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WARNING LETTER

February 02, 2021

Re: 610642

Dear Dr. Lewis Clarke M.D. and M. Christopher Clarke:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.clarkepharmaceuticals.com in December 2020 and January 2021, and has determined that you take orders there for the products “OsteoBLAST®,” “Cell Block #19,” “High Potency Vitamin D3,” “Neupanex®,” and “Natural Progesterone Skin Cream.” We have also reviewed your YouTube video recordings posted under the account “Clarke Pharmaceuticals”; your YouTube channel directs consumers to your website www.clarkepharmaceuticals.com to purchase your products. In addition, we observed that your “Cell Block #19” product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19¹ in people. The claims on your website establish that the products “OsteoBLAST®,” “Cell Block #19,” “High Potency Vitamin D3,” “Neupanex®,” and “Natural Progesterone Skin Cream” are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

OsteoBLAST®

On your product webpage for “OsteoBLAST®” at https://www.clarkepharmaceuticals.com:

• “OsteoBLAST® is designed to . . . reducing osteoporosis risk”
• “Tags: … Fracture, Osteoporosis”
• “Researchers have found that strontium [an ingredient in your OsteoBLAST® product] improves cartilage metabolism in osteoarthritis ….”
• “[L]ow vitamin A [an ingredient in your OsteoBLAST® product] levels are associated with osteoporosis and increased risk of fracture.”

On your YouTube video recording at https://www.youtube.com/watch?v=Dln-NOCM2_E titled “OsteoBLAST Video”:

• 02:27-02:59: “I’ve used my OsteoBlast in many patients, severe osteoporosis patients … with broken bones and they’ve healed in a fraction of the expected time.”
• Video Description: “[Y]ou can regrow bone, no matter if the person has osteoporosis, arthritis, or a fracture.”

Cell Block #19
On your product webpage for “Cell Block #19” at https://www.clarkepharmaceuticals.com:

• “Tags: allergies, cancer, COVID-19, Flu …”
• “This compound is designed to strengthen your immunity to viruses and bacterial infection.”
• “Studies have shown that vitamin A [an ingredient in your Cell Block #19 product] . . . increases the immunoglobulin igA which coats all our mucus epthelium [sic] in our noses, lungs, GI tract. IgA is a front line barrier to bacteria like staph, strep, etc. AND to virus entry into the epithelial cells which is the beginning of the great tribulation of viral infections like pneumonias and influenzas and HIV and measles . . . IgA drastically suppresses the release of viruses, specifically studied in influenza viruses, from infected cells which would infect other cells. … So vitamin A is making IgA which blocks and imprisons the virus.”
• “Vitamin D [an ingredient in your Cell Block #19 product] proteins pair up with Vitamin A proteins in what is called a heterodimer. This complex can then bind to a Vitamin D receptor and this causes the CAMP gene in immune cells to secrete peptides defensin, cathelicidin and LL-37 all of which simply put, KILL BUGS! Both viruses and bacteria.”

On your YouTube video recording at https://www.youtube.com/watch?v=QbZ_1pQNbAE titled “Vitamin A and Vitamin D for Virus Protection.”

• 00:22-00:36: “What if I told you about two simple over-the-counter vitamins that you can use right now to hedge your bets against COVID-19 and potentially keep you out of the ICU and off a ventilator.”
• 02:16-02:24: “Vitamin A and Vitamin D [ingredients in your Cell Block #19 product] work both together and separately to augment the function of the immune system and suppress inflammation.”
• 03:45-04:00: “I think it’s clear that all infections—viral, bacterial, parasitic, and fungal infections—must have adequate if not super doses of Vitamin A and D. These steroid vitamins are preventive of influenzas as per the volumes of supportive scientific literature.”
• Video Description: “Cell Block #19 High dose vitamin A and D …. These [vitamins] can be used for flu season, as well as hedging your bets against a viral outbreak.”

High Potency Vitamin D3
On your product webpage for “High Potency Vitamin D3” at https://www.clarkepharmaceuticals.com:

• “Individuals with a suitable level of dietary vitamin D [an ingredient in your High Potency Vitamin D3 product], and those who supplement, are typically much better equipped to fight off colds and ailments.”
• “Those ailments, illnesses and diseases reported to benefit from vitamin D include, but are not limited to: osteoporosis, conditions of the heart and blood vessels, high blood pressure and high cholesterol, diabetes, obesity, multiple sclerosis, rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), asthma, bronchitis, tooth and gum disease, and skin conditions including vitiligo, scleroderma, psoriasis, actinic keratosis, and lupus vulgaris.”
• “It is also used for preventing autoimmune diseases, and preventing cancer.”

Neupanex®
On your product webpage for “Neupanex®” at https://www.clarkepharmaceuticals.com:

• “Tags: Alzheimers, Brain Injury, Concussion, CTE, Paralysis, Spinal Cord Injury, Stroke, Traumatic Brain Injury”
• “Neupanex® is the first intracranial helmet for the brain.”
• “It contains ingredients that have been shown individually to be both neuroprotective and neuroregenerative by healing neuronal cells from injuries such as stroke, concussion, locked in syndrome, traumatic brain injury, or an anoxic event.”
• “Neupanex® has been used to help an injured brain recover from:
• Stroke
• Traumatic Brain Injury
• Concussion
• Anoxic event
• Locked in Syndrome
• CTE
• Dementia
• Spinal Cord Injury”

On your webpage at www.clarkepharmaceuticals.com titled “A Promising Alternative for Traumatic Brain Injuries, Concussions, and Dementia”

• “Neupanex® is the result of 25 years of research by Lewis Clarke, M.D., Ph.D. …When he began treating patients with debilitating neurologic diseases such as strokes, spinal cord injuries, Guillian-Barre [sic], and degenerative neurologic processes such as MS, ALS, Alzheimer’s, and Parkinson’s, he began implementing interventional and neuroregenerative neuropharmacology.”
• “Dementia & Alzheimer’s . . . With Neupanex® cognitive and socialization improvements in dementias and improvements in motor deficits and paralysis have all been observed.”
• “Concussions . . . Neupanex® supports the body with the most cutting-edge biochemistry to help it curtail the cascade of brain injury and by repairing damage through neuro-regeneration.”
• “Traumatic Brain Injuries . . . Neupanex® is the result of 25 years of research by Dr. Lewis K. Clarke, M.D., PhD. and used in the treatment of his patients with debilitating and degenerative neurologic injuries.”

On your webpage at www.clarkepharmaceuticals.com titled “What is Neupanex®”

• “Neupanex® is the result of 25 years of research by Lewis Clarke, M.D., Ph.D. . . . When he began treating patients with debilitating neurologic diseases such as strokes, spinal cord injuries, Guillian-Barre [sic], and degenerative neurologic processes such as MS, ALS, Alzheimer’s, and Parkinson’s, he began implementing interventional and neuroregenerative neuropharmacology.”
• “Clinically, many of Dr. Clarke’s patients have benefited from Neupanex® over the past 20 or more years. Cognitive and socialization improvements in dementias and improvements in motor deficits and paralysis have all been demonstrated. …It can be used in athletes as an aide to neuroprotection, especially after a concussive injury.”

On your webpage at www.clarkepharmaceuticals.com titled “Video Testimonials of Neupanex®”:

• “Can a 6 year old traumatic brain injury be effectively reversed?”
• “When a parent has dementia . . . When your parent is diagnosed with dementia, and the neurologist’s tests confirm your fears, where do you turn? Monica and her family tried Neupanex®. When they went back for a follow-up exam, they were shocked.”
• “Using Neupanex® on post concussive disorder . . . NFL wide receivers sustain an average of 49 concussions during a regular season. …This ultimately leads to CTE (chronic traumatic encephalopathy), with the same symptoms of dementia or Alzheimer’s disease. … This is Courtney and his wife Candace’s testimonial as to how Neupanex® has helped him heal both physically and emotionally from repetitive head trauma.”
• “Using Neupanex® to address dementia … Bill Turner started exhibiting the warning signs for early onset dementia … His wife Toni . . . called Dr. Clarke to see how Neupanex® could help her husband.”
• “Using Neupanex® on a recent concussion”
• “Using Neupanex® on a spinal cord injury … This left Julius completely paralyzed from mid-stomach down. … Julius was sent to the rehabilitation hospital where he received the Neupanex® protocol … regaining his mobility.”

On your YouTube video recording at https://www.youtube.com/watch?v=eun2rHl2zsI titled “Neupanex- Natural Supplement for TBI and Post Concussion Syndrome”

• 11:11-11:25: “I have used Neupanex in Alzheimer’s, traumatic brain injury, multiple sclerosis, dementia, strokes, and Hall of Fame NFL players with CTE both inpatients and outpatients.”
• 11:30-11:40: “Neupanex is formulated to function as an antioxidant and antiinflammatory and to block neurotoxic neurotransmitters.”
• 11:50-11:56: “Neupanex may also promote brain repair following concussion and traumatic brain injury.”
• Video Description: “In this video, Dr. Lewis Clarke shows exciting evidence on the use of Neupanex for people who have suffered a concussion, traumatic brain injury or are still suffering from post concussive syndrome.”

On your YouTube video recording at https://www.youtube.com/watch?v=pLmF5kMCBL8 titled “Concussion treatment: Where they fall short”

• 05:30-05:45: “There is a supplement called Neupanex that is really a combination of 26 supplements known to help repair your brain it works remarkably in all kinds of neurologic injury and diseases Alzheimer’s Parkinson’s Strokes…”

Natural Progesterone Skin Cream

On your product webpage for “Natural Progesterone Skin Cream” at https://www.clarkepharmaceuticals.com:

• “Natural Progesterone cream is used in hormone replacement therapy and for treating menopausal symptoms such as hot flashes.”
• “This topical progesterone cream is also used for treating or preventing certain allergies in which hormones play a role; and for treating bloating, breast tenderness, decreased sex drive, depression, fatigue, lumpy (fibrocystic) breasts, headaches, low blood sugar, increased blood clotting, infertility, irritability, memory loss, miscarriages, brittle bones (osteoporosis), bone loss in younger women, symptoms of PMS, thyroid problems, foggy thinking, uterine cancer, uterine fibroids, water retention, weight gain, and vaginal irritation.”

Your “OsteoBLAST®,” “Cell Block #19,” “High Potency Vitamin D3,” “Neupanex®,” and “Natural Progesterone Skin Cream” products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no approved applications under section 505 for your “OsteoBLAST®,” “Cell Block #19,” “High Potency Vitamin D3,” “Neupanex®,” and “Natural Progesterone Skin Cream” products. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the Act, 21 U.S.C 355(a) and 331(d).

A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your “OsteoBLAST®,” “Cell Block #19,” “High Potency Vitamin D3,” “Neupanex®,” and “Natural Progesterone Skin Cream” products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, “OsteoBLAST®,” “Cell Block #19,” “High Potency Vitamin D3,” “Neupanex®,” and “Natural Progesterone Skin Cream” products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].

This letter is not intended to be an all-inclusive review of your website and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

You should take prompt action to address the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and any other violations. Failure to promptly address the violations specified above may result in legal action without further notice, including, without limitation, seizure of violative products and/or injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address the above violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related

documentation. If you cannot complete addressing these violations within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. You may respond in writing or by telephone to Dana M. Lewis, Compliance Officer, at [email protected] or (214) 253-5205.

Sincerely,
/S/
Edmundo Garcia Jr.
Director, Division III
Office of Human and Animal Foods West

cc: Lori Woznicki, Food and Drug Inspections Branch
Manager, Division of Regulatory Services
Texas Department of State Health Services
[email protected]

__________________________

1 There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell a product that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.