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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. 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. Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 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. 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. 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. 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. 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. Introduction of this adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C.

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.

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