Posts Tagged ‘FDA approval’

FDA Bites the E-cigarette Regulation Bullet

April 24th, 2014

E-CigIt’s no public health secret that tobacco use continues to be a dominant cause of preventable disease and death in the US.  While the trend has been encouraging (Arizona’s smoking rate is down to 17%), there’s still much work to be done- and continued efforts to provide creative and effective ways to help adult smokers kick the habit are a key public health intervention strategy.

The flurry of electronic cigarettes that have come on the market recently have thrown us a tobacco cessation curve ball.  Over the last couple of years the public health community has been asking itself “… do the risks of electronic cigarettes outweigh their potential benefit as a smoking cessation tool?”.   The answer to that question depends on whether and how electronic cigarettes are regulated by the FDA.  Today, we got some information to help answer this key question.

Today the FDA released proposed new regulations that (when finalized) would: 1) ban selling of e-cigarettes to minors (it’s already illegal in AZ); 2) prohibit the distribution of free samples to anyone; 3) ban selling e-cigarettes in vending machines unless they’re in places where kids can’t come; 4) require e-cigarettes to have labels stating that they contain addictive nicotine; 5) require e-cigarette manufacturers to disclose the ingredients in their products; 6) require current e-cigarettes to provide  justification for remaining on the market…  and require new e-cigarettes to get FDA approval before being sold; and 7) only let e-cigarette claim that their product reduces risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health.

The  proposed new regulations wouldn’t restrict or ban the sale of fruit and chocolate flavored e-cigarettes that some believe are designed to attract and hook young people.  They also wouldn’t restrict TV advertising or online sales.

The FDA will begin accepting public comment on the proposed new regulations tomorrow.

Scorpions!

August 10th, 2011

Here in the Sonoran Desert monsoon season = scorpion season.  There are more than 56 species of scorpions in Arizona- but only one- the bark scorpion is of any public health significance.  The problem is that it’s the most common scorpion found in Arizona homes.  Since you live in the bark scorpion’s territory, you probably have them around or maybe even inside your home.  The Arizona Poison and Drug Information Center and Banner Good Samaritan Poison & Drug Information Center answer thousands of calls every year about scorpion stings- and last year they recorded more than 10,000 scorpion stings in AZ.

Scorpion stings are super painful but usually don’t require special medical treatment. Washing the sting area and using a cool compress along with over the counter pain medication handles the injury. The pain and numbness can last several days.  But… sometimes a scorpion sting causes severe symptoms that require fast and expert medical care. Symptoms to look for are difficulty breathing, uncontrolled jerking, drooling and wild eye movements.  Small kids are the highest risk group for these more severe reactions.  Each year there are about 200 kids in Arizona end up needing intensive medical treatment.   A recent study by the Banner Good Samaritan Poison and Drug Information Center showed that 33% of scorpion stings happen in the bedroom with 24% in the living room and 6% in bathroom.

OK… but what should you do in scorpion season? Here are some simple precautions:

  • To prevent scorpions from either climbing or falling into a baby’s crib- move the crib away from the wall, and take off any crib skirts that reach to the floor.
  • Roll back bed linens and check for scorpions before getting into bed.
  • Shake or examine all clothing and shoes before putting them on.
  • Move furniture and beds away from the walls.
  • Wear shoes when outdoors, especially at night around swimming pools.
  • Be especially careful of wet/damp towels in the bathroom and pool area.

We got some good news this week regarding scorpion sting treatment.  The FDA approved Anascorp® which is an antivenin produced in Mexico and tested in clinical trials conducted through the U of A for use in treating patients suffering the effects of scorpion stings.  Getting FDA approval took a lot of perseverance (12 years) partly because the antivenin process happens in Mexico… but it’s a good example of collaboration among academic and clinical researchers with partners in business and industry from both sides of the U.S.-Mexico border. Our own Arizona Biomedical Research Commission provided some of the funding for this research (P.S. check out our new ABRC Website).  You can read more about the research that went into the approval in a recent article in the New England Journal of Medicine.