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 ECBLEND - FDA REGISTRATION - PMTA STATUS

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ECBlend State-of-the-PMTA
(Update February 25, 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.
 
 
 
E-Liquid Flavor submissions or discontinuations
AS OF February 25, 2020,
 
Flavor Submissions:  Include over 100 of our most popular flavors, including flavorless, tobacco flavors, fruit flavors, dragon series, desserts, mint and menthol (Most of the submissions will include flavors carried in our retail stores brochure: https://helpdesk.ecblendflavors.com/ECBlend-Menu-Brochure/RetailStoresMenu/ECBlendSTORESELiquidProductCatalog.pdf) 
 
Nicotine variations of 0mg, 3mg, 6mg, 12mg, 18mg, 24mg, and 36mg.  (NicSalt submissions are pending our next meeting with FDA, however, we plan on submitting the same 100 flavors in limited NicSalt variations)
 
Base Mix submissions are tested at 70% VG ratios.  We will submit variations for Max VG and 40% VG.  We will be eliminating all other base mixes except 70%VG, MaxVG, 40%VG.
 
Flavors known to be discontinued:  Unfortunately, the cost to submit PMTA's is extremely high.  In the deeming rule, the FDA estimates the Average Cost to submit a single e-liquid product (without any options, i.e. extra flavor, flavorshots, etc) as $398,324 per e-liquid.  In addition to the costs borne by ECBlend alone for each submission, the coalition together has spent a great deal to share in areas such as literature reviews and statistics, consumer studies, surveys, legal challenges, and other pro-active activities to assist the members through to the successful conclusion of the PMTA process.
 
ECBlend is planning to discontinue
  • Our entire All-Natural-and-Organic line of products will be discontinued.  Although loved by thousands of customers over the years and has a reasonably strong following, the sales on any single AN&O product by itself, would not produce enough sales to pay for the costs of the PMTA process.  Therefore, we sadly will be eliminating this awesome product line.  The last day these will be sold will be 5/11/2020.
  • Cinnamon Fireball & Fire and Ice will be discontinued.  Two of our most popular flavors, cinnamon flavors will not be submitted (these flavors will be discontinued before the 5/2020 date).
  • Gummy Bear and Big Bubble eliquids will be discontinued by March 31, 2020.  The FDA believes these products are enticing to minors. 
  • All Floral Flavors
  • All Novelty Flavors
  • All other products will be either submitted through bridging or discontinued.  These will be announced at a later date.

Over the next few months, products will be marked with ("PMTA in process", or "To Be Discontinued")

 

 

 
Renaming Products - Making our e-liquid products less attractive to minors
AS OF February 25, 2020,
 
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.
 
 
Packaging Compliance
AS OF February 25, 2020
 
All ECBlend bottles are fully in compliance with FDA and other government regulations.  We have received the testing data and are including all information with our PMTA submissions.
 
 
Wholesale, Distributors, and Private Label CUSTOMERS
AS OF February 25, 2020
 
Resellers:  Please read above information as this pertains to ALL products ordered under ECBlend Brands, as well as our other Brands and your private label brand if any.  
 
PRIVATE LABEL CUSTOMERS:  We have registered and submitted all Private Labels and Brands.  These have been kept current since 2016.
 
WHITE LABEL Products:  Products we are fulfilling for private label customers:  Your products will have PMTA's submitted by ECBlend, however, the cost for the testing and stability portions are the responsibility of the Private Label customer.  Please contact your ECBlend sales rep for questions or to arrange for further testing of your products.  
 
We are keeping in contact with most of our P/L customers directly, however, we have been unable to contact a few.  If you have not been contacted, please call 541-393-9840 x 2530.
 
 
 
 
 
 
 
FDA REGISTRATION and REGULATION
ECBlend will be deeply involved and committed to a successful outcome for our products
 
ECBlend commends the FDA in its efforts to provide safe and meaningful regulation for our industry.  ECBlend is committed to quality and safe standards in the manufacture of our products as indicated by our successful certification as a member of the American E-Liquid Manufacturers Standards Association (AEMSA).
 
 
ECBlend, Aemsa and the FDA
FDA Regulations
Food and Drug Administration:  FDA DEFINITION OF TOBACCO PRODUCT MANUFACTURER
FD&C Act § 900(20) defines “tobacco product manufacturer” as:
“any person, including any repacker or relabeler, who-
(A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or
(B) imports a finished tobacco product for sale or distribution in the United States.” [source:FDA.GOV]

 

ECBlend has registered our manufacturing facility and products with the FDA.    
We want you to know that you can continue to order with confidence in the knowledge that we are getting involved, collaborating with experts in the industry, and have the necessary plans in place to enable us to continue to provide you with the exceptional products and services that you have come to expect.
 
08/18/2017 - 9/29/2017 Update:  ECBlend's products are registered with the FDA and have undergone our first FDA inspection during the late summer 2017.   It was informative for both the FDA and ECBlend.  We look forward to working with FDA as this industry continues its journey. 
 
4/5/2018 - ECBlend has had it's first FDA inspection and has received a report.  We had one issue with labeling wording which we have immediately addressed.  We are scheduled to have inspections every 2 years, or whenever the FDA desires it.  Inspections are un-announced.
 
6/18/2018 - Updated Master E-LIQUID Product Registration List (link below) - Attached FDA TP Numbers to Master Product Listing (per FDA)  (Products are same as previously registered, 301 products discontinued)
 
8/2018 - 9/2018 - FDA third-party inspectors inspected our Manufacturing Facilities for a second time, and some of our retail stores for the first time.
 
  
Current 
FDA REGISTRATION:   We have uploaded the final master product list for e-liquid products manufactured by ECBlend, LLC. and have completed the registration portion for our E-Liquid products.
 
FDA registration number   ECBLEND, LLC FEI #3010610744 (Facility Reg Number)  
 
The assignment of the FDA registration number does not denote the approval of establishments or products by the U.S. FDA. The FDA registration number only recognizes that, establishments are registered with US FDA. Any representation of FDA registration number on product labels or labeling which creates an impression of U.S. FDA approval may cause misbranding of the product.  We do not print this number on your labels for that reason.
 
 
 
ARE ECBLEND E-LIQUIDS "TOBACCO" PRODUCTS?
Yes and No.  *Products that are "derived from tobacco" are considered "Tobacco Products" by the Tobacco Control Act.  
This gives the FDA the authority to regulate these products.  ECBlend E-Liquids with NICOTINE are "derived from tobacco" and are subject to FDA rules.  ECBlend E-Liquids without nicotine do not contain tobacco and our tobacco flavoring is artificial is not extracted from tobacco. *[Source: FDA.GOV] "The TCA [Tobacco Control Act] defines 'tobacco product' as meaning 'any product made or derived from tobacco that is intended for human consumption' - The nicotine in e-liquids is 'derived' from tobacco."
 
 
ARE ECBLEND PRODUCTS "APPROVED" BY THE FDA?
From the FDA website fda.gov:  
"FDA does not “approve” tobacco products, but the Tobacco Control Act provides legal ways for tobacco products to be marketed. If FDA determines a new tobacco product meets the relevant legal requirements, we will issue a written notification permitting the marketing of the new tobacco product." 
 
DOES REGISTRATION AND INSPECTED MEAN "APPROVED" BY THE FDA?
No.  Any company making that claim for its products, violates section (301(tt) of the FDA&C Act (21 U.S.C. 331(tt)), which prohibits:
“[m]aking any express or implied statement or representation directed to consumers with respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that—
(1)   the product is approved by the Food and Drug Administration;
(2)   the Food and Drug Administration deems the product to be safe for use by consumers;
(3)   the product is endorsed by the Food and Drug Administration for use by consumers; or
(4)   the product is safe or less harmful by virtue of—
(A)  its regulation or inspection by the Food and Drug Administration; or
(B)  its compliance with regulatory requirements set by the Food and Drug Administration…”
 
 
WHAT IS ECBLEND REQUIRED TO DO?
 
REGISTER AS A MANUFACTURER:  We have registered of our manufacturing facilities and products with the FDA - 
  • FDA registration number   ECBLEND, LLC FEI #3010610744 (Facility Reg Number)  
OUR LABORATORY IS UNDER THE MANAGEMENT OF A HIGHLY COMPETENT AND ACS CERTIFIED CHEMIST and is tasked with all FDA premarket submissions: [Source: FDA.GOV] "Before a new tobacco product can be legally marketed, FDA must issue an order permitting marketing of that product.  To issue an order, FDA must evaluate that product based on a public health standard that considers the risks and benefits of the product on the population as a whole, including tobacco product users as well as non-users. "
 
 
Only make direct and implied claims of reduced risk if the FDA confirms that scientific evidence supports the claim and that marketing the product will benefit public health as a whole:  
We do not, and never have, made claims of health or reduced risk.
 
Not distribute free samples:  
We randomly give appreciation gifts or gifts of new flavors with zero nicotine and are not derived from tobacco.  At this time, we do not believe these zero nicotine/non tobacco derived products are the intent of the proposed regulations.   We will modify our Company Policies and behavior to comply once the exact text of this law is written/known.
 
MINIMUM AGE 18 or the legal age in your jurisdiction:
Minimum age and identification restrictions to prevent sales to underage youth;  We will modify our online sales, if necessary, to include physical Age Verification by carrier.  We are awaiting more specific details regarding online sales.  We have always refused to sell to anyone under the age of 18 in our retail stores, and have carded anyone who appears younger than age 27. 
 
Requirements to include health warnings on labels:
ECBlend labels >  If Nicotine is in the e-liquid: THIS PRODUCT CONTAINS NICOTINE. NICOTINE IS AN ADDICTIVE CHEMICAL. 
E-Liquid without nicotine and does not contain any ingredients derived from tobacco state "Does Not Contain Nicotine or tobacco" and may not be subject to FDA regulation.  
 
Prohibition of vending machine sales, unless in a facility that never admits youth.
We do not utilize vending machines
 
 
 
 
 
 
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