WARNING LETTER
Conners Clinic
MARCS-CMS 616763 —
November 07, 2022
Delivery Method:
Via Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Dr. Kevin Conners, D.Psc., FICT, FAARM
Conners Clinic
8519 Eagle Point Blvd, Suite 170
Lake Elmo
,
MN
55042
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
November 7, 2022
WARNING LETTER
RE: 616763
Dear Dr. Conners:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address, www.connersclinic.com, in May 2022 through August 2022 and has determined that you take orders there for the products “Fenbendazole Starter Pack #1”, “Panacur-C Fenbendazole”, “Breast Cancer Prevention Protocol Bundle”, “Curcu Clear”, “Black Cumin Seed Oil,” “Chronic LX”, “Cayenne”, “D3-Xym”, “Rapid Immune Boost”, and “Glucosamine Sulfate Chondroitin Sulfate MSM”. We have also reviewed your social media websites at www.facebook.com/connersclinic, www.instagram.com/conners.clinic/, and www.twitter.com/connersclinic. These websites direct consumers to your website, www.connersclinic.com, to purchase your products.
The claims on your website and social media websites establish that the products 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. 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 these products are intended for use as drugs include:
“Fenbendazole Starter Pack #1”
On your webpage titled, “Fenbendazole Starter Pack #1”:
• “Fenbendazole… is fast becoming a successful anticancer treatment in many late-stage cancers in humans due to the experience of Joe Tippens over at MyCancerStory.rocks.”
“Panacur-C Fenbendazole”
On your webpage titled, “Panacur-C Fenbendazole”:
• “How would I take it? . . . Those with later-stage cancers may choose to take 2-3 packets per day and take NO days off!”
• “It can be taken as a single dose in the morning, with or without food. Remember, those with later-stage cancers may choose to take 2-3 packets per day and take NO days off!”
On your Facebook page www.facebook.com/connersclinic:
• In a February 4, 2020 post that links to an article on your website titled, “Is Fenbendazole The Anti-Cancer Drug Treatment For You?” which includes a link to purchase your “Panacur-C” product:
o “. . . [P]atients with late-stage cancers can take more than one packet per day and can choose to take it
daily
instead of only 3 days per week!”
o “It can be taken as a single dose in the morning, with or without food. Remember, those with later-stage cancers may choose to take 2-3 packets per day and take NO days off!”
On your Twitter account www.twitter.com/connersclinic:
• In an August 4, 2021 tweet that links to an article on your website titled, “Is Joe Tippens Still Alive? 2021 Update – Fenbendazole Anti-Cancer Drug Treatment” which includes a link to purchase your “Panacur-C” product:
o “Fenbendazole…is fast becoming a successful anticancer drug treatment in many late-stage cancers in humans due to the experience of Joe Tippens over at MyCancerStory.rocks.”
“Breast Cancer Prevention Protocol Bundle”
On your webpage titled, “Breast Cancer Prevention Protocol Bundle”:
• “Breast Cancer Prevention Protocol Bundle…OUR BREAST CANCER PREVENTION PROTOCOL BUNDLE: 1. Take BreastDefend – 2 capsules, twice per day 2. Take EstroClear – 2 capsules, twice per day 3. SulforaXym – 1 capsule, twice per day”
“Curcu Clear”
On your webpage titled, “Curcu Clear 60 Gels”:
• “Curcu Clear . . . lower the risk of brain diseases.”
• “[L]owers risk of heart disease . . .”
• “[L]owers risk/prevalence of cancer”
• “[R]educes oxidative damage associated with Alzheimer’s disease”
• “[R]educed symptoms of arthritis”
• “[A]cts as an antidepressant”
On your Facebook page www.facebook.com/connersclinic:
• In a June 30, 2021 post: “Why is CurcuClear one of our best selling [sic] products? [C]urcumin … can also halt cancer growth. Curcumin’s anti cancer effect is attributed to induce normal, programmed cell death (apoptosis) in cancer cells without cytotoxic effects on healthy cells. Additionally, curcumin has been found to inhibit mTOR complex, which is a major growth pathway that seems to be unregulated in those with cancer.”
On your Instagram page www.instagram.com/conners.clinic:
• In a November 13, 2020 post with an image of your Curcu Clear product:
o “Potential Benefits…Boosts brain-derived neurotrophic factor, linked to improved brain function & lower risk of brain diseases” “Lowers risk of heart disease. . .”
o “Lowers risk/prevalence of cancer”
o “Reduces oxidative damage associated with Alzheimer's disease”
o “Reduced symptoms of arthritis”
o “Acts as an antidepressant”
“Black Cumin Seed Oil”
On your webpage titled, “Black Cumin Seed Oil 7 fl. Oz”:
• “ANTI-BACTERIAL”
• “ANTI-FUNGAL”
• “ANTI-VIRAL”
• “ANTI-PARASITIC”
• “Traditionally, the seeds have been used medicinally for: asthma, hypertension, diabetes . . . bronchitis, headache, eczema, fever, dizziness, and gastrointestinal disturbances.”
• “. . . [T]his oil could be beneficial for the management of: epilepsy, autoimmune disorders, skin irritation and disorders… kidney stone prevention, chronic fatigue . . .”
• “[M]ay help prevent cardiovascular disease. It may be beneficial for enhancing immune functions, lowering cholesterol.”
• “Black cumin seed oil is a potent anti-cancer, antibacterial, antifungal, antiviral, and anti- parasitic oil.”
“Chronic LX”
On your webpage titled, “Chronic LX – Chronic Phase 2 Lyme and Other Infections”:
• “LX Chronic has been specially designed for those with chronic, stubborn, and often hidden infections.”
“Cayenne”
On your Facebook page www.facebook.com/connersclinic:
• In a May 18, 2021 post that links to an article on your website titled, “Treating Cancer With Cayenne Pepper & Capsaicin” which includes link to purchase your “Cayenne” product:
o “Capsaicin [an ingredient in your “Cayenne” product] was capable of killing 80 percent of prostate cancer cells.”
“D3-Xym”
On your Facebook page www.facebook.com/connersclinic:
• In an April 29, 2021 post: “D3 is a key player in preventing cancer! D-Xyme helps prevent cancer & is downright good for you. . .” which links to a YouTube video titled, “Vitamin D-Xyme – Dr. Kevin Conners and Jason Rozin” at https://www.youtube.com/watch?v=Nd_hRAl2AeA containing the following claims:
o “Always excited about D3 because of treating cancer patients. You wanna prevent cancer, you wanna use D3…that’s a key player” [at approx. 0:46 – 0:53]
o “How about for… an autoimmune patient or someone struggling with a nasty infection?… [D3] helps balance a hyper immune system … somebody with autoimmune issues or allergy issues, that can be really beneficial with that” [at approx. 2:44 – 3:18]
o “If it helps anybody, people with any tachycardia issues, you can literally be a lifesaver for somebody with vitamin D3” [ at approx. 3:26 – 3:36] “You have any idea what people’s cholesterol levels are, or you know that they are on Lipitor or something like that it’s good to get them on Vitamin D … take one a day” [at approx. 6:10 – 6:19]
“Rapid Immune Boost”
On your Facebook page www.facebook.com/connersclinic in a June 23, 2021 post titled, “Let’s talk Echinacea!” and a blog post on your webpage titled, “Echinacea: Unique AntiCancer & Immune Boosting Abilities” which includes a link to purchase your “Rapid Immune Boost” product:
• “Echinacea [an ingredient in your “Rapid Immune Boost” product] mediates its antineoplastic (cancer killing) activity via the immune system and has no influence on the tumor cells themselves (it stimulates the NKC activity) . . . By stimulating the first line of defense, i.e. NKCs, which are so effective in detecting and killing tumor cells immediately upon detection, the value of Echinacea can be readily seen.”
“Glucosamine Sulfate Chondroitin Sulfate MSM”
On your webpage titled, “Glucosamine Sulfate Chondroitin Sulfate MSM – 120 Caps”:
• “May help reduce risk of developing cancers believed to be associated with chronic inflammation.”
Your “Fenbendazole Starter Pack #1”, “Panacur-C Fenbendazole”, “Breast Cancer Prevention Protocol Bundle”, “Curcu Clear”, “Black Cumin Seed Oil”, “Chronic LX”, “Cayenne”, “D3- Xym”, “Rapid Immune Boost,” and “Glucosamine Sulfate Chondroitin Sulfate MSM” 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 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.
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 C.F.R. § 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 “Fenbendazole Starter Pack #1”, “Panacur-C Fenbendazole”, “Breast Cancer Prevention Protocol Bundle”, “Curcu Clear”, “Black Cumin Seed Oil”, “Chronic LX”, “Cayenne”, “D3- Xym”, “Rapid Immune Boost”, and “Glucosamine Sulfate Chondroitin Sulfate MSM” products are intended for prevention or treatment of one or more diseases that are not amenable to self- diagnosis, prevention, 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, your “Fenbendazole Starter Pack #1”, “Panacur-C Fenbendazole”, “Breast Cancer Prevention Protocol Bundle”, “Curcu Clear”, “Black Cumin Seed Oil”, “Chronic LX”, “Cayenne”, “D3-Xym”, “Rapid Immune Boost”, and “Glucosamine Sulfate Chondroitin Sulfate MSM” products fail to bear adequate directions for their intended use and, therefore, these 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 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 this office in writing, within 15 working days of receipt of this letter, of the specific steps that you have taken to address 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 cannot complete corrective action within 15 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.
Your written reply should be directed to Dr. Aaron Dotson, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Food and Drug Administration
Content current as of:
11/15/2022
Regulated Product(s)
Drugs
Food & Beverages