Senators and state AGs urge FDA action as deadline nears

Written by || 8 August, 2014 || Business news analysis , Regulatory news analysis |

FDA logoThe public comments period on the U.S. Food and Drug Administration’s proposed e-cigarette regulations now has only hours left to run, with the agency likely to have received well over 70,000 responses by the time it closes.

Among those sent this week from powerful names in government were more arguments that flavours and advertising be restricted, and a suggestion that the final version of the regulations should define e-cig components more precisely. A group of law-makers also said that Washington could restrict e-cigarettes under existing legislation rather than waiting for new regulations to come into effect.

The Food and Drug Administration (FDA), which in April issued its so-called “deeming regulations” that would bring e-cigarettes under federal regulation for the first time by extending its authority over tobacco products to the new technology, was reported in U.S. media to have already been sent more than 69,000 comments by Wednesday. The comments period originally ended 9th July, but was extended by a month.

Many of those will most probably have been identical submissions by individual citizens supporting organised campaigns, but some heavyweight voices are also making themselves heard. Among them in recent days have been 13 members of Congress who wrote jointly to the FDA, and a second ensemble of 29 state and other attorneys general.

Both those groups urged tighter regulation than the FDA has suggested, including a prohibition on most flavours for e-cigarettes – which, it is argued, attract minors to e-cigs – and a ban on online marketing, because of the difficulty of age verification. As originally written, the rules cover neither issue.

Act now

The members of Congress said the need for rules was urgent, telling the FDA that “strong regulatory actions on marketing to children, e-cigarette flavors, and online sales cannot wait”.

The FDA has proposed that e-cigarette manufacturers be given two years from the date that regulations are finalised before products even have to be submitted for approval, let alone actually approved.

But the members of Congress want it to act immediately, and say that the agency can do so through the powers given to it by the Family Smoking Prevention and Tobacco Control Act, which “makes marketing new tobacco products illegal without prior FDA authorization.  The law also gives FDA the authority to place restrictions on the sale and marketing of newly deemed tobacco products, especially those that pose a risk to children, as a condition of FDA authorization.”

Beef up warnings, define components

The 29 attorneys general asked for similar restrictions on the e-cigarette industry. They want a ban on remote sales, including mail order as well as online; the same advertising limitations as for tobacco; and no online marketing.

They also say the health warnings on e-cigarettes should be more powerful than the FDA has outlined – describing effective warnings as “varied, explicit, vivid, and emotionally persuasive” – and they call on the agency to define which components and parts of e-cigarettes should be covered by age restrictions, vending machine sale bans, and the health warning rule.

These would include not only e-liquid but also atomisers, cartridges, tanks, batteries and even chargers, they argue, “as it is foreseeable that manufacturers may market batteries, atomisers, and tanks or cartridges as accessories in order to avoid the requirements and restrictions imposed on them once e-cigarettes are deemed a tobacco product”.

They propose a definition that reads: “A component or part is anything that is used or could be used to make or use the finished product that affects the nicotine, controls the nicotine, is affected by the nicotine, can be mixed with the nicotine, is required for proper function of the device, or monitors nicotine use either for refill level or for user data to measure user habits and personal use of nicotine.”

The letter from the members of Congress was signed by senators Tom Harkin, Dick Durbin, Jay Rockefeller, Richard Blumenthal, Edward J. Markey, Sherrod Brown, Jack Reed, Barbara Boxer, Jeff Merkley and Dianne Feinstein, as well as representatives Henry Waxman, Frank Pallone, Jr., and Diana DeGette. Several of these have been vocal proponents of strong e-cigarette regulation in Washington.

The attorneys general who wrote to the FDA, meanwhile, were from Arizona, California, Colorado, Connecticut, Delaware, the District of Columbia, Guam, Hawaii, Idaho, Illinois, Indiana, Iowa, Maine, Maryland, Massachusetts, Mississippi, Nevada, New Hampshire, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, and Washington.

What we said

ECigIntelligence was also among those submitting comments to the FDA this week. Describing ourselves as “welcoming coherent, proportionate, equitable and enforceable regulation without taking a position on specific detail”, we encouraged the FDA to consider “a significant and sometimes overlooked point: that marketplace trends in the consumer purchase and use of e-cigarettes cannot be disconnected from the public health effects of this product category”.

In particular, we said:

  • “A widely-documented shift away from ‘cigalike’ products (which strongly resemble combustible tobacco cigarettes, in both appearance and use) to ‘tank systems’ (which bear much less resemblance to conventional cigarettes) may diminish any ‘re-normalisation of smoking’ effect that e-cigarettes might have. This shift may also markedly affect individual consumption patterns; moreover, there is evidence to suggest that tank systems are most favoured by more experienced e-cigarette users who no longer smoke tobacco, and this also may mean that the calculus of their public health effects differs from that for cigalikes.”
  • “Restrictions on flavours may lessen the appeal of e-cigarettes to consumers, and thereby diminish any net public health benefit of e-cigarettes over tobacco cigarettes, by discouraging existing tobacco smokers from switching to e-cigarettes (research consistently demonstrates that virtually all e-cigarette users were previously tobacco smokers). FDA may wish to set this point against the common assumption that flavours are primarily, or substantially, marketed in order to attract minors to the products.”

What This Means: Some of the thousands of comments delivered to the FDA will have focused on conventional tobacco products such as small cigars, which are also addressed by the deeming regulations.

But it is likely that the majority relate to e-cigarettes, and will be expressing potent arguments on both sides  – in favour of tighter regulation, primarily to protect minors, or advocating of a looser regime, to maximise the potential of e-cigarettes in reducing tobacco smoking.

Which way the FDA will turn is anyone’s guess, but in the face of apparently irreconcilable arguments it may have a hard time fully maintaining its commitment to science-based regulation, given the absence of conclusive science on some of the biggest questions.

Last-minute comments for the FDA can be submitted here.

– Barnaby Page ECigIntelligence staff