As of Aug. 8, it has been 90 days since the US Food and Drug Administration (FDA) announced its final “deeming” regulations for cigars, pipe and hookah tobacco, and electronic cigarettes. Aug. 8 marked the date when the regulations officially went into effect.
A press release from FDA’s center for tobacco products (CTP) outlines which provisions affecting retailers are going into effect.
As of that date, retailers:
- Must not sell e-cigarettes, hookah or pipe tobacco, or cigars to people under 18 years of age;
- Must check photo ID of everyone under age 27 who is attempting to purchase such products;
- Must not sell tobacco products covered under the rule in a vending machine (except in a facility where people under age 18 are not allowed on the premises); and
- Must not give away free samples of any newly regulated tobacco products (this provision also applies to manufacturers, importers, and distributors).
Also, as of Aug. 8, manufacturers are prohibited from marketing “modified-risk tobacco products” without an FDA order in place. Among other interlocking compliance requirements for tobacco products and several provisions related to limiting youth access to covered products that we are not describing, as of that date:
- E-cigarette manufacturers and distributors will be required to register their manufacturing establishments with FDA and list their products;
- Manufacturers will be required to submit ingredient lists to FDA and report harmful and potentially harmful constituents; and
- New warning label statements about tobacco-addictiveness will be required on packaging and in advertisements. Those warning statements apply only to “covered tobacco products,” which excludes any component or part that is not made or derived from tobacco.
In addition, August 8 is a critical date for all newly deemed tobacco products, because they are now subject to premarket authorization from FDA. The agency has implemented that market authorization requirements as follows:
- Tobacco products that were on the market prior to Feb. 15, 2007 are grandfathered in and do not require any sort of premarket authorization.
- Tobacco products that were on the market before the effective date (Aug. 8, 2016) but were not on the market as of February 15, 2007 are required to obtain premarket authorization. For these products, FDA has provided two compliance periods – the first is a deadline for an application to be submitted and the second is a deadline for receiving authorization. FDA has no plans to take enforcement action against any products that remain on the market during these compliance periods provided that applications are submitted; the agency also has stated its intention to review all these incoming applications expeditiously.
- Tobacco products that were not on the market as of the effective date cannot be introduced without marketing authorization from FDA and will be subject to enforcement if distributed and sold without authorization after August 8.
FDA said modified-risk tobacco products using descriptors such as “low,” “light,” or “mild” will be provided additional time to comply.
Aug. 8 also marks the deadline for manufacturers of newly deemed products to introduce new products without first obtaining FDA approval. Products 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.
The press release acknowledged that additional requirements for retailers and manufacturers will become effective at the end of the month, the end of 2016 and in the years that follow.try.