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.
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
- 21 CFR 801 Label and Labeling Requirements
- 21 CFR 110 Good Manufacturing Practices Requirements
- 21 CFR 820.180 Record keeping Requirements
While Class II medical device (denture adhesive and cushion, product’s code EHS) is exempt from 510k requirement, GMP requirements under 21 CFR 820 is not exempt and must be complied with in full when manufacturing takes place.
ReplyDeleteThe owner Jennifer Watson has publicly made the following statements by her own words in the Denture Living forum site and her website.
ReplyDeleteAbout her background:
Mother of two children.
Graduate of Jacksonville University with a chemical engineering degree.
Karaoke bar manager
About self-claimed patent:
“Hello everyone, I have patented my own version of cushion grip. I call it Comfort Lining.”
No patent for Comfort Lining exists, period. She merely filed a non-examined provisional patent application that expires one year after its filing. It should be expiring shortly if not already. And this is not a patent far from it. It’s merely a nominal few pages application that anyone can file with the USPTO.
About the FDA compliance:
“For those of you, who have asked for the ingredients. It's a all natural thermoplastic and has been approved by the US Patent and checked by the FDA. Comfort Lining is not considered, under the FDA.”
Checked by the FDA? …not considered under the FDA? What exactly does this mean?
In a good faith (?) dispute the owner of the business Comfort Lining; Jennifer Watson presented her business entity as Comfort Lining, Inc. while it isn’t really incorporated. The letter from Florida State Corporations Division indicates they have no record of “COMFORT LINING INC.” foreign or domestic, active or dissolved. This ipso facto constitutes a fraudurant misrepresentation and a violation of the Florida Unfair & Deceptive Trade Practices Act. I am making a flat statement that I am not a competitor as her counsel is attempting to portray.. I have no dog in this fight. Furthermore, her statement saying all of her products are registered and contain the proper listing and labeling requirements is false beyond the pale. Her such statement made in response constitutes a perjury. If this isn’t a farce of good faith dispute, I don’t’ know what is.
ReplyDeleteThese illicit products are used inside the consumer’s mouth and the safety of the device is far from assured without the FDA, Florida State and the local regulatory agency approval.
Simply providing a proof of FDA and other regulatory agency compliance will end this matter altogether in an instant, but of course she can't if none exists.
As her legal counsel asserts the alleged violations are currently under investigation and all efforts are being undertaken to ensure that Comfort Lining is in full compliance. However the following issues are outstanding for everyone to clearly see and understand at present:
1. No US patent exists for the Comfort Lining Products contrary to her claim.
2. The business is not incorporated yet presenting itself as Comfort Lining Inc.
3. No FDA GMP (Good Manufacturing Practice) regulations have been complied with
4. No County use permit that allows her business to operate in OR (open rural) zoning area
5. No Business Tax Receipt from the County authorizing to conduct the business at given location exists
6. Making this manufacture/seller and its products illegal
It then seems not appropriate to allow the site to be hosted by any service provider against its own policy and rules and it should be held in abeyance until such time when all becomes compliant.
Please stop with the harassment and false statements.
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