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Argument: Sufficiency of Scientific Evidence

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Health for Millions Trust v. Union of India [India] [January 08, 2018]

Using the powers conferred by India’s omnibus tobacco control law, the government introduced new graphic health warnings in October 2014 that, among other things, increased the graphic health warning size from 40 percent of one side to 85 percent of both sides of tobacco product packaging and amended the rotation scheme of the warnings.  The Karnataka Beedi Industry Association, the Tobacco Institute of India, and other pro-tobacco entities challenged the validity of the 2014 pack warning rules in five cases in the Karnataka High Court – Bengaluru, and the court initially stayed the implementation of the warnings via interim orders.  Following a petition by tobacco control advocates, the court lifted the stays, and a division bench of the court affirmed the decision on appeal.  The association and others challenged this ruling in the Supreme Court.  Paving the way for immediate implementation of the warnings, the Supreme Court, on May 4, 2016, directed that the matter be decided within six weeks in the Karnataka High Court by a bench constituted by the Karnataka Chief Justice and that any stays of the warnings in other high courts not be given effect until the conclusion of the matter.  After months of hearings, a two judge bench of the Karnataka High Court struck down the 2014 rules, and the Government and public health groups appealed the matter to the Supreme Court. The Supreme Court stayed implementation of the Karnataka High Court order and set final disposal of the matter for March 12, 2018. The Court stated: "[W]e are inclined to think that health of a citizen has primacy and he or she should be aware of that which can affect or deteriorate the condition of health. We may hasten to add that deterioration may be a milder word and, therefore, in all possibility the expression ‘destruction of health’ is apposite." India’s 85% graphic health warning rules accordingly remain in effect for now.

Karnataka Beedi Industry Association v. Union of India [India] [December 15, 2017]

Using the powers conferred by India’s omnibus tobacco control law, the government introduced new graphic health warnings in October 2014 that, among other things, increased the graphic health warning size from 40 percent of one side to 85 percent of both sides of tobacco product packaging and amended the rotation scheme of the warnings.  The Karnataka Beedi Industry Association, the Tobacco Institute of India, and other pro-tobacco entities challenged the validity of the 2014 pack warning rules in five cases in the Karnataka High Court – Bengaluru, and the court initially stayed the implementation of the warnings via interim orders.  Following a petition by tobacco control advocates, the court lifted the stays, and a division bench of the court affirmed the decision on appeal.  The association and others challenged this ruling in the Supreme Court.  Paving the way for immediate implementation of the warnings, the Supreme Court, on May 4, 2016, directed that the matter be decided within six weeks in the Karnataka High Court by a bench constituted by the Karnataka Chief Justice and that any stays of the warnings in other high courts not be given effect until the conclusion of the matter.  The Supreme Court identified pending pack warning challenges in courts throughout India (more than 27 in number) and transferred these cases to Karnataka. After months of hearings, a two judge bench of the Karnataka High Court struck down the 2014 rules. One judge found the rules illegal, holding that the Ministry of Health did not possess authority to act unilaterally. Both judges found the rules to be arbitrary and unreasonable.

Nicopure Labs, LLC v. Food and Drug Administration [United States] [July 21, 2017]

A manufacturer of e-cigarette devices and liquids challenged a federal regulation that deemed e-cigarettes to be “tobacco products.” This rule subjects e-cigarettes to the same federal laws as traditional cigarettes under the Tobacco Control Act (TCA). The manufacturer argued that the Food and Drug Administration (FDA), which issued the regulations, did not have the authority to regulate empty e-cigarettes or nicotine free e-liquids, because they were not made or derived from tobacco. The company also argued that the TCA’s ban on distributing free samples and pre-approval for modified risk statements was arbitrary and violated their First Amendment rights.

In this decision, the District Court upheld the FDA’s rule. The TCA gives the FDA the power to regulate “components” of tobacco products. The court found empty e-cigarettes and nicotine-free e-liquids are “components” of a tobacco product because together they make up an electronic nicotine delivery system. Further, the court found that the rule did not violate the manufacturers’ First Amendment rights because the ban on free samples was regulating conduct, not speech. The court also held that pre-approval for modified risk statements did not violate the First Amendment because it does not ban modified risk statements, it only requires the claims be substantiated. Finally, the court found because of the public health risks associated with nicotine and increasing rates of e-cigarette use in adolescents and adults, the decision to subject e-cigarettes to the TCA was not arbitrary. 

ASA Adjudication on Healthy & Beauty Innovations Ltd [United Kingdom] [October 29, 2014]

A website for NicoBloc said that the product could help with nicotine addiction by blocking up to 99% of nicotine and tar. The Advertising Standards Authority (ASA) found that the ads violated the country’s Advertising Code because they claimed that the product could be used to treat nicotine addiction without being a licensed medical device. The ASA also concluded that the tests used to determine the product’s ability to block nicotine and tar were not sufficient to support the ad’s claims and the ads were therefore misleading. The ASA ordered the company not to use the ads again in their current form and required the company to provide robust documentary evidence to support smoking cessations claims in the future. 

ASA Adjudication on E&L Distributors [United Kingdom] [August 13, 2014]

A bus shelter ad for e-cigarettes contained the text “LOVE YOUR LUNGS.” In response to a complaint, the Advertising Standards Authority (ASA) investigated the ad and determined that the claim “LOVE YOUR LUNGS” had not been substantiated and was misleading. The ASA found that the ad could be interpreted to mean that the e-cigarettes are not harmful or that users experience improved lung health if they used the company’s product. The ASA also found that the claim could be interpreted to mean that the e-cigarettes are less harmful than traditional cigarettes. The ASA ordered the company not to repeat the statement or to make any claims that their products are not harmful or are beneficial to the health of users’ lungs unless they have sufficient evidence to substantiate such a claim.

ASA Adjudication on Gallaher Ltd [United Kingdom] [July 30, 2014]

A tobacco company ad included an email from the UK Department of Health saying that “there isn’t any hard evidence” to show that plain packaging of tobacco products is effective. Below the email the ad stated: “WE COULDN’T HAVE PUT IT BETTER OURSELVES” followed by the name of the tobacco company. The Advertising Standards Authority (ASA) found the ad was misleading. The ASA ruled that the ad implied that no real evidence existed to support the introduction of plain packaging at the time the ad appeared in 2013; however, the email was written in 2011. The ASA noted that because evidence did exist to support the introduction of plain packaging in 2013 the ad was likely to mislead. The ASA ordered the company that the ad must not appear in current form again.

ASA Adjudication on Department of Health [United Kingdom] [July 30, 2014]

An ad for the National Health Service smoke-free campaign claimed that “every 15 cigarettes you smoke will cause a mutation,” which is how cancer starts. In response to a number of complaints, the Advertising Standards Authority (ASA) investigated the claim and found that it was backed by scientific evidence and was not likely to be misleading. Therefore, the ASA found that the ad did not violate the country’s advertising code. 

Love Care Foundation v. Union of India [India] [July 21, 2014]

A non-governmental organization seeking to reduce smoking among Indian youths petitioned the Indian government to adopt plain packaging of tobacco products. The organization argued that attractive packaging is a form of advertisement and sought a rule prohibiting the use of logos, colors, or brand names on tobacco product packaging. After reviewing evidence supporting the impact of a tobacco plain packaging law in Australia and a study of plain packaging in Brazil, the court concluded that plain packaging and health warnings reduce the ability of attractive packaging to mislead consumers about the harms of smoking. The court urged the Indian government to consider the feasibility of implementing the plain packaging of cigarettes and other tobacco products as early as possible.

Boruski v. Crescent Housing Authority [Canada] [May 30, 2014]

Residents of subsidized housing for seniors and people with disabilities sued the nonprofit Housing Society that managed the housing for discrimination based on their physical disabilities. The residents claimed that the Housing Society failed to reasonably accommodate their disabilities by exposing them to secondhand smoke, which exacerbated their disabilities. The court dismissed the complaint, finding that that the Housing Society took reasonable steps to accommodate the residents and limit their exposure to secondhand smoke, including offering different units for relocation, adopting a smoking policy, changing the lease agreement for new tenants to prohibit smoking, maintaining and inspecting the ventilation system, and moving a “smoking pit” farther away from the building. The court said that the steps taking by the Housing Society were reasonable and that residents sought a “perfect and preferred” accommodation rather than a reasonable accommodation.

ASA Adjudication on Vapourlites Ltd [United Kingdom] [April 02, 2014]

An advertisement and website for e-cigarettes showed a hand dressed like Santa and claimed that the product is “recommended by Santa and pharmacies nationwide” and is “a harm reduction alternative to smoking.” The Advertising Standards Authority (ASA) found that the claims “recommended by . . . pharmacies nationwide” and “a harm reduction alternative to smoking” were misleading and not supported by evidence. Although e-cigarettes are sold in a majority of pharmacies, the ad suggested that their products were endorsed or promoted by pharmacies, and the ASA had not seen evidence to support this claim. The ASA also ruled that the reference to Santa was not irresponsible because the ads were not primarily targeted at children and merely depicted Santa’s hand. The ASA ordered that the ads must not appear again in their current form and the company’s future advertising must not include the disputed claims unless substantiated with robust evidence.

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