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If a firm commits one of the infractions, everyone who was in control of the company's business and was responsible to the company for the conduct of business, as well as the company, will be held liable unless anyone involved can show that they were unaware of the act or attempted to stop it.

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"Limbaugh Losing His Hearing"

However, FDA may allow some exemptions on a case-by-case basis for products such as heated tobacco devices or very low nicotine cigarettes

Department of Health and Human Services [USDHHS] 2004, 2006, 2010) discussing active smoking, exposure to secondhand smoke, and the biological basis of disease, respectively