FDA Prepares to Crack Down on E-Liquid Flavors and Non-Compliant Vapes
February 14, 2018:
The FDA releases a solicitation asking for bids on a contract to provide "vape inspection" services, implying a desire for more serious regulation of new vaping devices and tobacco products.
March 21, 2018:
The FDA publishes an advanced notice of proposed rulemaking (ANPRM) regarding the agency's intention to restrict and possibly ban "youth-appealing" E-Liquid flavors, such as candy, fruit, and dessert flavors.
The FDA and Flavored Tobacco Products
In a press statement released on March 20th, 2018, FDA Commissioner Scott Gottlieb expressed a desire to combat underage tobacco use under a new agency prerogative—one aimed chiefly at E-Liquid and vaping industry products. E-Liquid flavors, according to Gottlieb and the FDA, dangerously appeal to minors and young adults.
"As noted in today's ANPRM, youth consistently report product flavoring as a leading reason for using tobacco products. E-cigarettes are the most commonly used tobacco products among middle and high school students, and flavors are identified as one of the top three reasons for use." -fda.gov
In the eyes of the FDA, tobacco flavorings, including those found in popular E-Liquids, are major factors in promoting underage tobacco use.
An advanced notice of proposed rulemaking (ANPRM) was published by the FDA on March 21st, calling for public comments and submissions on the proposed inquiry into possibly restricting "youth-appealing" E-Liquid flavors.
Those wishing to express their opinions related to this issue can access the ANPRM on the government's Federal Register website.
In his statement, Gottlieb conceded that "[the FDA] must also consider the potential role certain flavors may play in helping some adult smokers transition to potentially less harmful tobacco products." In other words, flavored E-Liquid products are helpful to those wishing to quit cigarettes by taking up vaping instead, a habit that some say is 95 percent safer than smoking.
These are the areas, according to Gottlieb and the FDA, that will require more research before any legislative action against flavored E-Liquid is taken:
- The role that flavors play in initiation and patterns of tobacco use, particularly among youth and young adults.
- The role that flavors may play in helping some adult cigarette smokers reduce cigarette use and/or switch to potentially less harmful tobacco products.
- The role that flavors in non-combusted tobacco products may play in quitting combusted tobacco products use, quitting all tobacco use or starting to use more than one type of tobacco product.
- Consumer perceptions of health risks and addictiveness of flavored tobacco products.
- Whether certain flavors used in tobacco products present potential adverse health effects to users or others.
- The impact of local, state and international efforts to restrict the sale or marketing of flavored tobacco products.
The FDA will continue to seek public input as they advance their policy framework regarding flavored tobacco products.
I would like to take this opportunity to urge readers to think deeply about this issue and submit their informed opinions on the Federal Register website.
Regulations on "Innovative" Tobacco Products
The FDA's "Deeming Rule," accessible here, places restrictions on the sale and distribution of tobacco products within the US, as well as highlights regulations on the components and parts of tobacco products, including "any software or assembly of materials intended or reasonably expected: (1) to alter or affect the tobacco product's performance, composition, constituents, or characteristics; or (2) to be used with or for the human consumption of tobacco products."
After August 8th, 2016, no new tobacco product, including vape industry and E-Liquid products, could enter the market without first successfully going through one of three "pathways" offered by the FDA: Substantial Equivalence Inspection (SE), Premarket Tobacco Application(PMTA), or Modified Risk Tobacco Product Inspection (MRTP).
The prohibition on new products includes any changes made to existing products, no matter how minimal or cosmetic they may be. Modifications to firmware and even minor alterations to body design must be legally approved by the FDA before entering the U.S. market.
Until now, the FDA did not enforce this rule.
On February 14th, 2018, the agency released a bid contract calling for "Vape Inspection" services to be handled by a contractor. The agency is prepared to spend $23 million over a five-year period to verify market compliance with the new tobacco product regulations.
The contract specifies that the paid contractor will be required to service inspections of manufacturers (including vape shops that make their own E-Liquid), as well as other establishments engaged in the retail sale of FDA-regulated tobacco products.
Inspectors will be checking to see if any establishment is in violation of Section 910 of the FD&C Act, which "prohibits introducing or delivering for introduction into interstate commerce any 'new tobacco product' without an order from the FDA authorizing the marketing of the product."
This means that non-compliant products may be seized from retailers. The FDA "could even confiscate shipments to individuals from China or other countries after mail inspections."
A list of tasks to be completed during inspections is accessible HERE.
The vaping industry's future is unclear. It is rumored that independent vaping companies will have a more difficult time getting their products successfully approved by the FDA, but I do not know why this would be. Additionally, for many companies (independent or not), proving that their products came to market before the grandfather date of Aug. 8, 2016 will be a headache, and may cause some unnecessary blowback on manufacturers unable to provide the necessary documentation required to prove that their products are not new but who in reality have done nothing wrong.
In terms of banning or heavily restricting flavored E-Liquids on the market, I understand the FDA's impulse. I don't want kids smoking or vaping, either. 90% of smokers start the habit before the age of 18, leading me to believe that if unhealthy habits can be avoided early in life, we might have a real chance of combating unnecessary illness, death, and gross teeth. However, banning flavored E-Liquids would irreparably damage the thriving market, leading to a hemorrhaging of jobs all over the country. And for consenting adults who do as they please, vaping would become much less enjoyable. Most poignant, an elimination of flavored E-Liquids in the U.S. market would cripple vaping's number one positive public health factor: getting smokers to quit cigarettes.