Updated 8:25 p.m.
State public health officials acknowledged that they still do not know what is causing lung injuries and illnesses among some people who vape, and reiterated that the products should not be used. But the Public Health Council nonetheless rescinded a ban on sales of all vaping products and approved new regulations Wednesday that will make vaping products again available in stores.
On the heels of a new law that limited the availability of any flavored tobacco or vaping product, the Public Health Council adopted tighter restrictions on the sale of all e-cigarettes and other vaping products that spurred a public health emergency earlier this year.
The new regulations spell an end to the emergency ban on all vaping product sales in the state that the governor implemented in September amid a national outbreak of vaping-related lung disease, including three deaths in Massachusetts. That ban, which had been whittled away by the courts, had been set to lift on Dec. 24 but Baker announced late last month that it would instead remain in effect through Dec. 11.
"We don't understand what is causing these illnesses," Public Health Commissioner Monica Bharel told reporters after the new regulations were approved Wednesday. "From a public health point of view, we cannot recommend that anybody use vaping or e-cigarette products at this time. What the regulations do is allow a regulatory and legal framework to limit the access to these products, put in place warnings and signages so people can understand their risk and, importantly, limit access for youth and young people."
When Gov. Charlie Baker declared a public health emergency in connection with the vaping-related illnesses in September, he said it was intended to allow public health officials more time to understand what is causing the spate of lung injuries and illnesses.
"We as a commonwealth need to pause sales in order for our medical experts to collect more information about what is driving these life-threatening vaping-related illnesses," Baker said at the time. "We also need to better understand the inherent dangers of vaping both nicotine and marijuana. With all this information we can then develop a set of targeted measures and response."
Bharel said Wednesday that, at DPH, "we remain very concerned about the health impacts of vaping and e-cigarette products." She did not directly answer when asked if she is confident that DPH knows enough about the cause to allow vaping sales to resume, but said DPH will continue to work closely with federal partners to learn more.
The new regulations -- which will take effect as soon as they are filed with the secretary of state's office Wednesday -- will require shops that sell vaping products to post signs warning of the dangers of severe lung disease and other health risks, and keep all vaping products behind the counter; prohibit the sale of out-of-package tobacco or vaping cartridge refills; require that all vaping liquid containing nicotine be packaged in child-resistant packaging; clarify the public health commissioner's authority to prohibit the sale of a vaping product that is determined to cause vaping-related lung illness or otherwise pose a substantial health risk; establish inspection procedures to determine that retailers are in compliance with the law; and set out a series of fines and punishments for anyone who violates the rules.
A first-time violation of the new regulations will result in a $1,000 fine. A second violation within three years of the first will result in a $2,000 fine and could lead to an order to stop selling all tobacco and vaping products for up to a week. A third violation within three years would lead to a $5,000 fine and could result in an order to stop selling tobacco and vaping products for seven to 30 days.
The regulations were adopted Wednesday on an emergency basis and DPH plans to hold a public hearing and comment period on the new regulations at a future date. After DPH's staff reviews comments it receives from that hearing and comment period, the Public Health Council could be asked at a future meeting to approve amendments to the regulations, DPH officials said.
Bharel said that stores will be allowed to resume selling vaping products Wednesday, as long as they are in compliance with the new regulations.
"As long as retailers can comply with the regulations, they can go back into effect of selling," Bharel said. "In order to resume sales they have to comply with the regulations, which includes things such as for a retailer to understand that the nicotine level has to be less than 35 mg per ml, that flavored products must be available only in smoking bars and so on. Early this afternoon, we'll put into place the guidance and make available those signs so retailers will have that available to them."
Guidance for retailers, the required signage and more detailed information on the new regulations will be made available Wednesday afternoon on a new website DPH has created, www.mass.gov/newtobaccolaw. DPH plans to hold a conference call with municipal boards of health Thursday to provide an overview of the tobacco and vaping landscape now that a new law and a new set of regulations are in place.
Though nicotine vaping products can be sold again as of Wednesday, cannabis vaping products will remain unavailable.
The Cannabis Control Commission, not DPH, has authority over the regulation of marijuana vaping products and on Nov. 12 imposed an indefinite quarantine of all "marijuana products and devices that rely on vaporization or aerosolization, including, but not limited to, vape pens, vape cartridges, aerosol products, and inhalers" to keep oil-based vaping cartridges off the shelves of marijuana stores, even for medical marijuana patients.
CCC Executive Director Shawn Collins ordered the quarantine "based on his determination that these products pose an immediate or serious threat to the public health, safety or welfare and the quarantine is necessary to protect the public health, safety or welfare."
Jim Borghesani, the communications director for the 2016 marijuana legalization initiative, said that the lifting of the nicotine vape ban stikes him as an acknowledgement that legally-purchased vaping products were not the source of the illnesses.
"Given that the CDC has made a similar determination, it is clear that the ban on cannabis vape sales should also be lifted," Borghesani said Wednesday. "Cannabis consumers and patients should not continue to be pushed toward the illicit products that appear to be causing the health problems."
Last month, the U.S. Centers for Disease Control announced that vitamin E acetate, often added as a thickening agent to products that contain THC, had been identified in 29 out of 29 samples from patients afflicted with the illness.
Health and Human Services Secretary Marylou Sudders said last month that the lifting of the ban on nicotine vapes does not mean all vaping products will be available or that they will remain available as researchers learn more about the causes of the vaping-related injuries and illnesses.
"Again, the administration will consider other actions including prohibiting the sale of vaping product or products if it is determined by the CDC or the FDA that the product or products are a cause of vaping-related illness," Sudders said.
The new ban on flavored vaping products that Baker signed into law right before Thanksgiving took effect immediately, and its prohibition on selling other flavored tobacco products, including menthol cigarettes, will become effective in June. Flavored tobacco will not entirely be forbidden in Massachusetts; it will be allowed for sale exclusively for on-site consumption at licensed smoking bars.
Lea Susan Ojamaa, deputy director of DPH's Bureau of Community Health and Prevention, said that with the increased talk about smoking and vaping, it is important to remind people who smoke or vape of the cessation resources available to them.
"It is important to remember that nicotine is highly addictive. As we put new regulations in place, we want to be able to support those that smoke or vape that might be motivated to quit by the new regulations," Ojamaa said. She detailed the smoking and vaping cessation resources the state has made available, including counseling and a confidential texting program meant to help young people who vape.
Ojamaa said DPH saw a marked increase in the number of calls coming into its quit line since the public health emergency was imposed in September.
"Particularly, we were even able to track and we saw an increase in the number of people who are vaping calling our quit line," she told the Public Health Council. "We definitely saw an increase of self-referral, not just coming from providers, and again, we will track what the results of the regulation -- if you put a regulation in place, that might motivate some people who are using the product to quit, knowing it's not easy."
Between Sept. 11 and Nov. 26, DPH received 278 reports of suspected vaping-associated lung injuries from clinicians. After reviewing the cases that met the criteria for investigation, public health officials have referred a total of 93 cases (31 confirmed and 62 probable) to the U.S. Centers for Disease Control and Prevention.
Three people have died of vaping-associated lung injury in Massachusetts: a Hampshire County woman in her 60s who vaped nicotine, a Middlesex County woman in her 40s who vaped nicotine, and a Worcester County man in his 50s who reported vaping both nicotine and marijuana oil.
