Stanton Glantz, PhD's blog

Letter to FDA protesting public comment period for IQOS; says comment period should be 180 days after full application is posted

Lauren Lempert and I submitted this letter to Mitch Zeller at the FDA by email and submission to the PMI IQOS dockett (tracking number 1k1-90bh-d1uh ).  A PDF of the letter is here.
 
December 12, 2017
 
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FDA should not permit modified exposure claims for IQOS because they are likely to be misunderstood as modified risk claims

Lauren Lempert, our colleagues at UCSF, Georgia State University and Stanford, and I have submitted this comment on PMI's IQOS application to the FDA.  The tracking number is 1k1-90at-5wj2 and a PDF of the comment is available here.
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Detailed analysis of the Executive Summary (Section 2.7) submitted by Philip Morris International in support of its MRTP applica

Lauren Lempert and I submitted this public comment to the FDA on PMI's IQOS MRTP application.  The tracking number is   and the PDF is available here.
 
 
Detailed analysis of the Executive Summary (Section 2.7) submitted by Philip Morris International in support of its MRTP application for IQOS
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Evidence in PMI’s MRTP Application indicates that the proposed labeling and warnings for IQOS will mislead consumers

My colleagues at UCSF, Stanford, and Georgia State University have submitted this public comment to the FDA.  The tracking number is Read more »

PMI’s MRTP Application for IQOS Does Not Consider IQOS’s Appeal to Youth or Adolescents

My colleagues and I at UCSF, Stanford, and Georgia State have submitted this public comment to the FDA on PMI’s IQOS MRTP application.  The tracking number is 1k1-9087-458e.  A PDF of the comment is available here.
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Statement regarding litigation filed by Dr. Eunice Neeley

As reported in Buzzfeed and elsewhere, Dr. Eunice Neeley has filed a lawsuit against me alleging sexual harassment and discriminatory behavior. 
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IQOS emissions create risks of immunosuppression and pulmonary toxicity, so FDA should not accept PMI reduced risk claim

My colleagues at the UCSF TCORS just submitted this public comment to the FDA and PMI's application to market IQOS as a modified (less) risk tobacco product.  There is a PDF of the comment here and the tracking number is 1k1-903a-mnpl.
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PMI’s MRTP application for IQOS does not adequately evaluate potential for liver totoxicity risk

My colleagues at the UCSF TCORS just submitted this public comment to the FDA and PMI's application to market IQOS as a modified (less) risk tobacco product.  There is a PDF of the comment here and the tracking number is 1k1-9039-d91g.
 
PMI’s MRTP application for IQOS does not adequately evaluate potential for hepatotoxicity risk Read more »

Is FDA going to end up helping prolong the tobacco epidemic? It's beginning to look that way

Reuters has reported that “The U.S. Food and Drug Administration said on Wednesday it is considering measures to speed development of products that help people quit smoking, including easing requirements for approval of over-the-counter nicotine replacement therapies... Read more »

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