The FDA’s final rule extending the agency’s regulatory authority to products such as e-cigarettes, cigars, hookah and pipe tobacco, certain dissolvables as well nicotine gels goes into effect Aug. 8. Some of the rule’s provisions that apply to retailers and manufacturers will take effect immediately on Aug. 8 while others will take effect later.
Some information is particularly important for retailers, manufacturers, importers and distributors to know early on. For example, several provisions take effect Aug. 8 that restrict the sale of newly regulated tobacco products. Other provisions taking effect on or around that date relate to “modified risk tobacco products,” user fees associated with cigars and pipe tobacco as well as the marketing of certain new products.
On Aug. 8, several provisions take effect that restrict the sale of newly regulated tobacco products to youth. Starting on this date, retailers cannot:
• Sell e-cigarettes, hookah or pipe tobacco, or cigars to people under 18 years of age and must check photo ID of everyone under age 27 who is attempting to purchase such products;
• Sell tobacco products covered under the rule in a vending machine (except in a facility where people under age 18 are never allowed on the premises); and
• Give away free samples of any newly-regulated tobacco products (this provision also applies to manufacturers, importers and distributors).
On Aug. 8, another provision becomes effective that prohibits the marketing of “modified risk tobacco products” without an FDA order in place. A modified risk tobacco product includes a product whose label, labeling or advertising claims that:
• It presents a lower risk of tobacco-related disease or is less harmful; and
• The product or its smoke contains a reduced level of/presents a reduced exposure to a substance; or the product or its smoke does not contain/is free of a substance.
Also beginning Aug. 8, manufacturers of newly-regulated tobacco products will no longer be allowed to introduce new tobacco products to the market without first receiving authorization from FDA. A manufacturer with a tobacco product already on the market as of Aug. 8 will be provided additional time to comply with certain submission requirements, such as ingredient listing, health document submission and premarket tobacco applications.
Another August deadline relates to user fees for manufacturers and importers of cigars and pipe tobacco. Domestic manufacturers and importers of these products must report data to calculate user fees no later than Aug. 20.