On April 24, 2014, the U.S. Food and Drug Administration’s (FDA) issued a proposed regulation which would subject the currently unregulated e-cigarette industry to FDA regulation under the authority of the Federal Food, Drug and Cosmetic Act (FD&C Act). The proposed rule put e-cigarettes with a list of products FDA “deemed” tobacco products, and as such, subject to the FD&C Act. OMB intervened to weaken FDA’s original proposal.

If the proposed rule became final – e-cigarettes (and the other products “deemed” tobacco products) would have been 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; 
(6) premarket review requirements;
(7) Requirement for a minimum age of purchase; (what this will do to online sales was yet to be determined)
(8) health warnings for product packages and advertisements; and
(9) 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.

After analyzing the proposed rule and its potential economic effects, the White House’s Office of Management and Budget (OMB) intervened to weaken the proposed regulations of e-cigarettes and cigars.
The major OMB changes include:

  • This biggest of all changes is this one – Editing the FDA’s “prohibition of non-face-to-face sales (e.g. vending machines)” to “prohibition of vending machine sales,” leaving online sales of e-cigarettes unrestricted.
  • Deleting language detailing the FDA’s concerns about the safety of e-cigarettes, specifically the FDA’s review of electronic cigarette cartridges. The FDA sought to reduce “threats to the public healthy by investigating and responding to … poor quality control, significant variability in nicotine content, and the presence of humectants such as diethylene glycol – a chemical that has caused mass poisonings in other consumer products.”
  • Deleting language regarding electronic cigarette manufacturing concerns, specifically a proposal that the FDA would review e-cigarette cartridges for evidence of poor quality control, variable nicotine content or toxic ingredients.
  • Deleting extensive language in which the FDA calculated how many lives might be saved by regulating cigars. The FDA estimated a “welfare gain” of $16 million to $52 million from dissuading people from smoking cigars.
  • Removing the FDA’s cost-benefit analysis stating that exempting premium cigar manufacturers from issuing large warning labels would save the industry $1 million to $3 million, while incurring public health costs of $32.6 million to $34.2 million.

In a change that impacts “premium cigars” – the OMB also changed the FDA’s proposed rule from a two-part rule – one for traditional tobacco products and one for products that have not previously been regulated – into a “two-option” rule. Option 1 would deem all products meeting the statutory definition of “tobacco product” except accessories to be subject to the FDA’s control. Products that meet the statutory definition of “tobacco products” can include certain dissolvables, gels, hookah tobacco, e-cigarettes, cigars and pipe tobacco. Option 2, is the same as option 1 except that it exempts premium cigars.

The cigar industry has aggressively lobbied Congress for such an exemption to the proposed rule. In a December 2013 letter to Margaret Hamburg, FDA Commissioner, and Sylvia Mathews Burwell, Secretary of Health and Human Services and former Director of OMB, 24 Republican members of Congress (that represent premium cigar manufacturers) asked that premium cigars be exempt from the proposed rule. “As you know,” they wrote, “premium cigars are a niche product with an adult consumer base, much like fine wines. The majority of people who enjoy a cigar do so occasionally, often in social or celebratory settings.”

In Reuter’s June 25 article, Emily Cain, a spokeswoman for OMB, explained that “it is routine for agencies to make changes to their draft rules during the course of OMB review.” Adding that “the goal is to maximize the effectiveness and benefit of the rules we complete.” FDA spokeswoman Jennifer Haliski said the FDA does not comment on changes to a proposal during the review process but encouraged the public to comment on the proposal. The period for the public to comment has been extended until August 8. “All comments will be carefully considered as the final rule is being developed,” she said. “As the science base continues to develop for these products, the agency has the ability to take additional regulatory actions designed to further minimize the public health burden of tobacco use in this country.”

The FDA extended the comment period to August 8th.  Do you have comments on the proposed rule? Do you need lobbying assistance like the premium cigar manufacturers had? Do you need help submitting your comment? If so, let’s discuss, email me at jdiaz@bplegal.com.

Co-Authorized by Melissa Rodriguez, a law clerk at Becker & Poliakoff and a student at the University of Florida Levin College of Law.