WARNING LETTER

Infusionz, LLC MARCS-CMS 629248 — November 16, 2022

Delivery Method:: Via Overnight Delivery
Product:: Animal & Veterinary
Drugs
Food & Beverages

Recipient:: Recipient Name

Allan Marshall; Infusionz, LLC; 1710 Whitney Mesa Drive
Henderson, NV 89014
United States; info@cbdinfusionz.com

Issuing Office:: Center for Food Safety and Applied Nutrition (CFSAN); United States; Center for Veterinary Medicine

WARNING LETTER

November 16, 2022

RE: #629248

Dear Mr. Marshall:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://cbdinfusionz.com in October 2022 and has determined that you take orders there for various human and animal products, all of which you represent as containing cannabidiol (CBD). We have also reviewed your social media websites at www.facebook.com/cbdinfusionz and www.instagram.com/cbdinfusionz, which direct consumers to your website https://cbdinfusionz.com to purchase your products. FDA has determined that all strengths, varieties, and various flavors of your CBD gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops 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 gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops 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 gummies, CBD fruit snacks, CBD gum, CBD candy, and CBD lollipops 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 your CBD gummies, CBD fruit snacks, CBD gum, CBD candy, and CBD lollipops products; therefore, with these products there is a risk of unintended consumption of the CBD ingredient by consumers.

As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. 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 gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops products are foods to which CBD has been added. Specifically, the products bear Nutrition Facts labels and/or your website provides “Nutrition Facts” for these products. We have analyzed and confirmed that samples of your gummy, gum, and lollipop products contain CBD.

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 it 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. 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 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. Therefore, your CBD gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops products are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act 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 CBD gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops products 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 CBD gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops products 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.

* * *

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.

Additionally, we have the following comment:

We are concerned that it appears your firm is marketing the following products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals: CBD Dog Treats (Bacon & Cheddar Cheese Flavored) and Hemp CBD Tincture (also referred to as CBD Coconut Oil – CBD MCT Oil Broad/Full Spectrum). These products are marketed on your website and social media websites for intended uses including, but not limited to, separation anxiety, noise aversion, and seizures. There are FDA approved animal drugs to treat these conditions. If not treated appropriately, these conditions can have detrimental health and welfare consequences for animals. We also note that CBD is not an approved food additive and the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your response should be sent to the United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, at CFSANResponse@fda.hhs.gov. Please include “CMS 629248” 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/

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

______________________________________

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.