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  5. Natural Native LLC - 593385 - 11/22/2019
  1. Warning Letters

WARNING LETTER

Natural Native LLC MARCS-CMS 593385 —


Delivery Method:
Via Overnight Delivery
Product:
Dietary Supplements

Recipient:
Recipient Name
Mr. David Hopwood
Natural Native LLC

263 34th Avenue SW
Norman, OK 73072
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

5001 Campus Drive
Office of Compliance (HFS-608)
College Park, MD 20740-3835
United States


Dear Mr. Hopwood:                                                                                             

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.naturalnative.com (which directs customers to your wa.naturalnative.com website) and wa.naturalnative.com in October 2019 and has determined that you take orders on your website wa.naturalnative.com for the products “20 oz. Native CBD Water,” “CBD Baby Bears” (also referred to as “CBD Little Bears”), “CBD Big Bears,” “CBD Hemp Oil, Raspberry, 300mg” (Five Flavors), “Liposomal CBD Extract Spray,” “Native 225 mg Raspberry – 15 ml Broad Spectrum CBD Spray,” “CBD Balm – 250mg,” and “Native Pet CBD Oil (150mg, 300mg, & 600mg),” all of which you promote as products containing cannabidiol (CBD).  We have also reviewed your social media website at www.facebook.com/naturalnativecbd; this website directs consumers to your website naturalnative.com to purchase your products.  The claims on your websites and social media website establish that your  “20 oz. Native CBD Water,” “CBD Baby Bears,” “CBD Big Bears,” “CBD Hemp Oil, Raspberry, 300mg,” “Liposomal CBD Extract Spray,” “Native 225 mg – Raspberry 15 ml Broad Spectrum CBD Spray,”  and “CBD Balm – 250mg” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).  FDA has also determined that your “Native Pet CBD Oil (150mg, 300mg, & 600mg)” product is an unapproved new animal drug that is 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).  FDA has also determined that your “20 oz. Native CBD Water” product is adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because it bears or contains an unsafe food additive.  Furthermore, it is a prohibited act to introduce your “20 oz. CBD Water” product into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).

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

The Agency is particularly concerned that you market your unapproved new drug products for infants. Specifically, a post to your Facebook page links to an article entitled “CBD for Brain-Damaged Babies?” in which the following statement is made, “[t]he launch of a clinical trial examining the use of CBD in newborns suffering from hypoxic ischemic encephalopathy (brain damage caused by lack of oxygen) means new hope for the million plus babies born each year with this condition.” Your product has not been evaluated by the Agency for safety, effectiveness, and quality. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations. For example, infants may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of infants to absorb, metabolize, distribute, or excrete such drug products or their metabolites.
 

Dietary Supplement Labeling

Your product labels for “CBD Baby Bears,” “CBD Hemp Oil, Raspberry, 300mg” and “Native 225 mg Raspberry – 15 ml Broad Spectrum CBD Spray” products contain Supplement Facts panels, which indicates that you intend to market these CBD products as dietary supplements. However, your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded that, based on available evidence, CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii).[1] Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii), but you may present FDA with any evidence bearing on this issue. 

Unapproved New Drugs

Based on our review of your website,  your  “20 oz. Native CBD Water,” “CBD Baby Bears,” “CBD Big Bears,” “CBD Hemp Oil, Raspberry, 300mg,” “Liposomal CBD Extract Spray,” “Native 225 mg – Raspberry 15 ml Broad Spectrum CBD Spray,”  and “CBD Balm – 250 mg” 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 cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. 

Examples of claims observed on your website, wa.naturalnative.com, and your social media account, www.facebook.com/naturalnativecbd, that establish the intended uses of your products as drugs include, but may not be limited to, the following: 

On the website www.naturalnative.com; webpage titled “WHAT IS CBD?”: 

  • “Although CBD doesn’t make people feel high like THC does, it’s causing quite a buzz among scientists, health professionals, and medical marijuana patients who are using CBD-rich products to treat a wide range of conditions – chronic pain, cancer, Crohn’s, diabetes, rheumatoid arthritis, PTSD, cardiovascular disease, anxiety, antibiotic-resistant infections, multiple sclerosis, schizophrenia, and more.”
  • “Extensive preclinical research and some clinical studies have shown that CBD has strong anti-oxidant, anti-inflammatory, anticonvulsant, anti-depressant, anti-psychotic, anti-tumoral (sic), and neuroprotective qualities.  Cannabidiol can change gene expression and removal beta amyloid plaque, the hallmark of Alzheimer’s, from brain cells.”  

On the website https://wa.naturalnative.com: product page for “Raspberry Flavored CBD Oil Sample 150 mg”:  

  • “Pure Hemp Extract is know (sic) to help with Chronic Pain and Inflammation.”
     
  • “[E]ffects can help curb anxiety from stress…”
     

On the website https://wa.naturalnative.com: product page for “CBD Balm – 250 mg”: 

  • “Natural Native hemp balm is a CBD isolate infused with all organic ingredients and is absorbed through the skin to give localized relief of pain, soreness, and inflammation …” 

On your Facebook social media account www.facebook.com/naturalnativecbd: 

  • June 20, 2019 posting linking to an article entitled “CBD for Brain-Damaged Babies?” in which the following statement is made, “[t]he launch of a clinical trial examining the use of CBD in newborns suffering from hypoxic ischemic encephalopathy (brain damage caused by lack of oxygen) means new hope for the million plus babies born each year with this condition.”
  • November 19, 2018 posting – “CBD … has been shown to have anti-aging properties, and the anti-inflammatory properties have been shown to reduce acne!!”
     
  • November 6, 2018 posting – “There is ongoing research about utilizing cannabis to treat chronic pain, improve memory function, sustain metabolic health, and regulate blood sugar.”
     
  • May 19, 2018 posting entitled “Cancer Institute Finally Admits Marijuana Kills Cancer” in which you commented, “And so does the LEGAL cousin Hemp CBD!”
     
  • May 6, 2018 posting with a picture showing, “CBD benefits for Pain, Mental Illness, Anxiety & More.”
     
  • March 11, 2018 posting with an infographic which states CBD is:
     
    • “antibacterial”
    • “Inhibits cancer cell growth”
    • “Reduces blood sugar levels”
    • “Reduces inflammation”
    • “Reduces risk of artery blockage”
    • “Reduces small intestine contractions”
    • “Reduces vomiting & nausea”
    • “Relieves pain”
    • “Relieves anxiety”
    • “Suppresses muscle spasms”
    • “Treats fungal infection”
    • “Treats psoriasis”
    • “Vasorelaxant”

 

  • Second March 11, 2018 posting with an infographic which states:
     
    • “Suppresses muscle spasms”
    • “Immunosuppressive (Lupus, RA)”
    • “Anti-Diabetic – Reduces blood sugar”
    • “Anti-Psychotic – Tranquilizing”
    • “Reduces vomiting and nausea”
    • “Anti-depressant”
    • “Antibacterial”
    • “Relieves anxiety”
    • “Relieves Pain”
    • “Inhibits cell growth in tumors and cancer cells”
    • “Promotes Bone Growth”
    • “Aids psoriasis”
    • “Reduces risk of artery blockage”
       
  • January 12, 2018 posting – “If you are not seeing the results you want, you may want to increase your intake for chronic issues; like pain caused by arthritis and other causes of inflammation …”
     
  • December 14, 2017 posting – “Natural Native Hemp CBD Balm is the most popularly chosen for localized pain relief, muscle soreness, tension, and inflammation, but anecdotal evidence is beginning to show a widening spectrum of potential benefits, from psoriasis, dermatitis, and itching to headaches and cramping. Arthritic pain is caused by inflammation, CBD works well to get rid of inflammation and the pain that comes with it.”

Your “20 oz. Native CBD Water,” “CBD Baby Bears,” “CBD Big Bears,” “CBD Hemp Oil, Raspberry, 300mg,” “Liposomal CBD Extract Spray,” “Native 225 mg – Raspberry 15 ml Broad Spectrum CBD Spray,” and “CBD Balm – 250mg” 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 FD&C 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 the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).  FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above-mentioned products.

Misbranded Drugs
 

Your “20 oz. Native CBD Water,” “CBD Baby Bears,” “CBD Big Bears,” “CBD Hemp Oil, Raspberry, 300mg,” “Liposomal CBD Extract Spray,” “Native 225 mg – Raspberry 15 ml Broad Spectrum CBD Spray,” and “CBD Balm – 250mg” products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.)  The aforementioned products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson.  However, your products are not exempt from the requirement that their labeling bear adequate directions for use, 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved applications are in effect for them. 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).  

301(ll) and Adulterated Human Foods
 

Furthermore, it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD. There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. However, based on the available evidence discussed above, FDA has concluded that this is not the case for CBD.  FDA is not aware of any evidence that would call into question its current conclusion that section 301(ll) of the FD&C Act prohibits the introduction into interstate commerce of any food to which CBD has been added, but you may present FDA with any evidence bearing on this issue.

According to your product labeling, your “20 oz. Native CBD Water” product is a food to which CBD has been added.  Therefore, the introduction or delivery for introduction into interstate commerce of this product is a prohibited act under section 301(ll) of the FD&C Act.

You should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term "food additive" refers to any substance the intended use of which results in its becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.[2]  

Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act (21 U.S.C. 348(a)) and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i).  Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

There is no food additive regulation which authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in conventional foods.   FDA's regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).

We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for GRAS status. Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. Our review of publicly available data associated with the one FDA-approved CBD drug, as well as our review of published scientific literature, identified potential for liver injury from CBD and potentially harmful interactions with certain drugs. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males. Therefore, based on our review, the use of CBD in your product does not satisfy the criteria for GRAS status under 21 CFR 170.30.

FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in a conventional food. Therefore, CBD added to a conventional food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act, 21 U.S.C. 348.  Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i).  Therefore, your “20 oz. Native CBD Water” product is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of this adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Unapproved New Animal Drugs

During our review of your firm’s websites wa.naturalnative.com and www.facebook.com/naturalnativecbd, FDA determined that your firm is marketing the unapproved new animal drug “Native Pet CBD Oil (150mg, 300mg, & 600mg).” Based on our review of your websites, your “Native Pet CBD Oil (150mg, 300mg, & 600mg)” product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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 animals.  Further, as discussed below, this product is an unapproved new animal drug and marketing it violates the FD&C Act.

Examples of claims observed on your website wa.naturalnative.com that establish the intended use of your product as a drug include, but may not be limited to, the following:  

On the product page for “Native Pet CBD Oil (150mg, 300mg, & 600mg)”: 

  • “Care for your dogs and pets from the inside out with whole-plant cannabinoids specifically developed with your furry family member in mind.
     
    • Maintain cognitive function
    • Assist normal hip and joint mobility
    • Support the immune system
    • Bring about a sense of calm
    • Aid the digestive tract
    • Sustain blood sugar levels”

 On the webpage titled “Proper Dosage of CBD for pets handout”

  • “Pet parents in various forums and case studies report a plethora of positive effects, like relief from allergies, skin issues, weight, seizures, neurological issues and pain. Not to mention anxiolytic and nerve calming effects which can literally save a pets life when there are fireworks, storms and other havoc outside.”
     
    Additional claims observed on your social media site www.facebook.com/naturalnativecbd include, but may not be limited to, the following: 
  • November 10, 2018 posting – “Did you know our pet products can be used as a painkiller, anticonvulsant, anti-inflammatory, stress reliever, antiemetic, and promote homeostasis!”

Your “Native Pet CBD Oil (150mg, 300mg, & 600mg)” product is a “new animal drug” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because it is 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-l. This product is not approved or index listed by the FDA, and therefore this product is 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 this adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

301(ll) and Adulterated Animal Foods
 
Moreover, to the extent that you market any of your products containing CBD as animal food, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any animal food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD, as described above.
 
You should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term “food additive” refers to any substance the intended use of which results in its becoming a component of any animal food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.[3]
 
There is no animal food additive regulation that authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal foods.  FDA’s regulations in 21 CFR 570.30(a)-(c) describe the criteria for eligibility for classification of an animal food ingredient as GRAS. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food (see 21 CFR 570.30). We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958. Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal foods are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity. Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30.
 
Under section 409, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any animal food. Animal food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act.  Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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. 

Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these 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 Shawn Goldman, U.S. 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 by email to FDAADVISORY@fda.hhs.gov.

Sincerely,

Donald D. Ashley
/S/
Director                                                      
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

William A. Correll Jr.
/S/
Director                                      
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

Eric Nelson
/S/
Director of Compliance                                                   
Office of Surveillance and Compliance
Center for Veterinary Medicine
Food and Drug Administration


[1] CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex.  (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect.  Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

[2] Under section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food, (2) pesticide chemicals, (3) color additives, (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act), (5) new animal drugs, and (6) dietary ingredients in or intended for use in a dietary supplement. 

[3] Under section 201(s)(5) of the FD&C Act (21 U.S.C. 321(s)(5)), new animal drugs are excluded from the food additive definition. If a new animal drug is unsafe within the meaning of section 512 because it is not approved for use in animal food, then the animal food is adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.