Can self-imposed vaping standards prevent at-will FDA confiscations?

Posted by Matt Rowland on

A May 1 press release announced the issuance of thirteen warning letters by the U.S. Food and Drug Administration (FDA) to very specific e-liquid manufacturers of the vaping industry.  In accordance with the Federal Trade Commission (FTC), the government agencies allege that these suppliers were selling products with packaging and/or branding that closely resemble the marketing campaigns of common, child-friendly food items like cookies, candies, and juice boxes.  The FDA and FTC also targeted several companies utilizing “cartoon-like imagery” in their promotional campaigns.

The issuance of a warning letter is only the first step in this latest FDA crackdown.  Should these thirteen vendors continue to keep their FDA-rebuked products on the market, the agency has the authority to march into their shops and confiscate all related products at-will.  The FDA isn’t messing around.

Turning the vaping industry into a police state

Then on May 9, the U.S. government published the Spring 2018 Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) where federal agencies provide updates to the American people about their upcoming goals and objectives.   On the same day, FDA Chief Scott Gottlieb posted a blog on his agency’s website referring to this Unified Agenda while also highlighting those mysterious thirteen warning letters.

Related Article:  BREAKING: 13 vaping companies receive FDA warning letters about ‘kid-friendly’ marketing

What many vapers may not know is that he also included another bombshell buried several paragraphs into the post.  Gottlieb and the FDA now want to seek federal approval to confiscate or seize all kid-appealing vaping products immediately upon sight and without a prior issuance of a written warning letter.   He essentially wants to implement a kind of police state for the American vaping industry.

“As part of our comprehensive approach, we’ll also be proposing new regulations to establish requirements for the administrative detention of tobacco products encountered during an inspection that an officer or employee believes to be adulterated or misbranded. These steps will allow us to more effectively block the distribution and use of products that are ultimately found to be violative, including products that are misbranded because their labeling or advertising causes them to resemble kid-friendly foods.”
 
- Scott Gottlieb, M.D. via FDA Voice

 

The warning letters should come as no big surprise to those in the vaping community.  After all, FDA Chief Scott Gottlieb has made his position very clear in recent weeks regarding “kid-appealing” vaping products.  Take, for example, his February 17 tweet were he all but explicitly stated to the vaping community, “Stop selling to kids, or else!”

Even though Mr. Gottlieb was once a major financial investor in the NJOY e-cig company, he is still a member of the political establishment.  Meanwhile, anti-vaping propogandist groups like the Campaign for Tobacco-Free Kids (CTFK) have been consistently bombarding mainstream and social media with disinformation campaigns about vaping.

Related Article: FDA Chief may have just threatened vaping a 42-word tweet

It is organizations like the CTFK which are responsible for keeping the false assertion in the news that vaping is a gateway to teen smoking.  Even though volumes of scientific evidence disprove this claim, thousands of voters, constituents, and high-paying political donors are likely ramping up their protestations over vaping, and more recently, e-liquid flavors specifically.  Even if Gottlieb happens to be the biggest advocate of vaping on the planet, he probably feels the political pressure to do something – anything - if he wants to keep his job.   

Self-imposed vaping standards may be the answer

The vaping advocacy group SFATA (Smoke-Free Alternatives Trade Association) has recently requested all vendors, vape shops, and manufacturers within the community to adhere to a Code of Conduct. The document expressly states that targeting minors for vaping sales is not to be tolerated.  The document is also being shared with the FDA as a last-ditch attempt to show Gottlieb that we “got the message.”  However, if the federal government grants the FDA’s request for extra power and authority to seize kid-appealing vaping products at-will, then a non-binding Code of Conduct may not be enough.

Related Article: The FDA hotline for deeming regulations (and flavor ban) complaints

Furthermore, in one of the thirteen warning letters sent to the Chill E-Liquid Company regarding its Chill Purple Grape E-Liquid, the FDA mentions another of its major concerns that is not getting a lot of reporting.  While the packaging strongly resembles a can of Fanta grape soda, the smell of the e-liquid itself seems to be very concerning to the FDA as well.

“The labeling and/or advertising of Chill Purple Grape e-liquid also includes: a cylindrical shape and design that is substantially similar to a soda can; a foil covering on the top of the can that is substantially similar to soda cans in Exhibit B; the appearance of a soda-can tab when the foil covering is removed; and a color scheme that is substantially similar to soda cans in Exhibit B. Further, Chill Purple Grape e-liquid has a strong scent like grape soda.  This labeling and/or advertising causes the product to imitate a food or beverage, particularly one that is marketed toward, and/or appealing to, children and is therefore misleading.”

Does this mean that e-liquid manufacturers must be responsible for creating odorless products, too?  According to SFATA, the answer is somewhat unclear, which is why the vaping industry should consider adopting self-imposed industry standards that conform to the FDA’s demands.  In a May 16 email, SFATA makes the following argument.

“The industry needs to come together and create standards which the FDA will have to accept.  Under the National Technology Transfer and Advancement Act of 1995, and OMB Circular A-119, if voluntary consensus standards are developed and used in the private sector, then the government must adopt those standards, unless contrary to law or impractical.”

Will self-imposed standards end the War on Vaping?  Probably not, but it certainly can’t hurt.  And as SFATA also suggests, the FDA might be willing to accept the adoption and publication of industry-developed, voluntary consensus standards as an alternative to the controversial Pre-Market Tobacco Application (PMTA) process which threatens to bankrupt a significant portion of the American vaping industry by 2022.

Remember, Gottlieb is under a great deal of political pressure to do something – anything – to prevent teen vaping.  Maybe these self-imposed vaping regulations could be the perfect compromise that allows Gottlieb to save face without eviscerating the American vaping industry at the same time.

Related Article: The 2019 Cole-Bishop Amendment is bad news for vaping

The 2019 version of the Cole-Bishop Amendment has also undergone a rather nasty revision just this week and has all-of-a-sudden become almost anti-vaping in tone.  The original proposal attempted to redefine the February 2007 predicate date of the PMTA process for the vaping industry.  The latest version does not.  In fact, to make matters worse, the predicate date will only be extended to manufacturers of cigars and pipe tobacco products, as if that doesn’t rub more salt into the wound.

The time to take action is now.  Contact SFATA for more information on how best to get involved with the writing and implementation of self-imposed industry standards.  It’s never too late to get involved. 

Related Article: 5 Ways to save vaping and STOP an FDA flavor ban before it begins

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