Source: FDA, 7/29/16

FDA’s final rule, which extends the agency’s regulatory authority to products such as e-cigarettes, cigars, hookah (waterpipe) and pipe tobacco, certain dissolvables, and nicotine gels, goes into effect on August 8, 2016. Some of the rule’s provisions that apply to retailers and manufacturers will take effect immediately on August 8, and others will take effect later. To help make the process of complying as smooth as possible, CTP will continue to provide information along the way. 

Some information is particularly important for retailers, manufacturers, importers, and distributors to know early on. For example, several provisions take effect on August 8 that restrict the sale of newly-regulated tobacco products to youth. Other provisions taking effect on or around that date relate to “modified risk tobacco products,” user fees associated with cigars and pipe tobacco, and the marketing of certain new products.
More Provisions Take Effect August 8 and Later in the Month
On August 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;
• 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.

For modified risk tobacco products using descriptors such as “low,” “light,” or “mild,” additional time is provided to comply.(Details can be found at FDA.gov by searching for “modified risk.”)

Beginning on August 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 August 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 August 20.(Additional information is available at FDA.gov by searching for “tobacco user fees.”)
Additional requirements become effective at the end of 2016 and in the years that follow.

Read more here about the provisions that take effect in August.