On April 24, 2014, the U.S. Food and Drug Administration (FDA) announced what some call a “long- awaited” proposed regulation that will impact the future of the currently booming e-cigarette industry. Currently, e-cigarettes are not a part of FDA’s purview and have no FDA oversight – FDA’s proposed rule intends to change this in a big way.
How is Tobacco Defined Currently?
Section 201(rr) of the Federal Food, Drug and Cosmetic Act (FD&C Act), (21 U.S.C. 321(rr)),as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), currently defines the term “tobacco product,” as ” any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product… “.
The Tobacco Control Act permitted FDA to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco automatically as “tobacco product” under the FD&C Act.
Section 901 of the FD&C Act gives the FDA leeway to include “any other tobacco products that the Secretary by regulation deems to be subject to this chapter” and therefore subject to FDA regulation under the FD&C Act.
The FDA is proposing to “deem” products meeting the statutory definition of “tobacco product,” except accessories of a proposed deemed tobacco product, to be subject to the FD&C Act. The FDA proposed 2 options for public comment. Option 1 extended the definition of “tobacco product” in the FD&C Act to “electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not already under the FDA’s authority”. Option 2 deleted premium cigars from the equation. In both cases, accessories are not included.
Bottom line, if the Proposed Rule becomes final, the products that will be “deemed” tobacco products would be subject to:
- (1) Enforcement action against products determined to be adulterated and misbranded;
- (2) required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products;
- (3) required registration and product listing for all tobacco products;
- (4) prohibition against use of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order permitting their use;
- (5) prohibition on the distribution of free samples; and
- (6) premarket review requirements
FDA would also impose:
- (1) Requirement for a minimum age of purchase; (what this will do to online sales is yet to be determined)
- (2) health warnings for product packages and advertisements; and
- (3) prohibition of vending machine sales, unless the vending machine is located in a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time.
The proposed rule discusses a “premarket review” process for new “deemed” tobacco products. The FDA stated:
The statute establishes a “substantial equivalence” (SE) pathway for a new tobacco product to enter the market if it is substantially equivalent to a “predicate product,” meaning a product commercially marketed in the United States as of February 15, 2007. FDA is proposing to extend the compliance period for submitting a marketing application under this pathway to 24 months following the effective date of a final rule. FDA is also proposing a 24-month compliance period for the submission of premarket tobacco applications (PMTAs). In addition, we intend to continue the compliance policy pending review of marketing applications if those applications are submitted within the 24 months after the final rule’s effective date.
Smoking Cessation Products
Products that are marketed for therapeutic purposes, like electronic cigarettes claiming to help you stop smoking, will continue to be regulated as medical products under the FDA’s existing drug and device authorities in the FD&C Act.
Luckily for e-cigarette companies, the prohibition against characterizing flavors established in the Tobacco Control Act currently applies to cigarettes only. FDA requests comments on the characteristics or other factors it should consider in determining whether a particular tobacco product is a “cigarette” as defined in section 900(3) of the FD&C Act and, consequently, subject to the prohibition against characterizing flavors, despite being labelled as a little cigar or other non-cigarette tobacco product. FDA is also seeking research regarding the long-term effects of flavored tobacco product usage including data as to the likelihood of whether users of flavored tobacco products initiate cigarette usage and/or become dual users with cigarettes. FDA provided research findings in its Proposed Rule that “flavored product use is higher among 18-to-24-year-olds than 25-to-34-year-olds” and requested that comments be filed that address “what additional actions, if any, should FDA take to address the sale of candy and/or fruit-flavored tobacco products to children and young adults?”
FDA & E-Cigarette Industry Feedback
In the FDA’s blog, Margaret Hamburg, Commissioner of the FDA, said
Today we usher in a new chapter in FDA’s role in tobacco control, which began nearly five years ago when the Family Smoking Prevention and Tobacco Control Act enabled us to regulate certain tobacco products, including cigarettes and smokeless tobacco. Now, FDA has proposed a rule that would extend our authority to additional products meeting the legal definition of a tobacco product. This would include electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not already under the FDA’s authority, as well as future tobacco products.
FDA is committed to protecting public health. Expanding our authority over tobacco products gives FDA additional tools to help reduce the number of illnesses and premature deaths associated with the use of tobacco products. Under FDA’s proposal, these powerful regulatory tools would include age restrictions, rigorous review of new tobacco products and claims, and health warnings.
Reactions from the e-cigarette industry reported in various news sources were mostly favorable and are summarized below:
Washington Post reported mixed reviews –
- “This is worse than I expected,” said Greg Conley, a board member of the American Vaping Association, who said he welcomed the age-restriction rules but had hoped the FDA would grandfather in existing products, rather than force e-cigarette makers to file lengthy applications for any product on the market dating to early 2007. “A lot of these companies, they are supporting several employees, investing any profits back into their business … They can’t afford this, and it’s going to lead to a whole lot of consolidation and increased prices for consumers.”
- “What they did today was very encouraging … We’ve already done many things to prepare ourselves and act responsibly,” said Miguel Martin, president of Logic Technology Development one of the nation’s leading e-cigarette companies. “At least speaking for my company, this will not be the tobacco wars of the 80s and 90s.”
CNBC reported the main concern I noted, the proposed “pre-approval” process for e-cigarettes, as well as many positive comments by e-cig companies summarized here:
- “But one concern among e-cig advocates was that the Food and Drug Administration’s proposal that all e-cig products first receive FDA approval before being sold would slow down the ability to introduce technological improvements in the battery-powered devices, which could in turn harm efforts to convert smokers of cancer-causing tobacco cigarettes.”
- “Any ‘Johnny-come-lately’ will not just be able to throw a product out to the public without it in any way, shape or form being regulated,” said Jeff Holman, president of the e-cig company Vapor Corp. “I think it raises the bar.”
- “I’m very encouraged” by the proposed rules, said Miguel Martin, president of LOGIC, the second-best-selling e-cig company in the U.S., according to recent Nielsen surveys. … “There’s no question that the FDA’s oversight, which we welcome, brings legitimacy to the category,” Martin said. “Companies that are acting responsibly, I think, will be given every opportunity to be successful from a business perspective.”
- Rob Burton, director of corporate regulation affairs at White Cloud Electronic Cigarettes, was pleased there was no outright ban on flavoring proposed by the FDA. White Cloud sells e-cig liquid in five different strengths—including zero-percent nicotine—and in 19 different flavors.
- “With these proposed deeming regulations, we believe FDA has an unprecedented opportunity to advance public health goals by recognizing that some types of tobacco products may have significantly lower risks compared to cigarettes,” Altria said. “We believe FDA should adopt a regulatory framework that recognizes the differences in tobacco products and fosters innovation that may benefit public health. The framework must be grounded in science and evidence. FDA is in the best position to assess the science and determine how best to communicate relative risk information to consumers.”
Do you have comments on the proposed rule? You have 75 days (until July 9) to get your thoughts together, and send them to the FDA here, reference Docket No. FDA-2014-N-0189. FDA requests that parties provide comment and scientific evidence on the Proposed Rule – and specifically on:
- How the FDA should address the sale of candy/fruit flavored tobacco products to children. The current prohibition on flavored cigarettes and whether or not that should also apply to other “deemed” tobacco products.
- Whether FDA should proceed with option #1 “deeming” “electronic cigarettes, some or all cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco and dissolvables not already under the FDA’s authority” as tobacco products or #2, not including cigars as “deemed” tobacco products
- Pre-approval process – specifically, whether and, if so, how FDA should consider a different regulatory mechanism for newer proposed deemed tobacco products that cannot, as a practical matter, use the substantially equivalent (SE) pathway.
- Whether the FDA should stagger the compliance dates for the protection of public health.
- Behavioral data related to co-use of e-cigarettes and more traditional tobacco products, including data on the effects of e-cigarettes on the initiation and continuation of use of other tobacco products.
- How e-cigarettesshould be regulated; scientific data on whether they are less hazardous than combustible products.
We still have to remember, states can also set more restrictive rules. American Nonsmoker’s Rights Foundation has published a list of state and local laws regulating the use of e-cigarettes.