Late in October, ECigIntelligence reported that the U.S. Food and Drug Administration (FDA) had submitted its final rule deeming e-cigs as tobacco products to the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) at the White House.
Subsequently, the Tobacco Vapor Electronic Cigarette Association (TVECA) released alleged copies of the table of contents of the final deeming rule and the FDA’s guidance on pre-market tobacco applications (PMTAs).
We will be analysing the implications of the purported PMTA guidance shortly. But in the meantime, what is certain is that the fate of the deeming regulations now lies in the hands of the OIRA, and here we answer some of the major questions concerning its role and the likely next steps.
Why is the OIRA required to review the final deeming rule before publication?
Executive Order 12866 explains the OIRA’s role in the rule-making process.
Among other things, the OIRA is charged with providing “meaningful guidance and oversight so that each agency’s regulatory actions are consistent with applicable law [and] the President’s priorities, [and] do not conflict with the policies or actions of another agency”.
The executive order also directs agencies of the federal government to adhere to certain rule-making principles, including the consideration of alternative rules, and to undertake cost-benefit analyses of proposed regulations.
How many regulatory actions does the OIRA review at any given time?
The number of regulatory actions (or “rules”) pending review by the OIRA depends on the activity of the federal government’s many agencies. As of 28th October, 116 regulatory actions were in the hands of the OIRA.
Of the 15 largest executive departments, the Department of Health and Human Services (HHS) – the agency in which the FDA is located – currently has the most (18) rules pending review.
When is the deadline for the OIRA to complete its review of the deeming regulations?
There is no deadline. The OIRA could finish its review today, tomorrow, next year, or the year after next. The time taken varies widely.
Of the 116 bills that the OIRA had under review toward the end of October, 32 (or 28%) had been in the process for more than 90 days, so reviews of that length are not uncommon.
When will the OIRA most likely hand the regulations back to the FDA?
Some industry insiders speculate that the OIRA will quickly finish its required review of the final rule and return it to the FDA for publication by the end of the year. But although this prediction is economically advantageous for vaping associations, who will likely see an increase in donations over the next couple of months to fund their lobbying efforts, ECigIntelligence does not expect the final deeming rule to be issued before the spring of 2016.
Why does ECigIntelligence believe the earliest date the final deeming rule will be published is in the spring of 2016?
The FDA has been criticised for failing to meet its original estimated publication date of June 2015. However, critics are aware that the OIRA has the responsibility of reviewing the rule before it can be issued. When the FDA sent the final deeming rule to the OIRA, the agency not only transferred the regulation – it also transferred those critics’ scrutiny. So the pressure that did exist on the FDA to hurry up with the rule is no longer such a factor.
Moreover, the deeming rule has been classified as “economically significant”, which means the review is conducted in more detail than for some other regulations.
Changes to the rule made since the FDA first published its proposal last year may also hold up progress. The purported table of contents that was recently leaked implies that there have been significant alterations, which will probably increase the length of the OIRA’s review.
Finally, we believe the OIRA intends to hold meetings with a number of stakeholders to obtain their views on the proposed regulations. It is required to give notice of these, and has not yet done so: another indication that it will not be finishing its work imminently.
What does the senators’ letter to the OIRA mean?
On 21st October, 11 Democratic senators sent a letter to the OMB urging the fast-tracking of the review process. However, the OIRA does not answer to Congress but to the executive branch (the president and his team), and will therefore only feel pressured – rather than obligated – to quickly complete its review of the rule.
In their letter, the senators also urged the OMB to ensure that the final rule includes strong regulations to help prevent youth tobacco use and other harmful effects, including a minimum age standard, limits on advertising, compulsory health warnings on products, bans on the use of flavourings and marketing that appeals to children, and mandatory child-proof packaging of e-liquids to protect young children from accidental nicotine poisoning.
They also urged the administration not to grandfather products such as e-cigarettes from reviews to determine whether they constitute threats to public health.
The signatories, all Democrats, were:
- Richard Blumenthal (Connecticut)
- Barbara Boxer (California)
- Sherrod Brown (Ohio)
- Dick Durbin (Illinois)
- Dianne Feinstein (California)
- Edward J. Markey (Massachusetts)
- Jeff Merkley (Oregon)
- Patty Murray (Washington)
- Jack Reed (Rhode Island)
- Charles E. Schumer (New York)
- Elizabeth Warren (Massachusetts)
– Carly Souther ECigIntelligence staff