WARNING LETTER

JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health MARCS-CMS 612754 — May 26, 2021

Delivery Method:: United Parcel Service
Product:: Drugs
Food & Beverages

Recipient:: Recipient Name

Jeffrey Neil Burgee; Recipient Title

CEO; JLM Nutritionals, Inc. dba JLM Nutrition—Super Naturals Health; 1309 ½ S. Roxbury Dr.
Los Angeles, CA 90035
United States

Issuing Office:: Office of Human and Animal Food Operations- West Division 5; United States

WARNING LETTER

May 26, 2021

WL 612754

Dear Mr. Burgee:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the internet addresses https://www.supernaturalshealth.com and https://www.ibsformula.com in May 2021 and has determined that you take orders there for the products Super Naturals brand IBSolution, Premium Probiotic, Sleep Solution, Joint Solution, and Ultra Omega Fish Oil. We also reviewed your IBSolutions product page and seller’s profile page at Amazon.com, and your Facebook pages at www.facebook.com/supernaturalshealth and www.facebook.com/ibsrelief, which are linked to your websites at the internet addresses https://www.supernaturalshealth.com and https://www.ibsformula.com. The claims on your websites, Amazon pages, and Facebook pages 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 the FDA’s home page at http://www.fda.gov.

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

Super Naturals IBSolution (https://www.supernaturalshealth.com)

Your product name implies use for the treatment of Irritable Bowel Syndrome (IBS).

On your product description page:
• “Designed to relieve Irritable Bowel Syndrome (IBS) symptoms including diarrhea and constipation”
• “Reduced. . .abdominal pain”
• “Clinical trials and studies on the natural ingredients in IBSolution have proven to provide relief for IBS”
• “4 out of 5 patients who try IBSolution see relief. We’re confident that there’s a strong chance YOU’LL EXPERIENCE IBS RELIEF TOO!”
• “INGREDIENTS. . .Walnut Hulls - antidiarrheal, antifungal, antiviral. . .Ginger. . .anti inflammatory”

On your blog “The Amazing Proven Beneficial Side Effects of Taking IBSolution” page:
• “You may know that many of the ingredients in our natural IBS treatment are clinically proven to provide relief from irritable bowel syndrome symptoms.”
• “We’ve thoroughly researched several of the ingredients in IBSolution to determine the positive effects these antioxidant-rich super-foods can provide, in addition to relieving IBS.”

o “ACAI

Anti-stroke

Anti-cancer

Anti-inflammatory

Lowers Cholesterol

Anti-cardiovascular disease . . .

Hypertension reduction (High Blood Pressure)

Anti-diabetes via steadying of insulin-glucose balance.”

o “GINGER

Anti-cancer

Anti-inflammatory

Reduces menstrual pain

Antiviral, Antibiotic, Anti-fungal properties

Anti-Alzheimer’s. . .

Anti-nausea. . .”

o “CHLORELLA . . . Anti-cancer”

o “PSYLLIUM . . . Crohns relief

Peptic Ulcer relief

Hemorrhoid relief

Anti-inflammatory

Lowers Cholesterol

Diverticulosis relief . . . Reduces risk of Stroke

Ulcerative Colitis relief

Kidney stone reduction

Anti-cardiovascular disease

Hypertension reduction (High Blood Pressure)

Anti-diabetes via steadying of insulin-glucose balance”
• “When taken twice a day, IBSolution not only can diminish your IBS symptoms. . .”

On your blog “Natural IBS Treatment Versus Prescription Treatment For IBS Symptoms” page:
• “On 04/25/16, Jordyn in Los Angeles wrote: . . . I have been suffering for about a year now with IBS-D. . . . I was then diagnosed with IBS-D. I had no idea that IBS could be so debilitating. . .Luckily I found IBS Formula! I have been off my medications and on this formula for a month. An entire month of no issues, no stomach pains, no missed days of work.”
• “If you’re still suffering with the horrible symptoms of irritable bowel syndrome, I urge you to try IBS Formula today. . . . It fixed me, it has fixed Jordyn and many others, and it can probably fix you too.”

On your “IBSolution-All natural IBS treatment-FAQs” page:
• “Are the ingredients in IBSolution clinically proven to relieve IBS symptoms? Yes. Clinical trials and studies on several of the ingredients in our natural IBS treatment have proven to provide relief for IBS. . . . By combining these proven digestive aids with naturally-occurring superfoods, IBSolution is able to provide real relief from IBS symptoms.”
• “[T]he additional clinically-proven benefits include . . . decreased risk of cancer . . . lowered risk of heart disease . . . lowered inflammation . . . and lower cholesterol to name a few.”

On your “IBSolution-Clinical Trials & Studies on the Ingredients” page:
• “Clinical trials and studies on the natural ingredients in our IBS treatment have proven to provide relief for IBS. . . , IBSolution is able to provide real relief from IBS symptoms.”
• “PSYLLIUM- In a study published online August 27, 2009 entitled Soluble or insoluble fibre (sic) in irritable bowel syndrome in primary care? Randomized placebo controlled trial . . .. The teams CONCLUSION ‘Psyllium offers benefits. . .patients with irritable bowel syndrome in primary care.’”
• “ALOE- In a study published on August 18, 2013 entitled Aloe vera in treatment of refractory irritable bowel syndrome: Trial on Iranian patients . . . . The team summarizes their findings by reporting ‘In conclusion, Aloe vera can reduce abdominal pain/discomfort as well as flatulence in patients with constipation predominated IBS…’” (ellipses in original)

Webpage https://www.ibsformula.com
• Your website address “https://www.ibsformula.com” implies use for the treatment of Irritable Bowel Syndrome (IBS).

On your product description page:
• “JOIN THE TENS OF THOUSANDS LIVING IBS FREE”
• “Designed to relieve Irritable Bowel Syndrome (IBS) symptoms including diarrhea and constipation”
• “Reduced. . .abdominal pain”
• “Clinical trials and studies on the natural ingredients in IBSolution have proven to provide relief for IBS”
• “INGREDIENTS . . . Walnut Hulls- antidiarrheal, antifungal & antiviral . . .

Ginger-. . .anti inflammatory”

On your “FAQ - All natural IBS treatment Treatment & Relief for irritable bowel syndrome” page:
• “Our extensive research of the ingredients in our all natural IBS Treatment (IBSolution). . . . [T]he additional clinically-proven benefits include . . . decreased risk of cancer . . . lowered risk of heart disease . . . lowered inflammation . . . and lower cholesterol to name a few.”

On your Super Naturals Health Facebook page:
• Facebook post from September 6, 2019: “Our all natural IBS treatment is designed to provide powerful relief for both IBS-D and IBS-C.”

On your IBSolution Facebook page:
• Facebook post from August 6, 2020: “Walnut Hulls- antidiarrheal, antifungal, antiviral. . .Ginger -. . .anti inflammatory”

On your All Natural IBS Treatment (JLM Nutritionals) storefront on www.amazon.com::
• “A Testimonial From Our Founder Jeff Burgee: I cured myself, and then my fiancé of our IBS symptoms. . . . My fiance Lindsay, who suffered from regularly occurring constipation, took it one step further by pushing me to develop not only a formula that relieved IBS-D (diarrhea) but one that would also help the awful reality of bloating and constipation or IBS-C. . . . We took all the wonderful natural ingredients we knew cured our own IBS and created IBS Formula.”

Webpage www.amazon.com
On the product page:
• “This alternative medicine can help support stomach ache relief and help alleviate other IBS symptoms . . . .”
• “IBSolution helps with the symptoms of Irritable Bowel Syndrome such as. . .diarrhea. . .abdominal pain.”

Super Naturals Premium Probiotic

Webpage https://www.supernaturalshealth.com
On your product description page:
• “Probiotics are proven to reduce the severity of diarrhea. . . .”
• “Regular use of probiotics help negate symptoms of digestive issues including Irritable Bowel Syndrome, IBD, Ulcerative Colitis and Crohn's.”

Webpage https://www.ibsformula.com
On your blog “The Many Benefits and Users of Probiotics” page:
• “The leakiness triggers systemic inflammation and contributes to a variety of ills, including . . . inflammatory bowel disease, type 2 diabetes, heart disease. . .and even Alzheimer’s disease or other forms of dementia. Probiotics can help reverse this condition.”
• “What are the benefits of probiotics? . . . Other benefits include prevention or relief from:

Diarrhea . . .

Colds and flu . . .

Eczema

Irritable bowel syndrome

Ulcers

Digestive side effects of cancer therapy

Constipation . . .

Impaired mental function with people with Alzheimer’s

Toxicity from mercury, arsenic, and cadmium

Vaginal infections

Depression in people with IBS

Unhealthy blood-sugar levels in diabetics”

Super Naturals Sleep Solution
Webpage https://www.ibsformula.com

On your product description page under the “Sleep Solution Ingredients” tab, you promote the following ingredients in the product:
• “L-Tryptophane . . .

Reduces anxiety

Prevents depression”
• ”Valerian

Reduces anxiety . . .

Reduces headaches”

• “Calcium . . .

Lowers blood pressure”

• “Magnesium . . .

Fights depression

Lowers blood pressure and blood sugar

Anti-inflammatory“

• “Gojo (Wolfberry) . . .

Controls blood sugar and blood pressure . . .

Improve cholesterol”

• “Chamomile . . .

Slows osteoporosis”

• “Lemon Balm . . .

Minimizes pain (headache, toothache. . .”

• “Passion Flower

Reduces Anxiety . . .

Helps with ADHD symptoms”

• “L-Taurine . . .

Reduces glucose levels

Insulin resistance

Reduces cholesterol”

• “Hops . . .

Anti- bacterial

Lowers cholesterol

Reduces high blood pressure”

• “St John’s Wort . . .

Treats Depression”

• “GABA (Gamma-Aminobutyric Acid) Relives Anxiety . . . Treats diabetes

• Lowers blood pressure”

• “Ashwagandha . . . Lowers blood sugar Reduces symptoms of depression . . . Lower cholesterol & triglycerides”

• “Inositol . . . Reduces symptoms of depression”

• “5-HTP . . . Reduces symptoms of depression Improves symptoms of Fibromyalgia”

• “Melatonin . . . Treats ulcers and heartburn”

On your blog “Sleep Solution’s Powerful Natural Sleep Aids” page:
• “Melatonin. . .effective at easing insomnia . . .”
• “L-tryptophan. . .tryptophan has been investigated. . .for its role in treating sleep disorders. . . . A review of 20 randomized controlled trials . . . showed an overall improvement of insomnia . . . .”
• “[Valerian] . . .was used by ancient Greeks to treat insomnia.”

On your Super Naturals Health Facebook page:
• Facebook post from October 13, 2018: “Helps improve insomnia. . .”

Super Naturals Joint Solution

Webpage https://www.supernaturalshealth.com
On your product description page:
• “All-natural joint pain relief with anti-inflammatory ingredients. . .”
• “Suppresses chronic inflammation, which is proven to contribute to several common Western diseases.”
• “Comprised of the ideal natural supplements and herbs to aide with arthritis relief, reduced inflammation . . . .”

Webpage https://www.ibsformula.com
On your product description page:
• “All-natural joint pain relief with anti-inflammatory ingredients . . . .”
• “Suppresses chronic inflammation, which is proven to contribute to several common Western diseases.”
• “Comprised of the ideal natural supplements and herbs to aide with arthritis relief, reduce inflammation. . .”

On your product description page under the “Joint Solution Ingredients” tab:
• “Boswellia Extract – This powerful herbal extract derived from a tree has been used for hundreds of years . . .to relieve chronic inflammatory issues and health conditions such as osteoarthritis, rheumatoid arthritis, asthma and IBD.”
• “Turmeric – . . . found to reduce swelling and inflammation. . .”
• “Quercetin – . . . quercetin includes . . . anti-inflammatory agents which may reduce inflammation, cancer cells, maintain blood sugar and reduce heart disease risk.”
• “MSM – Science backed benefits include joint pain reduction . . . and improvement of arthritis symptoms.”
• “Bromelain – . . .bromelain’s anti-inflammatory and pain-relieving elements help reduce swelling of the soft-tissues . . . and assist with osteoarthritis joint mobility.”

On your product description page under the “Our Founders Review” tab:
• “I have suffered from Rheumatoid Arthritis for 24 years . . . . I was able to remove the toxic injectable drug I have taken for decades from my life with our Joint Solution.”

On your blog “5 Natural Supplements for Arthritis” page, you promote the ingredients in Joint Solution as providing “natural pain relief,” “targeting inflammation,” and fighting rheumatoid and osteo arthritis.

Super Naturals Ultra Omega Fish Oil

Webpage https://www.supernaturalshealth.com

On your product description page:
• “Omega-3 Fatty Acids are proven to improve heart health including the prevention of heart disease, lower blood pressure, reduced chance of heart attack and stroke, lower levels of triglycerides, reduced plaque development and more.”
• “The proven anti-inflammatory effects of fish oil can greatly improve joint pain . . ., reduce stiffness, and relieve rheumatoid arthritis.”
Webpage https://www.ibsformula.com

On your blog “Science-Backed Benefits of Fish Oil” page:
• “Fish Oil and Mental Health . . .Fish oil can help break this cycle of depression . . .. A study published in the journal General Hospital Psychiatry showed that subjects with depression who ate a combination of a diet rich in fish oil and supplementation for six months reported greater mental health improvement than subjects who attempted to attenuate depression through social interactions alone. . . .Fish oil has been shown to stimulate hippocampal growth while also counteracting the deficiency of EPA and DHA in depressed people.”

Your websites https://www.supernaturalshealth.com and https://www.supernaturalshealth.com also contain evidence of intended use in the form of personal testimonials recommending or describing the use of Super Naturals IBSolution for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:

Super Naturals IBSolution

“TESTIMONIALS AND REVIEWS OF OUR ALL NATURAL IBS TREATMENT. . .

• “I’ve tried so many OTC IBS meds over the years and never was really sure if any of them was actually helping at all with my alternating diarrhea and constipation. With IBS Solution, I am 100% sure!!!”
• “Like most of IBS sufferers I’ve tried everything. I have IBS-C and this had significantly helped.”
• “Your IBS Solution is a life saver. Have been dealing with IBSD for the majority of my life and the only thing that has worked is your IBS Solution.”
• “This IBS diagnosis I received from my doctor left me feeling depressed and helpless. He suggested I try this prescription called Viberzi but . . . I said NO WAY . . . . Took a chance on IBS Solution and I’m so glad I did. It took a few months to get all the way back but I’m feeling really great these days . . . .”

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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 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 Super Naturals brand IBSolution, Premium Probiotic, Sleep Solution, Joint Solution, and Ultra Omega Fish Oil 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 safety for their intended purposes. Accordingly, Super Naturals brand IBSolution, Premium Probiotic, Sleep Solution, Joint Solution, and Ultra Omega Fish Oil 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 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 15 working days of receipt of this letter, of the specific steps 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 actions 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 response should be directed to:

Sergio Chavez, Director Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612

Refer to the Unique Identification Number CMS 612754 when replying.

If you have questions regarding this letter, please contact Rochelle R. Blair, Compliance Officer at rochelle.blair@FDA.hhs.gov, or (949) 608-4496.

Sincerely,
/S/

Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations- West Division 5

cc: Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435