Cholrem Pty Ltd dba Cholrem and Cholrem Pharmaceuticals - 684036 - 07/09/2024

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WARNING LETTER

July 9, 2024

RE: 684036

Dear Kyle Hodgetts:

This letter is to advise you that the United States (U.S.) Food and Drug Administration (FDA) reviewed your websites at www.cavadex.com, www.cholrem.com, www.cholrem.com.au, www.cholrem-cavadex.com, www.remchol.com, and www.cavadextrin.com in May 2024. We have also reviewed your social media websites at www.facebook.com/CAVADEX.Cholrem and www.facebook.com/cholrem and www.twitter.com/cholrem. Your websites direct consumers to your www.cholrem-cavadex.com website to purchase your products. The FDA has observed that you offer “RemChol,” “RemChol Saver Set,” “RemChol Starter Pack,” and “RemChol Ultra Set” for sale in the United States.¹ Based on our review, these products are unapproved new drugs under section 505(a) of the U.S. Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Unapproved New Drugs

Based on a review of your websites, your “RemChol,” “RemChol Saver Set,” “RemChol Starter Pack,” and “RemChol Ultra Set” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples of claims from your websites and social media websites that provide evidence of the intended use of these products as drugs include, but are not limited to, the following:

On your firm’s product webpages for “RemChol,” “RemChol Saver Set,” “RemChol Starter Pack,” and “RemChol Ultra Set” found on www.cholrem-cavadex.com:
• “RemChol contains Cavadex, a revolutionary cyclodextrin that[’]s proven safe in the treatment of atherosclerosis.”

On your firm’s webpages www.cavadex.com and www.cholrem.com:
• “Some of the world[’]s leading Doctors and Professors confirm CAVADEX reverses heart disease”
• “Douw has been using RemChol for 18 months . . . Douw was facing triple by-pass surgery. 18 months later[,] his arteries are clear.”

On your firm’s webpages www.cavadex.com, www.cholrem.com and www.cavadextrin.com:
• “Mice on CAVADEXTRIN lived 10% longer.”
• “The human trial of CAVADEXTRIN conducted by Cholrem has consist[e]ntly shown the scientific evidence proving the benefits of Cyclodextrin on mice also has sim[i]lar benefits on humans. It would be fair to assume that based on the science, humans treated with CAVADEXTRIN would also experience a sim[i]lar benefit of lifespan exten[s]ion as the mice.”
• “Cyclodextrin protects podocytes in diabetic kidney disease.”

On your firm’s webpages www.cavadex.com, www.cholrem.com and www.remchol.com:
• “Patients using RemChol report . . . Reduction of Angina within 2-4 weeks[,] Significant reduction of plaque within 2-3 months”
• “Cavadex is directly reversing the arterial disease . . . Cavadex is a universal antidote to atherosclerosis . . . Cavadex improves lower extremity and brain blood flow”

On your firm’s webpage www.cholrem.com:
• “Cavadex is NOT A DRUG . . . Cavadex is a ring-shaped starch that absorbs cholesterol from artery walls[,] Cyclodextrins have been used safely in medicine for over 30 years and are FDA approved . . . CAVADEXTRIN can only be absorbed into the blood stream when administered as an IV or as an enema. RemChol delivers CAVADEXTRIN via an enema . . . CAVADEXTRIN . . . circulates around the vascular system sucking up cholesterol and other lipids and transporting it out via the urinary system.”

On your firm’s webpage www.cholrem.com/about:
• “Scientific studies and research into cyclodextrin are showing that enhanced cholesterol transport within the body has major benefits in a huge range of health issues, including Atherosclerosis, Alzheimer disease, Kidney disease, Macular degeneration etc. . . . Cholrem inc. is the only company with a commercially available cyclodextren treatment. Our first product, the RemChol enema, is now available giving consumers immediate access to this incredible compound.”

On your firm’s webpage www.cholrem-cavadex.com:
• “BACKED BY CARDIOLOGISTS[,] ‘Cavadex is a universal antidote to atherosclerosis’”
• “No matter what your lifestyle, RemChol reduces plaque and removes cholesterol from arterial walls.”
• “Running without angina. Before RemChol I couldn't walk more than 25 meteres [sic] without angina pain. I just ran a 100 metre [sic] sprint without any angina at all!”

On your firm’s webpage www.cholrem-cavadex.com/blogs/dr-james-roberts-talks-cavadex/cavadex-a-breakthrough-in-heart-disease-treatment-by-dr-james-roberts:
• “About a year ago, Dr. Roberts began incorporating Cavadex into his treatment regimen for patients with persistent symptoms of coronary disease. The results were nothing short of delightful. To date, he has treated over 150 patients with Cavadex, observing its incredible safety, effectiveness, and rapid onset of benefits. Dr. Roberts hails Cavadex as the most crucial anti-atherosclerotic therapy in his arsenal.”
• “One of the most compelling aspects of Cavadex is its universal applicability. Irrespective of the underlying cause of arterial disease, Cavadex has shown to be an effective remedy. Dr. Roberts emphasizes its role in avoiding repetitive invasive procedures, offering patients a more sustainable and less intrusive treatment option.”

On your firm’s webpage www.cholrem.com.au:
• “TREATMENT FOR ATHEROSCLEROSIS[,] CAVADEXTRIN is a brand of Cyclodextrin developed by Cholrem that removes cholesterol and plaque from arteries.”
• “CAVADEXTRIN has shown to lower triglycerides by 50% and cholesterol by 40% in just 2 weeks.”
• “CAVADEXTRIN BENEFIT ON LIPIDS AND LIVER[,] 12 grams of CAVADEXTRIN was administered for 17 days over a 30 day period. STUNNING RESULTS! Lipids drop. Liver improves.”

On your firm’s webpage www.cholrem.com.au/research:
• “As an active ingredient, CAVADEX entraps and removes intracellular cholesterol and lipids that can cause injury to the kidneys and other organs, including the brain and liver.”
• “A recent study by the University Hospital in Bonn, Germany discovered that cyclodextrin melts away cholesterol crystals (the main cause of arterial plaque that clogs arteries) and reduced existing plaque within just 4 weeks. The cyclodextrin bound to and dissolved the cholesterol crystals from the plaque of mice, leading to transport of the dissolved cholesterol away from the plaques. The same effects were seen in human plaque samples treated with cyclodextrin.”

On your social media websites at www.facebook.com/cholrem, www.facebook.com/CAVADEX.Cholrem and www.twitter.com/cholrem:
• December 15, 2020 Facebook.com/cholrem post: “More and more research shows CAVADEX cyclodextrin reduces atherosclerosis. New paper published a few months ago. Cholrem on the leading edge of this technology.”
• May 9, 2024 Facebook.com/CAVADEX.Cholrem post: “When it comes to managing cholesterol and reversing atherosclerosis, choosing the right Cavadex formulation is crucial. Our Ultra Pack offers a double dosage with 16 grams of Cavadex per tube, while the Standard Pack provides 8 grams. Both are designed to be administered as enemas, but the Ultra Pack is tailored for those who prefer a more concentrated dose to simplify their daily regimen.”
• May 2, 2024 X post: “HEART DISEASE #1 KILLER WORLDWIDE CAVADEX REVERSES HEART DISEASE AND REDUCES ARTERIAL PLAQUE . . . REDUCTION OF ANGINA SYMPTOMS[,] INCREASE BLOOD FLOW TO LIMBS[,] REDUCTION IN ARTERIAL PLAQUE[,] INCREASED MOBILITY[,] INCREASED ENERGY[,] LOWER CHOLESTEROL LEVELS”

Your “RemChol,” “RemChol Saver Set,” “RemChol Starter Pack,” and “RemChol Ultra Set” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). No FDA approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these products. Accordingly, the introduction or delivery for introduction of these products into U.S. interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/

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

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1 Cavadextrin, Cavadex, and RemChol are used interchangeably throughout your websites. You market Cavadextrin as Cavadex. Further, you state that RemChol delivers Cavadex via enema.