 
  
 
     TO: Commissioner Monica Bhar el, MD, MPH and Members of the Public Health 
Council 
 FROM: Lindsey Tucker, Associate Commissioner 
  Ruth Blodgett, Director for the Bur eau of Community H ealth and Prevention 
 DATE:  October 25, 2019  
 RE:  Request of the Public Health Council to Approve Proposed Emergency 
Regulation 105 CMR 800.000, Severe Lung Disease Associated with Vaping 
Products   
  Introduction On September 24, 2019, Governor Baker issued a D eclaration of Emergenc y Detrimental to the 
Public Health made pursuant to M.G.L. c. 17, §2A  (“Declaration”), due to severe lung disease 
associated with the use of e-cigarettes and va ping products in the Co mmonwealth. Pursuant to 
this Declaration, the Commissioner of the Massa chusetts Department of Public Health 
(“Commissioner”) and Public Health Counc il (“Council”) approved two Orders of the 
Commissioner (“Orders”) that same day to addr ess the public health em ergency, as follows: 
 
1. Prohibit the sale of all vaping products in retail establishmen ts, online, and through any other 
means, including all non-flavored and flavored  vaping products, includ ing mint and menthol, 
including tetrahydrocnnabinol (THC) and a ny other cannabinoid, in the Commonwealth 
 
2. Order expanded access to nicotine replacement therapy through a statewide standing order  
 The Council additionally authorized the Commi ssioner, during the period of emergency, take 
such other actions, incur such liab ilities, and establish such proce dures which are consistent with, 
and of necessity are required by, the provi sions of the Governor’s Declaration. 
  In continued response to the emergency va ping-related lung diseas e presents for the 
Commonwealth, the Department proposes an emerge ncy regulation to formally adopt and clarify 
through regulation the Orders approved and issu ed on September 24, 2019 to effectuate the The Commonwealth of Massachusetts 
Executive Office of Heal th and Human Services 
Department of Public Health 
250 Washington Street, Boston, MA 02108-4619 
 
 
CHARLES D. BAKER 
Governor 
KARYN E. POLITO 
Lieutenant Governor  
MARYLOU SUDDERS 
Secretary 
MONICA BHAREL, MD, MPH 
Commissioner 
 
Tel: 617-624-6000 
www.mass.gov/dph 
 Governor’s Declaration.  Such emergency regu lation will ensure the c ontinued and necessary 
prohibition on sales of vaping produ cts in Massachusetts in order to protect the public health.  
 Basis for Ongoing Emergency As described in our September 24, 2019 memo to  the Council, clinicia ns across the country 
began raising concerns in August 2019 related to possible cases of unexplained vaping-
associated pulmonary illness.  On August 30, 2019, the Centers for Disease Control and 
Prevention (CDC) released a clinical advisory  providing background information on e-cigarette 
products, information on the multistate outbreak of severe pulmonary disease associated with e-
cigarettes, and clinical features of patient s with severe pulmonary disease, with a 
recommendation clinicians report al l cases of severe pulmonary di sease of unclear etiology and a 
history of e-cigarette product use within the past 90 days to stat e or local health departments. 
CDC recommendations have now been expanded to  encompass other vaping products in addition 
to e-cigarettes.  In response to trends nationwide, CDC recomme ndations, and growing public  health concerns in 
Massachusetts, on September 11, 2019, Commissioner Bharel declared all suspected cases of 
unexplained e-cigarette or  vaping-associated pulmonary dise ase immediately reportable to the 
Department of Public Health for the next 12 months.
1  Since that declaration, the Department has 
received 184 reports from clin icians of suspected vaping-rela ted disease in Massachusetts 
residents. Of these reports, the Department ha s reported to the CDC 16 cases which meet the 
CDC definition for confirmed case, and 30 cases  which meet the CDC definition for probable 
case; the remainder still remain  under Department investigation.2  These reports of vaping-
related illness represent a threef old increase in reports received  and five times the number of 
confirmed cases reported to C ouncil members a month ago.  During that same timeframe, the 
Department reported one fatality as a result of vaping-related disease.  
 This trend is true nationwide as well:  as  of October 15, 2019, the CDC has confirmed 1,479, 
almost three times the number reported less than a month prior, across 49 st ates, the District of 
Columbia, and one U.S. territory – meaning 10 additional states have confirmed cases over that same timeframe.  While cases still show a hi story of vaping and a hi story of using vaping 
products containing tetrahydrocannabinol (THC), ni cotine, or a combination of both, the cause of 
the disease continues to remain unknown.  To date, no specific vaping product, including the 
related devices and liquids, or other substance has been identified as linked to all cases.  
 Due to the continued, significant danger vaping products present during the ongoing 
investigation into the cause of vaping-related disease, the CDC issued guidance advising the only 
way people may assure they are not at risk while  the investigation continues is to consider 
refraining from use of all e- cigarette and vaping products.
3   
 
                                                 
1 https://www.mass.gov/files/ documents/2019/09/11/Vaping-Assoc-L ung-Disease-Declaration-9-11-19.pdf  
2 https://www.cdc.gov/tobacco/basic_inform ation/e-cigarettes/severe-lung-diseas e/health-departmen ts/index.html#case-
definitions  
3 https://www.cdc.gov/tobacco/basic_informa tion/e-cigarettes/severe-lung-disease.html  Concurrent to the ongoing threat to public hea lth for residents of the Commonwealth, the state 
judiciary outlined a process through which the De partment may promulgate regulations in order 
to maintain the sales prohibition on vaping produ cts currently establishe d through an Order.   
 Accordingly, the Department finds that imme diate adoption of this proposed regulation is 
necessary for the preservation of the public health, safety or gene ral welfare, and that observance 
of the requirements of notice and a public hearing would be cont rary to the public interest.  
Therefore, the Department seeks to promulgate this regulation as an emergency regulation.   
 Proposed Emergency Regulation  and Requested Action   
To preserve the existing prohibi tion on sales of vaping products fo r purposes of protecting public 
health, continuing our investigation into instances of this disease in Massachusetts residents, and 
continue to learn from the CDC’s nationwide investigation, the proposed emergency regulation 
adopts all Orders issued pursuant to  the Governor’s Declaration.  It  is respectfully requested that 
the Public Health Council vote to approve  the proposed regulation, 105 CMR 800.000, on an 
emergency basis, which allows the regulation to take effect upon filing with the Secretary of 
State’s office while the regulatory process continues,  as provided for in th e state’s administrative 
procedure laws outlined in M.G.L. c. 30A.   