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News from Abroad


       PRODUCT SAFETY
       Lab finds benzene formation at ‘unacceptably high

       levels’ in certain acne products


          High levels of benzene, a known  handled at high temperatures –  such  of benzene is substantially  different
       human carcinogen, can form in acne  as when left in a hot car at more than  than  Valisure’s  previous  findings  of
       treatment products containing benzoyl   150°F for at least 14 days – they can  benzene in sunscreens, hand sanitisers
       peroxide,  according  to a new report  generate high  levels of  benzene, the   and other consumer products. The ben-
       from Valisure, an independent laboratory  lab said.                zene we found in sunscreens and other
       bases in the US.                                                   consumer products were impurities
                                           Of 175 acne  treatment  products  that came from contaminated  ingredi-
          In a petition filed with the US Food  initially tested by Valisure, all 76 that  ents; however, the benzene in benzoyl
       and Drug Administration, Valisure said  contained other ingredients – most  peroxide products is coming from the
       acne products from US brands includ-  commonly salicylic acid or adapalene –  benzoyl peroxide  itself, sometimes at
       ing Proactiv, Target Corp.’s Up & Up  had benzene levels that were either un-  hundreds of times the conditional FDA
       and Clinique have elevated levels of  detectable or below the US-FDA’s cur-  limit. This means the problem broadly
       benzene.  The lab asked the US-FDA  rent limit of 2 parts per million (ppm),  affects benzoyl peroxide products, both
       to recall the affected treatments, while  the company said in its citizen petition.  prescription  and over-the-counter, and
       regulators investigate.           However, 94  of the  99 benzoyl  per  necessitates urgent action”.
                                         oxide  products contained  benzene,
          Benzene has  been earlier detected  often with values well above 2 ppm.  Valisure also pointed to the past
       in consumer products like  hand sani-                              example of ranitidine. In 2019,  Vali-
       tisers, sunscreens, spray deodorants,   The lab not only detected benzene  sure  filed  a  citizen  petition  to  the
       and dry shampoos. The Valisure report  inside the product, benzene gas was  USFDA “showing that the ranitidine
       said benzene “can form at unaccept-  found in the airspace around it – which  molecule is fundamentally unstable
       ably high levels” in both prescription  was the equivalent  of air typically   and  degrades  to  form  high  levels  of
       and over-the-counter benzoyl peroxide  found in a  compact  car  – at  around  the carcinogen NDMA (N-nitrosodi-
       products, and results from  Valisure’s  1,270 times the threshold that the US  methylamine),” it stated. By 2020, the
       tests showing that some products could  Environmental  Protection Agency  has  USFDA requested that manufacturers
       form more than 800 times the “condi-  for  long-term inhalation exposure  to  withdraw all ranitidine products from
       tionally restricted” US FDA concentra-  benzene, according to the lab.  the market because NDMA had been
       tion limit for benzene.                                            found  to  “increase  significantly  in
                                           Mr.   David   Light,  Valisure’s  samples stored at higher temperatures,
          Tests involving  dozens of these  Co-Founder and President, stated,  including temperatures the product
       products suggest that when benzoyl  “This discovery of benzoyl peroxide’s  may be exposed to during distribution
       peroxide acne treatments are stored or  fundamental instability and  formation  and handling by consumers”.





















       Chemical Weekly  March 19, 2024                                                                 167


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