodborne Illness From Pet Food and Pet Treats
• Get FDA Health Information by Podcast
• Science in the News: FDA Issues Public Health Advisory on Nonprescription Cough and Cold Medicine Used in Children
• Calendar of National Health Events

FDA Studies Whether Photos Help Consumers Identify Recalled Food Products

When popular types of peanut butter and seafood are recalled, one of the greatest challenges may be helping consumers identify the affected products. To try and improve the process, FDA is studying the benefits of using photos in public recall notices.

For 6 months, from mid-February to mid-August, 2007, FDA ran a pilot program to test the effectiveness of posting photos of food products involved in Class I recalls as part of the recall notice. Originally suggested by several congressional committees, the goal of the pilot program is to determine whether posting photos can help consumers identify and avoid potentially hazardous recalled products.

Food Recalls

Recalls occur when a product violates the laws enforced by FDA, and poses a risk to consumer safety. The pilot program focused on Class I recalls of food products. A Class I recall occurs when it’s believed that a product on the market poses a serious public health threat or could result in death. Over 100 Class I recalls involving food products took place in the U.S. during the 2006 fiscal year. During the past five years, there have been an average of 188 Class I food recalls each year, so you can probably imagine why FDA wants to help the public identify a recalled product.

Typical food risks that FDA alerts the public to include foods contaminated with dangerous bacteria, such as Salmonella, and Listeria monocytogenes which causes the potentially fatal disease Listeriosis. Foods containing substances that may cause an allergic reaction (allergens) that are not listed on the label are also considered significant food risks.

According to the American Academy of Allergy, Asthma, and Immunology, about 12 million Americans have food allergies. They estimate that 90 percent of all allergic reactions in the U.S. are caused by 8 foods:

• Milk
• Eggs
• Fish (such as bass, flounder, and cod)
• Crustacean shellfish (such as crab, lobster, and shrimp)
• Tree nuts (such as cashews, almonds, and walnuts)
• Wheat
• Peanuts
• Soybeans

The Pilot Program

While the recent pilot included only human food products, if FDA receives feedback from consumers and industry that says that adding photos to recall notices is helpful, FDA may expand the program to include other products it regulates, like pet food, medicines, and medical devices.

The photos that were posted as part of the pilot showed a sample of the main display panel of the food’s package, because that’s the part of the label that shoppers usually see when the product is on a store shelf or is stored in their homes. In the case of recalled peanut butter, photos posted to the recall notice showed the label on the front of the jar with the brand name and package art.

In most cases each recall notice had one photo, even when multiple products or multiple varieties of a food product were recalled, such as different flavors of the same brand of ice cream. However, the number of photos posted could change in the future if posting multiple photos will more clearly identify the affected products. And, some recalled products may not have photos posted if FDA determines they won’t provide a benefit to the public, or would likely cause consumers to be confused.

Even though the photos may make recognizing a product easier, it’s still VERY IMPORTANT for consumers to also read the press release for specific information, including lot numbers or manufacturer names, that can help them identify recalled products.

Using feedback it receives through a specially designated email address (pilotphotofoods@fda.gov), FDA will evaluate the pilot program’s effectiveness. Consumer and industry feedback will weigh heavily in FDA’s evaluation, and if the program seems beneficial, FDA may adopt it permanently and possibly expand it to include recalls for other types of products it regulates.

More Information:

• The FDA Pilot Program
  • Recognizing Recalled Foods
  • FDA's Pilot Program to Better Educate Consumers about Recalled Food Products
• FDA Recalls Website
• Food Allergies -The Food Allergy and Anaphalxis Network

Source: Recognizing Recalled Foods, FDA's Pilot Program to Better Educate Consumers about Recalled Food Products

Back to Table of Contents

What food safety precautions should I take when shopping at the supermarket?

While shopping, try to keep raw meat, poultry, seafood, and eggs separate from ready-to-eat foods, like bagged vegetables, ice cream, and cereal, in your shopping cart. The same rules apply when food is packed in grocery bags. Consider placing raw foods in plastic bags to keep the juices contained. Take food home right away and refrigerate perishables immediately to prevent any bacteria from rapidly multiplying in the food. When the weather's hot, make sure to put groceries in the air-conditioned compartment of your car rather than the hot trunk.

• More Information on Preventing Foodborne Illness

Back to Table of Contents

Proposed Sunscreen Rating System May Help Consumers Make Better Informed Decisions about Sun Protection

Have you ever shopped for sunscreen and wondered what the information on the label really means? FDA is proposing changes to the labeling on all sunscreens sold in the U.S. that might help you understand more about protection against the sun's harmful rays.

While you may not see any changes to the label for several years, FDA has proposed that sunscreen labeling be expanded to provide

• A four-star rating system that informs consumers how well the product protects them against Ultraviolet A (UVA) light.
• Information on other ways people can limit their risks to dangers posed by overexposure to sunlight.

Sunlight is composed of the visible light that we can see, and ultraviolet (UV) light that we can’t. There are two types of UV light, UVA and UVB. UVB light is more effective at producing sunburns, while UVA light is more effective for tanning. Both can damage the skin and increase the risk of skin cancer.

The proposed regulation creates a consumer-friendly rating system for UVA products designed to help consumers identify the level of UVA protection offered by a product. It also provides a ratings system for UVA sunscreen products on a scale of one to four stars.

• One star will indicate low UVA protection
• Two stars, medium protection
• Three stars, high protection
• Four stars, the highest UVA protection available in an over-the-counter (OTC) sunscreen product.
• If a sunscreen product doesn’t rate at least one star, FDA is proposing that it have a "no UVA protection" marking on the front label, near the SPF (sun protection factor) value. As a general rule, the higher the SPF number, the more protection against sunburn and other skin damage the sunscreen provides.

In addition, all sunscreen product manufacturers will be required to print a new “Warning” statement in the “Drug Facts” label on their products. The new warning is intended to increase awareness that sunscreens are only one part of a sun protection program.

Many consumers incorrectly believe that the only way to protect themselves from skin damage caused by the sun is to apply sunscreens. The proposed labeling strengthens the existing labeling for sunscreens by educating consumers on the importance of limiting their time in the sun and wearing protective clothing as part of a sun protection regimen.

• FDA Consumer Health Information
• FDA’s Tanning Website

Source: FDA Aims to Upgrade Sunscreen Labeling

Back to Table of Contents

Learn About It Online: Tanning

Looking for general information on tanning and sun protection products?

Look no further than FDA’s revised Tanning website! The site has information on:

• The effects of UV exposure from the sun and tanning products
• The risks of indoor and outdoor tanning
• Sunscreens and other methods of protecting the skin from UV
• Tanning lotions and pills

VISIT
www.fda.gov/cdrh/tanning
to learn more

Back to Table of Contents

Medicines in my Home: Caffeine and Your Body

Caffeine occurs naturally in more than 60 plants including coffee beans, tea leaves, kola nuts used to flavor soft drink colas, and cacao pods used to make chocolate products. Man-made caffeine is sometimes added to foods, drinks, and medicines. Ninety percent of people in the world use caffeine in one form or another. In the U.S., 80 percent of adults consume caffeine every day – the average adult has an intake of 200 mg per day, the amount in two 5-ounce cups of coffee or four sodas. A study of 7th, 8th, and 9th grade students in Ohio found that students took in an average of 53 mg of caffeine per day, but almost one in five students took in more than 100mg of caffeine each day.

Whether caffeine is consumed in food or as a medicine, it changes the way your brain and body work and changes how you behave and feel. Caffeine is a central nervous system stimulant. Your central nervous system includes your brain, spinal cord, and the other nerves in your body. Caffeine’s main effect on your body is to make you feel more awake and alert for a while, but it can also cause problems.
It can:

• Make you jittery and shaky
• Make it hard to fall asleep, stay asleep, or get a good night’s sleep
• Make your heart beat faster
• Cause an uneven heart rhythm
• Raise your blood pressure
• Cause headaches, nervousness, and/or dizziness
• Make you dehydrated (dried out) especially after a workout
• Make you dependent on it so you need to take more of it

The FDA says that caffeine is both a drug and a food additive. Caffeine is used in both prescription and over-the-counter medicines to treat tiredness or drowsiness and to improve the effect of some pain relievers. People with heart problems shouldn’t use caffeine because it makes their hearts work too hard, and people with anxiety problems or panic attacks may find that caffeine makes them feel worse.

After drinking caffeine, it usually reaches its peak level in your blood within one hour and stays there for four to six hours. Caffeine increases the release of acid in your stomach, sometimes leading to an upset stomach or "heartburn." Caffeine is a diuretic, meaning it makes your body lose more water. So, drinks that contain caffeine aren’t good for quenching your thirst. Whether you drink sodas or coffee with caffeine or use medicines with caffeine, take care to drink extra water when you are working out or in the heat so your body doesn’t get dehydrated (dried out). Most experts feel that using small amounts of caffeine during pregnancy is safe, but larger amounts of caffeine can be harmful during pregnancy. Women who are pregnant or planning to get pregnant should speak with their doctor about using caffeine. (Organization of Teratology Information Specialists. Caffeine and Pregnancy. December 2006.)

When people use caffeine every day, their bodies get used to it, and they don’t get the “good effects” of feeling more awake and able to concentrate unless they use more of it. This is called “tolerance.” Some studies show that caffeine causes a physical dependence or addiction. If a person gets withdrawal symptoms when they suddenly stop using caffeine, then the person has a physical dependence on caffeine. Withdrawal symptoms don’t feel good and can include: severe headaches, muscle aches, temporary feelings of depression, and irritability. When people experience these symptoms, they often just take in more caffeine to make them go away. This cycle is hard to break.

Studies suggest that moderate amounts of caffeine are not harmful. How much is moderate? One hundred to 200 mg (one to two 5-ounce cups of coffee) each day is the limit that some doctors suggest, but each person is a little different. How caffeine affects people varies with their size, their sex, and how sensitive they are to caffeine’s effects. Experts agree that 600 mg (four to seven cups of coffee) of caffeine or more each day is too much.

Caffeine overdose is dangerous and can kill you. FDA knows of a 19 year old college student who died after taking an overdose of caffeine tablets to stay awake. A caffeine tablet contains as much caffeine as one to three 5-ounce cups of coffee.

Be informed. Learn how much caffeine is in your foods and drinks. Check the Caffeine Content Table to see how much caffeine you take in each day. If you’re taking in too much caffeine, you may want to cut back. This isn’t easy – reduce your caffeine slowly to make withdrawal symptoms (like bad headaches, and feeling tired, and depressed) as mild as possible.

Back to Table of Contents

How Much Do You Know About Hepatitis?

For most teens, back to school means more than shopping for pencils and notebooks, it usually means a trip to the doctor for immunizations (vaccines) against viruses, like hepatitis.

Hepatitis is a condition that affects the liver, causing it to become inflamed. That’s bad news for anybody, because the liver is an organ with some very important jobs. Although it only weighs about three pounds, the liver is the largest organ inside your body. It has more than 500 known functions including filtering harmful substances from the blood, digesting fats from food, and storing the sugar your body uses for energy.

There are several things that can cause hepatitis, including a virus, a bacterial infection, liver injury caused by a toxin (poison), and even an attack on the liver by the body's own immune system. There are six types of hepatitis: A, B, C, D, E and G. However, the condition is usually caused by one of three viruses: Hepatitis A, Hepatitis B, or Hepatitis C.

Hepatitis A

The hepatitis A virus (HAV) is spread from person to person by putting something in the mouth that has been contaminated with the feces (poop) of a person with the virus. For this reason, the virus is more easily spread in areas with poor sanitary conditions. Unfortunately, a person with HAV may not have any signs or symptoms of HAV, so they may not realize they have it. Older people are more likely to have symptoms of HAV than children, and most symptoms last between three weeks and six months. HAV usually includes a sudden onset of flu-like symptoms, such as:

• Health Tip You can help prevent the spread of disease by always washing your hands with soap and water after using the bathroom, changing a diaper, and before preparing or eating food.

  Fatigue
• Fever
• Nausea/Vomiting
• Diarrhea
• Severe stomach/abdominal pain
• Loss of appetite

A test of body fluid (serum), performed in a doctor’s office or clinic, can help determine if someone has an HAV infection. The good news is that people who recover from HAV develop antibodies that provide life-long protection from future infections. So they can’t get it again, and they can’t transmit the virus to others. About 22,700 cases of HAV, or about 38 percent of all hepatitis cases, are reported every year in the U.S., and about one third of Americans have evidence of past infection (immunity).

Most cases of HAV only require a treatment of bed rest and abstinence from all sexual activity. There are two medical options that have been approved as safe by the FDA for the prevention of HAV, the hepatitis A vaccine and Immune Globulin. The vaccine is recommended for:

• Travelers to areas with increased rates of HAV
• Men who have sex with men
• All children 12 through 23 months of age
• Those who live with people infected with HAV
• Injecting and non-injecting illegal drug users
• People with chronic liver disease
• People who have clotting disorders
• Those who engage in sexual activity with people infected with HAV

The vaccine includes two doses given at least 6 months apart. The vaccine may be started whenever a person is at risk of infection, and may be given at the same time as other vaccines. The risks of the vaccine, if any, are very low. Mild side effects have been reported, including soreness, headache, loss of appetite, and tiredness. The HAV vaccine could protect you for at least 25 years, and protection begins four weeks after the first dose.

Immune Globulin is a mixture of antibodies that gives immediate, but temporary protection. It’s recommended for short-term protection against hepatitis A, or for people who have already been exposed to HAV.

Hepatitis B

Hepatitis B is caused by a virus that attacks the liver. The virus, which is called hepatitis B virus (HBV), can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death. The hepatitis B virus (HBV) is spread by exposure to infected blood. It can be spread by unprotected sex with an infected partner, by sharing drugs, needles, or "works" when "shooting" drugs, through needlesticks or sharps exposures on the job, or from an infected mother to her baby during birth. Many people infected with HBV have no symptoms at all. However, some show signs of:

• Flu-like symptoms
• Joint pain
• Oddly-colored (clay, gray, tan) bowel movements

Long term affects of chronic HBV can include:

• Lifelong infection
• Scarring (cirrhosis) of the liver
• Liver cancer/liver failure
• Death

A blood test is the only way to determine whether someone has an HBV infection. The FDA has approved the first fully automated product that combines both screening and confirmatory tests for HBV. It’s approved to test blood and organ donors, and it can also be used to screen blood from cadavers for organ and tissue donation.

There are two types of HBV, acute and chronic. Acute infections last several weeks, and usually go away without treatment. Chronic HBV is more prominent in younger children and infants. There are a number of drugs used for the treatment of people with chronic HBV, but there is currently no cure.

Though the number of new infections per year has declined from an average of 260,000 in the 1980s to about 60,000 in 2004, there are currently an estimated 1.25 million Americans infected with chronic HBV. Each year, about 80,000 people are infected with HBV, and 4,000 to 5,000 people die from chronic HBV. Some experts estimate that one out of 20 people in the U.S. will be infected with HBV at some time during their lives.

A vaccine for HBV has been available since 1982. It’s recommended for:

• All babies, at birth
• All children 0-18 years of age who have not been vaccinated
• People of any age whose behavior or job exposes them to HBV-infected blood

The vaccine is injected in three doses into a muscle (intramuscular). The second dose is given one month after the first, and the third dose six months after the second.

The vaccine has proven to be safe for use in adults as well as children, and it may be given at the same time as other vaccines. It’s not recommended for those with yeast allergies.

Recent studies indicate that the vaccine provides immunity for at least 23 years. In its chronic state, HBV can lead to primary liver cancer. The Centers for Disease Control and Prevention has recognized the HBV vaccine as the first anti-cancer vaccine, because it can prevent primary liver cancer.

Hepatitis C

Hepatitis C is the most serious type of hepatitis. Like HBV, the hepatitis C virus (HCV) is spread by direct contact with infected human blood. It’s most commonly spread by contaminated tattoo or body piercing needles, or needles used for illegal drug use. Infected mothers also may infect newborns during birth. In rare cases, HCV can be spread through unprotected sex with an infected partner.

Eighty percent of infected people don’t show any symptoms, but some show signs of flu-like symptoms. Long-term affects of chronic HCV can include:

• Lifelong infection
• Chronic liver disease
• Death

In 2001, the FDA approved two blood tests that indicate if an HCV infection is active. FDA has also approved the Home Access® Hepatitis C Test kit for home use, so that people can diagnose themselves at home.

Thanks to prevention awareness in America, the number of new infections per year has declined from an average of 240,000 in the 1980’s to about 26,000 in 2004. Still, an estimated 4.1 million Americans have been infected with HCV, and 1 to 5 percent of people with long-term HCV are at risk for liver cancer or cirrhosis.

There is no vaccine currently available to prevent HCV. People with mild HCV may be advised by their doctors’ to eat a nutritious diet, avoid alcohol, and stay in shape to maintain their strength, energy, and overall well-being. For more severe cases, combination therapy using two drugs, interferon and ribavirin, may be necessary. The FDA has approved this treatment for use in children aged 3-17 years. About 10 percent of patients have no side effects, and about 10 percent have very severe side effects, such as suicidal behavior, heart problems, or other internal organ damage.

The remaining 80 percent have tolerable side effects such as flu-like symptoms, low red blood cell count (anemia), fatigue, hair loss, and depression.

For More Information:

• The Five Faces of Hepatitis
• CDC Viral Hepatitis

Source: CDC Viral Hepatitis

Back to Table of Contents

Tips for Preventing Foodborne Illness From Pet Food and Pet Treats

Just like human food, pet food and treats are susceptible to bacterial contaminants that may cause illness in pets and people. So far this year 15 pet products have been recalled due to Salmonella contamination; however, to date none of these products have been directly linked to human illness. FDA offers the following steps consumers can take to help prevent foodborne illness, including Salmonella-related illness, when handling pet foods and treats.

Salmonella in pet foods and treats can cause serious infections in dogs and cats, and, if there is cross contamination, in people too, especially children, the aged, and people with compromised immune systems. Salmonella can potentially be transferred to people eating or handling contaminated pet food and treats.

While the FDA has increased its efforts to reduce the incidence of foodborne illness associated with pet foods and treats, it’s important that consumers be aware of the potential risks. Pet owners can reduce the chance of infection from contaminated pet foods and treats by practicing safe food handling.

Buying Tips for Pet Food

• Buy products (canned or bagged) that are in good condition with no visible signs of damage to the packaging such as dents, tears, or discolorations.

Preparation Tips for Pet Food

• Begin with clean hands. Wash your hands for 20 seconds with hot water and soap before and after handling pet foods and treats.
• Wash pet food bowls, dishes and scoops with soap and hot water after each use.
• Do not use the pet’s feeding bowl as a scoop – choose a clean scoop, spoon or cup that will only be used for pet food.
• Dispose of old or spoiled pet food products in a safe manner, like in a securely tied plastic bag in a covered trash can.

Storage Tips for Pet Food

• Refrigerate or throw away any unused, left-over wet pet food (cans, pouches, etc.). Refrigerating foods quickly keeps most harmful bacteria from growing and multiplying. Refrigerators should be set at 40º F. The accuracy of the setting should be checked occasionally with a refrigerator thermometer.
• Dry products should be stored in a cool, dry place--under 80º F.
• If possible, store dry pet food in its original bag inside a clean, plastic container with a lid, keeping the top of the bag folded closed.
• Keep pets away from food storage and preparation areas.
• Keep pets away from garbage and household trash.

Raw Food Diets

The FDA does not advocate a raw meat, poultry or seafood diet for pets, but is stepping up its efforts to minimize the risk such foods pose to animal and human health because the agency understands that some people prefer to feed these types of diets to their pets. For the protection of both you and your pet, the FDA recommends you follow these instructions when handling or using raw meat, poultry or seafood, for use in a pet’s diet:

• Keep raw meat and poultry products frozen until ready to use.
• Thaw food in a refrigerator or microwave.
• Keep raw foods separate from other foods. Wash work surfaces, utensils (including cutting boards, preparation and feeding bowls), hands, and any other items that touch or contact raw meat, poultry or seafood with hot soapy water.
• Cover and refrigerate leftovers immediately or discard safely.

In addition:

• For added protection, kitchen sanitizers should be used on cutting boards and counter tops periodically. A sanitizing solution can be made by mixing one teaspoon of chlorine bleach with one quart of water.
• If you use plastic or other non-porous cutting boards, run them through the dishwasher after each use.

For additional information about safe food handling, please see Food, Nutrition, and Cosmetics Questions & Answers - How can I prevent foodborne Illness?

Source: FDA Tips for Preventing Foodborne Illness Associated with Pet Food and Pet Treats

Back to Table of Contents

Get FDA Health Information by Podcast

Getting information on health and safety just got easier! Now you can subscribe to FDA Podcasts and have the information you want delivered right to your computer.

Podcasting is a way to get audio and video broadcasts through the Internet using an automatic feed in a process called subscribing. You can play the podcast from your computer, using free software such as iTunes, QuickTime, or Windows Media Player. Or you can transfer the file to a portable media player, such as an iPod or any other mobile MP3 player.

On the FDA Website, Podcasts are identified by the icon. To subscribe to a podcast, click on the icon, then copy the URL (the text in the Address line at the top of your Web browser), and paste it into your podcasting application. The software applications are all a little different, so check the software’s online help and manuals for complete instructions.

Once you subscribe to a Podcast, new content is automatically downloaded to the podcasting software on your computer as the site updates its information.

Subscribe to FDA Podcasts:

• Drugs
• Patient Safety News

Back to Table of Contents

FDA Issues Public Health Advisory on Nonprescription Cough and Cold Medicine Used in Children

In October, FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee will meet to discuss the safety and effectiveness of over-the counter (OTC) cough and cold medicine use in children. Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially children under 2 years of age.

Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children. An OTC cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used. To avoid giving a child too much medicine, parents and childcare providers must carefully follow the directions for use of the product in the “Drug Facts” box on the package label.

What should you know about giving cough and cold medicines to children:

• Don’t use cough and cold products in children under 2 years of age UNLESS a doctor or other healthcare professional tells you to.
• Don’t give children medicine that is made for adults. Use only products marked for use in babies, infants or children (sometimes called “pediatric” use).
• Cough and cold medicines come in many different strengths. If you are unsure about the right product for the child, ask a doctor or pharmacist.
• If other medicines (OTC or prescription) are being given to a child, the child’s doctor or other health care professional should review and approve using them together.
• Read all of the information in the “Drug Facts” label so that you know the active ingredients and the warnings.
• Follow the directions in the “Drug Facts” label. Don’t give a child medicine more often or in greater amounts than is directed on the label.
• Too much medicine may lead to serious and life-threatening side effects, particularly in children age 2 years and younger.
• For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with each different medicine and that is marked to deliver the correct dose. A kitchen teaspoon or tablespoon may not give the right dose.
• If a measuring device is not included with the product, you can buy one at a pharmacy. Make sure that the dropper, dosing cup or dosing spoon has markings on it that match the dosing that is in the directions in the “Drug Facts” label or is recommended by the child’s doctor or other health care professional.
• If you DO NOT UNDERSTAND the instructions on the product, or how to use the dosing tool (dropper, dosing cup or dosing spoon), DON’T USE the medicine. Consult a healthcare professional if you have questions or are confused.
• Cough and cold medicines only treat the symptoms of the common cold such as runny nose, congestion, fever, aches, and irritability. They do not cure the common cold.
• If a child’s condition gets worse or doesn’t get better, call a health care professional.

The Nonprescription Cough and Cold Medicine Use in Children advisory is available by podcast at:
http://www.fda.gov/cder/drug/podcast/cough_cold_full.htm

Source: Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children, August 15, 2007

Back to Table of Contents

Calendar of National Health Events

Other health events that may be of interest to teens are listed on our website at

http://www.fda.gov/cdrh/fdaandyou/calendar.html

Back to Table of Contents