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FDA Announces New Regulations on Previously Unregulated Tobacco Products

Attorney: Soniya D. Khemlani | Published 5.6.16

On May 5, 2016, after a five year wait, the Food and Drug Administration (“FDA”) announced its intent to place e-cigarettes, e-liquids, vaporizers and other previously unregulated tobacco products under federal oversight.

The regulations will begin to be rolled out 90 days after the date of publication of the final rule, and will subject the vastly expanded list of tobacco products to: 1) Enforcement action against products determined to be adulterated or misbranded; 2) Required submission of ingredients and reporting of harmful and potentially harmful ingredients; 3) Required registration of manufacturers and product lists; 4) Prohibition against sale and distribution of product modified risk descriptions and claims (e.g. “light”, “low” or “mild”) unless the FDA issues an order authorizing their marketing; 5) Mandatory use of health advisory warnings on all products; 6) Prohibition on the distribution of free samples; and 7) Premarket review requirements.

In addition, beginning in August, retailers will be prohibited from selling the tobacco products to those under 18, in person or online. The expansion of the FDA’s powers will apply to manufacturers, importers, distributors and retailers of the expanded list of tobacco products and are meant to improve the public health, raise awareness of health risks and reduce death and disease from these products.