Industry View: Facts About FDA Deeming Regulations
On April 25, 2014, the U.S. Food and Drug Administration published the long-awaited “deeming regulations” that extend the agency’s regulatory authority to six additional categories of tobacco products. In its 241-page deeming-regulation document, the FDA includes 218 pages of explanation, commentary, rationale, questions and requests for additional input and research on regulating these additional tobacco products, along with 23 pages of the proposed deeming regulatory language.
▶ Two Options: The FDA deeming regulations contain two options. Option 1 would regulate all cigars, pipe tobacco, electronic cigarettes, nicotine gels, hookah tobacco and dissolvables, except accessories of a tobacco product. Option 2 would also regulate these six categories of tobacco products, except premium cigars and accessories of a tobacco product. Exempt accessories would include items such as lighters, cigar cutters, humidors, cases, and hookah tobacco tongs, charcoal burners and holders.
▶ Nine Regulations: The FDA is proposing that nine kinds of regulations already applicable to cigarettes, roll-your-own tobacco and smokeless tobacco products be extended to the six additional product categories, except premium cigars and accessories under Option 2. The nine regulations include the following:
1. Manufacturers would be required to register their tobacco manufacturing facilities with the FDA, and report any harmful and potentially harmful constituents.
2. Manufacturers would be required to submit a list of the tobacco products they produce and a list of ingredients in each product.
3. Modified-risk descriptors such as “light,” “low,” and “mild” could not be used to describe a regulated tobacco product.
4. Free samples of the deemed tobacco products would not be allowed.
5. For electronic cigarettes and other newer products that were not on the market as of Feb. 15, 2007, manufacturers of these would need to submit a premarket tobacco application (PMTA) to the FDA within 24 months after 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 PMTA process allows the FDA to authorize the introduction of products into the market where appropriate for the protection of the public health and prevent introduction of products that are detrimental to the public health.
6. FDA enforcement actions can be taken against manufacturers whose tobacco products are determined to be adulterated or misbranded.
7. The minimum age to purchase deemed tobacco products would be 18 and retailers would be required to verify through photographic ID the legal minimum age of a customer younger than 27.
8. A new health warning would be required on all deemed tobacco products, plus all cigarette tobacco and roll-your-own tobacco, and in all ads for these products: “WARNING: This product contains nicotine derived from tobacco. Nicotine is an addictive chemical.” This new warning would not be required for cigarettes or smokeless tobacco products because federal law already requires health warnings on them. However, this new warning would be required on advertisements created by retailers for deemed tobacco products, cigarette tobacco and RYO tobacco.
9. A prohibition of the sale of the deemed tobacco products through vending machines, unless the machine is located in an adult-only facility.
▶ Tobacco Flavors: The proposed regulations do 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 whether a particular tobacco product such as a little cigar or electronic cigarette could be characterized as a “cigarette” and thus subject to the current flavor ban.
▶ Regulations Not Proposed: The deeming regulations do not include a ban on the Internet sale of the deemed tobacco products. In addition, the regulations do not restrict or prohibit TV advertising of e-cigarettes. Only Congress has the authority to enact these kinds of restrictions.
▶Public Comments: The FDA is allowing the public a 75-day period to submit comments online at www.regulations.gov (type in FDA-2014-N-0189 in the Search box) or by mailing comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. (All written comments must reference “Docket No. FDA-2014-N-0189” and “RIN 0910-AG38.”) The comment period ends July 9, 2014. However, requests have been submitted to the FDA for an extension of the comment period.
▶ Future Regulations? Throughout the document, the FDA makes 29 specific requests for comments, alternatives, and scientific research on the six categories of deemed tobacco products. These specific requests underscore the fact that the FDA will likely consider the information that it receives from the public and then decide whether to propose additional regulations in the future. Specifically, the FDA’s request for comments on whether little cigars and e-cigarettes are similar enough to traditional cigarettes to apply the current cigarette flavor ban to these other products is an example of the agency’s inclination to propose additional regulations.
▶ Continuum of Risk The FDA acknowledges that there is a continuum of risk from different kinds of tobacco products, with traditional cigarettes being perhaps the most harmful and newer products such as e-cigarettes being potentially less hazardous. At the same time, the FDA clearly states that it does not have sufficient scientific data about matters such as tobacco product flavors and e-cigarettes to determine what effect they might have on the public health. For this reason, the FDA stresses that it will continue to analyze the potential benefits and harms of the deemed tobacco products along with their characteristics to determine whether more regulations should be applied.
▶Regulatory Process: Federal government agencies use a nine-step process in developing new regulations. The FDA is on Step 6, which is the period of time for the public to comment on the proposed regulations. In Step 7, the FDA will review all of the comments and then decide whether change any of the proposed regulations or draft additional regulations on the deemed tobacco products. In Step 8, the FDA submits the revised regulations to the White House Office of Management and Budget, which will conduct a final review of the regulations from an economic impact perspective. Finally, in Step 9, the FDA issues the final regulations and sets a date that the regulations will actually take effect.