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  5. CBD American Shaman, LLC - 628753 - 11/16/2022
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WARNING LETTER

CBD American Shaman, LLC MARCS-CMS 628753 —

Delivery Method:
Via Overnight Delivery
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Stephen Vincent Sanders II
Recipient Title
CEO
CBD American Shaman, LLC

2405 Southwest Blvd.
Kansas City, MO 64108
United States

support@cbdamericanshaman.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States

Center for Drug Evaluation and Research
Center for Veterinary Medicine

WARNING LETTER

November 16, 2022

RE: 628753

Dear Mr. Sanders:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address CBDAmericanShaman.com in October 2022 and has determined that you take orders there for various human and animal products which you promote as products containing cannabidiol (CBD). We also reviewed your social media websites at www.instagram.com/cbdamerican and www.facebook.com/cbdamericanshamanproducts, which link to your website cbdamericanshaman.com, to purchase your products. FDA has determined that your CBD Suckers, CBD Hard Candies, Cookies [with] 10mg CBD per Serving, CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, CBD Honey, Doggy Chews (all flavors), Soft & Tender Doggy Chews, Horsey Chews, Doggy Nugs, and Kitty Nugs products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. 342(a)(2)(C)(i)], because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce your CBD Suckers, CBD Hard Candies, Cookies [with] 10mg CBD per Serving, CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, CBD Honey, Doggy Chews (all flavors), Soft & Tender Doggy Chews, Horsey Chews, Doggy Nugs, and Kitty Nugs products into interstate commerce under section 301(ll) of the FD&C Act [21 U.S.C. 331(ll)].

FDA is particularly concerned that some of your products are in forms that are appealing to children. For example, your CBD Suckers, CBD Hard Candies, various Cookies [with] 10mg CBD per Serving, and various CBD Gummies products are all in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children. Furthermore, your products have not been evaluated by the Agency for safety, effectiveness, and quality. As discussed below, CBD has been studied as a drug, and it is the active ingredient in the approved drug product Epidiolex. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations, such as children. For example, children may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.

You also market other products that consumers may confuse with traditional foods for humans, including CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, and CBD Honey; therefore, with these products there is a risk of unintended consumption of the CBD ingredient by consumers.

In addition, “CBD + ZINC OXIDE Sunscreen” is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act [21 U.S.C. 355(a)], and is misbranded under section 502(ee) of the FD&C Act [21 U.S.C. 352(ee)]. Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act [21 U.S.C. 331(d) and (a)]. These violations are described in more detail below.

Further, the claims on your website and social media websites establish that your Canine 300 Tincture, Doggy Chews (all flavors), Soft & Tender Doggy Chews, Canine 300 CBD and Terpene Rich Hemp Oil Water Soluble, Feline 300 Tincture, Horsey Chews, Doggy Nugs, and Kitty Nugs products, which you promote as products containing CBD for use in pets, 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 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.

Adulterated Human Foods and 301(ll)

According to your product labeling, your CBD Suckers, CBD Hard Candies, Cookies [with] 10mg CBD per Serving, CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, and CBD Honey products are foods to which CBD has been added. We analyzed a sample of your Grandma’s Raisin & Pecan Hermit Cookies and confirmed that the product contains CBD. We also note that you may intend to promote your 10mg CBD Gummies, CBD Gourmet Gummies, CBD Energy Gummies, and Sugar Free CBD Gourmet Gummies as conventional food products. Specifically, you describe these gummy products as “adult gummy candy” and/or “the perfect way to satisfy your sweet tooth,” and the web pages for three of the products bear Nutrition Facts information.

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.1

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. The available data raise serious concerns about potential harm from CBD added to conventional food. 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 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 [21 U.S.C. 321(s)] 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 CBD Suckers, CBD Hard Candies, Cookies [with] 10mg CBD per Serving, CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, and CBD Honey products are 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)] because they bear or contain an unsafe food additive. Introduction of these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. 331(a)]. To the extent you intend to promote your 10mg CBD Gummies, CBD Gourmet Gummies, CBD Energy Gummies, and Sugar Free CBD Gourmet Gummies as conventional food products, they would be 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)] for the same reason.

Further, in regard to your Cookies [with] 10mg CBD per Serving, CBD Suckers, CBD Hard Candies, CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, and CBD Honey, and, to the extent you intend to promote your 10mg CBD Gummies, CBD Gourmet Gummies, CBD Energy Gummies, and Sugar Free CBD Gourmet Gummies as conventional food products, 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, including 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.2 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 [21 U.S.C. 331(ll)], 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.

Unapproved New Human Drug and Misbranded Human Drug

“CBD + ZINC OXIDE Sunscreen” is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act [21 U.S.C. 321(g)(1)(B)], because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act [21 U.S.C. 321(g)(1)(C)], because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as sunscreen.

Examples of claims from the product’s labeling, including the claims observed on your website, www.cbdamericanshaman.com, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product includes, but may not be limited to, the following:

“CBD + ZINC OXIDE Sunscreen . . . BROAD SPECTRUM SPF 35+ UVA • UVB” [from the label on your website, https://cbdamericanshaman.com/cbd-sunscreen]

“Drug Facts . . . Active Ingredients [s] . . . Cannabidiol (Hemp Exract [sic] (Aerial Parts), Cannabidiol) 0.072% . . . Purpose . . . Sunscreen . . .” [from the label on your website, website, https://cbdamericanshaman.com/cbd-sunscreen]

“This all natural CBD sunscreen lotion is a natural way to protect yourself from harmful UV rays while using an all-natural product that won’t harm you or our planet! This cbd infused sunscreen is 35+ SPF (broad spectrum) and is rated to block UVA and UVB rays. We use Zinc Oxide which is rated safe by EWG on their Skin Deep website and isn't hazardous for the environment like oxybenzone or octinoxate. There is 60mg of nano full-spectrum CBD oil per container.” [from the product information on your website, https://cbdamericanshaman.com/cbd-sunscreen]

Based on the above labeling claims, “CBD + ZINC OXIDE Sunscreen” is a topical product intended for use as a sunscreen drug. As described below, this sunscreen drug is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

In general, a drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. 321(p)], if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act [21 U.S.C. 355(a)]. No FDA-approved application pursuant to section 505 of the FD&C Act [21 U.S.C. 355], is in effect for this drug product.

“CBD + ZINC OXIDE Sunscreen” is a sunscreen drug subject to section 505G of the FD&C Act [21 U.S.C. 355h], which governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. In particular, sunscreen drug products are deemed to be GRASE and not a “new drug” if, among other things, they conform to the conditions of use set forth in the Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (hereinafter M020).3 However, this sunscreen drug product does not conform to the conditions of use specified in M020 because the product’s labeling lists CBD as an active ingredient in the Drug Facts panel. CBD is not an active ingredient allowed in any applicable final monograph. Thus, your “CBD + ZINC OXIDE Sunscreen” product does not meet the requirements under section 505G of the FD&C Act, under which it would be deemed to be GRASE and not a new drug.

Furthermore, even if CBD could be considered an inactive ingredient in “CBD + ZINC OXIDE Sunscreen,” this product would still need an approved new drug application to be legally marketed because the product would not be eligible for marketing under section 505G of the FD&C Act. In particular, such a product would not meet the conditions under section 505G(a)(1) or (2), insofar as it would not conform with the general requirement in 21 CFR 330.1(e) that inactive ingredients must be safe and suitable.4 A suitable inactive ingredient generally provides a beneficial formulation function, such as a tablet binder or preservative, or improves product delivery (e.g., enhances absorption or controls release of the drug substance).5 CBD has no known functional role as an inactive ingredient in a finished drug product.

Additionally, an inactive ingredient should not exert pharmacological effects6 and must be safe when used at the intended dosage.7 CBD, however, has a known pharmacological activity with demonstrated risks.8 It is unknown whether the level of CBD used in your “CBD + ZINC OXIDE Sunscreen” drug product has pharmacological activity or poses any concern for safety events. Accordingly, CBD cannot be considered a safe and suitable inactive ingredient as required under 21 CFR 330.1(e). Consequently, if CBD is intended to be an inactive ingredient in your “CBD + ZINC OXIDE Sunscreen” product, that product would not meet the general requirements for legal marketing of nonprescription drugs under sections 505G(a)(1) or (2) of the FD&C Act.

In addition, FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “CBD + ZINC OXIDE Sunscreen” is GRASE for use under the conditions prescribed, recommended or suggested in its labeling. Moreover, there is no evident basis under the FD&C Act under which this product would be legally marketed without an approved application. Accordingly, this product is an unapproved new drug marketed in violation of sections 505(a) of the FD&C Act. Introduction or delivery for introduction of such product into interstate commerce is prohibited under section 301(d) of the FD&C Act [21 U.S.C. 331(d)].

In addition, “CBD + ZINC OXIDE Sunscreen” is misbranded under section 502(ee) of the FD&C Act [21 U.S.C. 352(ee)] because it is a nonprescription drug subject to section 505G of the FD&C Act [21 U.S.C. 355h], is not the subject of an application approved under section 505 of the FD&C Act [21 U.S.C. 355], and does not comply with the requirements under section 505G of the FD&C Act [21 U.S.C. 355h]. Introduction or delivery for introduction of such a product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act [21 U.S.C. 331(a) and (d)].

Unapproved New Animal Drugs

During our review of your firm’s website cbdamericanshaman.com and your social media websites, www.instagram.com/cbdamerican and www.facebook.com/cbdamericanshamanproducts, FDA determined that your firm is marketing the unapproved new animal drugs Canine 300 Tincture, Doggy Chews (all flavors), Soft & Tender Doggy Chews, Canine 300 CBD and Terpene Rich Hemp Oil Water Soluble, Feline 300 Tincture, Horsey Chews, Doggy Nugs, and Kitty Nugs. Based on our review of your website and social media websites, these 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 animals. 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 that show the intended use of your products as drugs include, but are not limited to, the following:

• On your webpage titled “CBD Dog Treats” under the header “How do CBD dog treats help your pup?”:
  o “You can use CBD American Shaman dog treats to relieve your furry friends with high levels of stress. We include CBD oil for dogs in each treat to help calm pets during a storm, firework show, loud party or any other situation that puts them in a state of panic.”
  o “They [CBD dog treats] may also help regulate heartbeat and blood pressure”

• On your webpage titled “How To Choose A CBD Oil Product” under the header “Dogs”:
  o “If you would like to give your dog CBD every once in a while, like before the vet, for 4th of July fireworks, or when your dog may be extra anxious, we recommend any of our Dog CBD oils (https://cbdamericanshaman.com/pets) and Soft CBD Dog Treats (https://cbdamericanshaman.com/soft-cbd-dog-treats).”

• On your webpage titled “How To Choose A CBD Oil Product” under the header “Cats”:
o “Our feline CBD (https://cbdamericanshaman.com/feline-cbd-hemp-oil-tincture) oils are also great for when your cat needs help calming down or relaxing before a triggering event.”

Examples of claims observed on your social media websites that show the intended use of your products as drugs include, but are not limited to, the following:

• On your October 13, 2021 Instagram and Facebook posts: “Does your dog need support for #jointhealth or experience storm stress? Our unique recipe of high-quality CBD oil dog treats taste like peanut butter and will leave your pet wanting more.”
• On your February 23, 2018 Facebook post: A photo of a dog is posted by CBD American Shaman with the caption “#funfactfriday: CBD Oil is becoming more and more available for use on pets! In FACT, veterinarians are finding #cbdoil useful in arthritis, stress, digestive issues, and much more.”
  o A comment on this post and response from CBD American Shaman:
     Comment from follower: “I am considering trying this for our dog who had seizures.”
     Response from CBD American Shaman: “A lot of people are having success with their dogs [sic] seizures using CBD.”

• On your October 16, 2017 Facebook video post:
  o At the 20 second mark in the video a graphic states, “From arthritic canines to anxiety filled equines, CBD Oil is changing the way veterinarians and pet owners treat their furry family members.”
  o At the 28 second mark in the video a graphic with the heading “CBD Hemp Oil” states, “Whether a dog has cancer, seizures, or anxiety, cannabis oil can serve as an alternative medication to help treat symptoms.”

• On your September 27, 2017 Facebook post: “Animals have anxiety, joint discomfort, and many of the same disorders as humans. So, just as with our human line of products, we use the best of ingredients for our canine, feline, or equine customers.”

Your CBD-containing products for animals 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)].

301(ll) and Adulterated Animal 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 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.

According to your product labeling, your Doggy Chews (all flavors), Soft & Tender Doggy Chews, Horsey Chews, Doggy Nugs, and Kitty Nugs products are animal food to which CBD has been added. Specifically, the product labeling depicted on your website, cbdamericanshaman.com, refers to your Doggy Chews (all flavors), Soft & Tender Doggy Chews, and Horsey Chews, as a “treats.” Additionally, your Doggy Nugs and Kitty Nugs are referred to as food, for example, on your webpage titled, “How To Choose A CBD Oil Product,” a link is provided to the product page for your Doggy Nugs and states, “If you are seeking CBD benefits for your dog on a daily basis, we recommend our CBD Dog Food, which is made with real chicken and is bowl-licking good.” On the same webpage titled, “How To Choose A CBD Oil Product,” a link is provided to the product page for your Kitty Nugs and states, “If you are seeking an easy way to give your cat CBD on a daily basis, try our CBD cat food made with real chicken.” 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 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.9

Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in animal food is deemed to be unsafe under section 409(a) of the FD&C Act [21 U.S.C. 348(a)], and causes the animal 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 animal 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 that authorizes the use of CBD in animal food. Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal food. 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 food 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.

FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in animal food. Therefore, CBD added to animal 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 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 [21 U.S.C. 342(a)(2)(C)(i)]. Therefore, your Doggy Chews (all flavors), Soft & Tender Doggy Chews, Horsey Chews, Doggy Nugs, and Kitty Nugs are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of this adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. 331(a)].

* * *

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.

We have the following additional comments:

According to the label of your Grandma’s Raisin & Pecan Hermit Cookies [with] 10mg CBD per Serving, the product contains 10 mg CBD per one cookie serving. We collected a sample and analyzed this product and confirmed that the product contains CBD. However, FDA analysis found significantly higher levels of CBD than declared on the label, at 19.3 mg CBD per serving and 17.6 mg CBD per serving in our original and check analyses, respectively. As stated above, failure to accurately list the amount of CBD in the product further increases the risk associated with consumption of the product. We have significant concerns about products marketed with incorrect statements about the amount of CBD, particularly those that contain higher amounts of CBD than labeled because consumers may be consuming more CBD than intended. Nevertheless, even if the product labels were accurate regarding the level of CBD in the product, the product would still be adulterated because it bears or contains an unsafe food additive, as discussed above.

Dietary Supplement Labeling

Information on your website indicates that you intend to market some of your CBD products as dietary supplements. For example, the images of the labels on the product pages of your Rapid Dissolve CBD Tablets, CBD Capsules, VG Cloud Tinctures, Water Soluble Hemp Oil Extract, Gourmet Gummies Hemp Oil Isolate, Gourmet Gummies Energy, CBD Gummies, and Sugar Free Gourmet Gummies all bear the term “dietary supplement.” 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, based on available evidence, 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)]. 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.10 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, but you may present FDA with any evidence that has bearing on this issue.

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 CFSANResponse@fda.hhs.gov. Please include “CMS 628753” in the subject line of your email.

Sincerely,
/S/

Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration

/S/

Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

/S/

Neal Bataller
Director
Division of Drug Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine
Food and Drug Administration

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1 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.

2 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 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.

3 Section 505G(a)(1) of the FD&C Act specifies criteria under which certain nonprescription drugs without an approved application are deemed GRASE and not "new drugs", notably conformance with conditions detailed in applicable OTC monograph documents issued by FDA under 21 CFR 330, prior to enactment of the CARES Act. In the case of OTC sunscreen drug products, relevant documents were deemed under section 505G to be a final administrative order, Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use. (See Order ID OTC000006, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/.)

4 21 CFR 330.1(e) requires that “the product contains only suitable inactive ingredients which are safe in the amounts administered and do not interfere with the effectiveness of the preparation or with suitable tests or assays to determine if the product meets its professed standards of identity, strength, quality, and purity.”

5 See e.g., "Using the Inactive Ingredient Database" Guidance for Industry (July 2019), p. 1 at https://www.fda.gov/media/128687/download, and "Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients" Guidance for Industry (May 2005), pp. 1-2 at https://www.fda.gov/media/72260/download.

6 See e.g., 21 CFR 314.3(b) and 21 CFR 210.3(b)(7), which define an active ingredient as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man.” All other components of a finished drug product are considered inactive ingredients (see CFR 314.3(b), 21 CFR 210.3(b)(8)).

7 See 21 CFR 330.1(e).

8 For example, the labeling for Epidiolex (cannabidiol) prescription oral solution includes risks for the drug such as liver injury, interactions with other drugs or supplements, potential for male reproductive toxicity, somnolence, insomnia, diarrhea, decreased appetite, abdominal pain, upset stomach, changes in mood, irritability, and agitation. See https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210365s005s006s007lbl.pdf.

9 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.

10 As noted above, CBD is the active ingredient in the approved drug product Epidiolex and the existence of substantial clinical investigations regarding CBD has been made public.

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