Summary


The majority of the provisions for labeling have been removed from Rule R384-415, including the manufacturer's name, batch number, ingredients, tamper-evident warning, and the nicotine content. The rule's requirement for a safety warning on the label is amended to coincide with the requirements of the FDA Tobacco Control Act Deeming Rule. A separate safety warning specific to nicotine-free products has been added. The amended rule simplifies the restrictions on the retail sale of products that give the impression of a potential health benefit stimulant or are labeled as having colorants for emissions. The requirements limiting the variation of nicotine in a product have been removed. The provisions requiring products to feature tamper-evident packaging have been removed. The requirement that ingredients of electronic-cigarette substances meet certain manufacturing standards have been removed and replaced by a requirement that, by August 2019, the retailers can only sell products approved for sale by the FDA through their pre-market review or substantial equivalent application process. Record-keeping requirements that relate to deleted sections of the rule have been removed. This includes the requirement that retailers have a batch tracing system.