FDA Warning Letter to Company Selling THC Gummies Highlights Growing Concern

FDA issued a Warning Letter to a Florida company that sells THC Gummies.  FDA focused on those products containing Delta-8 THC, but this and other cannabinoids are not allowed for food use.

"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.

There was not inspection, as it appears, but this was from information obtained from the company's internet site.

The "U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address stnrcreations.com in March 2025 and determined that you take orders there for various human food products, which you represent as containing Delta-8 tetrahydrocannabinol (THC). FDA has determined that your products, STNR Delta-8 and Delta-9 Gummies in various flavors, STNR Delta-8 and Delta-9 Candy Clusters Nana Berry Gummies, STNR Delta-8 Gummies in various flavors, STNR Delta-8 and Delta-9 Cookies in various flavors, and STNR Delta-8 and Delta-9 Brownies in various flavors, 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)."

FDA states that there is an increasing amount of companies selling such products, and it is a concern.

FDA has observed a proliferation of products containing the cannabinoid, Delta-8 THC, and has 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, including for your Delta-8 and Delta-9 Watermelon Lemonade product specifically; 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

So what is Delta-8 THC and how does it differ from what we normally consider THC from marijuana?  This was a nice summary article in Forbes (https://www.forbes.com/health/cbd/delta-8-vs-delta-9/)

"Delta-8 THC is a naturally-occurring cannabinoid (a type of chemical in marijuana) in the cannabis sativa plant. However, as delta-8 typically occurs in relatively low quantities in the plant, the delta-8 found in retail CBD or cannabis products is often synthetically developed through a process of chemically converting CBD into delta-8.

Delta-8 and delta-9 THC produce similar psychoactive effects, but the effects from delta-8 are less potent. This is a result of the way delta-8 binds to the body’s endocannabinoid system (ECS), which regulates many functions in the central nervous system, including emotional and cognitive processing behavior, mood and more. Delta-8 binds to this system via a double bond structure in a particular carbon, which creates the psychoactive intoxicating effect, but to a lesser degree compared to delta-9.

“Delta-8 is a cannabinoid (cannabis-like molecule) that is very similar to the main active ingredient of regular cannabis, delta-9,” says Peter Grinspoon, M.D., a physician at Massachusetts General Hospital, instructor at Harvard Medical School, cannabis specialist and author of Seeing Through the Smoke: Cannabis: An Expert Doctor Untangles the Truth About Cannabis. “It functions by triggering our cannabinoid receptors in the same way that cannabis does.”

However, it’s worth noting that due to delta-8’s low natural presence in the cannabis sativa plant, artificially produced formulations of delta-8 may expose users to higher levels of the cannabinoid than they’d experience when using non-synthetic CBD. Additionally, commercially sold delta-8 and products containing delta-8 aren’t regulated by the U.S. Food and Drug Administration (FDA), meaning the chemical process by which the cannabinoids are made and the sanitary standard of the factories in which they’re made are also unregulated, potentially exposing users to unwanted risk and harm, according to the FDA."

FDA Warning Letters
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stnr-creations-llc-698700-07162025

STNR Creations, LLC
MARCS-CMS 698700 — July 16, 2025

Recipient:
Nicholas Schwarmann
STNR Creations, LLC
6541 N. Orange Blossom Trail Suite 600
Orlando, FL 32810
United States
support@stnrcreations.com

Issuing Office:
Human Foods Program
United States

WARNING LETTER

July 16, 2025

RE: 698700

Dear Mr. Schwarmann:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address stnrcreations.com in March 2025 and determined that you take orders there for various human food products, which you represent as containing Delta-8 tetrahydrocannabinol (THC). FDA has determined that your products, STNR Delta-8 and Delta-9 Gummies in various flavors, STNR Delta-8 and Delta-9 Candy Clusters Nana Berry Gummies, STNR Delta-8 Gummies in various flavors, STNR Delta-8 and Delta-9 Cookies in various flavors, and STNR Delta-8 and Delta-9 Brownies in various flavors, 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/newsevents/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 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, including for your Delta-8 and Delta-9 Watermelon Lemonade product specifically; 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 STNR Delta-8 and Delta-9 Gummies in various flavors, STNR Delta-8 and Delta-9 Candy Clusters Mixed Fruit Gummies, STNR Delta-8 Gummies in various flavors, STNR Delta-8 and Delta-9 Cookies in various flavors, and STNR Delta-8 and Delta-9 Brownies in various flavors, are foods to which Delta-8 THC has been added. FDA confirmed through laboratory analysis that a sample of your product, STNR Delta-8 and Delta-9 Watermelon Lemonade Gummies, contains 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

Additionally, your STNR Delta-8 and Delta-9 Cookies in various flavors, and STNR Delta-8 and Delta-9 Brownies in various flavors, are products represented for use as conventional foods and accordingly are not dietary supplements, as defined under Section 201(ff) of the FDCA [21 U.S.C. § 321(ff)]. The Act excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 U.S.C. § 321(ff)(2)(B)]. Your use of a “Supplement Facts” panel for nutrition labeling does not make your products dietary supplements, because your STNR Delta-8 and Delta-9 Cookies and your STNR Delta-8 and Delta-9 Brownies products are represented for use as conventional foods.

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 food. 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 conventional food 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 STNR Delta-8 and Delta-9 Gummies in various flavors, STNR Delta-8 and Delta-9 Candy Clusters Mixed Fruit Gummies, STNR Delta-8 Gummies in various flavors, STNR Delta-8 and Delta-9 Cookies in various flavors, and STNR Delta-8 and Delta-9 Brownies in various flavors, and other 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).

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 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 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 fifteen 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 fifteen 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 hfp-oce-dietarysupplements@fda.hhs.gov. Please include “CMS 698700” in the subject line of your email.




Sincerely,

/S/




Maria S. Knirk, JD, MBA

Acting Director, Office of Enforcement

Office of Compliance & Enforcement

Human Foods Program

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.