A number of public health and medical groups have filed a lawsuit against the FDA
Seven public health and medical groups, including Campaign for Tobacco-Free Kids, and several individual paediatricians have filed a lawsuit in federal court in Maryland, challenging the US Food and Drug Administration’s (FDA’s) decision which allows electronic cigarettes and cigars – including candy-flavoured products which appeal to children – to stay on the market for years without being reviewed by the agency.
The lawsuit was filed by the American Academy of Paediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five individual paediatricians.
Whilst the groups strongly support the FDA's efforts to reduce nicotine levels in cigarettes to non-addictive levels, they also believe that the FDA's August 2017 decision to exempt e-cigarettes and cigars from agency review for years to come is unlawful and harms public health.
The lawsuit contends that the FDA's decision to leave on the market tobacco products that appeal to kids, deprives the FDA and the public of critical information about the health impact of products already on the market, and relieves manufacturers of the burden to produce scientific evidence that their products have any public health benefit.
According to the lawsuit, the FDA's decision to delay product reviews leaves young people more vulnerable to kid-friendly e-cigarettes and cigars which may lead to a lifetime of tobacco addiction. An FDA review "should remove from the commercial marketplace those tobacco products that pose the greatest health risks, particularly those targeted at children and teenagers.”
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In addition, the FDA's decision not to annually review such products "will hinder the development of science needed to understand, and to educate the public about which products actually do promote smoking cessation and how they can be marketed without exposing young people to unnecessary risk."
The need for the FDA to review e-cigarettes on the market has been underscored by the recent surge in popularity of e-cigarette brand JUUL, which is used widely by high school and college students, a recent press release has explained.
Sold in various fruit and dessert flavours, the manufacturer claims that each JUUL cartridge contains as much nicotine as a pack of cigarettes.
The FDA in August 2016 implemented a new rule (known as the "deeming rule") extending its jurisdiction to e-cigarettes, cigars and other previously unregulated tobacco products. However, in August 2017, the FDA delayed a key provision of the rule that required manufacturers of products then on the market to provide critical information to the FDA about each product and undergo an FDA review of the product's impact on public health.
The FDA have now delayed the deadline for filing applications until August 2021 for cigars and other newly-regulated combustible products and until August 2022 for e-cigarettes. The FDA has also said that these products will remain on the market indefinitely during the review process and did not set a deadline for completing its review.
The health groups' lawsuit contends that the FDA's lengthy delay of product review deadlines exceeds the agency's authority under the Family Smoking Prevention and Tobacco Control Act (the 2009 law that established FDA oversight of tobacco products). It also contends that the FDA's decision violates the Administrative Procedure Act because the FDA did not give the public an opportunity to comment on the change and did not articulate an adequate factual basis for this radical change from the deadlines the FDA itself established in the deeming rule.
Advances in health "must ensure self-sovereign identity"
The UK government has announced that from September onwards COVID-19 vaccine passports will be necessary to gain entry into places with large crowds, such as nightclubs.
This has reignited the debate between those who believe having proof of vaccinations will enable people to gather in public places and travel safely, and those who view the digital certificates as an attack on personal freedom.
The arguments have increased in intensity since the recent announcement to drop COVID-19 restrictions in England, in a move to reopen the economy that has attracted fierce criticism both domestically and overseas.
Cross-party ministers are set to defy the government’s latest plans to introduce vaccine passports over civil liberties concerns. A number of MPs have already signed the Big Brother Watch declaration against “Covid status certification to deny individuals access to general services, businesses or jobs” in recent months.
However Mark Shaw, CEO of Tento Applied Sciences, says the Big Brother Watch campaign is based on false assumptions. “Big Brother Watch puts forward a compelling argument based around civil liberties, but some of the assumptions they make are simply incorrect” he says.
“For example, the BBW campaign claims that all Covid passes are discriminatory, counterproductive and would lead to British citizens having to share personal health information with anyone in authority, from bouncers to bosses. However, there are already privacy-first digital wallets that give individuals the freedom to store and share anonymised medical documents, work credentials and other types of documentation quickly, simply, and securely.
“I wholeheartedly agree that individuals should not be required to share their own personal health information with unknown third parties or with anyone in authority who demands it" Shaw adds. "But I strongly disagree with the suggestion that ‘events and businesses are either safe to open for everyone, or no one’. It creates a false dichotomy that either everyone is safe, or nobody is safe. If employers or event organisers don’t take action to properly manage workplace or venue safety, then they risk curtailing the safety and freedom of movement for the majority."
The subject of personal health data is under scrutiny in the UK at the moment, following controversial plans for the NHS to share patient data with third parties. These have been put on hold following public criticism.
Meanwhile a new report has found that the majority of the British public is willing to embrace digital healthcare tools such as apps and digital therapies prescribed by a trusted healthcare professional.
Shaw adds: “The vital point to make is this: innovations in health technology must ensure self-sovereign identity. This means the data held about an individual is owned by the individual and stored on their device. And, in the case of medical data, that data can be delivered from healthcare professionals to the device in an encrypted format, and the user chooses how they share their information."