An Update on FDA 'Deeming' Regulations

OMB tells NATO review continues, will be finalized "as quickly as possible"

Thomas A. Briant, NATO Executive Director

House Office of Management and Budget (OMB)

Last October, the U.S. Food and Drug Administration's Center for Tobacco Products submitted to the White House Office of Management and Budget (OMB) a set of proposed "deeming" regulations that likely included regulations on cigars, pipe tobacco, electronic cigarettes and hookah tobacco.

While the FDA's Center for Tobacco Products (CTP) currently regulates cigarettes, roll-your-own tobacco and smokeless tobacco, the Family Smoking Prevention and Tobacco Control Act which authorized the FDA to regulate tobacco products also grants the agency the authority to extend tobacco regulations to other products deemed to be tobacco products. For this reason, the FDA has submitted proposed regulations that are currently under review by the OMB.

NATO contacted the OMB two weeks ago to inquire about the status of the FDA deeming regulations. The OMB official informed NATO that in January of this year the FDA's CTP requested the OMB for an extension of time to complete the review of the proposed deeming regulations. The OMB official also informed NATO that the review of the deeming regulations continues and will be finalized as quickly as possible.

For background purposes, the federal government uses a nine-step regulatory process whenever regulations will be adopted. The FDA is using this nine-step process to extend its regulatory cigars, pipe tobacco, e-cigarettes and hookah tobacco.

Step 1 involves determining what criteria and events exist that necessitate drafting regulations. For example, in the FDA's case, is there a public health issue that needs to be addressed through regulations.

Step 2 is used to determine if a rule or regulation is actually needed. If Steps 1 and 2 are fulfilled, then an agency will move to Step 3 and draft a proposed set of regulations.

In Step 4, the OMB then reviews any regulations of significance. The OMB reviews the regulations to determine the financial impact on an industry and meets with interested parties to hear first hand their comments and concerns about the proposed regulations. Step 4 is the step that the FDA is currently on with its proposed deeming regulations. This step has involved the OMB holding meetings with more than 30 stakeholder companies and trade organizations, including NATO, to listen to concerns about the potential impact of the FDA regulations.

If the OMB approves the FDA going forward with its new deeming regulations, then the FDA will move to Step 5 and publish the proposed regulations.

In Step 6, the public will be given 60 days to submit comments on the proposed regulations. If a request to extend this 60-day period is submitted, the comment period could be lengthened.

Then, in Step 7, the FDA will review all of the comments submitted and decide whether to draft any changes to the proposed regulations based on the public comments.

Step 8 takes the process back to the OMB for a final review of any revisions to the initial proposed regulations.

Finally, in Step 9, the regulations are published and become effective.