Early Monday morning, the FY17 Omnibus Budget to fund the federal government through October was rolled out by leaders of both parties. Notable among the policies and priorities missing from the agriculture budget was a House Appropriations Committee-passed provision that would have saved tens of thousands of business and millions of U.S. consumers from government overreach. Democrats were quick to take credit in a press release explaining the provisions they ensured were kept out included those that protected small vapor businesses and consumers from crippling regulations imposed last year.
The May 2016 “Deeming Rule” imposed by the Obama Administration’s Food and Drug Administration (FDA) expanded the list of tobacco products subject to burdensome rules established by the Family Smoking Prevention and Tobacco Control Act to include tobacco-free vapor products and electronic cigarettes.
As we recently explained in a letter to House and Senate leadership:
“The Rule requires new products that did not exist on or before February 15, 2007 – the predicate date – to undergo a burdensome pre-market review process that achieves little in the way of protecting public health at a very high cost. The FDA’s own estimates found that the cost of completing and submitting the required Pre-Market Tobacco Application (PMTA) would exceed $300,000 per product and take at least 500 hours of time per application. At present, the deadline for the submission of PMTAs for each product manufactured in the United States is August 8, 2018…
Estimates from the startup industry suggest 99% of all businesses would be wiped out unless Congress or the Administration rein in the Deeming Rule’s burdensome barriers to approval for new products.”
In their FY17 Omnibus Appropriations Act press release, House Democrats claimed credit for ensuring an important provision that would have grandfathered in products currently being used by smokers to quit was not included, noting, “The Omnibus does not include a House provision allowing thousands of unregulated tobacco products to escape full FDA review.”
Setting aside for a moment that the products are not unregulated, the provision referenced is the Cole-Bishop Amendment to the Agriculture Appropriations Bill, bipartisan language that passed the Appropriations Committee by a vote of 31-19 last Spring. Stand-alone legislation, House Resolution 1136, also has the support of both Democrats and Republicans and would modernize the 2007 predicate date to August of 2016, ensuring that products being used by smokers to quit when the regulation took effect will remain available beyond net year.
“The Cole-Bishop Amendment and House Resolution 1136 would not weaken the TCA or the ability of the FDA to impose additional product standards or regulations on new products in the future. That is precisely why the efforts are bipartisan, because there is recognition that while regulations that protect consumers are important, the Rule imposed burdens that neither protect consumers, nor acknowledge that the consequence will be the new industry’s demise.”
This minor statutory change would ensure that products known to be at least 95% less harmful than cigarettes were not treated more harshly than their combustible counterparts and made illegal by August of next year. Every cigarette on the market avoided the type of regulatory regime established by Obama’s FDA when the Tobacco Control Act passed in 2009.
Without immediate action by the Secretary of Health and Human Services or the Food and Drug Administration, tens of thousands of businesses and jobs will be killed by next year. This will limit the availability of reduced risk products to millions of U.S. adult consumers, representing the greatest setback in public health in decades. This isn’t the first time that out-of-touch House Democrats have claimed credit for punishing businesses trying to help consumers quit smoking but they should absolutely be ashamed of themselves.