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FDA to investigate Juul over SF ads claiming vaping is safer than cigarettes

FDA to Investigate Juul Over SF Ads

Juul claimed vaping is safer than cigarettes.

juulBy Catherine Ho - San Francisco Chronicle

The Food and Drug Administration will investigate whether Juul is illegally claiming that vaping products are safer than cigarettes in political ads for Proposition C — the San Francisco ballot measure seeking to overturn the city’s e-cigarettes sales ban — without having received the agency’s authorization to make such claims.

Under federal law, tobacco manufacturers including Juul and other e-cigarette makers cannot claim their products are less harmful than cigarettes, or claim that they help people quit cigarettes, unless the FDA has granted them permission after reviewing scientific evidence showing the claims are true. The agency ordered Juul on Sept. 9 to immediately stop making unproven safety claims or face civil penalties or seizure of its products.

Then, last week, San Francisco Supervisor Shamann Walton, who co-wrote legislation that recently passed and suspends the sale of e-cigarettes in the city, sent the agency a letter raising concerns that even after the FDA had warned Juul to stop making unauthorized safety claims, the Juul-funded campaign committee behind Prop. C continued making similar claims in election mailers and ads.

The committee, called the Coalition on Reasonable Vaping Regulation, is wholly paid for by Juul, according to campaign finance records. Prop. C will go before San Francisco voters Nov. 5 and, if approved, would allow for the sale of e-cigarettes with some new restrictions.

In his letter, Walton cites a Prop. C mailer that includes a testimonial from a San Francisco woman and cancer patient who said vaping was the only thing that helped her quit smoking after nicotine patches and gum didn’t work. The letter also cites a presentation made by Prop. C campaign manager Tom Hsieh in which he tells an audience that vaping is less harmful than smoking and is “a legitimate off-ramp for people who are addicted to cigarettes.”

“Juul appears to be using the electioneering in San Francisco to systematically advance unauthorized health-related marketing claims about its products’ advantages to consumers,” Walton wrote. “These messages do not merely portray Juul as a safer alternative to traditional cigarettes — but also as a more effective smoking cessation option than FDA-approved products as Chantix, Nicorette, nicotine patches and gum.”

The tobacco company Altria, which owns Philip Morris, has a 35% stake in Juul.

The director of the FDA’s Center for Tobacco Products, Mitchell Zeller, told Walton’s office that the agency will review the Prop. C materials as part of its Juul investigation, according to an email reviewed by The Chronicle. It is unclear whether the agency was already looking into Prop. C ads as part of its investigation into Juul, or whether the agency sought to do so after Walton raised the issue. An agency spokeswoman declined to comment.

The matter is just one of a growing number of challenges Juul is facing in San Francisco, Washington and abroad. The company is being investigated by Congress and several state attorneys general for youth marketing tactics, while its much-touted plans to enter India and China — the two countries with the greatest numbers of cigarette smokers — are facing significant new hurdles. India moved last week toward implementing a nationwide ban on e-cigarettes. And within days of beginning sales in China this month, Juul products were taken off major e-commerce sites.

Jim Sutton, an attorney for the Prop. C campaign, said it is following the law.

“The law places restrictions on tobacco companies for making claims,” he said. “If you look at the (Prop. C) ads, there’s no tobacco companies making claims in those ads. Those are individuals who say vaping products help them quit smoking. ... They have a First Amendment right to say that.”

Hsieh, the campaign manager, called Walton’s letter “a desperate attempt ... to weaponize the federal government and squash free speech.”

“The statements alluded to in the letter encompass the heart of free, political speech,” Juul spokesman Ted Kwong said in a statement. “They are not promotional statements about any particular product, but are advocacy in support of an important policy position.”

Legal experts say the likelihood the FDA will crack down on a local political campaign, or even have the authority to do so, is slim. The courts have interpreted the First Amendment as giving political ads much more leeway than regular consumer ads to assert claims.

“There are two totally different standards for selling products to consumers and selling political ads and political campaigns to voters,” said Jon Golinger, an attorney and political strategist who teaches election law at Golden Gate University. “In the context of ballot measures, there are virtually no truth standards other than the B.S. meter of the voters.”

Still, Walton’s letter brings up interesting questions, experts said, drawing attention to “the two hats Juul is wearing at the same time in the Prop. C campaign — ballot measure proponent selling a campaign to voters, and business selling a product to consumers,” Golinger said.

“While they may not be violating any political campaign laws — since truth is not required in political ads and the voters are the judges — violations of consumer protection laws are an entirely different matter,” Golinger said. “If the FDA chooses to take an enforcement action, that would raise novel legal issues that ultimately a court would probably have to decide.”

It is unusual for a company ordered by the government to stop making unauthorized safety claims to, at the same time, be funding political ads in a local election that make virtually the same claims.

“I’d say this is a pretty unprecedented situation,” said Desmond Jenson, an attorney at the Public Health Law Center at Mitchell Hamline School of Law who specializes in FDA tobacco regulations.

Some studies have shown that vaping is less harmful than smoking cigarettes because vapor contains fewer combustible chemicals than cigarettes. Many longtime cigarette smokers say vaping helped wean them off of cigarettes. But for a manufacturer like Juul to make such a claim about its product — known as a modified risk claim — it must get permission from the FDA. And to make a smoking cessation claim, Juul would likewise have to get approval. Juul does not have approval for either; the Juul-backed Prop. C committee makes both claims in campaign ads.

“I’m not 100% sure what the FDA thinks about whether a third party can make a modified risk claim,” said Jenson, referring to the Prop. C committee — which, he points out, is controlled by Juul. “The (answer to the) question of, ‘Is Juul violating the law through their committee?’ might be ‘Yes.’”

Catherine Ho is a San Francisco Chronicle staff writer. Email:  Twitter: @Cat_Ho

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