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WARNING LETTER

July 1, 2021

WL 612831

Dear Mr. Jacob:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the Internet addresses https://nativeorigins.com and https://brlsports.com in May 2021 and has determined that you take orders at https://nativeorigins.com for your Calm Legs, Flexify, Collagen Peptides, Prohemia, Altitude RX, and Trimmunity products, and that you take orders at https://brlsports.com for your Flexify and Altitude RX products. We have also reviewed your website https://brlscience.com and your social media website at http://www.facebook.com/mynativeorigins, which direct consumers to your website https://nativeorigins.com to purchase your products. 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 diagnosis, 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 your products are intended for use as drugs include:

Calm Legs
On your website https://nativeorigins.com:
• On the Calm Legs product page:
  o “Are you suffering with symptoms of Restless Legs Syndrome? . . . Calm Legs provides natural relief from the jumpy legs and fatigue associated with RLS.”
  o “For many users, Calm Legs brings rapid relief from Restless Legs Syndrome...”
  o “Calm Legs is the first natural supplement to address nutrient deficiencies associated with Restless Legs Syndrome (RLS) while helping to reduce its symptoms. Calm Legs is the only RLS natural supplement that contains the seven natural ingredients clinically proven to relieve RLS symptoms. To learn more, read our blog post, ‘How Do the Ingredients in Calm Legs Relax Restless Legs?’”
  o “Each ingredient in the Calm Legs formula has been clinically tested and shown to reduce symptoms of RLS.”
• On the blog post “How Do the Ingredients in Calm Legs Relax Restless Legs?”:
  o “Calm Legs was the first natural supplement to address recently discovered nutrient deficiencies associated with Restless Legs Syndrome (RLS) while helping to reduce symptoms of RLS.”
  o “Researchers have suggested that valerian [an ingredient in Calm Legs] is a safe herb for managing RLS without side effects.”
  o “Restless legs are linked to bad circulation and unhealthy blood vessels. Vitamin C [an ingredient in Calm Legs] is famous for promoting flexible, healthy blood vessels. Vitamin C also boosts iron absorption, ‘regenerates’ Vitamin E and enhances circulation to the legs and feet. Research has found that vitamin C supplementation brings significant reductions in Restless Legs (RLS) symptoms.”
  o “Vitamin E [an ingredient in Calm Legs] is an RLS symptom relief multitasker that promotes flexible arteries, boosts leg circulation, modulates inflammation and supports healthy nervous system function. Research has shown that vitamin E supplementation was associated with ‘prompt and gratifying relief’ of nighttime leg cramping.”
• On the blog post “Hope for RLS Sufferers”:
  o “Here’s the real breakthrough: A specific combination of these natural compounds taken in precise ratios appears to unlock lasting RLS relief. This combination is found in Calm Legs.”
  o “Calm Legs combines seven different, clinically studied RLS relief nutrients into one tablet to make the most comprehensive remedy on the market. Calm Legs is producing results that many RLS sufferers, including Susan Thompson, call life- changing. After taking Calm Legs for three months, Susan stated: ‘Calm Legs gave me my life back. I'm sleeping better than I have in years. I feel happy and energetic. My legs are no longer jumpy. And no weird side effects! I feel like myself again.’”
• On the blog post “Top 5 Natural Therapies for Restless Legs”:
  o “Calm Legs restores these depleted nutrients, addressing multiple aspects of RLS to provide soothing relief.”
• On the blog post “How Stress Impacts RLS”:
  o “Calm Legs also contains four other vitamins (vitamin C, vitamin E, folic acid, and vitamin B12) that have been clinically shown to . . . manage inflammation . . . and overall reduce symptoms of RLS . . . ”
• On the blog post “What is Restless Legs Syndrome?”:
  o “RLS can lead to a number of consequences, none of them good, including depression, sadness, sleep deprivation, memory loss, stress and fatigue. Since its causes are likely multiple and largely unknown, and there is no known cure, the current approach is to treat the symptoms. Calm Legs is a safe, natural remedy that has helped thousands of people relax and get a good night’s sleep. Order Calm Legs today for rapid relief from RLS...”
On your website https://brlscience.com:
• “Calm Legs combines seven different clinically studied RLS relief nutrients into one tablet to make the most comprehensive remedy on the market.”
• An embedded YouTube video includes the following claims:
  o “CALM LEGS IS THE SOLUTION FOR RESTLESS LEGS!”
  o “The key a new supplement called Calm Legs that’s been featured on WebMD and in Prevention Magazine. Calm Legs helps RLS sufferers wake up refreshed and alert, experience deep restful sleep, and provides lasting relief from restless legs.”

On the Native Origins Facebook page:
• “You don’t have to endure the unpleasant side effect that sometimes accompany RLS drugs. #RLS #restlesslegs #nativeorigins #calmlegs” [from an August 6, 2019 post]
• “Stress is a major trigger for RLS. Find out how you can manage both ailments with natural remedies. #rls @nativeorigins #calmlegs #stress #rlstriggers” [from a July 29, 2019 post]

The above noted website claims are supplemented by metatags used to bring consumers to your website https://nativeorigins.com through Internet searches. The metatags are:
• “Feel more relaxed throughout the day and get restless leg relief with Calm Legs. Soothe jumpy leg muscles with natural supplements for restless legs syndrome.”
• “Try our supplements for restless leg syndrome and relive [sic] sensations of itching, tingling, crawling, and the urge to move legs. Learn about Calm Legs today!”
• “Natural Remedy for RLS”
• “Discover how the ingredients and vitamins in Calm Legs help reduce the symptoms of restless leg syndrome where other prescription drug therapies fall short.”
• “Learn more about Calm Legs, a natural remedy for RLS that offers relief from jumpy-jerky legs, creepy crawly sensations, and random kicking.”

Flexify
On your websites https://brlsports.com and https://nativeorigins.com:
• "What are early signs of arthritis? . . . Used consistently, Flexify will help alleviate painful joint stiffness, joint discomfort... If you are experiencing pain in your elbows, knees, hips, thumbs, shoulders or fingers, you can expect relief from aches and soreness..."
• “Boswellia [an ingredient in Flexify] has been clinically shown to significantly decrease joint pain and improve joint function within seven days of use.”
• “Glucosamine, chondroitin, and MSM [ingredients in Flexify] are well-studied ingredients for...relief from arthritis.”
• “Ginger [an ingredient in Flexify] has been shown to work about as well as ibuprofen when taken daily for hip and knee arthritis pain.”
• “Turmeric [an ingredient in Flexify] reduces joint pain and swelling by blocking inflammatory cytokines and enzymes.”

On your website https://nativeorigins.com:
• On the blog post “How Do the Ingredients in Flexify Help Relieve Pain and Nourish Joints?”:
  o “[G]lucosamine [an ingredient in Flexify] supplementation significantly reduced the symptoms of osteoarthritis in the lower limbs and delayed the structural progression of osteoarthritis.”
  o “Boswellia [an ingredient in Flexify] extracts can be an effective painkiller and have anti-inflammatory properties that may prevent the loss of cartilage. Research shows that boswellic acid can prevent the formation of leukotrienes in the body. Leukotrienes are molecules that have been identified as a cause of inflammation which may inhibit the autoimmune process.”
  o “Taken daily, ginger [an ingredient in Flexify] has been shown to work about as well as ibuprofen for hip and knee arthritis pain. Ginger has been shown to have anti-inflammatory properties similar to ibuprofen and COX-2 inhibitors (e.g., Celebrex). In a 2012 study, a specialized ginger extract was as effective in reducing inflammatory reactions in RA as steroids. Earlier studies showed that taking a certain extract four times daily reduced osteoarthritis pain in the knee after three months of treatment, and another taken twice daily worked about as well as ibuprofen taken three times daily for hip and knee OA pain.”
• On the blog post “5 Ways to Prevent Osteoarthritis in Athletes”:
  o “Flexify Advanced Joint Support is used by athletes and others affected by arthritis... Each tablet contains seven clinically tested, natural ingredients that help build and maintain healthy joints and cartilage, slowing the progression of osteoarthritis or preventing it completely.”

Collagen Peptides
On your product website https://nativeorigins.com:
• On the Collagen Peptides product page:
  o “Some studies have suggested that collagen supplementation may help lower your risk for heart disease . . . by reducing arterial stiffness and boosting ‘good’ HDL cholesterol.”
• On the blog post “What Are the Health Benefits of Collagen?”:
  o “Research suggests that collagen peptide supplementation may also be effective in reducing pain and inflammation associated with chronic conditions like osteoarthritis.”
  o “If you’re looking to relieve aches and pains from joint stiffness…Native Origins Collagen Peptides may be a good option to add to your daily routine.”
• On the blog post “4 Ways to Add Collagen to Your Day”:
  o “A 2018 systematic review published in the British Journal of Sports Medicine, researchers found that collagen supplements provided short-term relief from osteoarthritis-associated pain.”
• On the blog post “How Do Collagen Peptides Support Healthy Hair, Skin, Nails and Joints?”:
  o “The major type of collagen found in cartilage, collagen type II is frequently used in applications intended to help relieve pain from conditions like rheumatoid arthritis. . . . A 2015 study found that adding type II collagen from chicken [an ingredient in Collagen Peptides] to the diet of people with rheumatoid arthritis was effective in reducing pain, stiffness and swelling of joints.”
• On the blog post “Collagen and Joint Health”:
  o “Some studies have shown that taking collagen supplements may help increase bone mineral density, protect joint cartilage, and even reduce joint pain associated with arthritis.”
  o “Collagen . . . may help reduce pain, stiffness and swelling of the joints”

Prohemia
On your website https://nativeorigins.com:
• On the Prohemia product page:
  o “Prohemia helps support healthy blood levels in individuals suffering from symptoms associated with anemia.”
• On the blog post “How Do the Ingredients in Prohemia Fight Anemia-Related Fatigue and Improve Stamina?”:
  o “Prohemia contains several potent antioxidants to reduce inflammation . . .”

On your website https://brlscience.com:
• “Prohemia, promotes red blood cell production, . . . promotes hemoglobin production, and improves energy level and stamina in individuals with anemia.”
• The featured testimonial: “Mom had a stroke on Procrit. Since starting Prohemia she has not needed any more transfusions. Her hemoglobin went from 9.3 G/dL to 11.8 g/dL.”

Altitude RX
On your website https://nativeorigins.com:
• On the Altitude RX product page:
  o “The active components in Altitude RX have been demonstrated to increase oxygen levels and reduce symptoms of Acute Mountain Sickness.”
  o “Reduce the debilitating symptoms caused by high altitude and vertigo with Altitude RX”
• On the blog post “How Do the Ingredients in Altitude RX Help Prevent Altitude Sickness?”:
  o “Our scientists used the most potent compounds available in amounts shown to prevent symptoms of Acute Mountain Sickness.”
  o “Science has demonstrated that Ginkgo biloba [an ingredient in Altitude RX] has a remarkable ability to increase blood flow throughout the body, enabling it to cope better with decreased atmospheric oxygen levels. Antioxidant properties in the leaf extract increase vasodilation and peripheral blood flow in the capillary vessels, as well as decreasing blood viscosity and helping to regulate cerebral energy metabolism.”
  o “Rhodiola [an ingredient in Altitude RX] also has been shown to reverse the effects of asthenia. It reduces fatigue, labored breathing, rapid heart rate, sluggishness . . .”
  o “ALA, Vitamin C and Vitamin E [ingredients in Altitude RX] work synergistically to protect cells from free radical damage.”

On your website https://brlsports.com:
• “Altitude RX is a patent-pending formula of natural ingredients that takes a preventive approach to reducing AMS symptoms, including nausea, headache, fatigue, shortness of breath and insomnia.”
• “Altitude RX is designed to safely and significantly increase oxygen levels at high altitude…”
• “Ginkgo [an ingredient in Altitude RX] can help protect against altitude sickness through its ability to improve blood flow, and thus oxygen delivery to the brain."

On your website https://brlscience.com:
• “Altitude RX patent-pending formula of all-natural ingredients takes a preventive approach to reducing Acute Mountain Sickness (AMS) symptoms.”
• “One of the active ingredients in Altitude RX promotes increased blood flow throughout the body and decreases blood viscosity — which offsets the negative effects of the low oxygen levels found at high altitude. Better blood flow at altitude delivers more oxygen to your brain, eliminating headaches — and delivering more oxygen to your muscles...”

From a July 22, 2019 post on the Native Origins Facebook page: “Don’t let altitude sickness slow you down. #altituderx #altitudesickness”

The above noted website claims are supplemented by metatags used to bring consumers to your website https://nativeorigins.com through Internet searches. The metatags are:
• “Take Altitude RX for altitude sickness prevention…”

Trimmunity
On your website https://nativeorigins.com:
• On the Trimmunity product page:
  o “Contains antioxidants to help fight off free radicals, which can damage cells and impact immune health.”
• On the blog post “How Do the Ingredients in Trimmunity Help Improve Our Immune Defenses?”:
  o “[E]lderberry [an ingredient in Trimmunity] is most often used to alleviate seasonal illness and respiratory challenges.”
  o “Both human and animal studies have suggested that echinacea [an ingredient in Trimmunity] stimulates immune function and activates natural killer cells.”
  o “Vitamin D [an ingredient in Trimmunity] helps minimize inflammation. . .”
  o “Vitamin C [an ingredient in Trimmunity] supports the production and integrity of white blood cells, which help protect against infection.”
  o “Zinc [an ingredient in Trimmunity] . . . works by . . . reducing inflammation... zinc may help prevent dangerous, out-of-control inflammation that can result from haywire immune responses.”

Your Calm Legs, Flexify, Collagen Peptides, Prohemia, Altitude RX, and Trimmunity 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 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 products Calm Legs, Collagen Peptides, and Flexify 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, Calm Legs, Collagen Peptides, and Flexify 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 these matters 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 sent to:

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

Refer to Unique Identification Number 612831 when replying.

If you have any questions regarding this letter, please contact Elodie X. Tong-Lin, Compliance Officer, at elodie.tong-lin@fda.hhs.gov.

Sincerely,
/S/

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