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.