Urgent Care Overview

Urgent Care Centers provide care to patients with medical problems that are urgent, but not life threatening. Urgent care is treatment for a condition that requires prompt attention, but does not pose an immediate, serious health threat. A sprain, sore throat, or rising temperature are examples of conditions that urgent care staff can treat. Patients do not need an appointment at Urgent Care Centers and are seen as quickly as possible on a walk-in basis.

If you are having a life- or limb-threatening emergency, please call 911. If you are unsure what level of care you need, please call your primary care physician.

No appointment is necessary. Patients are seen on a walk-in basis according to their medical needs.Urgent care hours vary at each location. See our locations page for office hours.

Insurance and Payment Options

Fees are due and payable at the time of service. We accept cash, personal checks and major credit cards. A health insurance membership card should be presented at registration. We participate in and accept assignment from most insurance plans. We are a participating Medicare provider. Patients are responsible for any co-pay, deductibles or noncovered services.The following list is a comprehensive list of insurance programs that we participate in. While we do our best to keep this list up to date, please call us if your insurance company does not appear on this list. Need help finding the right insurance policy? Visit http://www.insuranceloudoun.com/  

Addressing Questions About Gardasil

* What is Gardasil?
* Why is Gardasil needed?
* Is Gardasil safe?
* Why have questions been raised about the vaccine's safety?
* Should these reports worry me?
* What non-serious problems have been reported?
* What are FDA and CDC doing about the concerns?
* How is Gardasil's safety being monitored?

Recently, questions have been raised about the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts, and some vulvar and vaginal cancers.
What is Gardasil?

Gardasil is a vaccine for use in girls and women 9 through 26 years of age. It is approved for preventing cancer of the cervix, vulva and vagina, and for preventing genital warts caused by the types of HPV contained in the vaccine.

These four HPV types (6, 11, 16, and 18) cause about 70% of cervical cancers and about 90% of genital warts. They are also known to cause some vulvar and vaginal cancers. (Percentages related to these conditions are not well defined.)

Why is Gardasil needed?

Gardasil may benefit the health of millions of people. Each year, more than 12,000 American women are diagnosed with cervical cancer, and almost 4,000 women die from this disease. In addition, about 6.2 million Americans become infected with genital HPV each year. Worldwide, cervical cancer is the second most common cancer in women, with 233,000 deaths per year.

Is Gardasil safe?

Based on ongoing assessments of vaccine safety information, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to find that Gardasil is a safe and effective vaccine.

Studies involving approximately 21,000 girls and women in the United States and worldwide were conducted to evaluate the safety and effectiveness of Gardasil before the vaccine was approved by FDA. Approximately half of the study participants received Gardasil, and the other half received a control.

Why have questions been raised about the vaccine's safety?

There have been reports of serious adverse events in girls and women that have received the vaccine. These include death and Guillain-Barre Syndrome (GBS), a rare neurological disorder that causes muscle weakness.

Should these reports worry me?

Based on the review and assessment of vaccine safety information available, FDA and CDC continue to find that the benefits of Gardasil outweigh the risks.

Twenty deaths had been reported to the FDA- and CDC-administered Vaccine Adverse Event Reporting System (VAERS) as of June 30, 2008, in women that received Gardasil.

However, no common pattern to these deaths has been detected that would suggest they were caused by the vaccine. In cases where autopsy, death certificate, and medical records were available, the cause of death was explained by factors other than the vaccine.

Given the large number of vaccine doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in a large population during the time period following vaccinations.

The manufacturer, Merck and Co., has distributed more than 16 million doses of Gardasil nationwide. As of June 30, there were 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events.

Also, FDA routinely reviews manufacturing information, and has not identified any issues affecting the safety, purity, and potency of Gardasil.
What non-serious problems have been reported?

* Syncope (Fainting)
* Pain at the injection site
* Headache
* Nausea
* Fever

Fainting, which may sometimes cause serious injuries from falling, is common after injections and vaccinations, especially in adolescents. FDA and CDC have reminded health care professionals that women receiving Gardasil should be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. The vaccine's prescribing information includes this as well.

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What are FDA and CDC doing about the concerns?

FDA and CDC take all concerns about vaccine safety seriously, and, as they do with all licensed vaccines, will continue to closely monitor Gardasil's safety.

Because available information indicates that Gardasil continues to be safe and effective, and that its benefits continue to outweigh its risks:

* CDC has not changed its recommendations for use of Gardasil.
* FDA has not made any changes to the Warnings or Precautions sections in the vaccine's prescribing information related to safety.

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How is Gardasil's safety being monitored?

* FDA and CDC closely monitor the safety of all vaccines through VAERS, which receives unconfirmed reports of possible side effects following the use of vaccines licensed in the United States.
* Each batch (known as a "lot") of Gardasil is manufactured and tested for quality control according to the requirements of its FDA license. FDA verifies this, as it does with other vaccines, by performing a lot-by-lot batch review process.
* FDA's review assures the appropriateness of manufacturing processes and confirmation of testing results. It also includes regular unannounced on-site inspections.
* No batch may be released for distribution until it has successfully completed all testing and review requirements.
* FDA analyzes possible side effects associated with individual lots to look for any unusual patterns.

CDC also has other systems in place to monitor the safety of all licensed vaccines.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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For More Information

CDC and FDA Information on Gardasil's Safety
www.fda.gov/cber/safety/gardasil071408.htm

Vaccine Adverse Event Reporting System (VAERS) Web site
www.vaers.hhs.gov

FDA Press Release (Sept. 12, 2008):
Approval of Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
www.fda.gov/bbs/topics/NEWS/2008/NEW01885.html

FDA Law Enforcers Crack Down on Illegal Botox Scammers

In November 2004, when four people became paralyzed after purportedly receiving Botox Cosmetic injections at a medical clinic in Oakland Park, Fla., the Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) was called to investigate. The four victims were hospitalized with severe botulism poisoning. The paralysis was temporary—a result of being injected with potent, unapproved botulinum toxin. The doctor who injected the toxin had passed it off as Botox Cosmetic, an FDA-approved drug to treat forehead wrinkles.

What began as one OCI investigation of a Florida medical clinic escalated into 210 investigations of health care professionals throughout the United States. As of July 2008, the work of OCI has led to 68 arrests and 29 convictions of individuals who purposely injected an unapproved, cheaper substitute toxin for FDA-approved Botox Cosmetic into nearly 1,000 unknowing patients.

Under federal law, no form of botulinum toxin may be commercially distributed for use on humans unless it has been approved by FDA. At this time, Botox Cosmetic, made by Allergan Inc. of Irvine, Calif., is the only type of botulinum toxin approved by FDA to temporarily soften the frown lines between the eyebrows. Botox Cosmetic is a sterile, purified version of the same toxin that causes botulism, a severe form of foodborne illness. In both cases, the toxin is produced by the bacterium Clostridium botulinum. The injectable form of sterile, purified botulinum toxin, when used in small doses, locally affects the muscles' ability to contract, smoothing out frown lines to make them nearly invisible.

Source of the Problem

OCI agents traced the fake Botox Cosmetic used in the Florida clinic to a California laboratory that sold botulinum toxin for research purposes. The agents found more of the laboratory's research product at Toxin Research International Inc. (TRI) in Tucson, Ariz. TRI was selling the unapproved toxin to health care professionals as a cheaper alternative to Botox Cosmetic. In December 2004, OCI agents seized vials of the botulinum toxin from TRI, along with numerous marketing materials targeted to physicians.

The vials were clearly labeled, "For Research Purposes Only, Not For Human Use." Invoices and product information sheets carried the same warning. Physicians who bought the cheaper, unapproved product from TRI increased their profits on each treatment by charging their patients the same fee as if they were using the FDA-approved Botox Cosmetic.

OCI agents arrested four individuals associated with TRI. Chad Livdahl, TRI's president, was convicted of fraud and misbranding a drug and sentenced to nine years in prison. His wife and co-owner, Zahra Karim, was sentenced to almost six years in prison. Other co-conspirators got lesser sentences.

OCI Special Agents examined TRI shipping records to track down more than 200 health care professionals who bought the unapproved drug from TRI. "The physicians were located throughout the country, from Manhattan to Las Vegas," says Philip Walsky, Assistant Special Agent in Charge in FDA's OCI Headquarters office. "They'd learn about the drug by going to a conference where TRI would give a spiel and demonstration to sell their product."

Many of the purchasers of the TRI product have been prosecuted. Some are serving time in federal prison and were ordered to pay restitution to their patients.

"Someone who abuses a position of trust for financial gain and subjects patients to unknown safety risks from unapproved medications will be held accountable," says Kim A. Rice, FDA Special Agent in Charge of OCI's Metro Washington Field Office. "FDA will aggressively pursue those who willfully circumvent laws that are in place to protect the consuming public."

OCI continues to investigate these cases, says Walsky.
How Patients Were Scammed

According to OCI agents, most of the health care professionals misrepresented the fake product to patients, leading them to believe they were receiving the real Botox Cosmetic. Some of the tactics they used were

* advertising in brochures, magazines, and on Web sites that they specialized in treating facial wrinkles with Botox Cosmetic
* displaying a certificate indicating they received training by the Botox Cosmetic manufacturer, when they did not
* informing patients they would be receiving Botox Cosmetic
* failing to tell patients they were getting a drug not approved for human use
* asking patients to sign a consent form indicating they would be receiving injections of FDA-approved Botox Cosmetic

Tips for Consumers Considering Botox Injections

* Botox Cosmetic is an injectable drug and should be administered by a trained, qualified health care professional.
* Know what you are being injected with. Make sure your health care professional is using only an FDA-approved product purchased within the United States. If he or she refuses to give you this information, look for another health care professional.
* Make sure the benefits and risks are fully explained to you in a patient consultation.
* Fully disclose any medical conditions you might have and medications you are taking, including vitamins and over-the-counter drugs.
* Botox Cosmetic should be administered in an appropriate setting using sterile instruments. A non-physician who is appropriately licensed and trained may perform the injections under the supervision of a qualified physician. Malls and private homes are not medical environments and may be unsanitary.

Warnings on Raw Jalapeño and Serrano Peppers from Mexico

Laboratory testing by the Food and Drug Administration (FDA) has confirmed that both a sample of serrano peppers and a sample of irrigation water collected by agency investigators on a farm in the state of Tamaulipas, Mexico (business address is in Nuevo Leon, Mexico) contain Salmonella Saintpaul with the same genetic fingerprint as the strain of bacteria that is causing the current outbreak in the United States.

As a result, until further notice, FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them.

The test results are part of FDA's continuing intensive investigation into the outbreak of Salmonella Saintpaul. The investigation has involved tracing back, through complex distribution channels, the origins of products associated with clusters of illness in the United States, as well as inspections and evaluation of farms and facilities in this country and in Mexico, and the collection and testing of environmental and product samples. One of these tracebacks led to a packing facility in Mexico, and to a particular farm, where the agency obtained the samples.

Previously, FDA inspectors collected a positive sample of jalapeño peppers from a produce-distribution center owned by Agricola Zaragosa in McAllen, Texas. FDA continues to work on pinpointing where and how in the supply chain this first positive jalapeño peppers sample became contaminated. It originated from a different farm in Mexico than the positive samples of serrano pepper and irrigation water.

FDA is still analyzing many of the samples taken at various farms in Mexico. If laboratory results warrant, FDA will provide consumers with additional cautions or warnings necessary to protect their health.

On July 17, 2008, FDA announced it had determined that fresh tomatoes now available in the domestic market are not associated with the current outbreak. As a result, the agency removed its June 7 warning against eating certain types of red raw tomatoes.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More Information

FDA's Salmonella Saintpaul Web page
http://www.fda.gov/oc/opacom/hottopics/tomatoes.html

FDA Statement
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01869.html

News From The FDA on Fibromyalgia

Living with Fibromyalgia, Drugs Approved to Manage Pain A fter meeting on the Internet in 1997, Lynne Matallana and Karen Lee Richardsdiscovered they had a lot in common. They both had seen numerous doctors before being diagnosed with fibromyalgia, a chronic condition characterized by fatigue and widespread pain in muscles and joints. They both had trouble finding medical information and support for coping with the illness. Seven months after meeting, they started gathering with five other people with fibromyalgia who also wanted to bring awareness to the issue. “We called ourselves ‘the pillow posse’ because we would meet and have our pillows to support our aching bodies,”Matallana says. Those gather- ings grew into the National Fibromyal- gia Association (NFA), an organization that now provides support, research information, medical education, and messages of hope to millions. Fibromyalgia affects 2 to 4 percent of the population, according to the American College of Rheumatology (ACR). It mostly affects women, and tends to develop in early to middle adulthood. But men and children also
can have it. “One of the challenges is that fibromyalgia hasn’t always been recognized as a specific illness,” says Jeffrey Siegel, M.D., clinical team leader in FDA’s Division of Anesthesia, Analgesia, and Rheumatology Products. “In 1990, the American College of Rheumatology developed criteria for diagnosing it, and this marked a major step forward in helping more people Getty Images understand how to recognize the symptoms and how to treat them.” Approved Drugs People with fibromyalgia have typically turned to pain medicines, antidepressants, muscle relaxants, and sleep medicines. In June 2007, Lyrica (pregabalin) became the first FDA approved drug for specifically treating fibromyalgia; a year later, in June 2008, Cymbalta (duloxetine hydrochloride) became the second. Both Lyrica and Cymbalta reduce pain and improve function in people with fibromyalgia. While those with fibromyalgia have been shown to experience pain differently from other people, the mechanism by
which these drugs produce their effects is unknown. There is some data suggesting that these drugs affect the release of neurotransmitters in the brain. Neurotransmitters are chemicals that transmit signals from one neuron to another. Treatment with Lyrica or Cymbalta reduces the level of pain experienced by some people with fibromyalgia. Lyrica, marketed by Pfizer Inc., was previously approved to treat seizures, as well as pain from damaged nerves that can happen in people with diabetes (diabetic peripheral neuropathy) and in those who develop pain following the rash of shingles. Side effects of Lyrica including sleepiness, dizziness, blurry vision, weight gain, trouble concentrating, swelling of the hands and feet, and dry mouth. Allergic reactions, although rare, can occur. Cymbalta, marketed by Eli Lilly and Co., was previously approved to treat depression, anxiety, and diabetic peripheral neuropathy. Cymbalta’s side effects include nausea, dry mouth, sleepiness, constipation, decreased appetite, and increased sweating. Like some other antidepressants, Cymbalta may increase the risk of suicidal thinking and behavior in people who take the drug for depression. Some people with fibromyalgia also experience depression. Studies of both drugs showed that a substantial number of people with fibromyalgia received good pain relief, but there were others who didn’t benefit. Lyrica and Cymbalta are approved for use in adults 18 years and older. The drug manufacturers have agreed to study their drugs in children with fibromyalgia and in breastfeeding women. Debilitating Effects Matallana, who is now president of NFA, says she was a partner in an advertising firm when her life turned completely upside down because of her symptoms. “I finally had to stop working in 1995 and spent most of the next two years in bed,” she says. Her husband quit his job and became a consultant working from home so that he could care for her. “I had a yoga instructor coming to my house three times a week to help me get out of bed. The pain and exhaustion were so bad that there were days that the only activity I was able to do was walk from my bed to the mailbox and back to bed. Each day seemed like an eternity and so I had to focus on just getting through one day at a time.” People with fibromyalgia can experience pain anywhere, but common sites of pain include the neck, shoulders, back, hips, arms, and legs. In addition to pain and fatigue, other symptoms include difficulty sleeping, morning stiffness, headaches, painful menstrual periods, tingling or numbness of hands
or feet, and difficulty thinking and remembering. Some people with the condition may also experience irritable bowel syndrome, pelvic pain, restless leg syndrome, and depression. What Causes Fibromyalgia? Scientists believe that the condition may be due to injury, emotional distress, or viruses that change the way the brain perceives pain, but the exact cause is unclear. People with rheumatoid arthritis, lupus, and spinal arthritis may be more likely to have the illness. According to ACR, people with fibromyalgia can have abnormal levels of Substance P in their spinal
fluid. This chemical helps transmit and amplify pain signals to and from \the brain. Researchers are looking at the role of Substance P and other neurotransmitters, and studying why people with fibromyalgia have increased sensitivity to pain and whether there is a gene or genes that make a person more likely to have it. Getting a Diagnosis Matallana says she felt her suffering was being dismissed as she went from doctor to doctor looking for answers. “Many doctors suggested that it was just stress,” she says. “Some of them even made references that it was all in my head. I was eventually misdiagnosed as having lupus.” When Matallana was 39, a rheumatologist who was just starting his practice, finally diagnosed her with fibromyalgia. “With my doctor’s help, I started to feel better,” she says. “It made all the difference that I had a health care provider who could give me insights as to what fibromyalgia research was showing, and that there were other people feeling what I was feeling.” Family physicians, general inter- nists, and rheumatologists are the doctors who typically treat fibromyalgia. There is no diagnostic test for it. Doctors make a diagnosis by conducting physical examinations, evaluating symptoms, and ruling out other conditions. For example, fibromyalgia can be distinguished from arthritis because arthritis causes inflammation of tissues and joints and fibromyalgia does not. Another condition with similar symptoms, hypothyroidism, can be confirmed with a blood test. Diagnostic criteria set forth by ACR include a history of widespread pain for at least three months and pain in at least 11 of 18 tender point sites. More than Medicine People with fibromyalgia may find relief of symptoms with painrelievers, sleep medicines, antidepressants, muscle relaxants, and anti-seizure medications. But medication is just one part of the treatment approach. What helped Matallana was a combination of medicines for pain and sleep, treatment for some of the over lapping conditions like migraines and irritable bowel syndrome, and a combination of water therapy, massage and yoga. Walking, jogging, biking, gently stretching muscles, and other exercises also can be helpful. Emotional support also is essential, Matallana says. “My husband always believed me, and when you have that kind of support it makes a difference. It’s really about facing chronic pain for the rest of your life. So dealing with the emotional impact and not just the physical side is very important.” This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA- regulated products. Sign up for free e-mail subscriptions at www.fda.gov/
consumer/consumerenews.html.
For More Information FDA Approves First Drug for Treating Fibromyalgia
www.fda.gov/bbs/topics/NEWS/2007/ NEW01656.html

National Institute of Arthritis and Musculoskeletal and Skin Diseases
www.niams.nih.gov/hi/topics/ fibromyalgia/fffibro.htm
American College of Rheumatology
www.rheumatology.org/public/ factsheets/fibromya_new.asp
National Fibromyalgia Association
www.fmaware.org
Fibromyalgia Network
www.fmnetnews.com

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Are You Storing Food Safely?

Whether putting food in the refrigerator, the freezer, or the cupboard, you have plenty of opportunities to prevent foodborne illnesses.The goal is to keep yourself and others from being sickened by microorganisms ...
REMINDERS:
• Refrigerate or freeze perishables right away.
• Keep your appliances at the proper temperatures.
• Check storage directions on labels.
• Use ready-to-eat foods as soon as possible.
• Be alert for spoiled food.
• Marinate food in the refrigerator.
• Clean the refrigerator regularly and wipe spills imediately.
• Keep foods covered.
• Check expiration dates.
• Don’t store food under the sink.
• Check canned goods for damage.

The goal is to keep yourself and others from being sickened by micro- organisms such as Salmonella, E. coli O157:H7, and C. botulinum, which causes botulism. Keeping foods chilled at proper temperatures is one of the best ways to prevent or slow the growth of these bacteria. These food storage tips can help you steer clear of foodborne illnesses. Storage Basics Refrigerate or freeze perishables right away. Foods that require refrigeration should be put in the refrigerator as soon as you get them home. Stick to the “two-hour rule” for leaving items needing refrigeration out at
room temperature. Never allow meat, poultry, seafood, eggs, or produce or other foods that require refrigeration to sit at room temperature for more than two hours—one hour if the air temperature is above 90° F. This also applies to items such as leftovers, “doggie bags,” and take- out foods. Also, when putting food away, don’t crowd the refrigerator or freezer so tightly that air can’t circulate.
Keep your appliances at the proper temperatures. Keep the refrigerator temperature at or below 40° F (4° C). The freezer temperature should be 0° F (-18° C). Check temperatures periodically. Appliance thermometers are the best way of knowing these temperatures and are generally inexpensive. Check storage directions on labels. Many items other than meats, vegetables, and dairy products need to be kept cold. For instance, mayonnaise and ketchup should go in the refrigerator after opening. If you’ve neglected to properly refrigerate something, it’s usually best to throw it out. Use ready-to-eat foods as soon as possible. Refrigerated ready-to-eat foods such as luncheon meats should be used as soon as possible. The longer they’re stored in the refrigerator, the more chance Listeria, a bacterium that causes foodborne illness, can grow, especially if the refrigerator temperature is above 40° F (4° C). Be alert for spoiled food. Anything that looks or smells suspicious should
be thrown out. Mold is a sign of spoil-age. It can grow even under refrigeration. Mold is not a major health threat, but it can make food unappetizing. The safest practice is to discard food that is moldy. Refrigeration Tips Marinate food in the refrigerator. Bacteria can multiply rapidly in foods left to marinate at room temperature. Also, never reuse marinating liquid as a sauce unless you bring it to a rapid boil first. Clean the refrigerator regularly and wipe spills immediately. This helps reduce the growth of Listeria bacteria and prevents drips from thawing meat that can allow bacteria from one food to spread to another. Clean the fridge out frequently.

Keep foods covered. Store refrigerated foods in covered containers or sealed storage bags, and check leftovers daily for spoilage. Store eggs in their carton in the refrigerator itself rather than on the door, where the temperature is warmer. Check expiration dates. If food is past its “use by” date, discard it. If you’re not sure or if the food looks questionable, throw it out.
Freezer Facts
Food that is properly frozen and cooked is safe. Food that is properly handled and stored in the freezer at 0° F (-18° C) will remain safe. While freezing does not kill most bacteria, it does stop bacteria from growing. Though food will be safe indefinitely at 0° F, quality will decrease the longer the food is in the freezer. Tenderness, flavor, aroma, juiciness, and color can all be affected. Leftovers
should be stored in tight containers. With commercially frozen foods, it’s important to follow the cooking instructions on the package to assure safety. Freezing does not reduce nutrients.
There is little change in a food’s protein value during freezing. Freezer burn does not mean food is unsafe. Freezer burn is a food quality issue, not a food safety issue. It appears as grayish-brown leathery spots on frozen food. It can occur when food is not securely wrapped in air-tight packaging, and causes dry spots in foods.
Refrigerator/freezer thermometers should be monitored. Refrigerator/ freezer thermometers may be purchased in the housewares section of department, appliance, culinary, and grocery stores. Place one in your refrigerator and one in your freezer, in the front in an easy-to-read location. Check the temperature regularly—at least once a week. If You Lose Electricity If you lose electricity, keep refrigerator and freezer doors closed as much as possible. Your refrigerator will keep food cold for about four hours if it’s unopened. A full freezer will keep an adequate temperature for about 48
hours if the door remains closed. Tips for Non-Refrigerated Items Check canned goods for damage. Can damage is shown by swelling, leakage, punctures, holes, fractures, extensive deep rusting, or crushing or denting severe enough to prevent normal stacking or opening with a manual, wheel-type can opener. Stickiness on the outside of cans may indicate a leak. Newly purchased cans that appear to be leaking should be returned to the store for a refund or exchange. Otherwise, throw the cans away. Don’t store food, such as potatoes and onions, under the sink. Leakage from the pipes can damage the food. Store potatoes and onions in a cool, dry place. Keep food away from poisons. Don’t store non-perishable foods near household cleaning products and chemicals. This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA regulated products. Sign up for free e-mail subscriptions at
www.fda.gov/consumer consumerenews.html.
For More Information Start at the Store: 7 Ways to Prevent
Foodborne Illness
www.fda.gov/consumer/updates/
foodillness051308.html
Prepare for Hurricanes and Floods: Advice from FDA
www.fda.gov/consumer/updates/ hurricane052307.html
Food and Water Safety During Hurricanes, Power Outages, and Flood
www.cfsan.fda.gov/~acrobat/fsdisas.pdf
FDA’s Foodborne Illness Web Page
www.cfsan.fda.gov/~mow/foodborn. html
Fightbac.org
www.fightbac.org/

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FDA 101: Dietary Supplements

The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.

Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. These products are available in stores throughout the United States, as well as on the Internet. They are labeled as dietary supplements and include among others

* vitamin and mineral products
* "botanical" or herbal products—These come in many forms and may include plant materials, algae, macroscopic fungi, or a combination of these materials.
* amino acid products—Amino acids are known as the building blocks of proteins and play a role in metabolism.
* enzyme supplements—Enzymes are complex proteins that speed up biochemical reactions.

People use dietary supplements for a wide assortment of reasons. Some seek to compensate for diets, medical conditions, or eating habits that limit the intake of essential vitamins and nutrients. Other people look to them to boost energy or to get a good night's sleep. Postmenopausal women consider using them to counter a sudden drop in estrogen levels.

Talk with a Health Care Professional

The Food and Drug Administration (FDA) suggests that you consult with a health care professional before using any dietary supplement. Many supplements contain ingredients that have strong biological effects, and such products may not be safe in all people.

If you have certain health conditions and take these products, you may be putting yourself at risk. Your health care professional can discuss with you whether it is safe for you to take a particular product and whether the product is appropriate for your needs. Here is some general advice:

* Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They cannot completely prevent diseases, as some vaccines can. However, some supplements are useful in reducing the risk of certain diseases and are authorized to make label claims about these uses. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord.
* Using supplements improperly can be harmful. Taking a combination of supplements, using these products together with medicine, or substituting them in place of prescribed medicines could lead to harmful, even life-threatening, results.
* Some supplements can have unwanted effects before, during, or after surgery. For example, bleeding is a potential side effect risk of garlic, ginkgo biloba, ginseng, and Vitamin E. In addition, kava and valerian act as sedatives and can increase the effects of anesthetics and other medications used during surgery. Before surgery, you should inform your health care professional about all the supplements you use.

How Are Supplements Regulated?

You should know the following if you are considering using a dietary supplement.

* Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
* Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
* For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
* In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
* Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
* Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
* Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
* Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.
* It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.
* There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit.

Are Supplements Safe?

Many dietary supplements have clean safety histories. For example, millions of Americans responsibly consume multi-vitamins and experience no ill effects.

Some dietary supplements have been shown to be beneficial for certain health conditions. For example, the use of folic acid supplements by women of childbearing age who may become pregnant reduces the risk of some birth defects.

Another example is the crystalline form of vitamin B12, which is beneficial in people over age 50 who often have a reduced ability to absorb naturally occurring vitamin B12. But further study is needed for some other dietary supplements.

Some supplements have had to be recalled because of proven or potential harmful effects. Reasons for these recalls include

* microbiological, pesticide, and heavy metal contamination
* absence of a dietary ingredient claimed to be in the product
* the presence of more or less than the amount of the dietary ingredient claimed on the label

In addition, unscrupulous manufacturers have tried to sell bogus products that should not be on the market at all.
Before taking a dietary supplement, make sure that the supplement is safe for you and appropriate for the intended purpose.

Be a Safe and Informed Consumer

* Let your health care professional advise you on sorting reliable information from questionable information.
* Contact the manufacturer for information about the product you intend to use.
* Be aware that some supplement ingredients, including nutrients and plant components, can be toxic. Also, some ingredients and products can be harmful when consumed in high amounts, when taken for a long time, or when used in combination with certain other drugs, substances, or foods.
* Do not self-diagnose any health condition. Work with health care professionals to determine how best to achieve optimal health.
* Do not substitute a dietary supplement for a prescription medicine or therapy, or for the variety of foods important to a healthful diet.
* Do not assume that the term "natural" in relation to a product ensures that the product is wholesome or safe.
* Be wary of hype and headlines. Sound health advice is generally based upon research over time, not a single study.
* Learn to spot false claims. If something sounds too good to be true, it probably is.

Report Problems

Adverse effects with dietary supplements should be reported to FDA as soon as possible. If you experience such an adverse effect, contact or see your health care professional immediately. Both of you are then encouraged to report this problem to FDA. For information on how to do this, go to www.cfsan.fda.gov/~dms/ds-rept.html.

Adverse effects can also be reported to the product's manufacturer or distributor through the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports they receive about serious adverse effects to FDA within 15 days.

For a general, nonserious complaint or concern about dietary supplements, contact your local FDA District Office (www.cfsan.fda.gov/~dms/district.html).

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
For More Information

Fortify Your Knowledge About Vitamins
http://www.fda.gov/consumer/updates/vitamins111907.html

Final Rule Promotes Safe Use of Dietary Supplements
www.fda.gov/consumer/updates/dietarysupps062207.html

Tips for the Savvy Supplement User: Making Informed Decisions
www.fda.gov/fdac/features/2002/202_supp.html

Overview of Dietary Supplements
www.cfsan.fda.gov/~dms/ds-oview.html

Food Labeling and Nutrition
www.cfsan.fda.gov/label.html

Primary Care Overview

You need a primary health care provider so that your health can be checked regularly to ensure optimum health and to catch any problems early so that they do not become worse. With Primary Care as your care provider we will help you make smart choices to stay healthy. We can talk with you about health risks, such as smoking, alcohol, and nutrition and give you advice. If you have a serious or unusual medical problem, we can refer you to a specialist so that you can recieve specialized care that would be difficult to obtain without a refferal. For those who do not have a regular physican or who are interested in the services we provide on a “walk-in” basis, we provide Primary Care for many of our patients. From check-ups to the common cold, from an ear ache to a serious disease – your primary care provider is your partner in health throughout your life.