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WARNING LETTER

Noli Oil, LLC MARCS-CMS 593497 —


Delivery Method:
Via Overnight Delivery
Product:
Drugs

Recipient:
Recipient Name
Heather King
Noli Oil, LLC

2001 West Southlake Boulevard STE 111
Southlake, TX 76092-6749
United States

INFO@NOLIOIL.COM
Issuing Office:
Center for Drug Evaluation and Research | CDER

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


WARNING LETTER


November 22, 2019


RE: 593497

Dear Ms. King:

This letter is to advise you that the U.S. Food and Drug Administration (FDA or Agency) reviewed your website at https://nolioil.com in September 2019 and has determined that you take orders there for the products “CBD Oil,” “CBD Oil Infused Balm," “CBD Roll-on
Gel,” “CBD Organic Gummy Bears,” “CBD Infused Caramels,” “CBD Watermelon Rings,” “CBD Softgels,” “Repair with CBD, Collagen & Retinol” cream, “Tattoo Care Cream,” “Ultra Eye CBD Repair Cream,” “Face AM/PM Moisturizing Cream,” “CBD Soap,” “Refreshing & Revitalizing CBD Face Mask,” “Dog Treats (Beef Flavored)” and “Pet CBD Oil,” all of which you promote as products containing cannabidiol (CBD). We have also reviewed your social media websites at www.facebook.com/nolioil and https://www.instagram.com/nolioil/; these websites direct consumers to your website https://nolioil.com to purchase your products. The claims on your website and social media websites establish that your “CBD Oil,” “CBD Oil Infused Balm," “CBD Roll-on Gel,” “CBD Organic Gummy Bears,” “CBD Infused Caramels,” “CBD Watermelon Rings,” “CBD Softgels,” “Repair with CBD, Collagen & Retinol” cream, “Tattoo Care Cream,” “Ultra Eye CBD Repair Cream,” “Face AM/PM Moisturizing Cream,” “CBD Soap,” and “Refreshing & Revitalizing CBD Face Mask” 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 “CBD Oil,” “CBD Oil Infused Balm," “CBD Roll-on Gel,” “CBD Organic Gummy Bears,” “CBD Infused Caramels,” “CBD Watermelon Rings,” “CBD Softgels,” “Repair with CBD, Collagen & Retinol” cream, “Tattoo Care Cream,” “Ultra Eye CBD Repair Cream,” “Face AM/PM Moisturizing Cream,” “Face AM/PM Moisturizing Cream,” “CBD Soap,” and “Refreshing & Revitalizing CBD Face Mask” 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 “Dog Treats (Beef Flavored)” and “Pet CBD Oil” products are unapproved new animal drugs that are 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).

As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses 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/newsevents/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-productsincluding-cannabidiol-cbd.

Unapproved New Drugs

Based on our review of your website, your “CBD Oil,” “CBD Oil Infused Balm," “CBD Roll-on Gel,” “CBD Organic Gummy Bears,” “CBD Infused Caramels,” “CBD Watermelon Rings,” “CBD Softgels,” “Repair with CBD, Collagen & Retinol” cream, “Tattoo Care Cream,” “Ultra Eye CBD Repair Cream,” “Face AM/PM Moisturizing Cream,” “CBD Soap,” and “Refreshing & Revitalizing CBD Face Mask” 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 observed on https://nolioil.com that establish the intended use of your products as drugs include, but may not be limited to, the following:

On your webpage titled “CBD Benefits” you state CBD
• “Inhibits cancer cell growth”
• “Treats psoriasis”

“There is extensive scientific and clinical research, including research by the US government, which exposes CBD’s potential as a treatment for a wide range of conditions, including…
• “ADD and ADHD”
• “Alcoholism”
• “Antibiotic-resistant Infections”
• “Autism”
• “Bipolar Disorder”
• “Depression”
• “Diabetes”
• “Epilepsy”
• “Fibromyalgia”
• “Irritable Bowel Syndrome”
• “Migraines”
• “Mood Disorders”
• “Multiple Sclerosis”
• “Parkinson[‘]s”
• “Psychosis”
• “PTSD”
• “Schizophrenia”

On your webpage titled “WHAT IS CBD?”:
• “CBD has demonstrable neuroprotective and neurogenic effects, and it’s anticancer properties are currently being investigated at many academic and independent research centers in the United States and worldwide.”

On your product page for “CBD Oil Infused Balm”:
• “CBD Oil infused balm is a powerful topical cream designed for sore muscles, or areas where pain is felt.”

On the product label depicted on your product page for “CBD Roll on Gel”:
• “CBD PAIN RELIEF ROLL-ON GEL”

On your product page for “Repair with CBD, Collagen & Retinol” cream:
• “CBD can help with many skin conditions. CBD has anti-inflammatory properties that can help with acne, psoriasis, and eczema.”

On your product page for “Tattoo Care Cream”:
• “Infused with CBD, this intricate formulation helps promote the regrowth of skin cells while rejuvenating the skin.”

On your product page for “Ultra Eye CBD Repair Cream”:
• “Anti-inflammatory properties help reduce puffiness”

Your “CBD Oil,” “CBD Oil Infused Balm," “CBD Roll-on Gel,” “CBD Organic Gummy Bears,” “CBD Infused Caramels,” “CBD Watermelon Rings,” “CBD Softgels,” “Repair with CBD, Collagen & Retinol” cream, “Tattoo Care Cream,” “Ultra Eye CBD Repair Cream,” “Face AM/PM Moisturizing Cream,” “CBD Soap,” and “Refreshing & Revitalizing CBD Face Mask” 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 “CBD Oil,” “CBD Oil Infused Balm," “CBD Roll-on Gel,” “CBD Organic Gummy Bears,” “CBD Infused Caramels,” “CBD Watermelon Rings,” “CBD Softgels,” “Repair with CBD, Collagen & Retinol” cream, “Tattoo Care Cream,” “Ultra Eye CBD Repair Cream,” “Face AM/PM Moisturizing Cream,” “CBD Soap,” “Refreshing & Revitalizing CBD Face Mask” 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 violate section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Prohibited Act under 301(ll) and Adulterated Human Foods

We note that your “CBD Organic Gummy Bears,” “CBD Infused Caramels,” and “CBD Watermelon Rings” products appear as if they might be promoted as conventional foods. Specifically, all three products are marketed in a form that is commonly associated with
conventional foods; and at least two of the products (your “CBD Infused Caramels” and “CBD Watermelon Rings”) are marketed for their taste. However, 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 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.1 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, 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.

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 conventional food products 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. 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. 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).

Unapproved New Animal Drugs

During our review of your website, https://nolioil.com, FDA determined that your firm is marketing the unapproved new animal drugs “Dog Treats (Beef Flavored)” and “Pet CBD Oil.” Based on our review of your website, your Dog Treats (Beef Flavored)” and “Pet CBD Oil” 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 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 observed on your website https://nolioil.com that show the intended use of these products include, but are not limited to, the following:

On your main webpage in the section titled “Testimonials”:
• “My Great Dane Emmitt was diagnosed with osteosarcoma, or bone cancer, a few weeks ago. Folks, I am shocked and flabbergasted beyond belief! Never in my wildest imagination did I expect anything like the improvements I saw after only a few days of treatment with the CBD oil! I am almost at a loss for words to describe how wonderful it felt to see my big baby feeling so very much better, and I’m really not sure who feels the best at this moment, Emmitt or myself!”

On your product page for “Dog Treats (Beef Flavored)”:
• “CBD Pet Treats … may be able to help aid in pain relief...”
• “Reduces stress in your pet, especially in situations like stormy weather, fireworks and other generally loud noises”

Additional claims observed on your social media accounts, www.facebook.com/nolioil and https://www.instagram.com/nolioil/ include, but are not limited to, the following:

On your Instagram account, https://www.instagram.com/nolioil/:
• “Our treats and oil can help your dog and cat with anxiety, skin conditions, arthritis, and more”

On your Facebook page, www.facebook.com/nolioil:
• “Help your pet through the storm with CBD. Our veterinarian formulated pet treats and oil will help your pets stay calm during the storm.”

These products 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-l. These products are not 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 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 of the FD&C Act, 21 U.S.C. 348, 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/or injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing 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 U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 or by email to FDAADVISORY@fda.hhs.gov.


Sincerely,

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

/S/

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


/S/ 

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