A bi-partisan team of seven U.S. senators recently sent a letter to the Food and Drug Administration (FDA) questioning several aspects of the recently announced FDA e-cig regulations. Two Republicans and five Democrats followed the tactics of Sen. Ron Johnson from Wisconsin who has previously sent two such letters in the past 8-weeks. While Johnson’s letters have been largely ignored by the FDA so far, this latest attempt by the Big Seven addresses the issue of federal regulation from a different angle, which might prove to bolster Johnson’s previous efforts as a result.
Rather than focusing on e-cigs and vaping devices, Sen. Bill Nelson and six other senators are questioning the FDA e-cig regulations as they pertain to “large, premium cigars.” By taking this slightly different approach, the e-cig and vaping community might discover an unlikely ally in the fight to have the FDA e-cig regulations overturned or at least modified. The seven U.S. senators signing the new letter include,
- Bill Nelson (D-Florida)
- Bob Casey (D-Pennsylvania)
- Jon Tester (D-Montana)
- Marco Rubio (R-Florida)
- Robert Menendez (D-New Jersey)
- Joe Minchin (D-West Virginia)
- James Inhofe (R-Oklahoma)
(Related Article: WISCONSIN SENATOR RON JOHNSON FORCES FDA TO EXPLAIN DEADLY E-CIG REGULATIONS)
FDA e-cig regulations and the PMTA process
Even though the new letter is focused primarily on the cigar industry, many of the listed concerns are identical to those previously outlined by Sen Ron Johnson regarding the e-cigs and vaping industry. The new FDA e-cig regulations require a somewhat mysterious Pre-Market Tobacco Applications process (PMTA) that many small business owners fear will ultimately drive them out of business within the next two years.
“The final rule imposed a number of new requirements on premium cigars manufacturers and retailers, many of whom are small businesses. For example, the final rule required manufacturers to pursue one of three pathways for pre-market review for all newly deemed tobacco products first sold after February 15, 2007. Depending on the approval pathway selected, manufacturers have between 12 and 24 months to submit applications and to allow for FDA review. Absent an FDA determination with the original timeframe, products will receive up to an additional 12 months, during which time the FDA can issue a final decision on the application.”
(Related Article: NEW FDA E-CIG REGULATIONS AND THE MILLION-DOLLAR PMTA PROCESS)
The seven senators go on to ask whether the FDA has an effective plan in place to manage the huge number of expected PMTA applications that are sure to flood their offices. They also wonder how many applications the agency expects to receive in the first 24 months once the FDA e-cig regulations take effect. Other questions surround the possible consequences to small business owners if the FDA cannot approve or deny the application in the required length of time.
There were a total of eight separate points of concern listed in the new letter, most of which were mimicked in the two previously sent letters to the FDA by Sen Ron Johnson. But one thing remains clear. The cigar industry seems to have many of the same fears and concerns that local vape shop owners have over the future of their small businesses. Even though these seven senators are focusing on cigars rather than e-cigs, most vaping advocacy groups are anxiously awaiting the FDA’s response. To
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