FDA PMTA Wholesale Submissions and Discontinued Products |
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State of our E-Liquid Pre-Market Authorizations (PMTA) |
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Affects: U.S. Sales (updated February 27, 2020)
Since we last updated you on our PMTA applications and process, more than a year ago, ECBlend has joined a coalition of Industry Manufacturers along with a team of experts including Analytical Third-Party Testing Labs, Legal Counsel, Experts on Environmental Impact Studies, and other experts to fulfill the requirements of all components of the PMTA submissions that are due May 12, 2020.
Scientific Reviews, Analytics, Studies: We are well into the process, and ECBlend has received (or is in the process of receiving) comprehensive scientific reviews in Epidemiology, Biostatistics, Advanced Analytics, and Real-World Evidence. The coalition provides legal counsel and project management support for our ongoing FDA regulatory submissions.
We have received our authorization letters from most (not all) of our bottle suppliers, and product raw materials suppliers. Manufacturers that have not complied with our PMTA requests, will be discontinued from our product lines.
HPHC Testing: Understanding the complex analytical testing and instrumentation required for regulatory compliance, ECBlend has contracted with an industry-leading, well-known, full-service laboratory with decades of experience, unparalleled regulatory knowledge, and unwavering commitment to quality. They are an independent testing lab experienced with new testing standards pertaining to the e-liquid product and the FDA's Pre Market Tobacco Authorization requirements (PMTA). In addition to the required 20 HPHC testing required by the FDA, ECBlend has identified an additional 12 constituents we will be testing for.
Stability Testing: Stability testing will be performed on a scheduled basis with the same testing lab over a 2 year period.
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ECBlend E-Liquid Flavors we will continue to offer Updated February 26, 2020 |
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With FDA PMTA deadline fast approaching in May 2020, many customers are asking which of their favorite flavors will be available after the deadline.
The cost is extraordinary and we cannot submit all of our flavors, but we are submitting as many as we can. Other factors affecting this process are lab availability and time to complete all the tests necessary for each flavor or variant.
ECBlend Flavor Submissions (flavors we will continue to offer) include many of our most popular flavors, including flavorless, tobacco flavors, fruit flavors, dragon series, desserts, mints and menthol.
LOOK HERE FOR YOUR FAVORITE: Our submissions include our most popular flavors which are carried in our retail stores brochure If your favorite flavor is listed in this brochure, it is likely we will continue to sell these flavors online (see To Be Discontinued below)
Nicotine Strengths will be available at 0mg, 3mg, 6mg, 12mg, 18mg, 24mg and 36mg
With flavor bans up before the House and Senate, and bills introduced in many states, we are moving forward in the hope that common sense will allow vaping products to remain on the market.
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TO BE DISCONTINUED
STOCK UP NOW |
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The following products will not be submitted this year for FDA PMTA approval |
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- Fire and Ice E-Liquid
(Will be continued to be sold in Bulk for re-manufacture or for sale outside the U.S.)
- Our entire All-Natural-and-Organic line
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Due to the extremely high cost of FDA approval, E-Liquid products not in our top sales will not be submitted in 2020.
Products that are not submitted by May 12, 2020 are required to be removed from the market until they are submitted.
The last date these will be available will be announced in March 2020 along with additional discontinued e-liquids. These are currently planned for discontinuation no later than March 31, 2020.
Cinnamon Fireball, Fire and Ice, Big Bubble, and Gummy Bear will still be available in FlavorTudes FlavorShots, or FlavorArtists Concentrated Flavoring. These products are very popular in baking, candy making and other flavoring applications.
Our All Natural Line will be available until May 11, 2020 and then will be discontinued permanently. |
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PRIVATE LABEL FDA PMTA SUBMISSIONS |
| ECBlend contract manufacturers custom flavors for many of our wholesale customers. Those flavors PMTA's will be created including Environmental Assessments, Scientific Reviews and Studies in Epidemiology, Biostatistics, Advanced Aalytics, Real-World Evidence, Container and Packaging analysis. |
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COSTS TO SUBMIT
FDA PMTA for
CONTRACT FLAVORS
CONTACT US ASAP
if you would like us to submit your flavors for HPHC testing |
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| Wholesale customers who contract with us for custom flavors and brands will be responsible for the HPHC testing and long-term stability testing portion of the PMTA submission. The average cost per SKU is estimated at $20,000 for the initital service testing (up-front costs), plus an estimated total of $20,000-$30,000 in stability testing (paid when tested over a 2 year period). |
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To be perfectly honest, there is no guarantee FDA will approve any flavor, or whether Congress will pass a bill prohibiting flavors.
However, those that make it through, we believe will have a large viable U.S. market. |
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Product Name Changes
(coming in March 2020)
Updated February 25, 2020 |
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ECBlend will rename many of our products to their more 'generic names' in order to make products less attractive to minors. Our Dragon Series will be renamed to each of their Generic Names, but notated as our "Creamy Series". (i.e. Dragon's Blood will become Dragon Fruit and Cream (tag Creamy Series).
We will evaluate all names, and any name we feel may be attractive to a minor will be renamed. The website will carry both the new name and the legacy name to make it easy for long-time customers to find their favorite products. |
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RESELLERS ARE REQUIRED
TO AGE VERIFY |
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All resellers are required by our terms of service and FDA rules to Age Verifies Every Customer, online or in retail stores.
The FDA requires us to make this notice to our distributors, resellers and wholesalers. The FDA has taken a ZERO TOLERANCE approach to companies selling vapor products to anyone under 21. |
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FDA ENFORCEMENT PRIORITIES |
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FLAVORLESS + CONCENTRATES |
Try Flavor Artists Concentrated Flavoring!
Pure Multi-purpose Flavoring for use in baking, cooking, candy-making, beverages hot or cold, or add extra flavor to your favorite liquids. |
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Convert your biggest sellers! Create a desire for Flavored Concentrates in your stores |
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Flavored Concentrates are available in
YOUR PRIVATE LABEL!
GIVE US A CALL (541) 393-9840 x2530 |
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