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WARNING LETTER

May 4, 2022

RE: # 618368

 

Dear Delta 8 Hemp:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://delta8thc.market/ in April 2022 and has determined that you take orders there for various human products, which you represent as containing Delta-8 tetrahydrocannabinol (THC). The claims on your website establish that your products, some of which are available in multiple varieties, “Delta 8 THC Distillate Oil," “Delta 8 THC Vape Cartridge,” “Delta 8 THC Disposable Vape Pen,”  “Delta 8 THC Tincture,” “Delta 8 Infused Gummies,” and “Delta 8 Infused Sour Gummies” (hereinafter referred to as “Delta-8 THC products for humans”), are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).  Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).  

FDA has also determined that your “Delta 8 Infused Gummies” and “Delta 8 Infused Sour Gummies” 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.

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 cannabis-derived products at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.

Over the past several years, FDA has warned the public on various illegally marketed CBD-containing products. FDA has also observed a proliferation of products containing another 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.

Unapproved New Human Drugs

Based on a review of your websites, your Delta-8 THC products for humans 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, and/or intended to affect the structure or any function of the body. 

Examples of claims from your website https://delta8thc.market/ that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

On your blog post titled, “3 Ways to Boost Your Immune System with Delta-8 THC”:

• “Delta-8 THC can be used to suppress the immune response in your body. If a patient is suffering from autoimmune diseases, Delta-8 THC will offer some relief and support. Some of these diseases include lupus, HIV/AIDS, and multiple sclerosis.”
• “Delta-8 THC prevents rapid cell growth while promoting cellular death . . . people who have a hyperactive immune system will gain significantly since such properties assist in the healing process.”
• “If you have cancer, rheumatoid arthritis, and migraines, Delta-8 THC can help alleviate the pain because it has immunosuppressant properties.”
• “[R]esearchers have currently noted that Delta-8 THC reduces inflammation, prevents autoimmune diseases, and offers pain relief.”

On your blog post titled, “Does Delta-8 THC help to Reduce Anxiety?”:

• “Where there are many benefits of Delta-8 THC, such as ways to boost your immune system with Delta-8 THC, some reason [sic] to try Delta-8 THC are as follows:
  • Substance Abuse Treatment”
• “Yes, Delta-8 THC does help to reduce anxiety.”

On your webpage titled, “What is Delta 8 THC?”:

• “In non-medical terms, researchers linked Delta 8-THC to anti-nausea (antiemetic), anti-anxiety (anxiolytic), and pain relief (analgesic) benefits, among other effects . . . It could also protect brain cells thanks to its neuroprotective effects.”
• “The most notable benefits linked to Delta 8-THC include:
  • Help with pain and inflammation
  • Eliminate nausea in cancer patients”
• Posted on this page is your YouTube video titled “What is this Delta 8 Stuff?” which includes the text “Delta-8 is known to be successful in many cancer treatments.”

Your Delta-8 THC products for humans are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C 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 FD&C Act, 21 U.S.C. 355(a).  FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above-mentioned products.

Misbranded Human Drugs

Your Delta-8 THC products for humans are misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) Your Delta-8 THC products for humans are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use because no FDA-approved applications are in effect for your products.

The introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Adulterated Human Foods

According to your product labeling, your “Delta 8 Infused Gummies” and “Delta 8 Infused Sour Gummies” products are foods to which Delta-8 THC has been added. 

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 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 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 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.  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 FD&C Act.  Therefore, your “Delta 8 Infused Gummies” and “Delta 8 Infused Sour Gummies” 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).

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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. 

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 U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.

 

Sincerely,

/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

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