Donald D. Ashley
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
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:
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. 
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).
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 that establish the intended use of your product as a drug include, but may not be limited to, the following:
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.
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).
Our Hemp CBD Gold Capsules contain 5 mg of CBD and 25mg of CBD per capsule each making them great for dogs 40 lbs and up. At this body weight level, most pet owners find raising the dosage in increments of 5 mg of CBD is effective and easily managed.
If you’re looking for precise dose of CBD, our PurCBD+ oil/tincture is still your best option as capsules and treats will carry a one-size-fits-all dose.
Our Hemp CBD dog treats and Hemp CBD soft chews are 5 mg of CBD per treat and ranging from 1mg of CBD to 2.5mg of CBD per chew depending on which specific chew you choose. Making the treats and chews fantastic for most dogs as you are able to break them in half for very small breeds. Our Soft Chews are great for small pets under 20 lbs and older dogs that have trouble chewing harder treats or any dog with dental issues.
How to Dose with CBD Capsules, Treats, Chews, and Pellets
Instead of making a large one-size-fits-all pellet we broke up the large dose into mini-pellets. This allows goats, sheep, and even pocket pets like rabbits to benefit from taking hemp CBD.
Your veterinarian will be able to help you monitor your pet to ensure that hemp CBD oil interaction with the other drug is positive. With digestive issues, it’s usually the hemp oil carrier that causes the stomach irritation rather than the CBD.
All in all, giving your pet too much CBD will just likely result in you wasting money. This often limits small pet owners to the tincture form, but at Innovet Pet, we were determined to not have that happen to you.
In fact, some pet owners purposely give their pets high doses of CBD oil to help with insomnia. Common side effects such as nausea or diarrhea may happen, but they are fairly rare and mild. With digestive issues, it’s usually the hemp oil carrier that causes the stomach irritation rather than the CBD.