Blackbriar Regulatory Services

Blackbriar Regulatory Services Contact information, map and directions, contact form, opening hours, services, ratings, photos, videos and announcements from Blackbriar Regulatory Services, Business service, 820 Southlake Boulevard, Richmond, VA.

At Blackbriar Regulatory Services we specialize in helping small to mid-sized domestic and international companies navigate the regulatory landscape to bring their FDA regulated product concepts to market.

The PMTA final rule and SE final rule both go into effect today, November 4th. As of today, all applications submitted t...
11/04/2021

The PMTA final rule and SE final rule both go into effect today, November 4th. As of today, all applications submitted through the PMTA and SE pathways must meet the requirements laid out in these final rules.
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SOURCE: FDA For Immediate Release: October 4th, 2021 Today, the U.S. Food and Drug Administration issued two final

BREAKING NEWS: FDA Grants ENDS Industry's First Product Marketing Authorization to RJ Reynolds' VUSE V***r Products ...
10/12/2021

BREAKING NEWS: FDA Grants ENDS Industry's First Product Marketing Authorization to RJ Reynolds' VUSE V***r Products

SOURCE: FDA Agency Also Denies Applications for Flavored Products for Failing to Demonstrate that Marketing of These Products Would Be Appropriate for the Protection of Public Health Today, the U.S. Food and Drug Administration announced it has authorized the marketing of three

BREAKING NEWS: FDA Rescinds MDO For Turning Point Bands, Products Now Back Under Review“We are encouraged by the FDA’s d...
10/11/2021

BREAKING NEWS: FDA Rescinds MDO For Turning Point Bands, Products Now Back Under Review
“We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed” - Larry Wexler, President and CEO, Turning Point Brands
https://lnkd.in/gZNi6Dj2
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SOURCE: BUSINESSWIRE The Company’s portfolio of proprietary v***r products remains under review October 11, 2021 07:30 AM Eastern Daylight Time LOUISVILLE, Ky.--(BUSINESS WIRE)--Turning Point Brands, Inc. (“TPB” or the “Company”) (NYSE: TPB),

FDA announced on 09/23/2021 they had issued additional MDOs for PMTAs, with the total now reaching 323 MDOs for more tha...
09/24/2021

FDA announced on 09/23/2021 they had issued additional MDOs for PMTAs, with the total now reaching 323 MDOs for more than 1.1 million flavored ends products. For confidentiality purposes, products not confirmed to be currently marketed are not listed publicly by the FDA. View the full list of public MDO's here:

DENIAL ORDERS SOURCE: FDA Denial Orders: 260 Last Update: 09/23/2021 **Note: This list is not comprehensive. Companies who received MDOs for products

Total marketing denial orders listed to date: 240**Note: This list is not comprehensive. Companies who received MDOs for...
09/20/2021

Total marketing denial orders listed to date: 240
**Note: This list is not comprehensive. Companies who received MDOs for products not confirmed to be currently marketed are not listed publicly by the FDA to protect confidential commercial information. FDA announced on 09/17/2021 they had issued a total of 295 MDOs.
MDO's are product specific. If a company is listed, it does not mean ALL products submitted by that company have received an MDO. FDA has not yet released a product-specific list of MDO's issued.

https://lnkd.in/g5cQvwSt

DENIAL ORDERS SOURCE: FDA Denial Orders: 240 Last Update: 09/20/2021 **Note: This list is not comprehensive. Companies who received MDOs for products

In addition to the marketing denial orders to JD Nova Group LLC, Great American V**es, and V***r Salon released on Augus...
09/08/2021

In addition to the marketing denial orders to JD Nova Group LLC, Great American V**es, and V***r Salon released on August 26th, the FDA has quietly released an additional 23 marketing denial orders to:
Big Time V**es
SS V**e Brands Inc. Dba Monster V**e Labs
J-V***r LLC dba North Shore V***r
Custom V***rs
The Va**ng Tiger
Gothic V***r
TrendSetters E-liquid LLC
SWT Global Supply
Diamond V***r
American V***r Group
MV Enterprises
Planet of the V**es
CITTG dba Orgnx E Liquids
V***rs of Ohio Inc. dba Nostalgic V**es
Buckshot V***rs Inc.
Royalty Premium E Juice
Imperial V***rs
Midwest V**e Supply
Dominant V***r
Mountain V***rz
Sir V**es -A-Lot
Loveli Design LLC dba Alice in V**eland
Nicquid

SOURCE: FDA On August 26th, 2021, the FDA published a press release announcing they had issued marketing denial orders to JD Nova Group LLC, Great American V**es, and V***r Salon for their applications for about 55,000 flavored ENDS products. Since that original

Is your company struggling to keep up with state excise tax requirements for v***r and ENDS products? We've just made it...
08/24/2021

Is your company struggling to keep up with state excise tax requirements for v***r and ENDS products? We've just made it a little easier! Our team has created an easy-to-navigate list of the current requirements for each state, and it is now readily available on our website.
If your company is looking for additional assistance in managing PACT Act and excise tax requirements, contact us today, we are happy to help!
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STATE EXCISE TAXES ON E.N.D.S. PRODUCTS With the many changes included in the PACT Act, the term "Excise Taxes" is often mentioned. What exactly are "Excise Taxes" though? We have compiled need-to-know information in regards to these taxes and insights into how they vary from state to state.

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