FDA Registered? The FDA doesn't say so.

FDA Registered? The FDA doesn't say so.

Cushion Grip alternative products have been long existed...If you only look - Case Closed!

Petition drive to Bayer?  Appeal to AG?  Investigate by Chicago Tribune reporter? 
Do all you like but what for?  Those viable CG equivalent or better products by major Japanese pharmaceutical companies are available today for anyone who wants to try.  All can be ordered perfectly legally by click of a mouse and delivered to your door step within a week or so. Many are already doing it and all have positive reviews. 

A little background

Last November 2015, a new post about Japanese cushion grip like product was posted on the Denture Living forum site first time and the Comfort Lining’s owner Jennifer Watson immediately begun attacking the post and its poster vehemently together with a few of her corroborating cantankerous termagants on the forum site. What is it that she and her shills have to attack so viciously on what appears to be any other useful piece of information posted by one of the new forum members? It turned out to be a Pandora’s Box of her own.

 Here's a list of CG alternative products vs Comfort Lining

Click on picture to enlarge

Open Pandra's Box - This is how it's all started

In last November 2015, Jennifer Watson first posted about her Cushion Grip replacement product on Denture Living forum site. She was offering free sample for anyone who wants to try it. Shortly after, there's a post about Japanese cushion grip like product posted on the same forum site. Jennifer immediately begun attacking the post and its poster vehemently together with a few of her corroborating cantankerous termagants on the forum site. What is it that she and her shills have to attack so viciously on what appears to be any other piece of information posted by one of the new forum members. I am piqued thus my gumshowing on Comfort Lining begun.

 “Avoiding careless attack on other can prevent disaster falling on oneself.”  
This rings all the more true here. In other words, this is a self-induced disaster.

This is what Jennifer Watson has publicly stated on the forum site so far:

Picking a fight with the poster - Initial attacks

•  ....trying to scam people or just writing nonsense          Groundless accusation/attack
•  It looks like a fake e-mail address that spammers use   Valid and active address

• I have patented a new product...                     No patent exists, period
• All natural and safe....                                     It's just her words and no proof
• Comfort Lining INC                                         No incorporation record exists
• Checked by the FDA                                       What check? 
• Comfort Lining is not considered, under the FDA     The FDA doesn't say so

Adding more employees

"We are adding more and more employees everyday." Really?

No federal employer ID exists....how come?

St. Johns County, FL Zoning Ordinance prohibits business activities to be conducted at the owner Jennifer Watson's residence.

Truth is indisputable and undeniable

Synopsis

This business "Comfort Lining" is a complete sham operation violating every local, state and federal regulatory requirements.

County regulatory requirements violations:

The business is operated out of the owner's house in OR (open rural) zoning area which allows for residential single family uses. It does not have a necessary Business Tax Receipt from the county authorizing to operate its business.

Also the owner claims its product has US patent but no such patent exists, period..

Florida State regulatory requirements violations:

The owner claims its business entity as Comfort Lining Inc. while it isn't really incorporated.

This is a violation of the Florida Unfair & Deceptive Trade Practices Act.

Furthermore 607.0204 F.S. prescribes liability which reads in pertinent part, “…All persons purporting to act as or on behalf of a corporation, having actual knowledge that there was no incorporation under this chapter, are jointly and severally liable for all liabilities created…”.

Also the business is in violation of the Florida State Drug and Cosmetics Act Statute violations.

Federal regulatory requirements violations:

No Employer ID from IRS exists.

The owner falsely claims the business is registered with the FDA and its products are FDA approved. The FDA's database shows no record of registration and the product approval.

In summary, following violations appear to have been committed by Jennifer Watson; the owner of Comfort Lining, Inc.

To wit:

County violations:

•  Zoning, use permit violation
• Business Tax Receipt violation

Florida State Violations:

Florida Unfair & Deceptive Trade Practices Act.

Drug and Cosmetics Act

• 499.005 Prohibited acts
• 499.0054 Advertising and labeling of drugs, devices, and cosmetics; exemptions.
• 499.006 Adulterated drug or device.
• 499.007 Misbranded drug or device.
• 499.01 Permits.
• 499.012 Permit application requirements.
• 499.04 Fee authority.
• 499.041 Schedule of fees for drug, device, and cosmetic applications and permits, product registrations, and free-sale certificates.

Federal Regulatory Violations:

Title 18 USC –Crimes and Criminal Procedures that could apply to the Comfort Lining case

•  §371 Conspiracy to commit offense or to defraud United States
•  §1001 Fraud and False Statements
• §1341 Mail Fraud
• §1343 Wire Fraud

 FDA violations:

• 21 CFR 801 Label and Labeling Requirements
• 21 CFR 110 Good Manufacturing Practices Requirements
• 21 CFR 820.180 Record keeping Requirements

Facebook, Drugs.com, Amazon.com, eBay and MANTA have since all removed this manufacture and its products from their platform upon independently verifying its violations with the FDA and the Florida Department of Health.