On September 28, a series of traditional public health organizations, including the American Lung Association and the American Heart Association, as well as the Campaign for Tobacco-Free Kids (CTFK), sent a letter to Janet Woodcock, Interim Commissioner of the Food and Drug Administration (FDA). Aside from its actual substance – a predictable demand that all flavored vaping products, including menthol, be taken off the market – the letter reached a few rare notes of agreement with tobacco harm reduction advocates: urging the agency to speed up its long-awaited review process and panorama. the lack of transparency that accompanies it.
Due to a lawsuit filed and won by most of the signatories, the FDA had until September 9 to authorize or deny the marketing applications that vaping manufacturers had to submit a year earlier. Many of these pre-market tobacco product (PMTA) applications have already received refusal to market (MDO) orders from the agency, which means these products can no longer be sold. But the biggest companies, most of which make electronic pod cigarettes, remain in a regulatory vacuum.
The FDA has said it needs more time to look at the related science, an excuse that has encountered vitriol from all sides: Small and medium-sized vape makers have basically concluded that the industry will turn into an oligopoly. well-funded brands. ; prohibitionists are not happy that the agency has yet to target the most influential players.
The FDA’s opacity has left everyone guessing its next move, fueling rumors and turning manufacturers, consumers and activists of all stripes into pseudo-sleuths.
Meanwhile, speculation has grown that anti-vaping organizations will grow impatient and return to court. In the letter, they chide the FDA for its delay, saying it allows big companies to perpetuate an “epidemic” of youth vaping. They also ridicule the agency for not having “been transparent about the products for which it has issued MDOs”.
“To ensure the continued availability of electronic cigarette products that the FDA has determined to fail to meet the legal public health standard, and to allow the public to assess the FDA’s application against these products, the FDA should disclose the products and their flavors, for which MDOs have been issued and should continue to publicly identify these products in the future, âthey said. write.
This sentiment, ironically enough, has been a recent refrain from proponents of tobacco harm reduction (THR). Amid a lack of information, they fear the FDA is creating a de facto ban policy on all flavors (which many adult vapers find essential to quitting smoking) without admitting it. The FDA’s opacity has left everyone in the position of guessing their next move, fueling rumors and turning manufacturers, consumers and activists of all stripes into pseudo-sleuths.
Is the FDA preparing for another trial? Does he invite one? Does he have a secret policy of rejecting all products with flavors other than tobacco or menthol? Speaking at the industry-sponsored Global Tobacco and Nicotine Forum (GTNF) in London last week, Todd Cecil, deputy scientific director of the FDA’s Center for Tobacco Products, denied the latter suggestion, while giving the less possible.
Yet both polarized tobacco control camps – those who embrace safer alternatives to nicotine for adults and those who would somehow prefer to legislate on the substance – find themselves agreeing that the FDA has done a bad job since. start.
âThe FDA had nothing to do with all of this,â Amanda Wheeler, president of the American Vapor Manufacturers Association, said in a keynote speech at the GTNF. âThe FDA could have addressed this by enabling companies that have historically been registered with and inspected by them to continue to serve their customers while addressing the larger issue on the basis of solid science and genuine public health.
She also made fun of Cecil‘s state that the MDGs were issued on the basis of individualized evaluations of flavored products, noting that many of its organizations‘s members received rejection letters that were basically the same.
âThe whole process hasn’t been clear from the very beginning,â Wheeler said. Filtered. âWhere we are now shouldn’t come as a surprise. “
Over the past month, the FDA has issued MDOs to hundreds of companies for millions of products because they have not completed certain scientific and behavioral studies, all of which are arduous and prohibitively expensive for all companies. except the largest – and some of them the agency did not specify that they were needed before the PMTA submission deadline expired.
“The FDA must be transparent, not only about its approach to specific low-risk alternatives to lethal cigarettes, but about the agency’s general direction.”
At the very least, it has led to a situation of abject anger and confusion. Many producers are now turning to synthetic nicotine, seen as a legal gray area potentially outside the jurisdiction of the FDA; others categorically challenge the FDA’s rulings, claiming that the agency has wrongly refused particular products. At least one large company, Turning Point Brands, has filed a petition with a United States court of appeals.
“The FDA must be transparent, not only about its approach to specific low-risk alternatives to lethal cigarettes, but about the agency’s general direction,” David Sweanor, tobacco industry expert and assistant professor of law at the ‘University of Ottawa, said Filtered.
âPeople who practice abstinence are acting exactly like the groups that have vigorously opposed pure food laws and science-based drug regulations,â he continued. âFor them, moralism trumps science. Such people perpetuate the very problems that the FDA is set up to solve, and the agency needs to be clear on the direction it plans to take. “
Photograph by Alex Proimos via Flickr / Creative Commons 2.0