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Tag: FDA

  • Food Labels Will Soon Be Easier to Decipher

    Food labels are changing for the first time in 20 years in an effort to continue the fight against obesity. They will begin prominently displaying things like calories for the typical serving size for regular people, not supermodels.

    They will also have to clearly state added sugars like corn syrup, white and brown sugar, and fruit juice concentrate, according to Reuters.

    Michelle Obama, champion of the “Let’s Move” Campaign, made the big announcement on Thursday on behalf of the FDA.

    She explained in a statement the principle behind the new label concept, saying it is “very simple”. She added, “You as a parent and a consumer should be able to walk into your local grocery store, pick up an item off the shelf, and be able to tell whether it’s good for your family.”

    That will be nice to not have to become a detective every time you enter the grocery store in order to decode food labels and add up calories because obviously, no one eats half a cup of ice cream.

    Dr. David Kessler, former Commissioner of the FDA, said the new label are a “critically important” advance in the way food is presented to the consumer.

    “The food label is not just about giving consumers information but about creating incentives for the industry to create healthier products. No company wants their product to look bad on the food label.”

    The updates won’t be immediate. In fact, you may not see widespread use of them for up to 3 years. The transition begins with a 90-day public comment period, then the FDA will finalize the rules. After rules are finalized, food companies have 2 whole years to comply.

    Current FDA Commissioner Margaret Hamburg stated that the proposed label change reflects what “has been learned about the connection between what we eat and the development of serious chronic diseases impacting millions of Americans.”

    Perhaps this will be a good weapon in the already fairly successful fight against the American obesity epidemic.

    Image via Wikimedia Commons

  • FDA Implements Pilot Program For Fast-Track Drug Importation

    The U.S. Food and Drug Administration (FDA) today announced that it has begun its two-year Secure Supply Chain Pilot Program. The program is meant to streamline some drug importation for select companies so that the FDA can focus its resources on more high-risk illegal importation. Following the two-year program the FDA will evaluate its success and possibly make it permanent, expanding it to other companies.

    Thirteen drug companies have been selected to participate in the trail program. The list reads as a rundown of the largest pharmaceutical companies based in the U.S. including Bristol-Myers Squibb, AbbVie, Allergan, GE Healthcare, Celgene, Astellas U.S. Technologies, GlaxoSmithKline, Mylan, Novartis, Pfizer, Teva, Watson Laboratories, and Merck Sharp & Dohme.

    Each of these companies will have to comply with a set of rules established by the FDA to get their expedited importation. These rules include a strict adherence to the Food, Drug, and Cosmetics Act; a secure supply chain protocol validated by U.S. Customs, and plans to correct problems or issue recalls in the event of mishaps. The companies will be required to have control over their drug imports through their complete distribution chain, from manufacture to entry into the U.S.

    “By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs,” said Carol Bennett, acting director of the Center for Drug Evaluation and Research’s Office of Compliance at the FDA. “The program also allows the FDA to focus resources on the areas with the greatest potential risk to consumers.”

  • Uncle Ben’s Infused Rice Recalled Over Food Poisoning Concerns

    The U.S. Food and Drug Administration (FDA) and Mars Foodservices today issued a recall of all Uncle Ben’s Infused Rice. The recall pertains to both five- and 25-pound bags of such rice. Other types of Uncle Ben rice, including Ready to Heat, boxed, or cup rice are not part of the recall.

    The recall was issued following illnesses reported in Katy, Texas public schools. According to the FDA, children and teachers who had consumed Uncle Ben’s Infused Rice Mexican Flavor experienced burning, itchy rashes, headaches, and nausea for up to an hour-and-a-half. The FDA and the U.S. Centers for Disease Control and Prevention (CDC) are currently investigating the illness and its cause.

    This latest incident follows a December 2013 case in which 25 children at an Illinois school experienced similar symptoms after consuming Uncle Ben’s Infused Rice. Another case in October involving several children at a North Dakota daycare facility was also reported to the FDA.

    Uncle Ben’s Infused Rice is most commonly distributed to schools, restaurants, and hospitals through food service companies. All flavors of the product are subject to the recall, including roasted chicken, garlic & butter, mexican, pilaf, saffron, cheese, and spanish.

    The FDA is recommending that the recalled rice be returned to distributors or, in the case of individual consumers, to the place where it was purchased. Consumers may also simply dispose of the rice themselves.

    Image via Mars

  • FDA to Tighten Baby Formula Standards

    The U.S. Food and Drug Administration (FDA) today announced new rules surrounding the manufacture of infant formula. The rules are meant to raise standards for formula manufacturing and ensure all formula is safe and nutritious.

    The new rule would improve quality control, notification, and record-keeping for manufacturers of infant formula. Microbial contamination testing will now also be required for infant forumla products. New quality factor requirements that will “support healthy growth” are also established by the rule, as are requirements that all infant formula contain federally-required nutrients.

    “Many families rely on infant formula as either the sole source of nutrition or an integral part of an infant’s diet through 12 months of age,” said Michael Taylor, deputy commissioner for Foods and Veterinary Medicine at the FDA. “The FDA sets high quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being. This rule will help to prevent adulteration in infant formula and ensure infant formula supports normal, physical growth.”

    According to the FDA, only 75% of U.S. infants are breast-fed from birth. Three months on from birth around two-thirds of all U.S. infants are estimated to rely on infant formula for at least part of their food intake.

    The new rule (technically an interim rule) will be available for public comment for 45 days. In the meantime, the FDA has stated that many of the rule’s provisions are already followed by infant formula manufacturers in the U.S.

  • California Egg Law Is Met With Opposition

    California has proposed a law set for 2015 that will regulate more stringent guidelines regarding the treatment of chickens. In order for farmers to qualify for selling eggs, space requirements must be met as well as other conditions such as not confining hens to cages. Missouri Attorney General Chris Koster has recently challenged this law and taken his concerns to the federal level.

    Koster claims that the newly-proposed law infringes on interstate business operations where California should not be granted the influence to determine how farmers from Missouri operate. “If California legislators are permitted to mandate the size of chicken coops on Missouri farms, they may just as easily demand that Missouri soybeans be harvested by hand or that Missouri corn be transported by solar-powered trucks,” Missouri Attorney General Koster said.

    Missouri Farm Bureau President Blake Hurst agreed with Koster. “A pretty good tradition in this country that’s worked pretty well is that we have free trade among the states, and we would not want to see that changed,” Hurst said.

    However, there is opposition against Koster’s view. Jennifer Fearing, who is the senior state director for the California branch of the Humane Society, articulated another reason behind this recent debate. According to Fearing, “Attorney General Koster’s lawsuit targeting California’s laws, filed just to curry favor with big agribusiness, threatens state laws across the country dealing with agriculture and food safety.”

    Bruce Friedrich, who is a senior policy director at Farm Sanctuary, echoed Fearing’s sentiments. “It’s a real embarrassment for the state of Missouri that Mr. Koster would defend a practice that is horribly abusive of animals with a legal theory that is tilting at windmills.”

    Concerns relating to agriculture guidelines, the treatment of animals, and interstate business guidelines are all at the center of this developing situation.

    Image Via Wikimedia Commons and Courtesy of Biswarup Ganguly

  • FDA Reveals New Anti-Smoking Campaign For Teens

    The U.S. Food and Drug Administration (FDA) today revealed a new anti-smoking ad campaign targeted at teens. The ads will be geared toward preventing teens aged 12 to 17 from ever smoking cigarettes. The agency estimates that 10 million teens in that age range have smoked a cigarette or would be open to doing so.

    The campaign is titled “The Real Cost” and uses what the FDA is calling a “comprehensive multimedia approach.” The campaign will use print ads, radio ads, online ads, and TV ads in conjunction with facts about smoking to discourage teens from picking up the habit.

    “The FDA has collaborated with some of the brightest and most creative minds to develop a multimedia initiative designed to make the target audience acutely aware of the risk from every cigarette by highlighting consequences that young people are really concerned about,” said Mitchell Zeller, director of the Center for Tobacco Products at the FDA.

    The new campaign will be evaluated over time by the FDA to measure its effectiveness. Some of the early ads will zero-in on menthol cigarettes, mentioning that they pose the same health risks as normal cigarettes. Future “The Real Cost” ads will highlight smoking risks for specific demographics such as “multicultural” teens, rural teens and LGBT teens.

    The centerpiece of the campaign is a series of 30-second “The Real Cost” TV ads. While some of the ads are purposefully disturbing about the health consequences of smoking, others highlight the control that addiction has over smokers’ lives using a bully metaphor:

  • FDA Outlines New Food Transportation Rules

    The U.S. Food and Drug Administration (FDA) today announced new proposed rules that would tighten restrictions on food transportation.

    The regulation would put new rules into place about sanitary practices for the food transportation sectors. The proposal includes criteria for food refrigeration, food protection during transportation, and cleaning procedures to follow between loads.

    Shippers, carriers, and receivers that transport food to be sold in the U.S. would be subject to the new rules. Smaller shipping businesses with less than $500,000 in revenue each year would be exempted from the rules, as would shippers using U.S. roads to ship food not meant for U.S. consumption. The rules also do not apply to fully-packaged foods or live animals.

    “This proposed rule will help reduce the likelihood of conditions during transportation that can lead to human or animal illness or injury,” said Michael Taylor, deputy commissioner for foods and veterinary medicine at the FDA. “We are now one step closer to fully implementing the comprehensive regulatory framework for prevention that will strengthen the FDA’s inspection and compliance tools, modernize oversight of the nation’s food safety system, and prevent foodborne illnesses before they happen.”

    The new rule is part of the Sanitary Food Transportation Act that was passed in 2005. It is also what the FDA is calling the “final major rule” of the agency’s Food Safety Modernization Act. Other provisions of the modernization act include pet food regulations and new rules on imported food safety.

  • Developmental Delay Test For Babies Approved by FDA

    The U.S. Food and Drug Administration (FDA) today approved a new test designed to detect developmental delays and intellectual disabilities in children. The test is marketed by Affymetrix under the name CytoScan Dx Assay and can detect disabilities such as Down syndrome.

    The test works by quickly analyzing a child’s genome, allowing it to detect chromosomal changes. The process specifically targets areas of the hman genome known to be associated with intellectual and developmental disabilities.

    The test is designed to allow health professionals to diagnose intellectual and developmental disabilities early in a child’s life, giving parents and doctors more time for interventions or to prepare for the consequences of such disabilities.

    The CytoScan Dx Assay test was approved under the FDA’s de novo classification, which provides a quick regulatory process for “novel low-moderate-risk medical devices.” The FDA determined through the process that the test adequately detects chromosomal variations based on size, type, and position. Another test reviewed by the FDA found that the CytoScan Dx Assay is better at detecting certain chromosomal variations than tests that are currently in common use.

    “This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing health care providers and parents to intervene with appropriate care and support for the child,” said Alberto Gutierrez, director of In Vitro Diagnostics and Radiological Health at the FDA. “The FDA’s review of the test provides clinical laboratories with information about the expected performance of the device and the quality of the results.”

  • Acetaminophen Warning By FDA: Overdose Can Be Fatal

    The FDA recently asked that healthcare providers be mindful of the dosage of Acetaminophen they choose to prescribe patients. According to the government regulatory agency, more than 325 mg of the drug could have negative consequences such as severe liver damage. In certain circumstances, an excessive dose of Acetaminophen might even be fatal.

    The FDA made the reasons for its request clear in a statement released on Tuesday.

    “Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.”

    The warning addresses the medical community, however the an admonishment for over-the-counter drugs was seemingly absent. This was curious to some since certain non-prescription drugs like Tylenol contain the substance.

    Overdoses of Acetaminophen may be startlingly common due to misconceptions about the drug. Though it is used for pain, it is most effective at treating mild or moderate symptoms. Extreme pain for many individuals requires greater dosages of pain medication. This may cause persons to take a prescription drug and then take an over the counter drug when they feel the prescribed medicine isn’t enough. Even if the pain lessens or goes away, the person has unwittingly put their health at risk.

    And that’s just if they combined their meds with a single over-the-counter drug. Acetaminophen can be found in more than just pills like Tylenol. It’s found in various cold and flu medication as well. With flu season upon us, there’s no telling what a problem this can cause those trying to treat various aches and pains associated with season illnesses.

    But the most worrying consequence involves children who are given Acetaminophen. Parents are advised to carefully read labels to determine the recommended dose for young children and infants. They should use any measuring cups made available exactly as recommended. Finally, if they aren’t sure about dosage, they should contact a doctor.

    Image via Wikimedia Commons

  • Acetaminophen Warning: FDA Says Limit Dose to 325 MG

    The Food and Drug Administration (FDA) issued an acetaminophen warning on Tuesday and recommends that healthcare professionals stop prescribing drugs that contain more than 325 milligrams of acetaminophen. Acetaminophen is a pain medicine that you may recognize from taking Tylenol. The FDA says that prescribing more than 325 mg of acetaminophen per dosage unit can put people at risk for liver injury.

    Many people may not realize it, but a number of prescription and over-the-counter drugs contain acetaminophen. According to a statement released by the FDA at the beginning of the cold and flu season, “more than 600 medications, both prescription and over-the-counter (OTC), contain the active ingredient acetaminophen to help relieve pain and reduce fever.” For example, oxycodone (Percocet), hydrocodone (Vicodin) and codeine are combination drugs that contain acetaminophen. Sometimes these drugs may contain more than 325 mg of acetaminophen, which prompted the FDA to issue a warning.

    “There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury,” the warning read.

    Since people often don’t realize that these combination drugs contain acetaminophen, they sometimes combine them with OTC drugs such as Tylenol or cold medications that contain acetaminophen. “Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much,” the FDA said.

    This acetaminophen warning is nothing new. In 2011, the FDA asked manufacturers to stop producing combination prescription drugs that contain more than 325 mg of acetaminophen. At the time of the current warning, the FDA notes that more than half of manufacturers have complied with the request. Since some manufacturers are still producing these pills three years later, the FDA now plans to begin working on withdrawing approval for medications containing more than the recommended level of acetaminophen because of the possible health risks.

    The FDA plans to address the current recommended acetaminophen dosage for Tylenol and other OTC drugs in another regulatory action. The maximum daily amount of acetaminophen is 4000 mg, which may be taken in 1000 mg doses in products such as Extra Strength Tylenol. Since the FDA now advises against prescribing combo drugs that contain more than 325 mg of acetaminophen, it will be interesting to see if the FDA decides to reduce the current OTC dosage in the forthcoming regulatory action.

    Check out the FDA’s video acetaminophen warning below.

    Image via YouTube

  • Acetaminophen Warning Issued By FDA Tells Of Possible Liver Damage

    Acetaminophen warnings issued by the FDA this week ask doctors to limit the dosage of the drug they give patients, which will prevent possible liver damage.

    The Food and Drug Administration says they asked “manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule”, in 2011, and that they had to comply by this week. However, there are still drugs available that contain more than the recommended dosage, and that spells danger for consumers.

    The effects of these “combination drugs”–prescription strength medication like Vicodin or Percocet mixed with acetaminophen–can sometimes wear off before it’s time to take another one, and patients will often supplement with an over-the-counter drug that also contains acetaminophen. That “accidental overdose” is where the possibility of liver damage can come in.

    “We recommend that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen,” the FDA said in a statement.”We also recommend that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product. Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death.”

    The FDA has not announced a change to the dosage in over-the-counter products that contain acetaminophen, but say there are changes on the way.

    Image via Thinkstock

  • Monster Energy Drinks Investigated By Attorneys

    Your company may want to stop pushing the envelope of your product if it has a history for being a potential causation of five deaths from reports by the Food and Drug Administration.

    Monster Beverage Corporation, the makers of the popular Monster Energy drink has been pitted against the combined forces of east and west: a New York state attorney general and San Francisco city attorney are investigating the company’s marketing towards children.

    San Francisco City Attorney Dennis Herrera and New York Attorney General Eric Schneiderman joined forces last month after a federal judge in California tossed out a lawsuit filed by Monster; the company wanted to stop Herrera’s ongoing investigation that first began in 2012.

    Herrera filed a lawsuit against the company that claimed that Monster Energy drinks posed serious health issues as well as violating California state law by misbranding and marketing them towards children.

    Roughly 3,000 miles away in New York, Scheniderman issued subpoenas to multiple energy-drink makers as well as Monster as part of his ongoing investigation.

    “We are disappointed that Monster has remained defiant in marketing products to children,” Herrera said. “We hope this effort will cause the company to correct its irresponsible marketing practices.”

    Monster Beverage Corporation didn’t have an immediate comment on the joint effort, spokesperson Tammy Taylor said.

    Hold the tall large aluminum can of Monster and look closely and you’ll find a warning for all:

    (image)

    Not not that… this:

    (image)

    “Limit 3 cans per day. Not recommended for children, pregnant women, or people sensitive to caffeine.”

    Yet despite the disclaimer, Herrera asserts that the company pushes its product on minors.

    According kidshealth.org, at most, minors should ingest no more than 100 mg of caffeine per day.

    In December 2011, 14 year old Anais Fournier died of cardiac arrest due to caffeine toxicity after consistently consuming two 710 ml cans (3 cups) of Monster Energy per day. The combined amount of Fournier’s daily caffeine intake was 475 mg (14 cans of Coca Cola). It should be noted that Fournier had a pre-existing heart condition known as Ehlers-Danlos syndrome.

    Like a record, Monster has stated repeatedly that its drinks are safe, claiming ignorance of any deaths caused by its products.

    “As a company, we vehemently deny that drinking two cans of Monster Energy by itself can cause a death from caffeine toxicity,” the company said to WRC-TV back in 2012.

    What do you think? Kid friendly?

    Update: Spokesperson Tamara Taylor of Sitrick And Company said in an email to WebProNews that:

    “The sale and consumption of more than 10 billion Monster energy drinks worldwide over more than 11 years has shown that our products are safe. Contrary to allegations, they are not “highly caffeinated” and they are not marketed to children. In fact, a 16-ounce Monster Energy drink contains less than half the caffeine of a 16-oz (medium) size cup of Starbucks brewed coffee. Monster’s labels state: “Consume responsibly: Not recommended for children, people sensitive to caffeine, pregnant women or women who are nursing.”

    Images via Hoax Slayer, World Truth, Forbes, American Live Wire

  • Monster Drinks Investigated For Targeting Children

    Monster Beverage Corp. is coming under attack in an investigation by a New York state attorney general and a San Francisco city attorney general.

    Amidst all the death reports cause by energy drinks, the Food and Drug Administration (FDA) has confirmed that there is no solid evidence that the beverages have caused them.

    Yet in October, WebMD reported that a Maryland couple filed a lawsuit against Monster in the death of their 14-year-old daughter who drank two cans within one day from each other but then collapsed and was placed into an induced coma.

    Doctors declared that her heart had stopped following the consumption of the second 24-ounce drink.

    According to health experts, caffeinated Monster drinks contain on average 240 mg, but the daily recommended caffeine-intake for minors is 100 mg.

    The parents’ lawsuit claimed that the product’s ingredients are dangerous and shouldn’t be marketed towards young children and/or teenagers.

    Some have accused the company for not being completely transparent about the ingredients and even then the possible health risks the drink may expose to its consumers.

    It looks like other lawmakers couldn’t agree more.

    San Francisco attorney Dennis Herrera filed a lawsuit on the basis that Monster is intentionally marketing their products to minors.

    Monster responded to the lawsuit with their on lawsuit requesting to stop the investigation, but a California judge threw out the corporation’s case.

    However, the California-based company isn’t the only energy drink coming under scrutiny.

    New York attorney General Eric Schneiderman is also attacking the company along with others for marketing their products to children.

    The FDA doesn’t see the drink as a problem per se, but views the high concentration of caffeine as the reason for major health concerns.

    “FDA continues to evaluate the emerging science on a variety of ingredients, including caffeine,” a spokeswoman for the agency previously told WebMD.

    Monster Beverage Corp. has yet to make a statement on the investigations.

    UPDATE 1/15/13 2:06 p.m. 

    Here is a statement sent in by Monster Beverage’s PR:

    “The sale and consumption of more than 10 billion Monster energy drinks worldwide over more than 11 years has shown that our products are safe.  Contrary to allegations, they are not “highly caffeinated” and they are not marketed to children. In fact, a 16-ounce Monster Energy drink contains less than half the caffeine of a 16-oz (medium) size cup of Starbucks brewed coffee.  Monster’s labels state: “Consume responsibly:  Not recommended for children, people sensitive to caffeine, pregnant women or women who are nursing.” “

    Image via Wikimedia Commons

  • FDA Warns of Supplement Containing Steroid

    The U.S. Food and Drug Administration (FDA) this week warned consumers against a dietary supplement named Mass Destruction. The bodybuilding supplement has been found to contain a synthetic anabolic steroid.

    The FDA warning came on the heels of a death that is being blamed on the product. According to the North Carolina Department of Health and Human Services, a 28-year-old man was seriously injured by Mass Destruction. After using the supplement for what the FDA calls “several weeks” the man required a liver transplant due to liver failure.

    According to the FDA, liver injury is a known possible side-effect of steroid use. Other side effects of steroid abuse include testicle shrinkage, infertility, breast enlargement, and increased risks for heart attack and stroke.

    The FDA is advising anyone using Mass Destruction to stop doing so immediately. In addition, anyone believing they are experiencing side effects from the supplement is advised to see a doctor. Possible side effects include fatigue, abdominal pain, back pain, discolored urine, and unexplained health changes.

    Though Mass Destruction is marketed by the Blunt Force Nutrition company, the manufacturer of the supplement has not yet been identified by the FDA. The agency is also continuing to analyze the supplement to determine its ingredients.

    “Products marketed as supplements that contain anabolic steroids pose a real danger to consumers,” said Howard Sklamberg, director of the Office of Compliance at the FDA. “The FDA is committed to ensuring that products marketed as dietary supplements and vitamins do not pose harm to consumers.”

  • Cholesterol Levels: Keep Them Lo-Ho-Ho-W This Xmas

    Cholesterol is a hot topic this week, and for good reason– the Christmas dinner rivals the gloriousness of the Thanksgiving dinner, not to mention the cookies and sweets that seem to be everywhere all season.

    It has since been established that high cholesterol is no longer a worry just for “senior citizens,” according to the FDA, you should start getting your cholesterol checked after you hit the age of 20. If you are a bit overweight or have unhealthy habits such as smoking or excessive drinking, you should definitely keep up with your cholesterol levels to prevent heart disease.

    The FDA also tells us that the best way to keep your cholesterol down, in general, is to do things like:

    -Cut back on foods with lots of fat such as fatty meats, fried foods, whole milk, fatty cheeses, butter, margarine, oils, lard, and creams.
    -Cut back on food with lots of cholesterol, such as egg yolks and whole eggs.
    -Eat more fruits and vegetables.
    -Cut back on fatty snacks and desserts, such as candy, cookies, doughnuts, muffins, pastries and pies.
    – Exercise at least 30 minutes most days.

    Which sounds great in everyday life, but… this is Christmas.

    If you’ve been making a conscious effort to maintain your cholesterol levels all year, or don’t want to give yourself the gift of the beginnings of high cholesterol levels this Christmas, there is a lot that you can do.

    If you are in charge of the cooking:
    -Enlist the use of egg whites plus yolk in your cake batter
    -Drain your meat before cooking
    -Use olive oil or nonstick cooking spray instead of butter for cooking
    -Use fat-free milk and chicken broth
    -Don’t fry everything

    If you aren’t in charge of the cooking, just make sure that your plate is heavy on the vegetables, fruit and lean meats and light on dense foods heavy in oil.

    All in all, it’s likely that you’ll eat a bit more than you would on a regular day, but don’t fret. Catch up with an old friend or family member with a brisk walk around the neighborhood, or start a snowball fight for an enjoyable dose of exercise.

    Fun tech fact: If bleeding on your phone doesn’t give you the willies, ABC News tells us that you soon may be able to use a Smartphone Cholesterol Application for Rapid Diagnostics (SmartCARD) to measure your levels at any time. Once this nifty device is released, you’ll be able to get a quick reading by merely dropping a drop of blood into a holder attached to your smartphone.

    This Christmas, you can give the gift of a healthy cholesterol count this season to yourself as well as to your loved ones– a gift that’ll keep on giving for years to come.

    Image via Youtube

  • FDA to Require Food Supply Protections

    FDA to Require Food Supply Protections

    Most food scares in the U.S. are caused by negligence or accidents, not someone intentionally poisoning a large amount of food. The latter scenario might seem more like the scheme of a comic book villain, but the U.S. Food and Drug Administration (FDA) this week issued a proposed rule to curb the possibility of such a scenario from happening.

    The new rule would require food facilities in the U.S. to help prevent their foods from being intentionally contaminated. The rule requires food facilities that the FDA sees as most vulnerable to attack to write up a “food defense plan” that points out possible “vulnerabilities” in its food production. Those same facilities will then have to take action to monitor and defend these vulnerabilities. Training employees and keeping records will be part of the oversight required of food businesses.

    “The goal is to protect the food supply from those who may attempt to cause large-scale public health harm,” said Michael Taylor, deputy commissioner for Foods and Veterinary Medicine at the FDA. “Such events, while unlikely to occur, must be taken seriously because they have the potential to cause serious public health and economic consequences. The FDA’s goal is to devise an approach that effectively protects the food supply in a practical, cost effective manner.”

    Though the possibility of terrorists poisoning the U.S. food supply is an unsettling one (especially with Christmas just days away) the FDA in its statement made it clear that the agency is unaware of such a thing ever happening. The proposed rule is simply a precaution to prevent such a scenario from ever happening in the first place.

  • Antibacterial Soap: What You Need To Know

    Antibacterial Soap: What You Need To Know

    Some of us pride ourselves on having antibacterial anything close by. In the bathroom, in the kitchen, and even in your purse. You know, just in case you’re stuck in a public restroom and that blasted automatic soap dispenser is empty. When people see the words “kills 99.9% of germs” they probably get a little giddy inside.

    And why shouldn’t they?

    Americans have been led to believe that by washing their hands with antibacterial soap they’re protecting themselves from harmful bacteria. The nation’s ceaseless vigilance has been long credited with helping to stop the spread of flu germs.

    Well, the Food and Drug Administration has finally gotten around to eroding all of that smug self-satisfaction. The organization is now demanding that all companies who manufacture items said to kill germs must actually prove it. This has Americans greeting the news with a bewildered, “Wait, you guys never checked to see if it was true?”

    Many American consumers just automatically assume that antibacterial soaps are safe. The “kills germs” in big bold letters is all anyone needed. Unfortunately, most shoppers don’t even bother to check for the words “FDA approved” in its stead. Between corporations and the government, it’s hard to peg who dropped the ball the hardest.

    Consumers have probably never even heard of Triclocarban, an ingredient found in antibacterial bar soaps and said to potentially interfere with hormone levels. The soaps could even cause bacteria resistance. That’s right, instead of protecting you from germs, you’d find yourself more susceptible to them.

    Officials are telling Americans they’re better off fighting germs the old fashioned way: by using plain soap and water.

    Before you despair, there may be an alternative coming to stores in the future. Scientists are currently working with cold plasma, which has been shown to be an effective tool for eliminating germs and treating infections. It may take a few years to perfect, but at least it will be scientifically proven to work.

    So chin up, germaphobes. Your day is coming.

    Image via ABC News Youtube

  • FDA to Take a Closer Look at Antibacterial Soaps

    The U.S. Food and Drug Administration (FDA) today announced that it will be taking a closer look into the safety of antibacterial soaps.

    Under a new rule proposed by the agency, antibacterial soap and body wash manufacturers would have to provide evidence showing that their products are safe for long-term daily use and that their products are more effective than regular soap. Manufacturers unable to provide such evidence, which includes clinical trial data, would have to relabel their product for sale in the U.S. or reformulate their products to remove certain active ingredients.

    “Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CEDR) at the FDA. “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

    According to the FDA there is currently no evidence products marketed as antibacterial are any more effective at preventing the spread of illnesses than normal soap and water. The FDA also feels there is evidence that some active ingredients in antibacterial soaps (the most common being triclosan and triclocarban) could “pose health risks” with long-term exposure, iincluding “bacterial resistance or hormonal effects.”

    The FDA’s new rule would not affect hand sanitizers or wipes. Also, manufacturers will not have to scramble right away to provide the FDA with the data it is looking for. The new rule will go into effect after 180 days and manufacturers will then have one year to submit their evidence to the agency.

    “While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” said Dr. Sandra Kweder, deputy director for New Drugs at CDER. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.”

  • Aura Migraine Treatment Device Approved by FDA

    The U.S. Food and Drug Administration (FDA) has approved the first device for the treatment of aura migraines. Aura migraines are described by the agency as severe migraine headaches preceded by a visual, sensory, or motor disturbance – and “aura.”

    The approved device is known as the Cerena Transcranial Magnetic Stimulator (TMS). The device is designed to be used after a migraine has already begun. Patients suffering from a migraine hold the TMS against the back of their head and press a button. The TMS then releases a “pulse of magnetic energy” that stimulates the occipital cortex, sometimes relieving migraine pain. The device is meant to be used once per day.

    “Millions of people suffer from migraines and this new device represents a new treatment option for some patients,” said Christy Foreman, director of the Office of Device Evaluation at the FDA.

    The Cerena TMA was approved following and FDA review of a clinical trial involving over 200 patients. The trial found that 38% of study participants who used the device had their migraine pain subside two hours after.

    Though the trial found that the TMS may relieve headach pain from migraines, it did not show that the device can relieve other symptoms associated with migraines. Light sensitivity, sound sensitivity, and nausea (all common migraine symptoms) were not affected by the device.

    The FDA has stated that the Cerena TMS is for the treatment of aura migraines only and that it is not for use by those younger than 18 or those with epilepsy. It is also not recommended for those with metals in their head or neck or people with a pacemaker, deep brain stimulator, or other type of implanted device. The device may also be associated with dizziness.

    (Image courtesy eNeura Therapeutics)

  • Generic Versions of Cymbalta Approved by the FDA

    The U.S. Food and Drug Administration (FDA) this week approved the first generic versions of the antidepressant duloxetine, commonly marketed as Cymbalta. The drug is a delayed-release medication used to treat depression and some other specific conditions.

    The new generic versions of Cymbalta will function the same as the branded version of the drug, and at the same strength. This also means, however, that the generic version carries the same side effects of Cymbalta, including nausea, dry mouth, drowsiness, fatigue, decreased appetite, excessive sweating, and dizziness. The drugs also carry the increased risk of suicidal thinking in those younger than 24 years old – a side effect seen in a variety of antidepressant drugs.

    The approval of the generic version of Cymbalta will bring the drug to market in the U.S. at a much lower price, allowing the drug to be used by a broader segment of Americans who may not be able to afford brand name drugs.

    The FDA emphasized that generic versions of drugs are just as potent as their branded counterparts. The generics go through the same approval procedures as branded drugs and generic drug manufacturers and packagers must meet the same standards as those that manufacture and pack brand names. The generics must also come with medication guides.

    “Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Dr. Kathleen Uhl, acting director of the Office of Generic Drugs at the FDA. “Generic drugs offer greater access to health care for many people.”

  • FDA to Tackle Antibiotic Use in Food Animals

    The practice of using antibiotics in farm animals has been debated for decades now. Farms will often put antimicrobials into the feed or water of animals bound for the dinner table to enable faster growth using less feed. Critics have argued that these antibiotics could have a dangerous effect on humans who eat the animals, and the U.S. government is now getting involved.

    The U.S. Food and Drug Administration (FDA) today announced a plan to phase out the use of “medically important” antimicrobial drugs in food animals. The plan would end the use of such drugs for animal food production and tightly control them for veterinary uses.

    Specifically, the FDA’s plan calls for animal pharmaceutical companies to revise the use conditions of their products on product labels. In addition, the FDA would like to end the over-the-counter status of such drugs, meaning veterinarian approval would be needed for disease treatment with the drugs. The FDA is calling for pharmaceutical companies to voluntarily implement these changes, and is giving companies three years to transition their products to comply.

    “Implementing this strategy is an important step forward in addressing antimicrobial resistance,” said Michael Taylor, deputy commissioner for Foods and Veterinary Medicine at the FDA. “The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal. Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”

    The medically important drugs targeted by the plan are those also used to treat humans. Researchers in recent years have seen a rise in antibiotic-resistant bacteria. The phenomenon is caused primarily by the overuse of antibiotics, which creates pressure for resistant bacteria to evolve and thrive. The CDC estimated this year that at least 23,000 American each year die from antibiotic-resistant bacterial infections.