WARNING LETTER
M Six Labs, Inc.
MARCS-CMS 618701 —
May 04, 2022
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Terry Maxwell
Recipient Title
CEO
M Six Labs, Inc.
725 N. Progress Dr.
Saukville
,
WI
53080
United States
sales@msixlabs.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
May 4, 2022
RE: # 618701
Dear Terry Maxwell:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at https://m6labs.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). The claims on your website establish that your products, most of which are available in multiple varieties, “Silver Lake Delta 8 Uncut Glass Dab Syringe,” “Silver Lake CBD MCT Oil Tincture,” “Magnolia Botanicals CBD Avocado Oil Tincture,” “Chaz Ortiz CBD 500mg Essential Balm,” “Magnolia Botanicals CBD 500mg Balm Stick,” “Silver Lake CBD Vegan Chew,” “Nobel Hemp CBD Snapping Rocks,” “Nobel Hemp CBD Chews,” “Nobel Hemp Delta 8 Vegan Gummy,” “Silver Lake Delta 8 Atomic Crystals,” “Silver Lake Delta 8 Tincture,” “Silver Lake Delta 8 Infused Sugar,” “Silver Lake Vegan Chews Delta 8,” “Magnolia Botanicals CBD Canna Rocks Popping Candy,” “Magnolia Botanicals Vegan Hemp Chews,” and “Silver Lake CBD Infused Sugar” (hereinafter referred to as “your CBD and Delta-8 THC products for humans”) 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).
In addition, your products, which are available in multiple varieties, “Magnolia Botanicals MB Pets Hemp Oil,” “Nobel Hemp Pet Comfort Tincture,” and “Silver Lake Pet Comfort Tincture” (hereinafter referred to as “your CBD-containing products for animals”) 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
your “Nobel Hemp CBD Snapping Rocks,” “Nobel Hemp CBD Chews,” “Silver Lake Delta-8 Atomic Crystals,” “Silver Lake Delta 8 Infused Sugar,” “Magnolia Botanicals CBD Canna Rocks Popping Candy,” “Silver Lake CBD Infused Sugar,” and “Magnolia Botanicals Vegan Hemp Chews” 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
“Nobel Hemp CBD Snapping Rocks,” “Nobel Hemp CBD Chews,” “Magnolia Botanicals CBD Canna Rocks Popping Candy,” “Silver Lake CBD Infused Sugar,” and “Magnolia Botanicals Vegan Hemp Chews”
products into interstate commerce under 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.
Dietary Supplement Labeling
Information on your website at https://m6labs.com indicates that you intend to market your CBD products “Silver Lake CBD MCT Oil Tincture” and “Silver Lake CBD Vegan Chew” as dietary supplements. The product webpages display an image appearing to be a supplement facts panel. However, your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.
[1]
There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on 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 CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.
Unapproved New Human Drugs
Based on a review of your website,
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 from your website https://m6labs.com 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, “What is Hemp Derived Delta 8 THC?”
“Fighting Cancer . . . Δ8 may also have cancer-fighting properties . . . [t]he researchers treated mice with cancer for 20 consecutive days with a combination of the isomer and cannabinol. The result? Tumors reduced in size.”
“Reducing Anxiety . . . Δ8 also has anxiolytic properties . . ..”
“Potential Treatment for Weight Disorders”
“Δ8 isomer . . . raised levels of acetylcholine, a neurotransmitter, in certain areas of mice brains . . . The relevance of these findings to future dementia research is easy to apprehend when you consider that Alzheimer’s disease is characterized by declining levels of acetylcholine in the human brain.”
“Δ8 improves cognitive function. In the course of the study, they gave oral doses of the isomer to rats with encephalomyelitis, a damaging inflammation of the brain and the spinal cord, and noticed that the neurological function improved.”
“[T]opical Δ8 isomer applications lowered corneal pain and inflammation in rats.”
“The isomer offers many benefits . . . include improved appetite, anxiety reduction, pain relief and improved cognitive function. In addition, the isomer has antiemetic and cancer-fighting properties.”
On your blog post titled, “How Does CBD Make You Feel?”
“CBD helps relieve pain, inflammation, nausea, and seizures in many cases.”
“CBD is believed to be helpful in the treatment of insomnia and anxiety.”
“People who undergo chemotherapy for cancer often suffer from terrible nausea. In some cases, CBD products may help suppress such nausea.”
On your blog post titled, “What is CBD and What Does CBD Stand For?”
“From pain to inflammation, depression, and insomnia, cannabidiol has been tried on people to treat a wide variety of health issues. The strongest scientific evidence of its medical effects, however, lies in its ability to treat serious childhood epilepsy in conditions such as the Dravet syndrome.”
“[C]annabidiol is of some use in the treatment of some cancers.”
“CBD is not a cure-all, but there is anecdotal evidence to show that it can be safe and effective for a variety of health conditions, including autoimmune diseases, metabolic syndrome, digestive disorders, cardiovascular dysfunction, chronic pain, and skin conditions.”
On your Magnolia Botanicals CBD Avocado Oil Tinctures product webpage
“Avocado oil is rich in antioxidants such as lutein which may help decrease inflammation and blood pressure levels.”
Your CBD and Delta-8 THC products for human use 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). 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. 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.)
Your CBD and 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 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 “Nobel Hemp CBD Snapping Rocks,” “Nobel Hemp CBD Chews,” “Magnolia Botanicals CBD Canna Rocks Popping Candy,” Silver Lake CBD Infused Sugar,” and “Magnolia Botanicals Vegan Hemp Chews” products are foods to which CBD has been added
. We note that these products are marketed as containing varying quantities of CBD.
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.
According to your product labeling, your “Nobel Hemp CBD Snapping Rocks,” “Nobel Hemp CBD Chews,” “Magnolia Botanicals CBD Canna Rocks Popping Candy,” Silver Lake CBD Infused Sugar,” and “Magnolia Botanicals Vegan Hemp Chews” products are foods to which CBD has been added. Therefore, the introduction or delivery for introduction into interstate commerce of those products is a prohibited act under section 301(ll) of the FD&C Act.
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.
[2]
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 “Nobel Hemp CBD Snapping Rocks,” “Nobel Hemp CBD Chews,” “Magnolia Botanicals CBD Canna Rocks Popping Candy,” “Silver Lake CBD Infused Sugar,” and “Magnolia Botanicals Vegan Hemp Chews” 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).
Further, according to your product labeling, your “Silver Lake Delta 8 Atomic Crystals” and “Silver Lake Delta 8 Infused Sugar” products are foods to which Delta-8 THC has been added.
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 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 “Silver Lake Delta 8 Atomic Crystals” and “Silver Lake Delta 8 Infused Sugar” 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 food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Unapproved New Animal Drugs
During our review of your website, https://m6labs.com, FDA determined that your firm is marketing CBD-containing products for animals that are unapproved new animal drugs. Based on our review of your website, your CBD-containing products for animals are drugs under section 201(g)(1)(B) of the FD&C 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 in animals. 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://m6labs.com that show the intended use of your products for animals as drugs include, but may not be limited to, the following:
On your product page for “Magnolia Botanicals MB Pets Hemp Oil”:
“[S]upport the reduction of symptoms associated with seizure disorders, ease inflammation and pain . . . and reduce anxiety and nervousness.”
On your product page for “Nobel Hemp Pet Comfort Tincture”:
“[S]upport the reduction of symptoms associated with seizure disorders, ease inflammation and pain . . . and reduce anxiety and nervousness.”
On your product pages for “Silver Lake Pet Comfort Tincture”:
“[S]upport the reduction of symptoms associated with seizure disorders, may help ease inflammation and pain . . . and could reduce anxiety and nervousness.”
Your
CBD-containing products for animals 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).
*           *           *
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]
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.
[2]
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.
Content current as of:
05/04/2022
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages