Misc. FDA Information

FDA For You

Consumer Health Information

Here you will find key FDA initiatives, consumer health information and partnerships, consumer health according to audience among several other helpful information.

http://www.fda.gov/consumer/default.htm

How Plants Protect Us From Disease

ScienceDaily (Apr. 27, 2009) — Everyday foods, beverages, and spices contain healthful compounds that help us fight harmful inflammation. And, in doing that, these phytochemicals—the resveratrol in red wine or the catechins in green, white and black teas, for instance—may also reduce our risk of diseases associated with chronic inflammation, including cancer and diabetes.

At the Agricultural Research Service (ARS) Western Human Nutrition Research Center in Davis, Calif., research molecular biologist Daniel H. Hwang conducts studies to solve the complex puzzle of precisely how phytochemicals fight inflammation. His investigations with cells cultured in his laboratory have uncovered probable modes of action used by phytochemicals from red wine, green tea, garlic, curcumin and cinnamon.

Hwang's team has found, for example, that phytochemicals can interfere with the normal flow of certain chemical signals or messages sent to and from cells involved in chronic inflammation. The messages these cells send are in the form of proteins. In particular, his group is closely examining proteins known as TLRs (short for "Toll-Like Receptors") and NODs (an abbreviation for the tongue-twisting "nucleotide binding oligomerization domain containing proteins").

To Read Full Article: http://www.sciencedaily.com/releases/2009/04/090419202029.htm

How to Evaluate Health Information on the Internet

Millions of consumers are using the Internet to get health information. And thousands of Web sites are offering health information. Some of those sites are reliable and up-to-date; some are not. How can you tell the good from the bad?

First, it's important to carefully consider the source of information and then to discuss the information you find with your health care professional. These questions and answers can help you determine whether the health information you find on the Internet or receive by e-mail from a Web site is likely to be reliable.

Qs & As: Evaluating Internet Health Information

1. Who runs the Web site?

Any good health Web site should make it easy to learn who is responsible for the site and its information. On the U.S. Food and Drug Administration's (FDA) Web site, for example, the FDA is clearly noted on every major page, along with a link to the site's home (main) page, www.fda.gov.

Information about who runs the site can often be found in an "About Us" or "About This Web Site" section, and there's usually a link to that section on the site's home page.

2. What is the purpose of the Web site?

Is the purpose of the site to inform? Is it to sell a product? Is it to raise money? If you can tell who runs and pays for the site, this will help you evaluate its purpose. Be cautious about sites trying to sell a product or service.

Quackery abounds on the Web. Look for these warning signs and remember the adage "If it sounds too good to be true, it probably is."

Does the site promise quick, dramatic, miraculous results? Is this the only site making these claims?
Beware of claims that one remedy will cure a variety of illnesses, that it is a "breakthrough," or that it relies on a "secret ingredient."
Use caution if the site uses a sensational writing style (lots of exclamation points, for example.)
A health Web site for consumers should use simple language, not technical jargon. Get a second opinion. Check more than one site.

3. What is the original source of the information on the Web site?

Always pay close attention to where the information on the site comes from. Many health and medical Web sites post information collected from other Web sites or sources. If the person or organization in charge of the site did not write the material, the original source should be clearly identified. Be careful of sites that don't say where the information comes from.

Good sources of health information include

Sites that end in ".gov," sponsored by the federal government, like the U.S. Department of Health and Human Services (www.hhs.gov), the FDA (www.fda.gov), the National Institutes of Health (www.nih.gov), the Centers for Disease Control and Prevention (www.cdc.gov), and the National Library of Medicine (www.nlm.nih.gov)
.edu sites, which are run by universities or medical schools, such as Johns Hopkins University School of Medicine and the University of California at Berkeley Hospital, health system, and other health care facility sites, like the Mayo Clinic and Cleveland Clinic
.org sites maintained by not-for-profit groups whose focus is research and teaching the public about specific diseases or conditions, such as the American Diabetes Association, the American Cancer Society, and the American Heart Association
Medical and scientific journals, such as The New England Journal of Medicine and the Journal of the American Medical Association, although these aren't written for consumers and could be hard to understand.
Sites whose addresses end in .com are usually commercial sites and are often selling products.

4. How is the information on the Web site documented?

In addition to identifying the original source of the material, the site should identify the evidence on which the material is based. Medical facts and figures should have references (such as citations of articles in medical journals). Also, opinions or advice should be clearly set apart from information that is "evidence-based" (that is, based on research results).

5. How is information reviewed before it is posted on the Web site?

Health-related Web sites should give information about the medical credentials of the people who prepare or review the material on the Web site.

6. How current is the information on the Web site?

Web sites should be reviewed and updated on a regular basis. It is particularly important that medical information be current, and that the most recent update or review date be clearly posted. These dates are usually found at the bottom of the page. Even if the information has not changed, it is helpful to know that the site owners have reviewed it recently to ensure that the information is still valid. Click on a few links on the site. If there are a lot of broken links, the site may not be kept up-to-date.

7. How does the Web site choose links to other sites?

Reliable Web sites usually have a policy about how they establish links to other sites. Some medical Web sites take a conservative approach and do not link to any other sites; some link to any site that asks or pays for a link; others link only to sites that have met certain criteria. Look for the Web site's linking policy, often found in a section titled "About This Web Site."

To Read More of These: http://www.fda.gov/oc/opacom/evalhealthinfo.html

Here's how the federal government protects consumers from false or misleading claims posted on the Internet:

The Food and Drug Administration (FDA) regulates drugs and medical devices to ensure that they are safe and effective. The FDA's Buying Medicines and Medical Products Online Web page and "Buying Prescription Medicines Online: A Consumer Safety Guide" give guidance to consumers shopping for health care products online. "Tips for the Savvy Supplement User" gives advice about how to evaluate claims about dietary supplements and what to look for in Web sites selling them.

Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
1-888-INFO-FDA (1-888-463-6332) (toll-free)
www.fda.gov

The Federal Trade Commission (FTC) enforces consumer protection laws. As part of its mission, the FTC investigates complaints about false or misleading health claims posted on the Internet. The FTC's Operation Cure-All page has information to help evaluate health product claims.

Federal Trade Commission
Consumer Response Center CRC-240 Washington, DC 20580
1-877-FTC-HELP (1-877-382-4357) (toll-free)
TTY: 1-866-653-4261 (toll-free)
www.ftc.gov

A Quick Checklist

You can use the following checklist to help make sure that the health information you are reading online can be trusted.

Can you easily see who sponsors the Web site?
Is the sponsor a government agency, a medical school, or a reliable health-related organization, or is it related to one of these?
Is there contact information?
Can you tell when the information was written?
Is your privacy protected?
Does the Web site make claims that seem too good to be true? Are quick, miraculous cures promised?

Source: FDA Website Management Staff

To Read Entire Article: http://www.fda.gov/oc/opacom/evalhealthinfo.html

FDA 101: Clinical Trials and Institutional Review Boards

Clinical trials test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy.

Potential treatments are studied in laboratory animals first to determine potential toxicity before they can be tried in people. Treatments having acceptable safety profiles and showing the most promise may then be considered for use in clinical trials.

It is not known whether a potential new medical treatment offers benefit to patients until clinical research on that treatment is complete. Clinical trials are an integral part of new product discovery and development, and are generally required by the Food and Drug Administration (FDA) before a new product can be brought to the market.

To Read Full Article: http://www.fda.gov/consumer/updates/clinicaltrials041409.html

FDA Obtains Permanent Injunction Barring Two Companies from Manufacturing and Distributing Unapproved Drugs

Companies made and distributed adulterated, misbranded and unapproved drugs

The U.S. Food and Drug Administration today announced that it had obtained a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs.

Both Neilgen, which does business as Unigen Pharmaceuticals Inc. (Unigen), and Advent are contract manufacturers and distributors of more than 25 different unapproved drug products each. The more than 50 unapproved drug products primarily include prescription cough and cold products. The unapproved drugs manufactured by Unigen and/or Advent include, but are not limited to:

RE All 12 Suspension;
BP Allergy Junior Suspension;
PE Tann 20 mg/CP Tann 4 mg Suspension;
BP New Allergy DM Suspension;
D-Tann CT Tablets;
B-Vex D Suspension;
Histex SR; and
Chlorpheniramine Maleate 12 mg/Pseudoephedrine HCl 120 mg LA Tablets.

The unapproved drugs manufactured by these companies have not undergone the FDA's drug approval process, so their safety and effectiveness have not been established and the FDA has not reviewed the adequacy and accuracy of the directions for use and warnings on the labeling.

To Read Full Article: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01995.html

Food Protection Plan

American consumers enjoy one of the safest food supplies in the world; however, we know it can be made even safer. FDA regulates $417 billion worth of domestic food and $49 billion worth of imported food each year—everything we eat except for meat, poultry, and some egg products, which are regulated by the U.S. Department of Agriculture.

FDA has developed a comprehensive Food Protection Plan to address the changes in food sources, production, and consumption that we face in today's world. Building upon and improving an already sound food safety protection capability, the new plan presents a robust strategy to protect the nation's food supply from both unintentional contamination and deliberate attack. FDA's Food Protection Plan builds in prevention first, then intervention, and finally, response. This new strategy will help ensure that Americans continue to benefit from one of the safest food supplies in the world.

To Read More: http://www.fda.gov/oc/initiatives/advance/food.html

FDA to Review Medical Devices Marketed Prior to 1976

The FDA today announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process.

These 25 device types, which are listed in the Federal Register announcement posted today, were marketed in the U.S. prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976. That law authorized the FDA to review new medical devices. Today’s announcement is the first step towards completing the review of Class III device types predating the 1976 law, as was recommended by the U.S. Government Accountability Office (GAO) in a January 2009 report to Congress.

Insulin Pens are Not for Sharing

What are insulin pens?

Insulin pens are pen-shaped injector devices that contain a disposable needle and either an insulin reservoir or an insulin cartridge. The devices typically hold enough insulin for a patient to self-administer several doses of insulin before the reservoir or cartridge is empty.

All insulin pens are approved only for single-patient use (one device for only one patient). They are designed to be safe for one patient to use one pen multiple times with a new, fresh needle for each injection.

Why has FDA issued this alert?

FDA knows of incidents at two undisclosed hospitals involving more than 2,000 people in which the cartridge component of the insulin pens was used to administer insulin to multiple patients, although the disposable needles were reportedly changed among patients.

Who has been affected by these incidents?

Patients who have been exposed to shared insulin pens are being contacted by the two hospitals and are being offered testing for hepatitis and HIV. Some of the potentially exposed patients have reportedly tested positive for the hepatitis C virus, although it's not known if the virus was spread as a result of insulin pen sharing.

FDA, the Centers for Disease Control and Prevention, and professional organizations are working to address infection control issues related to insulin pens.

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.

Date Posted: March 25, 2009

A Guide to Safe Use of Pain Medicine

If you've ever been treated for severe pain from surgery, an injury, or an illness, you know just how vital pain relief medications can be.

Pain relief treatments come in many forms and potencies, are available by prescription or over-the-counter (OTC), and treat all sorts of physical pain— including that brought on by chronic conditions, sudden trauma, and cancer.

Pain relief medicines (also known as "analgesics" and "painkillers") are regulated by the Food and Drug Administration (FDA). Some analgesics, including opioid analgesics, act on the body's peripheral and central nervous systems to block or decrease sensitivity to pain. Others act by inhibiting the formation of certain chemicals in the body.

Among the factors health care professionals consider in recommending or prescribing them are the cause and severity of the pain.

For more information regarding this topic, please visit this link:

http://www.fda.gov/consumer/updates/painmeds022309.html

Food Allergies: Reducing the Risks

Food allergies can range from merely irritating to life-threatening. Approximately 30,000 Americans go to the emergency room each year to get treated for severe food allergies, according to the Food Allergy and Anaphylaxis Network (FAAN). It is estimated that 150 to 200 Americans die each year because of allergic reactions to food.

Food allergies affect about two percent of adults and four to eight percent of children in the United States, and the number of young people with food allergies has increased over the last decade, according to a recent report by the Centers for Disease Control and Prevention (CDC). Children with food allergies are more likely to have asthma, eczema, and other types of allergies.

Some food allergies can be outgrown. Studies have shown that the severity of food allergies can change throughout a person’s life.

“There is no cure for food allergies,” says Stefano Luccioli, M.D., senior medical advisor in the Food and Drug Administration’s (FDA) Office of Food Additive Safety (OFAS). “The best way for consumers to protect themselves is by avoiding food items that will cause a reaction.” OFAS is part of FDA’s Center for Food Safety and Applied Nutrition (CFSAN).

To reduce the risks from allergic reactions, FDA is working to ensure that major allergenic ingredients in food are accurately labeled in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). Allergenic ingredients are substances that are capable of causing an allergic reaction.

In addition, there has been widespread use of allergen advisory labels on products that may have allergenic ingredients that were introduced by way of cross contact during the manufacturing process. Cross contact occurs when a residue or other trace amount of an allergenic food is unintentionally incorporated into another food.

Because FALPCA does not require the declaration of allergenic ingredients introduced through cross contact, FDA is developing a long-term strategy that will help manufacturers use voluntary allergen advisory labeling that:

Is not misleading
Conveys a clear and uniform message
Adequately informs food-allergic consumers and their caregivers

For more information regarding this topic, please visit this link:

http://www.fda.gov/consumer/updates/foodallergies012209.html

Understanding Antidepressant Medications

Depression affects about 121 million people worldwide and is a leading cause of disability, according to the World Health Organization (WHO).

"In my experience as a practicing psychiatrist, I've seen that many people with depression don't realize that they have the condition or that it's treatable," says Mitchell Mathis, M.D., deputy director of the Division of Psychiatry Products at the Food and Drug Administration (FDA).

Some who suffer from depression don't recognize the symptoms, or they attribute them to lack of sleep or a poor diet. Others realize they are depressed, but they feel too fatigued or ashamed to seek help.

Not all depression requires treatment with medication.

"Studies have shown that the best way to treat a patient with the more severe form of major depressive disorder is through both therapy and prescribed antidepressant medication," Mathis says. "They work best in combination with one another."

For more information regarding this topic, please visit this link:

http://www.fda.gov/consumer/updates/antidepressants010909.html

If you would like to see more please visit the U.S. Food and Drug Administration at: http://www.fda.gov/

A Greener Ohio Plus

Multiple Sclerosis, EPA and the FDA