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WARNING LETTER

December 5, 2022

RE: # 641057

Dear Steven Haynes:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.cedarcreekdistributors.com, www.thriftmasterholdings.com, and https://apelindx.com in November 2022 and has determined that you take orders there for various products, which you represent as containing cannabidiol (CBD).¹ We have also reviewed your social media websites at www.instagram.com/thriftmasterholdings and www.facebook.com/thriftmasterholdings, which are accessible from your website www.thriftmasterholdings.com, where consumers can purchase your products. The claims on your websites and social media accounts establish that your products, “ApelinDx metered dose inhaler,” “Maia CBD Tincture Inhaler,” “Maia CBD Oil,” “Maia Dried Mango Slices,” “Maia Dried Pineapple Chunks,” “Maia Gummies,” and “CBD Pill” (hereinafter referred to as “your CBD products”), are unapproved new drugs introduced or delivered for introduction into interstate commerce 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). In addition, these products are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).

FDA has also determined that your “Maia Dried Mango Slices,” “Maia Dried Pineapple Chunks,” and “Maia Gummies” food 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. Furthermore, it is a prohibited act to introduce your “Maia Dried Mango Slices,” “Maia Dried Pineapple Chunks,” and “Maia Gummies” products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll). Consumers may confuse these products with traditional foods; therefore, with these products there is a risk of unintended consumption of CBD.

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.

We also observed that your website, www.thriftmasterholdings.com, and social media websites make claims that your CBD products may be intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.² As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Furthermore, your “ApelinDx metered dose inhaler” and “Maia CBD Tincture Inhaler” products are intended to deliver CBD through oral inhalation. These products are particularly concerning to the agency because the ingredients and potential impurities in oral inhalation sprays may trigger laryngospasm and bronchospasm and may be toxic to the tissues in the upper or lower airways. Inhalation products that are intended to act locally in the respiratory system also may be absorbed and exert undesirable systemic effects, such as increased heart rate or elevated blood pressure.

Unapproved New Drugs

Based on a review of your websites and social media websites, your CBD 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, and/or intended to affect the structure or any function of the body.

Examples of claims from your websites and social media websites that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:

On your “About Us” webpage https://cedarcreekdistributors.com/about-us/:

• “CBD is FDA approved to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome and Tuberous Sclerosis Complex.”
• “As of 2020, there are various clinical studies underway hoping to determine CBD’s long-thought potential to assist with a variety of physical and mental health ailments, including pain, mood disorders and respiratory problems.”

On your “We’re in the News” hyperlink https://thriftmasterholdings.com/wp-content/uploads/2021/07/USA-today-AD-compressed-7.15.21.pdf accessed through your website www.thriftmasterholdings.com:

• “CBD May Be Key to Reducing ARDS, the Leading Cause of COVID-19 Deaths”
• “Thriftmaster has been heavily involved in clinical studies, with a goal of proving CBD and CBC’s efficacy to improved conditions related to aliments such as . . . Alzheimer’s and Post Traumatic Stress Disorder.”

On your “CBD Helps” hyperlink https://www.eurekalert.org/pub_releases/2020-10/mcog-chr101620.php accessed through your website www.thriftmasterholdings.com:

• “CBD helps reduce lung damage from COVID by increasing levels of protective peptide”

On your Instagram social media website www.instagram.com/thriftmasterholdings:

• May 31, 2021 post – “Learn more about how ApelinDx™ supports ARDS and Alzheimer’s research (link in bio).”
• June 14, 2021 post – “TM Global Bioscience, LLC, a medically-focused division of ThriftMaster Global Holdings, announced that the patent-pending broad-spectrum CBD formulation in its ApelinDx™ metered dose inhaler may increase survival rates of COVID-19 patients.”
• June 21, 2021 post – “See our product being used in ‘a new research collaboration between the Dental College of Georgia and the Medical College of Georgia is investigating the affect [sic] CBD can have on reducing plaque in the brain of Alzheimer’s patients.’”
• June 30, 2021 post – “We are heading towards finding answers about the potential CBD has to make a change in the medical world . . . #apelindx #metereddoseinhaler #mdi #alzheimers #alzheimersawareness #dementia #dementiaawareness #cbd #cbdinhaler”

On your Facebook social media website www.facebook.com/thriftmasterholdings:

• February 1, 2021 post – “Early studies suggest that CBD may be a useful tool in the fight against COVID-19.”
• February 4, 2021 post – “[A] study out of the Innovare Journal of Medical Sciences produced promising results regarding #cannibidiols [sic] potential to assist with cognitive illnesses, including #anxiety and #depression.”
• March 25, 2021 post – “‘Researchers discovered in this trial that in mice who have been genetically altered to show symptoms of Alzheimer’s, #CBD normalized levels and functions; improving brain cognition’.”

Additionally, your website https://apelindx.com hyperlinks to a news report discussing the use of CBD to delay the progression of Alzheimer’s disease. The news report shows an image of a product that states “ApelinDx” on the label and appears to be a metered dose inhaler.

Your CBD products 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. 331(d) and 355(a). There are no FDA-approved applications in effect for any of the above-mentioned products. 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).

Misbranded Drugs

Your CBD products 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 CBD products 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 these products. The introduction or delivery for introduction into interstate commerce of misbranded drugs is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

301(ll) and Adulterated Human Foods

According to your product labeling, your “Maia Dried Mango Slices,” “Maia Dried Pineapple Chunks,” and “Maia Gummies” products are foods to which CBD has been added.

However, 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 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.³ 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, 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.

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 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.⁴

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 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. 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 “Maia Dried Mango Slices,” “Maia Dried Pineapple Chunks,” and “Maia Gummies” 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).

* * *

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/

Carolyn Becker
Director
Office of Unapproved Drugs and Labeling 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

____________________

1 Your websites www.thriftmasterholdings.com and https://apelindx.com redirect consumers to your website www.cedarcreekdistributors.com to purchase your products.

2 On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.

3 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.

4 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.