Inspections, Compliance, Enforcement, and Criminal Investigations

Capris Associates Inc. / BR Naturals 2/5/19

 

  

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WARNING LETTER
 
 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
February 5, 2019
 
BR Naturals
Boris Novosel, CEO
3249 9th Line
Innisfil, Ontario
L95 3Z4 Canada
 
RE: 566245
 
Dear Mr. Novosel:      
                                   
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.brnaturals.com in October 2018 and has determined that your website links to your Amazon sale page at www.amazon.ca/brnaturals where you take orders for your products Avocado Oil, Black Seed Oil, Moringa Powder, Premium Olive Oil D.O.P., Pumpkin Seed Oil, and Unrefined Coconut Oil.  FDA also reviewed your social media websites at www.facebook.com/BRNaturals and  www.twitter.com/BRNaturals, and your blog page at www.brnaturals.blog, which contain links to your website www.brnaturals.com and/or your Amazon sale page at www.amazon.ca/brnaturals. The claims on your websites establish that these 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 claims on your website www.brnaturals.com that provide evidence that these products are intended for use as drugs include the following:
 
Under the Edible Oils section of your website, titled “AVOCADO OIL”:
  • “Both the [avocado] fruit and the oil… help in reducing the levels of unhealthy LDL-cholesterol in the body … thus helping to prevent obesity, diabetes, heart disease, Alzheimer’s and even cancer.” 
Under the Edible Oils section of your website, titled “BLACK CUMIN SEED OIL”: 
  • “Relieving pain associated with rheumatism, back ache and arthritis”
  • “Can help fight off colds and flu”
  • “Can help with blood sugar management”
  • “Can help stabilize high blood pressure”
  • “Get rid of intestinal parasites”
  • “Help fight off bacterial infections”
  • “asthma relief”
Under the Edible Oils section of your website, titled “Pure Unrefined VIRGIN COCONUT OIL”:
  • “Coconut oil … is antibacterial…”
Under the Edible Oils section of your website, titled “PUMPKIN SEED OIL”:
  • “Pumpkin Seed Oil has been found to be helpful in preventing bladder and prostate problems as well as intestinal parasites. Pumpkin Seed Oil has also been used to … help relieve … arthritis, and help regulate cholesterol levels.”
Under the Ingredients section of your website, titled “AVOCADO OIL”:
  • “[Avocados] are also useful for… controlling blood pressure (potassium)…”
Under the Ingredients section of your website, titled “COCONUT OIL”:
  • “[Coconut oil] is also an aid when fighting heart disases, kidney problems, high blood pressure, diabetes, cancer and even HIV. . . . . All these benefits can be attributed to the presence of the short chained saturated lauric acid (approximately 50% of C.O. [Coconut Oil]) that gets transformed into monolaurin inside our body. Monolaurin … was proven to help the immune system fight harmful viruses and bacteria (herpes, cytomegalovirus, influenza, HIV).”
Additional examples of some of the claims and personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevention of disease that appear on your blog at www.brnaturals.blog include the following:
 
On the blog page titled “Alzheimer’s & Coconut Oil: Superfood for the Brain”:
  • “[Dr.] Mary Newport has much reason to celebrate these days. After helplessly watching her 58 year old husband [Steve Newport] rapidly degenerate into severe dementia only 5 years after MRI diagnosis with Alzheimer’s, Mrs. [sic] Newport decided to pursue unorthodox treatment of his condition with virgin coconut oil, instead of the expensive drug Axena [sic]…
Since Virgin Coconut Oil (VCO) is loaded with [Medium Chain Triglycerides (MCTs)], Dr. Newport began an intensive feeding program for her husband that consisted of a mixture of 2 TBL virgin coconut oil and the MCT pharmaceutical isolate with every meal.
Within 35 days, Steve Newport’s rapid neurological decline was arrested and 18 months later he had recovered enough brain function and normal behavior to test as only a mild case of Alzheimer’s – the same tests which, before the starting the VCO feeding program, had indicated that he was borderline severe dementia.
Dr. [Mary] Newport now travels all over the United States relaying the remarkable story of her husband’s recovery from borderline severe dementia using VCO to essentially rebuild his brain.
 
She is a strong advocate for continued research into the use of MCTs as a therapy for those with Alzheimer’s, Parkinson’s, multiple sclerosis and other debilitating neurological diseases.”
  • “Coconut oil . . . provides many benefits in addition to improving brain health . . . including . . . Removal of Amyloid plaque in the brain.”
  • “A new study in the . . . Journal of Alzheimer’s Disease supports existing evidence that coconut oil may help alleviate the neurodegenerative effects of Alzheimer’s disease and Parkinson’s.”
  • “Dr, Bruce Fife … recommends VCO [virgin coconut oil] instead of MCT drugs such as Axona…”
On the blog page titled “Black Seed Oil: ‘A remedy for all diseases except death’”:
  • “This humble, but immensely powerful seed kills MRSA … [and] stimulates regeneration of the dying beta cells within the diabetic’s pancreas.”
  • “Other black seed benefits include:”
o   “Can help fight off colds and flu”
o   “Get rid of intestinal parasites”
o   “Epilepsy: Black seeds were traditionally known to have anticonvulsive properties.”
o   “High Blood pressure: The daily use of 100 and 200 mg of black seed extract, twice daily, for 2 months, was found to have a blood pressure-lowering effect in patients with mild hypertension.”
o   “Asthma: Thymoquinone, one of the main active constituents within Nigella sativa (black cumin), is superior to the drug fluticasone in an animal model of asthma.”
o   “Colon Cancer: Cell studies have found that black seed extract compares favorably to the chemoagent 5-fluoruracil in the suppression of colon cancer growth…”
o   “Opiate Addiction/Withdrawal: A study on 35 opiate addicts found black seed as an effective therapy in long-term treatment of opioid dependence.”
  • “In a recent study scientists discovered that black seed oil . . . helps prevent both [liver] damage and disease”
  • “ . . . Nigella sativa [i.e., black cumin seed oil] is one of the few substances on the planet that is suggested to help prevent both type 1 and type 2 diabetes.”
  • “Black Cumin seed Oil can even be used to treat several serious skin conditions when applied directly to problem areas such as: … Eczema … Psoriasis Scales… Skin Fungal and other infections … Ringworm … Rosacea”
On the blog page titled “Coconut Oil Kills 93% of Colon Cancer Cells in Only 2 Days According to New Study”:
  • “An alternative treatment for cancer has come to light after various studies have found that it is able to effectively inhibit colon cancer.”
  • “[N]ew research has shown that coconut oil is a potential alternative to typical colon cancer treatment.”
  • “According to one study conducted by Adelaide University of Australia, researchers found that lauric acid, a saturated fat that is one of the main components of coconut oil, was able to destroy 93% of colon cancer cells that it was tested on over a 48-hour period.”
  • “Coconut oil has been found to have benefits that exceed its cancer-killing properties…”
  • “According to the [American Nutrition Association] studies, the fats found in coconut oil ‘can be useful in the curing and prevention of conditions like diabetes, osteoporosis, viral diseases (mononucleosis, hepatitis C, herpes etc.), biliary tract disease, Chron’s disease, and cancer.’”
On the blog page titled “Coconut Oil: Why Not All Saturated Fats Are Bad”:
  • “The Lauric Acid in Coconut Oil Can Kill Bacteria, Viruses and Fungi, Helping to Stave Off Infections”
  • “When coconut oil is enzymatically digested, it also forms a monoglyceride called monolaurin. Both lauric acid and monolaurin can kill harmful pathogens like bacteria, viruses and fungi…. For example, these substances have been shown to kill the bacteria Staphylococcus Aureus (a very dangerous pathogen) and the yeast Candida Albicans, a common source of yeast infections in humans . . ..”
  • “The Fatty Acids in Coconut Oil Are Turned into Ketones, Which Can Reduce Seizures”
  • “Coconut Oil Can Improve Blood Cholesterol Levels and May Lower Your Risk of Heart Disease”
  • “[R]esearchers have speculated that ketones can … reduce symptoms of Alzheimer’s”
  • “[M]edium chain triglycerides are being intensively studied as potential therapeutic agents in Alzheimer’s disease”
On the blog page titled “The Number 1 Diet That Starves Cancer + Recipe”:
  • “Good, healthy fats deliver fatty acids that are converted to energy bestowing ketones when the body’s cells are deprived of glucose. That’s how coconut oil has reversed Alzheimer’s.”
Also, claims made on your Facebook page at www.facebook.com/brnaturals/, which links to your website at www.brnaturals.com and your Amazon sale page at www.amazon.ca/brnaturals, provide additional evidence that your products are intended for use as drugs: 
  • On August 15, 2018, your Facebook post includes a link titled, “Clinical Trial Reveals Black Seed May Treat Hypothyroidism (Hashimoto’s Disease).” This link directs to a post on your blog, which includes the following additional claim:
o   “‘black seed’ … may provide an ideal treatment for the autoimmune thyroid condition known as Hashimoto’s disease”
  • On April 24, 2018, your Facebook post includes a link titled, “Fight Inflammation and Cancer with Black Seed Oil.” This link directs to a post on your blog, which includes the following additional claims:
o   “Black cumin seed oil … strengthens the delicate layer of mucus that lines the stomach, preventing ulcers …. It also decreases inflammation in the gut, which prevents leaky gut, [and] colitis…”
o   “[A] 2008 study found that daily oral treatment with black cumin oil lowers blood pressure, LDL (bad cholesterol), and total cholesterol. This … helps prevent atherosclerosis”
o   “Black cumin seed oil has been impressive in the treatment of cancer. It appears that Thymoquinone (TQ) takes the lead as the most powerful anticancer, antitumor, and anti-angiogenic component of this oil, as it boosts the ability of key immune cells to . . . destroy infected or cancerous cells.”
  • On March 22, 2018, your Facebook post regarding Moringa Powder states: “Moringa has been used for hundreds of years for treating widespread conditions such as: inflammation-related disease, cancer, diabetes, anemia, arthritis and other joint pain, allergies, an asthma, epilepsy, constipation, stomach pains, chronic headaches, heart problems, including high blood pressure, kidney stones, thyroid disorders, … [and] bacterial fungal, viral and parasitic infections …”
Claims on your Twitter page at www.twitter.com/brnaturals, which links to your website at www.brnaturals.com, provide additional evidence that your products are intended for use as drugs: 
 
Posts by your company on your Twitter page include the following:
  • On June 13, 2017, your Twitter page includes a link titled “Olive oil nutrient found to HALT brain cancer cells in their tracks.” This link directs to a post on your blog, which includes the following additional claims:
o   “Olive oil … might help prevent brain cancer … suppresses brain tumor formation.”
o   “Olive oil … could kill cancer cells in less than an hour”
o   “Olive oil has been proven to … prevent osteoporosis, fight dementia”
 
Your 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)]. 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 products Avocado Oil, Black Seed Oil, Moringa Powder, Premium Olive Oil D.O.P., Pumpkin Seed Oil, and Pure Unrefined Coconut Oil 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, Avocado Oil, Black Seed Oil, Moringa Powder, Premium Olive Oil D.O.P., Pumpkin Seed Oil, and Unrefined Coconut Oil 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)].
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 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 written reply should be directed to Shawn Goldman, 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. If you have any questions, please contact Mr. Goldman at Shawn.Goldman@fda.hhs.gov.
 
Sincerely,
/S/
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition

 

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