Director, Center for Tobacco Products
FDA Document Control Center
10903 New Hampshire Avenue
Building 71, Room G335
Silver Spring, MD 20993-0002
October 17, 2016
Re: Center for Tobacco Products Efforts to Address Tobacco-Induced Human Germ Cell Damage
Dear Mr. Zeller,
I am a science philanthropist primarily concerned about adverse mutagenic and epimutagenic effects of various drugs, pharmaceuticals and tobacco on the human germline.
Based on my admittedly partial review of CTP activities, it appears that the CTP limits its concern for adverse outcomes of tobacco exposure to the somatic level. While questions of somatic pathology such as lung cancer, addiction, and heart disease are clearly of utmost importance in safeguarding public health, they also miss an entire dimension of risk.
Owing to its various toxic components, tobacco smoke has been shown to cause adverse impacts on germ cells. It has been shown to induce mutation in germ cells in human studies and animal models, as well as somatic mosaicism in animal models. At least one study points to transgenerational neurodevelopmental effects of nicotine, most likely via epigenetic mechanisms. The mutagenic and epimutagenic properties of tobacco smoke are now well known.
It is therefore surprising that the FDA’s CTP does not seem to include human germ cells, both male (sperm and precursors) and female (eggs and precursors), as a potential endpoint for tobacco toxicity. If in fact the high pregnancy smoking rates of the past decades increased risk for germline mutation and/or epimutation, developmental abnormalities in resulting offspring may be significant, and may include neurodevelopmental disorders such as autism and ADHD.
I am writing to inquire about what you think could be done at the CTP to ensure the FDA expeditiously addresses tobacco-induced risks to germ cells, particularly the highly vulnerable early germ cells that lie within fetuses. Health Canada, for example, has an admirable program on the gametic genetic toxicology of tobacco. What can we do to ensure a vigorous response here in the United States at the FDA as well?
Thank you for your consideration.
Very truly yours,
Escher Fund for Autism