WARNING LETTER
ATLRx, Inc.
MARCS-CMS 618341 —
May 04, 2022
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Chase Slappey
Recipient Title
CEO
ATLRx, Inc.
875 North Main St., Suite 351
Alpharetta
,
GA
30009
United States
info@atlrx.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
May 4, 2022
RE: # 618341
Dear Chase Slappey:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address
www.atlrx.com
in February 2022 and has determined that you take orders there for various human and animal products, which you represent as containing cannabidiol (CBD) or Delta-8 tetrahydrocannabinol (THC).
We have also reviewed your social media websites at
https://twitter.com/AtlantaRx,
https://www.facebook.com/ATLANTARX
,
and
https://www.instagram.com/atlanta.rx/
;
which direct consumers to your website
www.atlrx.com
to
purchase your products.
The claims on your website and social media accounts establish that your products,
some of which are available in multiple varieties, “Delta 8 Terpene Gummies,” “Delta 8 Chocolate,” “Delta 8 THC Caramels,” “Delta 8 Gummies,” “Delta 8 THC Soft Gel Capsules,” “CBD Sleep Gummies,” “CBD Gummies,” “CBD Capsules,” “Delta 8 THC Tincture,” “CBD Oil Tincture,” “CBD Salve,” “CBD Topical Full Spectrum Lotion,” and “CBD Lavender Scented Hand Sanitizer” (hereinafter referred to as “your CBD and 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, your CBD and Delta-8 THC products for humans are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
In addition, your “CBD Pet Oil Tincture” and “CBD Pet Treats” products, which are available in multiple varieties, are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and are adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).
FDA has also determined that
certain
food
products that you market 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 into interstate commerce any food to which CBD has been added (see section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll)).
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, and Delta-8 THC may pose a serious health risk to consumers.
Unapproved New Human Drugs
Based on a review of your websites, your
CBD and 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 observed on your product labeling, including your website
and social media accounts, that provide evidence of the intended use of your CBD and Delta-8 THC products as drugs include, but may not be limited to, the following:
On your Twitter social media website https://twitter.com/AtlantaRx
:
January 28, 2019 post – “CBD Oil Benefits . . . Pain Relief and Inflammation . . . Helps Fight Cancer . . . Relieves Nausea . . . Treats Seizures . . . Lowers Risk of Diabetes . . . Anxiety . . . Depression . . . Panic Disorders . . . OCD . . . PTSD . . . Neurological Disorders . . ..”
March 3, 2019 post – “Introducing our line of extra strength CBD oil that is great for insomnia, epilepsy, MS, schizophrenia, and chronic pain.”
March 27, 2019 post – “If you suffer from one of these ailments, we encourage you to enhance your life by choosing a natural alternative such as CBD . . . pain . . . Inflammation . . . Anxiety . . . Movement Disorders . . . Memory . . . Seizure . . . ADHD . . . PTSD”
July 22, 2019 post – “CBD ‘resets’ endocannabinoid activity, which reduces sensitivity to pain and therefore, the symptoms of fibromyalgia.”
On your Facebook social media website https://www.facebook.com/ATLANTARX:
August 14, 2020 post – “Delta-8-THC benefits . . . Antitumor . . . Antiemetic . . . Appetite-stimulant . . . Analgesic . . . Neuroprotective properties . . .”
September 24, 2020 post – “Is Delta 8 THC Medicinal? . . . Yes! Delta 8 THC is used for a variety of symptoms including: . . . Pain Relief . . . Anxiety . . .Nausea . . . Brain Cell Protection . . . & Appetite Stimulation . . .”
October 21, 2020 video post – “Delta-8 THC is showing a lot of promise as an antiemetic that can relieve nausea and vomiting in pediatric cancer patients undergoing chemotherapy.”
On your Instagram social media website https://www.instagram.com/atlanta.rx/
August 9, 2021 post – “Preventing Vomiting . . . a small study suggested that Delta 8 THC is an effective option to treat vomiting during chemotherapy . . . Removes Anxiety”
On your “Buy Delta 8 THC Products Online at the Best Price” webpage https://www.atlrx.com/collections/delta-8-thc
“Thus when trying to find the best THC, Delta 8 comes out on top for many for the less strong effects and all the anxiety-reducing . . . effects”
On your CBD Lavender Scented Hand Sanitizer webpage https://www.atlrx.com/products/cbd-lavender-scented-hand-sanitizer/
“130 MG FULL SPECTRUM CBD”
“In the midst of the Covid-19 crisis, keeping yourself and your loved ones safe has never been more important. We’re proud to announce our new line of CBD Infused Lavender Scented Hand Sanitizer.”
“Hand sanitizer to help reduce bacteria and viruses that potentially can cause disease. For use when soap and water are not available . . . Apply and rub in enough sanitizer to keep hands wet for 15 seconds, usually 2-4 pumps.”
On your “Buy Delta 8 THC Gummies Online | Best Delta 8 Gummies” webpage https://www.atlrx.com/collections/delta-8-gummies
“Whether you have a hectic mind or suffer from an anxiety disorder, Delta 8 THC gummies can provide relief to calm down the mind.”
“The treatment of insomnia is another reason that many individuals enjoy taking Delta 8 THC gummies. A couple of hours before they intend to fall asleep, consumers of Delta 8 gummies take their candy edibles and are able to enjoy a peaceful night's sleep and deep rest.”
“As an antiemetic Delta 8 thc gummies can work wonders. Many cancer patients have trouble leaving their homes because of treatment, such as chemotherapy; shop for delta 8 gummies online to treat nausea and vomiting. Delta-8-THC has also been shown to be effective at killing cancer cells, making it doubly effective for cancer patients.”
“Many individuals take advantage of Delta 8 gummies because of their anti-inflammatory properties. The treatment of chronic pain is one of the uses of Delta-8-THC by many people all across the world.”
“Delta 8 THC gummies can provide appetite stimulation among many users, making them ideal for treating eating disorders such as anorexia or even for those who just do not get hungry often enough and need an appetite boost.”
Based on the above
labeling claims, your CBD and Delta-8 THC products for human use are drugs.
We are not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that any of these products are
generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended or suggested in their labeling. Thus, your CBD and Delta-8 THC products for human use are “new drugs” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here,
[1]
new drugs
may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a), 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your CBD and Delta-8 THC products for humans. There is no basis under the FD&C Act under which these products would be legally marketed without an approved application. 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 Human Drugs
Your
CBD and 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.)
The
se 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 your products.
[2]
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).
CBD-containing Drugs
Even if your
“CBD Salve,” “CBD Topical Full Spectrum Lotion,” and “CBD Lavender Scented Hand Sanitizer” were considered nonprescription drugs, we note that a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. Nonprescription drug products that include CBD as an active ingredient are not GRASE and are new drugs which require an approved application to be legally marketed. CBD is not an active ingredient in any OTC monograph under section 505G of the FD&C Act. Even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements under section 505G of the FD&C Act under which certain nonprescription drug products may be marketed without an approved new drug application. In particular, such a product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1(e).
[3]
,
[4]
301(II) and Adulterated Human Foods
We note that your “CBD Sleep Gummies” and “CBD Gummies” products appear to be promoted as conventional foods.  Specifically, you promote “CBD Sleep Gummies” as “tast[ing] amazing,” and the product labels for both products refer to their flavor.
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, 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.
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.
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.
[5]
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. 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).
Further, 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.
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.
In addition, according to your product labeling, your “Delta 8 Chocolate” and “Delta 8 THC Caramels” are foods to which Delta 8 THC has been added. Your “Delta 8 Terpene Gummies” and “Delta 8 Gummy” products also appear to be conventional foods to which Delta 8 THC has been added. Specifically, you promote these products with the claims “
assorted variety of delicious new flavors!” and “More delicious and new flavors.”
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 Chocolate” and “Delta 8 THC Caramels” products are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of these adulterated foods and other adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Unapproved New Animal Drugs
Based on our review of your website and social media websites, your
“CBD Pet Oil Tincture” and “CBD Pet Treats” 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 in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act.
Examples of claims observed on your website
https://www.atlrx.com/, and your social media
websites https://www.facebook.com/ATLANTARX/, https://www.instagram.com/atlanta.rx/, and https://twitter.com/AtlantaRx, that establish the intended use of these products
as drugs include, but are not limited to, the following:
From your website https://www.atlrx.com/
:
On your product page for “CBD Pet Treats”:
“CBD is . . . easing any anxiety present.”
On your blog post titled “New Pet Treat Formulation”:
“CBD is an excellent tool for easing several conditions pets may suffer from either occasionally or chronically including:
Stress and separation anxiety
Moderate to severe pain
Arthritis and joint pain
Digestion issues
Nausea
Epileptic seizures”
From your social media websites:
On your Facebook social media website at https://www.facebook.com/ATLANTARX/ for your "CBD Pet Treats":
March 5, 2020 posting with a photograph of a dog looking at your “CBD Pet Treats” product – “CBD has been linked to helping our four-legged fur babies with:
-anxiety and stress
-moderate to severe pain
-joint pain and arthritis
-seizures
-digestive problems
-decreased appetite”
On your Instagram social media website at https://www.instagram.com/atlanta.rx/ for your "CBD Pet Treats":
June 20, 2021 posting with a photograph of a person’s hand holding a treat in front of a dog’s nose – “CBD is . . . easing any anxiety or pain present.”
On your Twitter social media website at https://twitter.com/AtlantaRx:
March 24, 2019 posting with a photograph of your “CBD Pet Oil Tincture” product with two dogs sitting in the background – “This week ATLRx is releasing our additional line of pet products! CBD is a great supplement for all pets for . . . more serious issues such as anxiety, inflammation, and seizures.”
March 27, 2019 posting with a photograph of your “CBD Pet Oil Tincture” and “CBD Pet Treats” products with two dogs, a cat, and a bird and your website www.ATLRx.com printed across the bottom of the image – “ATLRx Pet Treats are now available for sale on our website! . . . Known for helping with joint pain, anxiety, lack of appetite, skin problems and other issues. #cbdforpets”
Your
“CBD Pet Oil Tincture” and “CBD Pet Treats” products are “new animal drugs” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-1. These products are not approved or index listed by the FDA, and therefore these products are considered unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). Introduction of these adulterated drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
301(II) and Adulterated Animal Foods
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 animal 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.
[6]
Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in animal food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the animal 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 animal 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 in animal food. We are not aware of any information to indicate that CBD is the subject of 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). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal food. FDA’s regulations in 21 CFR 570.30(a)-(c) describe the criteria for eligibility for classification of an animal food ingredient as GRAS. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food (see 21 CFR 570.30).
We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958. Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal food are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity.  Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30.
FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in animal food. Therefore, CBD added to animal 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, 21 U.S.C. 348. Under section 409 of the FD&C Act, 21 U.S.C. 348, an animal 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 animal food. Animal 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, 21 U.S.C. 342(a)(2)(C)(i). Therefore, your “CBD Pet Treats” is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of this adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Additionally, 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 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, as described above.
According to your product labeling, your “CBD Pet Treats” is an animal food to which CBD has been added. Specifically, your product page on your website, https://www.atlrx.com/, includes the following description: “The easiest way to integrate CBD into your furry friend's diet! These treats are 100% grain and gluten free. No meat by-products, added salt, corn, soy, or artificial colors and flavors, making them ideal for dogs with restrictive diets . . . Our CBD Pet treats also contain the superfood ingredients blueberry and cranberry, providing them with a daily source of vitamins and antioxidants.” Therefore, the introduction or delivery for introduction into interstate commerce of this product is a prohibited act under section 301(ll) of the FD&C Act.
*           *           *
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/
Neal Bataller
Director
Division of Drug Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine
Food and Drug Administration
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
[1]
For example, under section 505G of the FD&C Act, 21 U.S.C. 355h, certain nonprescription drug products may be lawfully marketed without an approved application if applicable conditions are met, including conformity with an applicable OTC monograph. However, your products could not be lawfully marketed under section 505G, because based on your claims regarding these products, including on your website labeling, your products are marketed for uses not considered nonprescription indications. Further, even if certain of your products, such as your “CBD Lavender Scented Hand Sanitizer,” were marketed only for nonprescription indications, they would not meet the conditions under section 505G for lawful marketing without an approved application. For example, CBD —considered an active ingredient under 21 CFR 201.66(b)(2) due to its prominent featuring on your product labeling—is not an active ingredient in any OTC monograph under section 505G of the FD&C Act.
[2]
Further, even if your products were marketed only for nonprescription indications, these products would be misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they would be nonprescription drugs subject to section 505G of the FD&C Act that do not comply with the requirements for marketing under that section (see footnote 1) and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.
[3]
21 CFR 330.1(e) requires in relevant part that "the product contains only suitable inactive ingredients which are safe in the amounts administered." A suitable inactive ingredient generally provides a beneficial formulation function, such as a tablet binder or preservative, or improves product delivery (e.g., enhances absorption or controls release of the drug substance). CBD has no known functional role as an inactive ingredient in a finished drug product.
[4]
Additionally, an inactive ingredient should not exert pharmacological effects and must be safe when used at the intended dosage. CBD has known pharmacological activity with demonstrated risks. For example, the labeling for Epidiolex (cannabidiol) prescription oral solution includes risks for the drug such as liver injury, interactions with other drugs or supplements, potential for male reproductive toxicity, somnolence, insomnia, diarrhea, decreased appetite, abdominal pain, upset stomach, changes in mood, irritability, and agitation. See
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210365s005s006s007lbl.pdf
. It is unknown whether the levels of CBD used in your CBD products have pharmacological activity or pose any concern for safety events.
[5]
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.
[6]
Under section 201(s)(5) of the FD&C Act, 21 U.S.C. 321(s)(5), new animal drugs are excluded from the food additive definition.  If a new animal drug is unsafe within the meaning of section 512 because it is not approved for use in animal food, then the animal food is adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.
Content current as of:
05/04/2022
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages