WARNING LETTER
White Label Leaf, LLC/Flying Monkey US, LLC
MARCS-CMS 681493 —
July 11, 2024
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Jonathan Daye, Co-Owner
Recipient Title
Zachary Daye, Co-Owner
White Label Leaf, LLC/Flying Monkey US, LLC
5525 Johns Rd., Ste 901
Tampa
,
FL
33634
United States
Sales@flyingmonkeyusa.com
Support@flyingmonkeyusa.com
Shop@flyingmonkeyusa.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
July 11, 2024
6050 Dawson Boulevard
Norcross, GA 30093-1288
RE: CMS 681493
Dear Jonathan and Zachary Daye,
This is to advise you that the the United States Food and Drug Administration (FDA) has reviewed your website, https://flyingmonkeyusa.com, in May 2024, and has determined that you take orders there for various human products, which you represent as containing Delta-8 tetrahydrocannabinol (THC). FDA has determined that your products, Flying Monkey Mango Tango Gummies, Flying Monkey Heavy Hitter Blend Mango Gummies, and Flying Monkey Heavy Hitter Blend Blueberry Gummies are adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the 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 adulterated food into interstate commerce under section 301(a) of the Act [21 U.S.C. 331(a)].
As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov. You can find specific information about how FDA regulates cannabis-derived products at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8
THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. See https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc. This letter is to inform you that your firm markets Delta-8 THC containing products that may pose a serious health risk to consumers.
Adulterated Human Foods
According to your product labeling, your Flying Monkey Mango Tango Gummies, Flying Monkey Heavy Hitter Blend Mango Gummies, and Flying Monkey Heavy Hitter Blend Blueberry Gummies are foods to which Delta-8 THC has been added. In addition, FDA confirmed through laboratory analysis that samples of these products contain Delta-8 THC.
As defined in section 201(s) of the 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 Act, 21 U.S.C. § 348(a), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the 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 Act, 21 U.S.C. § 331(a).
There is no food additive regulation that authorizes the use of Delta-8 THC. We are not aware of any information to indicate that Delta-8 THC is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that Delta-8 THC 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 Delta-8 THC 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 Delta-8 THC in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from Delta-8 THC. Our review of published scientific literature identified potential for adverse effects on the central nervous and cardiopulmonary systems. In addition, studies in animals have suggested that gestational exposure to Delta-8 THC can interfere with neurodevelopment. Therefore, based on our review, the use of Delta-8 THC 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 Delta-8 THC for use as an ingredient in a conventional food. Therefore, Delta-8 THC added to a conventional food is a food additive under section 201(s) of the Act and is subject to the provisions of section 409 of the Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Delta-8 THC 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 Act. Therefore, your Flying Monkey Heavy Hitter Blend Mango Tango Gummies, Flying Monkey Heavy Hitter Blend Mango Gummies, and Flying Monkey Heavy Hitter Blend Blueberry Gummies and other gummies or foods that contain Delta-8 THC are adulterated within the meaning of section 402(a)(2)(C)(i) of the 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 Act, 21 U.S.C. § 331(a).
Unapproved New Drugs
Based on a review of your website, https://flyingmonkeyusa.com, your Flying Monkey Mango Tango Gummies, Flying Monkey Heavy Hitter Blend Mango Gummies, and Flying Monkey Heavy Hitter Blend Blueberry Gummies (collectively, “Delta-8 50 mg THC Gummy products”) are drugs under section 201(g)(1)(B) of the Act 321(g)(1)(B)] of the Act, 21 U.S.C. 321(g)(1)(B), 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 from your website, https://flyingmonkeyusa.com that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
Under the product listing for “Delta-8 50mg THC Gummies, 20ct”:
“One of the main positives of Delta-8 THC is its potential therapeutic benefits. It is believed to have anti-inflammatory and pain-relieving properties, making it a potential treatment for a range of conditions such as arthritis, migraines, and neuropathic pain. Delta-8 THC may also help alleviate nausea and vomiting, making it a potential alternative to prescription drugs.”
Your Delta-8 50mg THC Gummy products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. There are no FDA approved applications in effect for the above-mentioned product. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).
Conclusion
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 cause(s) 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 without further notice, including, without limitation, seizure and injunction.
We also offer the following comment:
We note that your firm sells food products that contain cannabinoids other than Delta-8 THC. We know of no basis to conclude that any use in food of a cannabinoid, plant derived or otherwise, would be safe and lawful. For some cannabinoids, such as Delta-8 THC, the available data raise serious concerns about potential harm. For other cannabinoids, there is little or no available information concerning the safety of their use in food. No cannabinoid, plant derived or otherwise, is approved for any use in food as a food additive. Moreover, we know of no basis to conclude that any intended use in food of any cannabinoid satisfies the criteria for eligibility for GRAS status.
Please notify FDA in writing, within 15 working days from your 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 CFSANResponse@fda.hhs.gov. Please include “CMS 681493” in the subject line of your email.
Sincerely,
/S/
Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
____________________
1
Under section 201(s) of the 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 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.
Content current as of:
07/23/2024
Regulated Product(s)
Food & Beverages