The FDA Releases the ANPRM. What Does This All Mean?!
THIS. JUST. IN. The FDA, in collaboration with other mainstream regulatory agencies recently slammed a few other manufacturers in what appears to be one of the first "very real" steps in regulating our industry. While in the eyes of regulators, it is to stop the flow of accessible products from falling into the hands of underage consumers, what that means for us vapers is yet another hurdle that must be overcome to retain our civil liberty to do as we please.
Before you jump to the conclusion that we're anarchists or whatever negative connotation you might associate with our disdain for the actions taken against us by public health departments nationwide, let us bring you some facts to consider. This article will identify the key points the FDA makes in what it hopes to accomplish with its Advanced Notice of Proposed Rulemaking (ANPRM) and BLVK Unicorn's approach to remaining compliant amidst such concerns.
By the end of this article, our hope is that you leave with a little more information as to why this concern has been brought up and what you can do to help save our industry.
fdA: aNprm ANALYSIS
The FDA has recently released an Advanced Notice of Proposed Rulemaking (ANPRM) to collect comments, data, research results, and other information from interested parties to better understand how the inevitable implementation of the regulation and therefore control of e-liquid flavors will play out when regulation is ultimately enforced. You can read the full ANPRM document here; but we've taken the liberty to break down each section for you.
THE ROLE OF FLAVORS IN TOBACCO PRODUCTS USE:
- Youth under the federally-legal smoking age and Young Adults between the ages of 18-24 are statistically more inclined to develop a nicotine addiction.
- The primary demographic of concern are the youth and young adults who have not possessed a nicotine addiction prior to their experience with electronic cigarettes.
- The U.S. Surgeon General reports that certain depictions of flavor profiles such as sweet, fruit, and/or candy flavors are used to attract the youth by tobacco companies.
the appeal of flavors generally and in tobacco products specifically:
- Following the Gateway Theory, attractive flavors such as the aforementioned can trigger reward pathways in the brain to enhance the rewards of nicotine use.
TOBACCO PRODUCT USE PATTERNS BY YOUTH:
- The National Youth Tobacco Survey (NYTS) reports that between the 2011-2016, vaping is currently the most popular delivery system for tobacco use.
- In addition to sweet, fruit, and candy flavors, youth and young adult smokers are more likely to use menthol flavors compared to their adult counterparts.
FLAVORS AND PERCEPTIONS OF HARM AND LIKELIHOOD OF TOBACCO PRODUCT USE:
- Statistically speaking, 81% of youth, 86% of young adults, and 54% of adults have used flavored tobacco products without any history of using tobacco products prior to electronic cigarettes. By following the Gateway Theory, it's concluded that both youth and adults are more likely to continue using flavored tobacco products compared to those that do not use flavored blends.
YOUTH AND YOUNG ADULT FLAVOR PREFERENCES:
- The most common reasons to use e-cigarettes among the youth are curiosity, appealing flavors, and friends' influence.
- In a study comprised of 1567 young adults, the most common flavor categories for e-liquid are: fruit (66.9%), candy (35.1%), and bold dessert flavors such as caramel/vanilla/chocolate/cream (33.3%).
- Sweet flavors such as fruit, candy, and desserts appeal to the youth and young adult demographics more so than traditional tobacco-flavored blends.
ADULTs' use of flavors in tobacco products:
- 68.9% of e-cigarette adult users that use flavored e-liquids use at least one flavored product.
FLAVORS MAY CONTAIN OR FORM TOXIC COMPOUNDS:
- Diacetyl and acetyl propionyl have been detected in e-cigarette vapors with specific flavors. Both of which are highly irritating and volatile organic compounds.
- Adverse respiratory health outcomes have been linked to these compounds.
We apologize for the extensive list but this is the case the FDA has presented with us all. The agency firmly believes in the regulation of flavors and has made the seemingly illogical connection that flavored e-liquid blends serves as the pen-ultimate gateway to underage and youth addiction to nicotine.
BLVK UNICORN: COMPLIANCE
Now we can go into great detail analyzing and countering each point presented in the case, but we'll leave your own curiosity to slam the agencies logic to you. What we are interested in conveying is not only our willingness to remain compliant amidst the latest regulations to be enforced, but to uphold the strictest standard of safety from the production, to the distribution, and to the eventual enjoyment of our e-liquids.
All BLVK Unicorn E-Liquids are designed in Los Angeles, CA and manufactured domestically by LCF Labs in Ontario, CA. We also manufacture our products internationally under the full supervision of our production team. All our manufacturing facilities contain clean-rooms and are G.M.P-certified facilities. Every step of the manufacturing process is professionally handled to ensure the quality of the final product, which includes but is not limited to: testing, logging, multi-point inspections, and precise measurements.
Pending the final regulations set to be released by the FDA in the coming months, our production process also ensures every reasonable method in which our products remain inaccessible to persons that are not legally eligible to consume our products. Factors such as ensuring the use of child-proof caps to our packaging has been implemented and will continue to be implemented as operations continue.
Our compliance sales strategy falls into two aspects - the first stemming from our relationships with our distributors and wholesalers, and the second with our loyal fans that buy from us directly. The point of this multi-faceted strategy is to again, ensure our products remain inaccessible to those that are not legally eligible for consumption of vaping products.
When it comes to our distributors, wholesalers, and online websites that we service, our team is in the process of drafting a Master Services Agreement that is required to be signed and adhered to should business continue. This updated agreement ensures that our authorized vendors of BLVK Unicorn will adhere to the same practices that prevent unauthorized persons from obtaining our product such as a developed age verification procedure.
When it comes to our consumers that purchase our products directly off our site, we have already implemented an advanced age verification software. This easy-to-follow system allows purchases to be made directly off our site if, and only if, proper age verification is met.
For those that followed the announcement of E-Liquids Misleadingly Labeled or Advertised as Food Products published by the FDA and Federal Trade Commission (FTC), seventeen e-liquid brands were issued warning letters as a formal attack to reshape the way products are visually depicted through the use of media. Following the announcement, BLVK Unicorn's media team has already begun adjusting our strategies for remaining compliant and we're eager to share a few points.
We are working to refrain the use of any food ingredients that visually depict items that are historically more likely to attract underage users such as children's cereal, candy, and other noticeable sweets. In addition to the avoidance of said ingredients in the subject matter, all forms of media will include a nicotine warning to be visibly displayed on the image or video as well as the copy if applicable.
As a tobacco company, it is our job to not only provide the best possible product to smokers everywhere, but to also adhere to a moral code of conduct. As such, the method in which we advertise will also adjust according to any and all regulations.
WANT TO GET INVOLVED?
If you're interested in getting your voice heard regarding the FDA's ANPRM report, everyone has the opportunity to leave a comment on how vaping, particularly flavored blends such as BLVK Unicorn's product collections, have improved your health in comparison to combustible tobacco products. You may leave as many comments as you'd like; so please take this opportunity to GET YOUR VOICE HEARD. The window to leave a comment closes June 19, 2018.
Do you have more questions on our compliance policies?
Drop us a line below!