Acne products: THIS is what the FDA is worried about?

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Screen Shot 2014-06-26 at 12.50.32 PMA new warning about the dangers of acne medicines is enough to make you break out into a rash. It is all over the news. Here are a few representative headlines:

  • "Acne products can cause dangerous side effects, FDA warns"
  • "FDA: Acne products can cause severe allergic reactions"
  • "FDA Warns Of Life-Threatening Reactions With Acne Products"

One might think that virtually every ambulance in the country is currently making runs between high schools and emergency rooms. But, this is simply a different shade of the color that we at ACSH deal with almost every day: the inability of people, organizations, and agencies to properly assess real risk as opposed to miniscule or theoretical risk. But if the agency in charge of assessing risks and benefits of medications and many foods can t tell the difference between a tiny risk and an alert, we are in deep trouble, and there could not possibly be a better example than this.

This is what the FDA is warning about: Over a 44 year period, a grand total of 131 adverse reactions associated with the use of OTC acne medications either salicylic acid, benzoyl peroxide or both. And the FDA cannot even determine which, if either of these ingredients (or perhaps the inactive ingredients) were responsible for the development of cases of severe allergic reactions, such as wheezing, fainting and hives.

There were no deaths attributed to these products, but 44 percent of the reactions resulted in hospitalization (that s a grand total of 57.6 hospitalized victims figure that one out!).

Let s do some math. The average number of reactions over the period in question is 3 per year with a whopping total of 1.3 people per year requiring hospitalization. When this number is considered along with the 45 million people in the US who have acne and the global market of $3.3 billion for acne products, it becomes patently obvious how silly this warning is.

ACSH s Dr. Josh Bloom comments, It is currently 80 degrees in New York, with partly cloudy skies and a light wind. So, I was certainly surprised to look out the window and see a hailstorm. But upon closer examination, it became obvious that it was simply tubes of Clearasil flying from apartment windows.

While this may sound amusing, another FDA statistic is less funny.

According to ACSH trustee, Dr. Paul Offit, The F.D.A. estimates that approximately 50,000 adverse reactions to dietary supplements occur every year. Dr. Offit s new book Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine devotes considerable time to this subject. He takes on the now-infamous supplement huckster Dr. Oz in a rather unflattering way (and this is possibly the understatement of the century).

Dr. Bloom who recently called out the purveyor of another Internet supplement superstore, Dr. Joe (Crazy Joe) Mercola says, If you are wondering why life makes no sense at the moment, you are not alone. Although the current FDA warning is ridiculous, it is not fair to blame them for their inability to protect consumers from supplements a, REAL risk.

This is because the power to regulate supplements was taken away from them in 1994, courtesy of Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), whose perversely-named Dietary Supplement Health and Education Act was rammed through Congress amid many questions and criticisms of financial impropriety.

You ve probably seen John Oliver s brilliant, hilarious and scathing video about Oz and both senators. If not, we strongly suggest that you spend 16 minutes and do so. You will get quite an education about what really makes things tick in the supplement industry. (Warning: some colorful language.)

No- you do not have to worry about acne medicines. You will probably win the lotto simultaneously in all 50 states before you are harmed by these products.