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  5. Root Bioscience Brands, LLC dba Naternal - 673646 - 08/30/2024
  1. Warning Letters

WARNING LETTER

Root Bioscience Brands, LLC dba Naternal MARCS-CMS 673646 —

Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Garrett Perdue
Recipient Title
CEO
Root Bioscience Brands, LLC dba Naternal

951 Aviation Pkwy Ste 900
Morrisville, NC 27560
United States

info@naternal.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

Secondary Issuing Offices

Center for Veterinary Medicine

United States

WARNING LETTER

August 30, 2024

RE: 673646

Dear Garrett Perdue:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.naternal.com in August 2024 and has observed that your website offers various products which you represent contain, in part, cannabidiol (CBD), cannabigerol (CBG), and cannabinol (CBN). The claims on your website establish that your products, CBD Oils,1 Move CBD+CBG Oil, Rest CBD+CBN Oil, Nurture Broad Spectrum Gummies, and Ease Full Spectrum Gummies are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).

FDA has also determined that your Naternal Hemp Extract Oil for Pets (300mg, 600mg, and 1200mg)2 products for animals offered for sale on your website www.naternal.com, are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and are adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). Introduction of these adulterated drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find specific information about how FDA regulates cannabis-derived products at https://www.fda.gov/news-events/public-healthfocus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.

Unapproved New Drugs

Based on a review of your website, your CBD Oils, Move CBD+CBG Oil, Rest CBD+CBN Oil, Nurture Broad Spectrum Gummies, and Ease Full Spectrum Gummies products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Examples of claims from your website that provide evidence of the intended use of these products as drugs include, but are not limited to, the following:

On your webpage https://naternal.com/blogs/news/17-full-spectrum-cbd-oil-benefits-for-all-ages:

  • “In another recent study, correlations between CBD and blood pressure were examined. Two groups were evaluated, one being test subjects who were given CBD and the other being a control group with a placebo. All subjects were exposed to stressors that would induce a higher blood pressure. The study concluded that a dose of CBD was helpful to reducing blood pressure.”
  • “CBD may protect nerve cells from deteriorating, and a study from Frontiers in Pharmacology found that CBD can significantly decrease the negative effects of Alzheimer[’]s and also improve cognitive ability.”
  • “CBD oil has been shown to have addiction-recovery effects particularly for cocaine, opioids, and psycho-stimulants.”
  • “CBD oil has been shown to reduce the nature of PTSD attacks. A preliminary study has shown that the use of CBD oil, in conjunction with psychological therapy, has reduced the severity of the test subjects' attacks over the course of eight weeks.”
  • “CBD has been studied for its possible uses for children, and while the science is still preliminary, there are some promising opportunities. One of the best is the use of CBD for children with autism. One study of 188 children with autism, ages 5 to 18, found that some symptoms, such as seizures, restlessness and rage attacks, were lessened.”
  • “Further small studies have been done into calming ADHD and anxiety in children, and while the results thus far are anecdotal, they do show potential. A 2016 study backed up the suggestion that CBD can help with sleep and anxiety for children, and a 2013 study showed that CBD for anxiety can help with regulatory control.”

On your webpage https://naternal.com/blogs/news/cbd-for-veterans:

  • “What Is CBD? . . . It’s a great option for those that want the medicinal benefits of cannabis without the high, and many veterans are turning to CBD to help them battle PTSD, stress, anxiety, insomnia, chronic pain, and inflammation.”
  • “CBD has also shown promise in helping to fight anxiety, insomnia, and chronic pain; as well as helping with addiction recovery for those that have developed a substance abuse disorder while trying to cope with PTSD and other stressors. And since veterans are twice as likely to die from an opioid overdose than the general population, CBD can provide a real way forward as it is kinder to the mind and the body.”

On your webpage https://naternal.com/blogs/news/the-benefits-of-cbd-for-football:

  • “While CBD can’t prevent concussions, much research has gone into discovering ways that CBD can help treat them. One major study from the University of Miami has found that, in animal trials, combination therapy improved the cognitive function of subjects.(Combination therapy involves taking CBD along with dexanabinol, a synthetic cannabinoid.) In Canada, a study is being conducted on former hockey players to see if the severity of post-concussion brain disorders can be treated with CBD.”

On your webpage https://naternal.com/blogs/news/cbd-and-cbg-for-skincare:

  • “In the eyes, endocannabinoid receptors allow CBG to help treat glaucoma by reducing intraocular pressure, as well as acting as a powerful vasodilator to protect and soothe. Additionally, some experiments have shown that CBG is effective at decreasing inflammatory bowel disease, in addition to protecting neurons in animals with Huntington's disease.”
  • “On the cancer front, CBG has been shown to block receptors that contribute to cancer cell growth, slowing colon cancer in mice and inhibiting tumors in colon carcinogenesis.”
  • “As an antibacterial agent, CBG goes where other drugs can't, helping to fight Staphylococcus aureus (MRSA) strains. Cannabis topical formulations have also been used for decades to help fight skin infections, though an understanding of why it works is only recently coming into focus with the use of CBG for skincare.”
  • “Other medicinal benefits of CBG include appetite stimulation, which is of particular interest to cancer patients and other muscle wasting diseases.”

On your webpage https://naternal.com/blogs/news/the-endocannabinoid-system-part-2:

  • “Early studies into CBG indicate that it interacts with specific bodily systems, making it a promising medicinal substance. Research shows that it could be a highly effective treatment for glaucoma because it lowers intraocular pressure. Studies have also found it to decrease inflammation related to inflammatory bowel disease effectively.”
  • “One 2015 study on mice showed that CBG provided neuroprotection related to Huntington’s disease. Furthermore, CBG may inhibit the growth of certain cancer cells, such as those that cause colon cancer. It also has been shown to be an effective antibacterial agent, an appetite stimulant, and a potential treatment for bladder dysfunction disorders.”
  • “A different study also provided evidence that CBN could have anti-inflammatory, antibiotic, and anti-convulsant effects.”

On your webpage https://naternal.com/blogs/news/the-benefits-of-cbd-for-people-with-autism:

  • “We are starting to understand how CBD may be a game-changer for people with autism to help ease their anxiety, calm their stimming, and reduce any severe behaviors.”
  • “Many parents of children with autism report a lessening of aggressive behaviors and physical violence after taking CBD because it helps the child deal with the strong emotions that may come on without warning.”

Your CBD Oils, Move CBD+CBG Oil, Rest CBD+CBN Oil, Nurture Broad Spectrum Gummies, and Ease Full Spectrum Gummies products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for any of the above-mentioned products. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

The Department of Health and Human Services (HHS) has determined that a public health emergency exists nationwide involving the opioid crisis.3 You market your CBD products for the treatment or cure of opioid addiction. However, these products have not been determined by FDA to be safe and effective for these (or any other) uses. Further, the unproven treatments could cause patients to forego or delay FDA-approved treatments for opioid addiction or withdrawal. The marketing and sale of unapproved opioid addiction treatment products is a potentially significant threat to the public health. Therefore, FDA is taking measures to protect consumers from products that, without approval by FDA, claim to diagnose, mitigate, prevent, treat or cure opioid addiction.

Unapproved New Animal Drugs

During our review of your firm’s website www.naternal.com, FDA has determined that your firm offers for sale the unapproved new animal drugs Naternal Hemp Extract Oil for Pets (300mg, 600mg, and 1200mg). Based on our review of your website these products for animals are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act.

Examples of claims from your website that provide evidence of the intended use of these products as animal drugs include, but are not limited to, the following:

On your webpage https://naternal.com/products/cbd-for-pets:

  • January 24, 2023 customer review states, “I have been using this CBD for my pup who has seizures for some time, since starting CBD she has not had one. I like that there are no unnecessary ingredients, and she takes it with no problems.”

  o Naternal.com replied, “Thank you for the review, (b)(6) That is amazing news - we are so glad to hear that your pup's seizures stopped!!! – Naternal”

On your webpage https://naternal.com/products/cbd-for-pets-1200mg:

  • January 25, 2023 customer review states, “Best place for CBD oil. Really helps my older dog's arthritis pain”

  o Naternal.com replied, “Thank you, (b)(6). We are grateful to provide great service and products that help to our community. Glad to hear that it's helping ease your dog's pain.”

  • October 3, 2022 customer review states, “The full spectrum pet CBD helps our old girl not only get around easier, but also has helped regulate her diabetes symptoms! I'm not saying this is a replacement for regular medical treatment but it has helped with her quality of life tremendously. Her steps and movements aren't so rigid when she has had her dose of CBD!”

  o Naternal.com replied, “…We are so happy that our Pet 1200mg CBD Tincture is helping your sweet pup with her diabetes and her mobility! Give her an extra treat for us. Thank you very much for your support and positive feedback!”

On your blog post titled “CBD Dosing For Pets” at the URL https://naternal.com/blogs/news/cbd-dosing-for-pets:

  • “CBD has a wide range of uses-cases in relation to health and wellness reasons, including the potential to aid conditions like chronic pain, anxiety, insomnia and more... Many people with pets have begun looking into CBD oil use for pain and inflammation reasons because veterinarian-prescribed medications can be costly and come with a variety of unwanted side effects. Other people use CBD for their pets to help calm them on particularly stressful occasions, such as during travel or when fireworks are going off in the neighborhood.”
  • “If you are someone who is interested in more natural alternatives to prescription medications for your pets, then CBD might be worth looking into further. One study was done by Dr. Joseph Wakshlag of Cornell University and published in the journal Frontiers in Veterinary Science. Titled ‘Pharmacokinetics, Safety, and Clinical Efficacy of Cannabidiol Treatment in Osteoarthritic Dogs,’ the study looked at the effects of a hemp-based cannabidiol product to treat pain from arthritis in dogs. More than 80% of the dogs in the study saw a significant decrease in pain and improved mobility.”

On your blog post titled “9 Reasons to Use CBD for Pets” at the URL https://naternal.com/blogs/news/9-reasons-to-use-cbd-for-pets:

  • “CBD can be used to help your pets stay healthy, active, and happy. It may be beneficial for aiding some diseases and conditions in animals, especially dogs and cats, but also horses and other family animals.”
  • “We’ve all been around anxious pets - they may be nervous around other people or other animals, they may not like car rides or loud noises, and some even get nervous being left alone at home. The outputs of their induced anxiety is often hiding, barking and whining excessively, shaking and sometimes even destruction of furniture and other items around the house. People have found CBD to be helpful in aiding their pet’s anxiety for many of the use-cases listed above.”
  • “Typically used for skin ailments or injuries, CBD topicals are a great option for pets and they are easy to use! With the presence of fatty acids in hemp extract, these products can be used to calm inflammation caused by skin irritation and can even promote new cell growth, allowing for quicker healing.”
  • “If your pet has a chronic condition like arthritis, or other musculoskeletal problems, CBD may be a great option to talk to your veterinarian about. Known for its anti-inflammatory properties, daily incorporation of CBD may help provide some relief to pets that deal with chronic pain.”
  • “It May Help Avoid Seizures”

On your blog post titled “CBD Oil for Dogs - Your Full Guide” at the URL https://naternal.com/blogs/news/cbd-oil-for-dogs-your-full-guide:

  • “CBD may be an option for dogs that are recovering from surgery, battling certain ailments or illnesses, or are in need of comfort due to separation anxiety or other potential stressful events or situations they may need to deal with.”
  • “Many dog owners have gained interest in the use of CBD for reasons including pain and inflammation, separation anxiety or situational anxiety, nausea, and general wellness needs for their aging loved ones. CBD isn't some magical cure, but it can help improve the quality of life for your dog, and the best part is that it's better than other pain pills and medications that may cause your pup to deal with a long list of unwanted side effects.”
  • “One such study on the effects of CBD in dogs showed that four out of five dogs with osteoarthritis had an improvement in their pain and mobility after receiving a few mg of CBD per kg of body weight.”
  • “Another study on CBD oil for dogs showed that epileptic dogs had significantly fewer seizures when given CBD as opposed to receiving seizure medication or a placebo. While dogs also had a reduction with placebo and other treatments, the effects weren't as pronounced as those who received CBD.”

On your blog post titled “Does CBD help with Lyme Disease?” at the URL https://naternal.com/blogs/news/does-cbd-help-with-lyme-disease:

  • “My dog (b)(6) was diagnosed with Lyme disease in January 2020. Yes, our pets can get Lyme disease too! She was very lethargic, mostly slept all day and would hardly eat. I looked into a more natural remedy for her to ease her discomfort days, and Naternal offers our furry pets CBD oil in Full Spectrum! You'll see your furry pet do a complete turnaround with their pain level! Similar to how it is for us.”

Your Naternal Hemp Extract Oil for Pets (300mg, 600mg, and 1200mg) are “new animal drugs” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-1. These products are not approved, conditionally approved, or index listed by the FDA, and therefore these products are considered unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). Introduction of these adulterated drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Conclusion

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 fifteen working days of receipt of this letter, of the specific steps you have taken to correct 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 believe that your products are not in violation of the FD&C 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 response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.

Sincerely,
/S/
Jill Furman, J.D.
Director
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

/S/

Neal Bataller, ME, DVM
Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
U.S. Food and Drug Administration

____________________

1 This encompasses both broad spectrum and full spectrum CBD oils marketed on your website.

2 On your website www.naternal.com, your Naternal Hemp Extract Oil for Pets products are also referred to as Pet Full Spectrum CBD Oil 300 MG, CBD for Pets 600mg, and Pet Full Spectrum CBD Oil 1200 MG.

3 Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued October 26, 2017, and subsequently renewed), available at https://aspr.hhs.gov/legal/PHE/Pages/default.aspx.

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