Drug & Food - FAQs:

One cup refers to a common measuring cup (the kind used in recipes). In general, 1 cup of raw or cooked vegetables or 100% vegetable juice, or 2 cups of raw leafy greens can be considered as 1 cup from the vegetable group. One cup of fruit or 100% fruit juice, or ½ cup of dried fruit can be considered as 1 cup from the fruit group.

Some examples of measurements of fruits and vegetables:

1 Cup =

• 1 small apple
• 1 medium grapefruit
• 1 large orange
• 1 medium pear
• 1 small wedge of watermelon
• 2 large or 3 medium plums
• 8 large strawberries
• 1 large bell pepper
• 1 medium potato
• 2 large stalks of celery
• 1 large ear of corn

1/2 Cup =

• 1 small banana
• 1 cup of lettuce
• 6 baby carrots
• 16 grapes
• 1 medium cantaloupe wedge
• 5 broccoli florets
• 1 small box of raisins

In addition to fruits and vegetables, a healthful diet also includes whole grains, fat-free or low-fat milk and milk products, lean meats, poultry, fish, dry beans, eggs and nuts, and is low in saturated fats, trans fats, cholesterol, salt, and added sugars.

----------------------

*1 cup of lettuce counts as 1/2 cup of vegetables.

Here are some simple ways to cut calories and eat fruits and vegetables throughout your day:

Breakfast: Start the Day Right

• Substitute some spinach, onions, or mushrooms for one of the eggs or half of the cheese in your morning omelet. The vegetables will add volume and flavor to the dish with fewer calories than the egg or cheese.
• Cut back on the amount of cereal in your bowl to make room for some cut-up bananas, peaches, or strawberries. You can still eat a full bowl, but with fewer calories.

Lighten Up Your Lunch

• Substitute vegetables such as lettuce, tomatoes, cucumbers, or onions for 2 ounces of the cheese and 2 ounces of the meat in your sandwich, wrap, or burrito. The new version will fill you up with fewer calories than the original.
• Add a cup of chopped vegetables, such as broccoli, carrots, beans, or red peppers, in place of 2 ounces of the meat or 1 cup of noodles in your favorite broth-based soup. The vegetables will help fill you up, so you won't miss those extra calories.

Dinner

• Add in 1 cup of chopped vegetables such as broccoli, tomatoes, squash, onions, or peppers, while removing 1 cup of the rice or pasta in your favorite dish. The dish with the vegetables will be just as satisfying but have fewer calories than the same amount of the original version.
• Take a good look at your dinner plate. Vegetables, fruit, and whole grains should take up the largest portion of your plate. If they do not, replace some of the meat, cheese, white pasta, or rice with legumes, steamed broccoli, asparagus, greens, or another favorite vegetable. This will reduce the total calories in your meal without reducing the amount of food you eat. BUT remember to use a normal- or small-size plate — not a platter. The total number of calories that you eat counts, even if a good proportion of them come from fruits and vegetables.

Smart Snacks

• Most healthy eating plans allow for one or two small snacks a day. Choosing most fruits and vegetables will allow you to eat a snack with only 100 calories.

Learn more about healthy eating at FruitsAndVeggiesMatter.gov.

Consumers have an important role in reducing radiation risks from medical X-rays. FDA recommends these steps:

Ask your health care professional how an X-ray will help. How will it help find out what's wrong or determine your treatment? Ask if there are other procedures that might be lower risk but still allow a good assessment or treatment for your medical situation.

• Don't refuse an X-ray. If your health care professional explains why it is medically needed, then don't refuse an X-ray. The risk of not having a needed X-ray is greater than the small risk from radiation.
• Don't insist on an X-ray. If your health care professional explains there is no need for an X-ray, then don't demand one.

Tell the X-ray technologist in advance if you are, or might be, pregnant.

Ask if a protective shield can be used. If you or your children are getting an X-ray, ask whether a lead apron or other shield should be used.

Ask your dentist if he/she uses the faster (E or F) speed film for X-rays. It costs about the same as the conventional D speed film and offers similar benefits with a lower radiation dose. Using digital imaging detectors instead of film further reduces radiation dose.

Know your X-ray history. "Just as you may keep a list of your medications with you when visiting the doctor, keep a list of your imaging records, including dental X-rays," says Ohlhaber. When an X-ray is taken, fill out the card with the date and type of exam, referring physician, and facility and address where the images are kept. Show the card to your health care professionals to avoid unnecessary duplication of X-rays of the same body part. Keep a record card for everyone in your family.

If you have no symptoms of illness but are considering getting a whole-body CT screening exam, you may be thinking either or both of the following:.

1. "For my peace of mind, I just want to know that I don't have any diseases now."
2. "If I have a disease, I want to know about it now so that I can do something about it."

What you may not realize is that getting a whole-body CT screening exam may not accomplish either of these goals. In particular, an abnormal finding may not be a serious finding at all. And a normal finding may be inaccurate. We will consider these one at a time below, but before we do, the good news is that, if you have no symptoms of illness, the probability is high that there is nothing seriously wrong with you--and this is true without your ever getting a whole-body CT screening exam.

Should you be screened? Like any other medical procedure, there are risks involved. Before undergoing this exam, be sure to research all the issues.

Consider further that the FDA has never approved CT for screening any part of the body for any specific disease, let alone for screening the whole body when there are no specific symptoms of disease at all. No manufacturer has submitted data to FDA to support the safety and efficacy of screening claims for whole-body CT screening.

Salmonella is the name of a group of bacteria. In the United States, it is the most common cause of foodborne illness. Salmonella occurs in raw poultry, eggs, beef, and sometimes on unwashed fruit and vegetables.

Symptoms include fever, diarrhea, abdominal cramps and headache. Symptoms usually last 4 - 7 days. Most people get better without treatment. It can be more serious in the elderly, infants and people with chronic conditions. If Salmonella gets into the bloodstream, it can be serious, or even life-threatening. The usual treatment is antibiotics. (Read more about Salmonella) (MedlinePlus.gov)

E. coliis the name of a type of bacteria that lives in your intestines. Most types of E. coli are harmless. However, some types can make you sick and cause diarrhea. One type causes travelers' diarrhea. The worst type of E. coli causes bloody diarrhea, and can sometimes cause kidney failure and even death. These problems are most likely to occur in children and in adults with weak immune systems.

You can get E. coli infections by eating foods containing the bacteria. To help avoid food poisoning and prevent infection, handle food safely. Cook meat well, wash fruits and vegetables before eating or cooking them, and avoid unpasteurized milk and juices. You can also get the infection by swallowing water in a swimming pool contaminated with human waste. (Read more about E. coli) (MedlinePlus.gov)

While temporary and permanent tattoos are subject to regulation as cosmetics and are under the jurisdiction of the HHS Food and Drug Administration (FDA), state and local agencies have direct jurisdiction over the practice of tattooing by salon technicians. FDA is currently evaluating the safety of tattoos and permanent makeup as a result of their growing popularity. Among the issues being considered are tattoo removal, adverse reactions to tattoo colors and infections and infectious disease that result from the use of these products.

The inks, or dyes, used for tattoos are color additives. Currently no color additives have been approved for tattoos, including those used in permanent makeup.

Consumers should be aware of some of the risks presented by tattoos and permanent makeup:

1. Unsterile tattooing equipment and needles can transmit infectious disease, such as hepatitis; it is extremely important to confirm that all equipment is clean and sanitary before use;

2. Tattoos and permanent makeup are not easily removed and in some cases may cause permanent discoloration; think carefully before getting a tattoo and consider the possibility of an allergic reaction; and

3. Blood donations cannot be made for a year after getting a tattoo or permanent makeup.

Learn More:

• Think Before You Ink: Are Tattoos Safe? (FDA)
• Piercing and Tattoos (Medline Plus)
• Can I get HIV from getting a tattoo or through body piercing?
• Tattoos and Permanent Make-Up (FDA)
• Body Art (National Institute for Occupational Safety and Health, CDC)
• Temporary Tattoos and Henna/Mehndi (FDA)

Veterinarians and animal owners are encouraged to report adverse drug experiences and suspected product failures to the government agency that regulates the product in question. Visit the FDA Center for Veterinary Medicines', "Adverse Drug Experience Reporting" page at http://www.fda.gov/cvm/adetoc.htm for the information and forms that are needed to report adverse experiences with veterinary drugs.

Although some online pharmacies are legitimate businesses, patients must be cautious when purchasing drugs over the Internet. Patients should not buy drugs from web sites that:

• are not registered on a search engine;
• offer to prescribe a prescription drug without a physical exam;
• sell drugs not approved by the HHS Food and Drug Administration (FDA);
• do not offer the opportunity to ask questions of a registered pharmacist;
• require that you link to another web site to purchase the drug; and
• do not provide a U.S. phone number and address to contact for questions.

Before buying a prescription drug over the Internet, patients should check with the National Association of Boards of Pharmacy to see if the online pharmacy possesses a valid pharmacy license and has met state practice standards. Patients who believe that a web site is unlawfully selling a drug should report it to the National Association of Boards of Pharmacy or to the FDA.

For more information on buying medical products online, see the Agency's "Buying Medicines and Medical Products Online" Web page: http://www.fda.gov/ForConsumers/ProtectYourself/default.htm.

Due to confidentiality rules, the Food and Drug Administration (FDA) is prohibited from releasing information on any drug under development, review or pending approval unless the information has been made public. You may contact the manufacturer directly to ask about products under development.

Another possible source of information is the Pharmaceutical Research and Manufacturers of America (PhRMA).

FDA does provide information about the following subjects related to drugs:

Emergency Preparedness
Bioterrorism, drug preparedness and natural disaster response

Drug Approvals and Databases
Drug-Related Databases from FDA; Information on Drug Approvals

Drug Safety and Availability
Medication Guides, Drug Shortages, Public Health Advisories and Other Safety Announcements

Development & Approval Process (Drugs)
Conducting Clinical Trials, Types of Drug Applications, Forms and Submissions Requirements

Guidance, Compliance & Regulatory Information
Guidance for Industry, Warning Letters, Postmarket Surveillance Programs

The HHS Food and Drug Administration (FDA) works with pharmaceutical companies to ensure that all drugs marketed in the United States meet specifications for identity, strength, quality, purity, and potency. Before approving a generic drug product, FDA requires many rigorous tests and procedures to ensure that the generic drug can be substituted for the brand name drug.

FDA bases evaluations of substitutability or "therapeutic equivalence" for generic drugs on scientific evaluations. By law, generic drug products must contain the identical amounts of the same active drug ingredient as the brand name product. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product. FDA considers drug products to be substitutable if they meet the criteria of therapeutic equivalence, even though the generic drug may differ in certain other characteristics (e.g., shape, flavor, or preservatives).

For more information on generic drugs (FAQs), please visit: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm

The first rule of food storage in the home is to refrigerate or freeze perishables right away. The refrigerator temperature should be 5 degrees Celsius (40 degrees Fahrenheit), and the freezer should be -18 C (0 F). Check both "fridge" and freezer periodically with a good thermometer.

Poultry and meat heading for the refrigerator may be stored as purchased in the plastic wrap for a day or two. If only part of the meat or poultry is going to be used right away, it can be wrapped loosely for refrigerator storage. Just make sure juices can't escape to contaminate other foods. Wrap tightly foods destined for the freezer. Leftovers should be stored in tight containers. Store eggs in their carton in the refrigerator itself rather than on the door, where the temperature is warmer.

Seafood should always be kept in the refrigerator or freezer until preparation time

Don't crowd the refrigerator or freezer so tightly that air can't circulate. Check the leftovers in covered dishes and storage bags daily for spoilage. Anything that looks or smells suspicious should be thrown out.

A sure sign of spoilage is the presence of mold, which can grow even under refrigeration. While not a major health threat, mold can make food unappetizing.

Most moldy foods should be thrown out. But you might be able to save molding hard cheeses, salami, and firm fruits and vegetables if you cut out not only the mold but a large area around it. Cutting the larger area around the mold is important because much of the mold growth is below the surface of the food.

Many items besides fresh meats, vegetables, and dairy products need to be kept cold. For instance, mayonnaise and ketchup should go in the refrigerator after opening. Always check the labels on cans or jars to determine how the contents should be stored. If you've neglected to refrigerate items, it's usually best to throw them out.

For foods that can be stored at room temperature, some precautions will help make sure they remain safe. Potatoes and onions should not be stored under the sink, because leakage from the pipes can damage the food. Potatoes don't belong in the refrigerator either. Store them in a cool, dry place. Don't store foods near household cleaning products and chemicals.

Check canned goods to see whether any are sticky on the outside. This may indicate a leak. Newly purchased cans that appear to be leaking should be returned to the store, which should notify the HHS Food and Drug Administration.

Learn more about preparing and storing food safely at FoodSafety.gov.

The first cardinal rule of safe food preparation in the home is: Keep everything clean.

The cleanliness rule applies to the areas where food is prepared and, most importantly, to the cook.

• Wash hands with warm water and soap for at least 20 seconds before starting to prepare a meal and after handling raw meat or poultry.
• Cover long hair with a net or scarf, and be sure that any open sores or cuts on the hands are completely covered. If the sore or cut is infected, stay out of the kitchen.
• Keep the work area clean and uncluttered. Wash countertops with a solution of 1 teaspoon of chlorine bleach to 1 quart of water or with a commercial kitchen cleaning agent diluted according to product directions. They're the most effective at getting rid of bacteria.
• Also, be sure to keep dishcloths clean because, when wet, they can harbor bacteria and may promote their growth. Wash dishcloths weekly in hot water in the washing machine.
• Sanitize the kitchen sink drain periodically by pouring down the sink a solution of 1 teaspoon of bleach to 1 quart of water or a commercial kitchen cleaning agent. Food particles get trapped in the drain and disposal and, along with the moistness, create an ideal environment for bacterial growth.
• Use smooth cutting boards made of hard maple or a non-porous material such as plastic and free of cracks and crevices. Avoid boards made of soft, porous materials. Wash cutting boards with hot water and soap, using a scrub brush. Then, sanitize them by washing in an automatic dishwasher or by rinsing with a solution of 1 teaspoon of chlorine bleach to 1 quart of water.
• Always wash and sanitize cutting boards after using them for raw foods, such as seafood or chicken, and before using them for ready-to-eat foods. Consider using one cutting board only for foods that will be cooked, such as raw fish, and another only for ready-to-eat foods, such as bread, fresh fruit, and cooked fish.
• Always use clean utensils and wash them between cutting different foods.
• Wash the lids of canned foods before opening to keep dirt from getting into the food. Also, clean the blade of the can opener after each use. Food processors and meat grinders should be taken apart and cleaned as soon as possible after they are used.
• Do not put cooked meat on an unwashed plate or platter that has held raw meat.
• Wash fresh fruits and vegetables thoroughly, rinsing under running water. Don't use soap or other detergents. If necessary--and appropriate--use a small scrub brush to remove surface dirt.

The second cardinal rule of safe home food preparation is: Keep hot foods hot and cold foods cold.

• Use a digital or dial food thermometer to ensure that meats are completely cooked. Insert the thermometer into the center of the food and wait 30 seconds to ensure an accurate measurement. Beef, lamb, and veal should be cooked to at least 145 F (63 C); pork and ground beef to 160 F (71 C); whole poultry and thighs to 180 F (82 C); poultry breasts to 170 F (77 C); and ground chicken or turkey to 165 F (74 C).
• Eggs should be cooked until the white and the yolk are firm. Avoid foods containing raw eggs, such as homemade ice cream, mayonnaise, eggnog, cookie dough and cake batter, because they carry a Salmonella risk. Their commercial counterparts usually don't because they're made with pasteurized eggs. Cooking the egg-containing product to an internal temperature of at least 160 F (71 C) will kill the bacteria.
• Seafood should be thoroughly cooked to an internal temperature of at least 145 F (63 C). Fish that's ground or flaked, such as a fish cake, should be cooked to at least 155 F (68 C), and stuffed fish to at least 165 F (74 C).

If you don't have a food thermometer, look for other signs of doneness. For example:

• Fish is done when the thickest part becomes opaque and the fish flakes easily when poked with a fork.
• Shrimp can be simmered three to five minutes or until the shells turn red.
• Clams and mussels are steamed over boiling water until the shells open (five to 10 minutes). Then boil three to five minutes longer.
• Oysters should be saut??ed, baked or boiled until plump, about five minutes.

Protect food from cross-contamination after cooking, and eat it promptly.

• Cooked foods should not be left standing on the table or kitchen counter for more than two hours. Disease-causing bacteria grow in temperatures between 40 and 140 F (4 and 60 C). Cooked foods that have been in this temperature range for more than two hours should not be eaten.
• If a dish is to be served hot, get it from the stove to the table as quickly as possible. Reheated foods should be brought to a temperature of at least 165 F (74 C). Keep cold foods in the refrigerator or on a bed of ice until serving. This rule is particularly important to remember in the summer months.
• After the meal, leftovers should be refrigerated as soon as possible. (Never mind that scintillating dinner table conversation!) Meats should be cut in slices of three inches or less and all foods should be stored in shallow containers to hasten cooling. Be sure to remove all the stuffing from roast turkey or chicken and store it separately. Giblets should also be stored separately. Leftovers should be used within three days.

And here are just a few more parting tips to keep your favorite dishes safe.

• Don't thaw meat and other frozen foods at room temperature. Instead, move them from the freezer to the refrigerator for a day or two; or defrost submerged in cold water. You can also defrost in the microwave oven or during the cooking process. Cook foods immediately after defrosting in the microwave or cold water.
• Never taste any food that looks or smells "off" or comes out of leaking, bulging or severely damaged cans or jars with leaky lids.

Learn about the latest recalls and stories on food labels, food illnesses, and keeping it safe at: http://www.foodsafety.gov

Products found to be unfit for consumers are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. These products usually are destroyed, or in some cases, they are reconditioned to be in compliance with FDA regulations.

FDA is only able to regulate cosmetics after products are released to the marketplace. Neither cosmetic products nor cosmetic ingredients are reviewed or approved by FDA before they are sold to the public.

FDA cannot require companies to do safety testing of their cosmetic products before marketing. If, however, the safety of a cosmetic product has not been substantiated, the product's label must read: "WARNING: The safety of this product has not been determined."

FDA does not have the authority to require manufacturers to register their cosmetic establishments, file data on ingredients, or report cosmetic-related injuries. To keep abreast of such information, FDA maintains a voluntary data collection program. Cosmetic companies that wish to participate in the program forward data to FDA.

Recalls are voluntary actions taken by the cosmetic industry to call back products that present a hazard or that are somehow defective. FDA is not permitted to require recalls of cosmetics but does monitor companies that conduct a product recall. If FDA wishes to remove a cosmetic product from the market, it must first prove in a court of law that the product may be injurious to users, improperly labeled, or otherwise violates the law.

FDA collects cosmetic product samples as part of its plant inspections, import inspections, and follow-ups to complaints of adverse reactions. The agency does not, however, function as a private testing laboratory. FDA is prohibited from recommending private laboratories to consumers for sample analysis. Consumers may consult their local phone directory for testing laboratories.

FDA can inspect cosmetics manufacturing facilities, collect samples for examination, and take action through the Department of Justice to remove adulterated and misbranded cosmetics from the market. Domestic and foreign manufacturers must follow the same regulations. Foreign products that appear to be adulterated or misbranded may be refused entry into the United States.

Learn More:

• Cosmetics (FDA)
• Cosmetics (Medline Plus)
• Is It a Cosmetic, a Drug, or Both? (or Is It Soap?) (FDA)

A clinical trial is a research study conducted to evaluate a medical procedure or medical product, such as a drug. Each study is designed to answer scientific questions and find new and better ways to help people. With any new drug there are benefits as well as possible risks. There may also be some risks that are not yet known.

Clinical trials help us find out if promising new treatments are safe and effective for patients. During a clinical trial, more and more information is gained about a new drug, its risks, and how well it may or may not work. You may be interested in or asked to enter a trial. Learn as much as you can about the clinical trial before deciding. Only patients that volunteer take part in a clinical trial.

Learn More:

• ClinicalTrials.gov
• Educational Materials About Clinical Trials (National Cancer Institute/NIH)
• Clinical Trials (National Institute of Mental Health/NIH)
• Clinical Research & Clinical Trials (National Institute of Child Health and Human Development/NIH)
• Alzheimer's Clinical Trials (National Institute on Aging/NIH)
• Clinical Trials/Studies Seeking Patients (National Heart, Lung, and Blood Institute/NIH)
• Clinical Trials and Guidelines (National Digestive Diseases Information Clearinghouse/NIH)
• Women & HIV/AIDS Research and Clinical Trials (Womenshealth.gov)

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

For more information, see: http://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/Consumers/default.htm.