AN OPEN LETTER TO THE FDA: Founder of Cavadex Takes on FDA, Asserts He Has Cure for Atherosclerosis

The Office of the Commissioner
Department of Health & Human Services
Food and Drug Administration

And to:
Daniel J. Simonsen
Compliance Officer
U.S. Food and Drug Administration
One World Trade Center, Suite 300
Long Beach, CA 90802

And To:
Tina R. Smith, M.S.
Captain, U.S. Public Health Service
Director, Office of Unapproved Drugs and Labelling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Dear Recipients,
I am writing on behalf of Cholrem Pty Ltd regarding the recent actions taken by the U.S.
Food and Drug Administration (FDA) in relation to our Company’s product, REMCHOL.
I am simply amazed that your Administration could be so wrong as to assert that our
product as an “unapproved drug” under the Federal Food, Drug, and Cosmetic Act (FD&C
Act), 21 USC 355(a).

Misinterpretation of Approval Status

The Company’s preliminary research of your own database proves conclusively that the
ingredient in our product, Hydroxypropyl Betadex, has been approved by your
Administration on no fewer than seven separate occasions in the past. This indicates that
our product should not be classified as an unapproved drug, as your recent correspondence
suggests.

The Company intends to provide a more comprehensive explanation of the
misinterpretation in the coming days, but for now your conduct in issuing the following
items and disrupting our product shipments is not supported by fact and threatens the
health and wellbeing of countless Americans:

1. a "Warning Notice" (Reference 684036) on July 7, 2024;
2. a "Response Letter" on September 12, 2024;
3. "Refusal and Administrative Destruction" notices, such as Notice number 1 on
September 26, 2024;

Some of our customers are beyond conventional medical help and rely upon our product
for their very existence!

Remchol Cavadex is not an “unapproved drug,” as you assert. It is an innovative therapy that
clearly reverses heart disease, the number one killer worldwide and an incurable disease for
those who suffer with it. Until the introduction four years ago of Remchol Cavadex, heart
disease due to intractable, progressive atherosclerosis was considered essentially terminal.
The Company has been trading with individuals, worldwide and in the USA, for in excess of
four years providing Remchol products without so much as a hint of administrative
compliance issues.

Yet you decide to deny your citizens this life saving treatment which is not only approved by
your organisation but is backed by rigorous science. In supplying tens of thousands of boxes
of Remchol the Company has never received a single report of side effects related to
Cavadex.

The company only sells its product online through its website which displays all the science
of Cavadex on the front page. Consumers read all data before making an informed decision
to purchase.

On the company’s website it is declared, in bold font, that Cavadex is NOT FDA APPROVED to
treat heart disease.

The Company’s Requirements

The Company demands you to forthwith cease this improper criticism of our product
immediately, and advise of the names and addresses of those good people whose products
you have chosen to destroy and thereby prevent from receiving our lifesaving technology.
The Company will replace their wrongly-confiscated products immediately. We have
consistently provided REMCHOL at no cost to U.S. Armed Forces veterans and others in
need. The Company is fully committed to ensuring access to its product for the well-being of
those who might otherwise die from heart disease.

If you do choose only an enforcement path, rather than a synergistic one with our
company, the blood of countless American citizens will be on your hands.
We await your response and a resolution to this matter at your earliest convenience.

Yours sincerely,
Kyle Hodgetts
CEO
Cholrem Pty Ltd