A member of Congress has directly challenged the FDA with hard questions about its deeming regulations, which amount to a ban on all products now available. Sen. Ron Johnson, a Republican from Wisconsin, sent a letter to FDA Commissioner Robert Califf on May 18 expressing his concerns, according to a press release from the Senate Homeland Security and Governmental Affairs Committee.
Johnson is chairman of that committee, which is reviewing the regulatory burdens that federal agencies place on small businesses. The letter may have been prompted by complaints from one of Johnson’s constituents, Christian Berkey, chairman of Johnson Creek Vapor Company, which is located in Hartland, Wisconsin. Johnson Creek is one of the oldest vapor products companies in the United States.
Berkey, according to Johnson’s letter, says the FDA regulations will “extinguish a multi-billion dollar industry and put tens of thousands of people out of business.” This is exactly right, since the regulations mandate an exhorbitantly expensive application process that few can afford, and still doesn’t guarantee approval.
Sen. Johnson gives the FDA commissioner a deadline of May 31 to provide answers — and supporting documentation — to a series of specific questions about the regulations:
- “Will the FDA issue a revised rule if there is sufficient data that finds that e-cigarettes are a safer alternative to traditional cigarettes? Please explain.”
- “How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have ‘sufficient data’ about e-cigarettes to determine the effects on the public’s health?”
- “Did the FDA determine how many e-cigarette businesses will be affected by the rule? If not, why? If so, please provide that data.”
- “Of the e-cigarette businesses that will be affected by the rule, how many of those businesses does the FDA predict will exit the market as a result of the new requirements?”
- “Has the FDA considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products? Please explain.”
Most encouraging is Sen. Johnson’s concern over the potential of the regulations to destroy vaping product innovation and cause vapers to go back to combustible cigarettes. That’s certainly our biggest concern too.
“Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences,” writes Sen. Johnson. “The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking. It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes.”