FDA Deeming Summary and Timing
Regulations could take upwards of two years to finalize
Published in Tobacco E-News
MINNEAPOLIS -- Last week, the Food and Drug Administration released a proposed set of deeming regulations on cigars, pipe tobacco, electronic cigarettes, nicotine gels, hookah tobacco and dissolvable tobacco products. The proposed regulations answer some questions that industry members had about the extent of the regulations while a review of the proposed rules naturally leads to new questions being raised.
Essentially, the FDA is proposing two regulatory options. Option 1 extends the agency’s regulatory authority to all cigars, pipe tobacco, electronic cigarettes, nicotine gels, hookah tobacco and dissolvables, except tobacco accessories. Option 2 would extend the FDA’s regulatory authority to all of these categories of tobacco products, except premium cigars and accessories.
The most significant proposed regulations include the following:
- Manufacturers would need to register each of their tobacco manufacturing facilities with the FDA, submit a tobacco product list including a list of ingredients, and report any harmful and potentially harmful constituents.
- Modified risk descriptor words such as “light,” “low,” and “mild” could not be used to describe a tobacco product.
- Retailers would not be allowed to provide free samples of cigars, pipe tobacco, electronic cigarettes, nicotine gels, hookah tobacco and dissolvable tobacco products to adults.
- The minimum age to purchase these deemed tobacco products would be 18 years old and retailers will be required to verify through photographic identification the legal minimum age of a customer who is younger than 27 years old.
- For newer tobacco products that were not on the market as of February 15, 2007, manufacturers of these products would need to submit what is called a premarket tobacco application (PMTA) to the FDA within 24 months following the effective date of the final deeming regulations. If a PMTA application is filed with the FDA during this 24 month period, then the manufacturer can continue to market its products unless and until the FDA responds to the application.
- The FDA would require under Option 1 a new health warning on the packaging and advertisements for cigars, pipe tobacco, electronic cigarettes, nicotine gels, hookah tobacco and dissolvable tobacco products which would read: “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.” Under Option 2, this warning would not be required on premium cigars. Manufacturers, importers, distributors and retailers would be required to include this warning statement on all advertisements for deemed tobacco products, cigarette tobacco and roll-your-own tobacco products.
- The FDA is proposing to adopt four cigar health warnings that the Federal Trade Commission issued in 2000 as a result of legal settlements with the seven largest U.S. cigar manufacturers.
- The proposed deeming regulation does not ban flavors for the deemed tobacco products. The ban on flavors, except tobacco and menthol, continues to only apply to cigarettes. However, the FDA is requesting comments on factors it should consider in determining whether a particular tobacco product such as a little cigar or other non-cigarette tobacco product could be characterized as a “cigarette” and thus subject to the current flavor ban.
- In the proposed deeming regulations, the FDA acknowledges that the agency does not have sufficient scientific data about e-cigarettes to determine what effect they have on the public health. The FDA will continue to analyze the potential benefits and harms of e-cigarettes and is seeking additional scientific data to determine how e-cigarettes should be regulated given the fact that the products may be lower risk than combustible tobacco products. The FDA may consider additional regulations on e-cigarettes in the future.
- The deeming regulations do not include a ban on the Internet sale of the cigars, pipe tobacco, e-cigarettes, hookah tobacco, nicotine gels or dissolvables. In addition, the regulations do not restrict or prohibit television advertising of e-cigarettes.
The deeming regulations are a measured set of proposed regulations to help ensure that youth under the age of 18 do not purchase tobacco products. At the same time, some of the proposals raise new questions about how certain tobacco products can be marketed, how newer tobacco products can remain on the market, and what retailers will need to do to comply with the regulations once a set of final rules becomes effective.
For example, those manufacturers with newer tobacco products such as e-cigarettes would need to complete and file a premarket tobacco application to continue to sell their products. This application procedure is a complicated, expensive and time consuming process. The FDA estimates that it will take a manufacturer approximately 5,000 hours to complete one premarket tobacco application for a tobacco product, which includes conducting scientific studies on the new product and submitting all of the relevant paperwork.
The FDA is accepting comments on the deeming regulations for a period of 75 days, which ends on July 9, 2014. Given the scope of the deeming regulations, numerous manufacturers, wholesalers, retailers, trade associations, and tobacco consumers will all be involved in submitting comments to the FDA with responses to questions asked by the FDA, scientific data to respond to proposed regulations, and suggested changes to the deeming regulations.
These comments will be important since industry recommendations and data provided to the FDA would all be taken into consideration by the agency in determining what tobacco products are regulated and the extent of the regulations. From a timing perspective, this means that the process to finalize the deeming regulations will take many months and likely as long as a year or even two years. A factor that may delay the process further are requests by industry members for an extension of time to file comments with the FDA for a period longer than the 75 days set by the agency.
No one can predict the final outcome of the deeming regulation process, especially since the FDA has asked the public and the tobacco industry members for input not only on so many facets of the actual proposed regulations, but for ideas and feedback on potential regulations that the FDA may consider drafting in the future. This regulatory process will need to run its course and along the way the comments filed by industry members will help shape the final outcome of the deeming regulations.