As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Infusionz, LLC
Henderson, NV
A food firm in Nevada is on notice from the FDA for concern that some of the firm’s CBD products are in forms that are appealing to children.
In a Nov. 16, 2022, warning letter the FDA described an Oct. 2022, review of Infusionz, LLC’s website at the internet address “https://cbdinfusionz.com.”
The FDA’s review brought concern, that with these products, there is a risk of unintended consumption of the CBD ingredient by consumers.
Because of the following issues, the FDA determined that introducing or delivering these products for introduction into interstate commerce violates the FD&C Act.
Some of the violations:
Adulterated Human Foods and 301(ll)
According to the firm’s product labeling, their CBD gummies, CBD fruit snacks, CBD gum, CBD candy, CBD oil/tinctures, and CBD lollipops products are foods to which CBD has been added. Specifically, the products bear Nutrition Facts labels and/or their website provides “Nutrition Facts” for these products. The FDA has analyzed and confirmed that samples of their gummy, gum, and lollipop products contain CBD.
According to the FDA’s letter, there is no food additive regulation that authorizes the use of CBD. The FDA is not aware of any information to indicate that CBD is the subject of a prior sanction. Furthermore, they are not aware of any basis to conclude that CBD is Generally Recognized as Safe (GRAS) for use in conventional foods. FDA’s regulation describes 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.
The FDA knows of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to Jan. 1, 1958. Based on FDA 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. Many unanswered questions and data gaps about CBD toxicity exist, and 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 FDA review, the use of CBD in the firm’s products does not satisfy the criteria for GRAS status.
The full warning letter can be viewed here.
11-11-11 Brands
Newtown, PA
A food firm in Pennsylvania is on notice from the FDA because some of the firm’s CBD products are adulterated under FDA regulation.
In a Nov. 16, 2022, warning letter the FDA described an Oct. 2022, review of 11-11-11 Brands’ website at the internet address “mood33.com.”
The FDA’s review brought concern that the firm’s products are in a form (herbal tea or beverage) that consumers may confuse with traditional foods and that they appear to contain caffeine. Evidence suggests that CBD may affect caffeine metabolism and may increase and/or prolong caffeine’s effects.
Because of the following issues, the FDA determined that introducing or delivering these products for introduction into interstate commerce violates the FD&C Act.
Some of the violations:
Adulterated Human Foods and 301(ll)
The firm’s Mood33 Hemp Infused Herbal Tea products are foods to which CBD has been added. The FDA collected a sample and confirmed that it contains CBD; the product label for this product stated that the product contained cannabinoids derived from hemp (“with 33mg Full Spectrum Hemp Derived Cannabinoids”). The firm’s website bears analytical reports that list the CBD content in their products ranging from 21.30 mg CBD per unit to 35.50 mg CBD per unit. Furthermore, their press page at https://mood33.com/press/, which endorses the linked articles under the heading “Get the latest buzz on mood33 Hemp-Infused Teas,” has links to articles stating that their products use “proprietary CBD microencapsulation.” These linked articles include “A cup of CBD tea? mood33 launches hemp-infused herbal tea range” posted on Dec. 3, 2019, and “mood33 launches new line of hemp-infused herbal teas,” posted on Dec. 2, 2019.
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.
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 and causes the food to be adulterated. The introduction of an adulterated food into interstate commerce is prohibited.
The full warning letter can be viewed here.
Newhere Inc dba CBDFX
Chatsworth, CA
A food firm in California is on notice from the FDA because some of the firm’s CBD products are adulterated under FDA regulation.
In a Nov. 16, 2022, warning letter the FDA described an Oct. 2022, review of Newhere Inc dba CBDFX’s website at the internet address “cbdfx.com.”
The FDA’s review found that some of the firm’s products are in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children. As well as, the firm’s CBD-containing products for animals are unapproved new animal drugs that are unsafe under FDA regulation.
Because of the following issues, the FDA determined that introducing or delivering these products for introduction into interstate commerce violates the FD&C Act.
Some of the violations:
Adulterated Human Foods and 301(ll)
According to the firm’s product labeling, their CBD Chill Shots, and CBD Cookies with Protein 20mg, including Chocolate Chip, Oatmeal Raisin, and Peanut Butter flavors, are foods to which CBD has been added. The FDA analyzed a sample of their CBD Lemonade Chill Shot and CBD Chocolate Chip Cookies with Protein 20mg products and confirmed that the product contains CBD. The FDA also notes that they may intend to promote their Mixed Berries Gummies 1500mg as a conventional food product. Specifically, they describe these gummy products as “Gummies — like classic gummy bears — are one of the most popular candy treats on the planet. People love the burst of flavor that comes with these delicious chews.“
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.
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 and causes the food to be adulterated.
Unapproved New Drugs
Based on the FDA review of their website and social media website, their CBD-containing products for humans are defined by the FDA as drugs, 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 their website and YouTube social media account that establish the intended use of their CBD-containing products for humans as drugs include, but may not be limited to, the following:
From their website www.cbdfx.com:
On the June 9, 2021 blog titled, “CBD FOR SLEEP: BEATING INSOMNIA THE NATURAL WAY,”:
• “CBD FOR SLEEP: BEATING INSOMNIA THE NATURAL WAY”
• “Can CBD Help with sleep apnea? . . . In some areas, like sleep apnea, we have to rely on anecdotal evidence and our own reasoning” with the words “anecdotal evidence” hyperlinked to an article, “Finding a Natural Remedy for Sleep Apnea.” The article, “Finding a Natural Remedy for Sleep Apnea” includes statements such as, but not limited to:
o “CBD for sleep apnea . . . helped both my husband and me get better sleep at night.”
The full warning letter can be viewed here.
CBD American Shaman, LLC
Kansas City, MO
A food firm in Missouri is on notice from the FDA because some of the firm’s CBD products are adulterated under FDA regulation.
In a Nov. 16, 2022, warning letter the FDA described an Oct. 2022, review of CBD American Shaman, LLC’s website at the internet address “CBDAmericanShaman.com.”
The FDA’s review found that some of the firm’s products are in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children.
Because of the following issues, the FDA determined that introducing or delivering these products for introduction into interstate commerce violates the FD&C Act.
Some of the violations:
Adulterated Human Foods and 301(ll)
According to the firm’s product labeling, their CBD Suckers, CBD Hard Candies, Cookies [with] 10mg CBD per Serving, CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, and CBD Honey products are foods to which CBD has been added. The FDA analyzed a sample of their Grandma’s Raisin & Pecan Hermit Cookies and confirmed that the product contains CBD. The FDA also notes that they may intend to promote their 10mg CBD Gummies, CBD Gourmet Gummies, CBD Energy Gummies, and Sugar Free CBD Gourmet Gummies as conventional food products. Specifically, they describe these gummy products as “adult gummy candy” and/or “the perfect way to satisfy your sweet tooth,” and the web pages for three of the products bear Nutrition Facts information.
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.
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 and causes the food to be adulterated. The introduction of an adulterated food into interstate commerce is prohibited.
CBD is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated. Therefore, the firm’s CBD Suckers, CBD Hard Candies, Cookies [with] 10mg CBD per Serving, CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, and CBD Honey products are adulterated because they bear or contain an unsafe food additive.
To the extent the firm intends to promote their 10mg CBD Gummies, CBD Gourmet Gummies, CBD Energy Gummies, and Sugar Free CBD Gourmet Gummies as conventional food products, they would be adulterated.
Further, in regard to their Cookies [with] 10mg CBD per Serving, CBD Suckers, CBD Hard Candies, CBD Sparkling Tea, CBD Sparkling Water, CBD Coffee, CBD Honey Sticks, and CBD Honey, and, to the extent they intend to promote their 10mg CBD Gummies, CBD Gourmet Gummies, CBD Energy Gummies, and Sugar Free CBD Gourmet Gummies as conventional food products, the firm should be aware that it is a prohibited act, to introduce or deliver for introduction into interstate commerce any food, including animal food, to which has been added a drug approved 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 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 regulation prohibits the introduction into interstate commerce of any food to which CBD has been added, but the firm may present FDA with any evidence bearing on this issue.
Unapproved New Human Drug and Misbranded Human Drug
“CBD + ZINC OXIDE Sunscreen” is a “drug”, because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, because it is intended to affect the structure or any function of the body. Specifically, this product is intended for use as sunscreen.
Examples of claims from the product’s labeling, including the claims observed on their website, www.cbdamericanshaman.com, that provide evidence of the intended uses of the product include, but may not be limited to, the following:
“CBD + ZINC OXIDE Sunscreen . . . BROAD SPECTRUM SPF 35+ UVA • UVB” [from the label on their website, https://cbdamericanshaman.com/cbd-sunscreen]
“Drug Facts . . . Active Ingredients [s] . . . Cannabidiol (Hemp Exract [sic] (Aerial Parts), Cannabidiol) 0.072% . . . Purpose . . . Sunscreen . . .” [from the label on their website, website, https://cbdamericanshaman.com/cbd-sunscreen]
“This all natural CBD sunscreen lotion is a natural way to protect yourself from harmful UV rays while using an all-natural product that won’t harm you or our planet! This cbd infused sunscreen is 35+ SPF (broad spectrum) and is rated to block UVA and UVB rays. We use Zinc Oxide which is rated safe by EWG on their Skin Deep website and isn’t hazardous for the environment like oxybenzone or octinoxate. There is 60mg of nano full-spectrum CBD oil per container.” [from the product information on their website, https://cbdamericanshaman.com/cbd-sunscreen]
Based on the above labeling claims, “CBD + ZINC OXIDE Sunscreen” is a topical product intended for use as a sunscreen drug. As described below, this sunscreen drug is an unapproved new drug marketed in violation of FDA regulation.
In general, a drug product is a “new drug”, if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling; and in general, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect.
“CBD + ZINC OXIDE Sunscreen” is a sunscreen drug subject to section 505G of the FD&C Act [21 U.S.C. 355h], which governs nonprescription drugs marketed without an approved application. Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “OTC monograph drugs”—may be legally marketed if they meet applicable requirements. In particular, sunscreen drug products are deemed to be GRASE and not a “new drug” if, among other things, they conform to the conditions of use set forth in the Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (hereinafter M020). However, this sunscreen drug product does not conform to the conditions of use specified in M020 because the product’s labeling lists CBD as an active ingredient in the Drug Facts panel. CBD is not an active ingredient allowed in any applicable final monograph. Thus, their “CBD + ZINC OXIDE Sunscreen” product does not meet the requirements.
Furthermore, even if CBD could be considered an inactive ingredient in “CBD + ZINC OXIDE Sunscreen,” this product would still need an approved new drug application to be legally marketed because the product would not be eligible for marketing.
Unapproved New Animal Drugs
During the FDA’s review of the firm’s website cbdamericanshaman.com and their social media websites, www.instagram.com/cbdamerican and www.facebook.com/cbdamericanshamanproducts, FDA determined that the firm is marketing the unapproved new animal drugs Canine 300 Tincture, Doggy Chews (all flavors), Soft & Tender Doggy Chews, Canine 300 CBD and Terpene Rich Hemp Oil Water Soluble, Feline 300 Tincture, Horsey Chews, Doggy Nugs, and Kitty Nugs. Based on FDA review of their website and social media websites, these products are drugs 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 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 their website that show the intended use of their products as drugs include, but are not limited to, the following:
• On their webpage titled “CBD Dog Treats” under the header “How do CBD dog treats help your pup?”:
o “You can use CBD American Shaman dog treats to relieve your furry friends with high levels of stress. We include CBD oil for dogs in each treat to help calm pets during a storm, firework show, loud party or any other situation that puts them in a state of panic.”
o “They [CBD dog treats] may also help regulate heartbeat and blood pressure”
• On their webpage titled “How To Choose A CBD Oil Product” under the header “Dogs”:
o “If you would like to give your dog CBD every once in a while, like before the vet, for 4th of July fireworks, or when your dog may be extra anxious, we recommend any of our Dog CBD oils (https://cbdamericanshaman.com/pets) and Soft CBD Dog Treats (https://cbdamericanshaman.com/soft-cbd-dog-treats).”
• On their webpage titled “How To Choose A CBD Oil Product” under the header “Cats”:
o “Our feline CBD (https://cbdamericanshaman.com/feline-cbd-hemp-oil-tincture) oils are also great for when your cat needs help calming down or relaxing before a triggering event.”
Examples of claims observed on their social media websites that show the intended use of their products as drugs include, but are not limited to, the following:
• On their Oct. 13, 2021 Instagram and Facebook posts: “Does your dog need support for #jointhealth or experience storm stress? Our unique recipe of high-quality CBD oil dog treats taste like peanut butter and will leave your pet wanting more.”
• On their Feb. 23, 2018 Facebook post: A photo of a dog is posted by CBD American Shaman with the caption “#funfactfriday: CBD Oil is becoming more and more available for use on pets! In FACT, veterinarians are finding #cbdoil useful in arthritis, stress, digestive issues, and much more.”
o A comment on this post and response from CBD American Shaman:
Comment from follower: “I am considering trying this for our dog who had seizures.”
Response from CBD American Shaman: “A lot of people are having success with their dogs [sic] seizures using CBD.”
• On their Oct. 16, 2017 Facebook video post:
o At the 20 second mark in the video a graphic states, “From arthritic canines to anxiety filled equines, CBD Oil is changing the way veterinarians and pet owners treat their furry family members.”
o At the 28 second mark in the video a graphic with the heading “CBD Hemp Oil” states, “Whether a dog has cancer, seizures, or anxiety, cannabis oil can serve as an alternative medication to help treat symptoms.”
• On their Sept. 27, 2017, Facebook post: “Animals have anxiety, joint discomfort, and many of the same disorders as humans. So, just as with our human line of products, we use the best of ingredients for our canine, feline, or equine customers.”
Their CBD-containing products for animals are “new animal drugs” 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.
The full warning letter can be viewed here.
Naturally Infused LLC
New Port Richey, FL
A food firm in Florida is on notice from the FDA for concern that some of the firm’s CBD products are in forms that are appealing to children.
In a Nov. 16, 2022, warning letter the FDA described an Oct. 2022, review of Naturally Infused LLC’s website at the internet address “www.naturallyinfused.com.”
The FDA’s review brought concern, that with these products, there is a risk of unintended consumption including a child,of the CBD ingredient by consumers.
Because of the following issues, the FDA determined that introducing or delivering these products for introduction into interstate commerce violates the FD&C Act.
Some of the violations:
301(ll) and Adulterated Human Foods
According to the firm’s product labeling, their CBD Lollipops, CBD Infused Sugar, CBD Gummies, and CBD Infused coffees products are foods to which CBD has been added.
Food additives require premarket approval based on data demonstrating safety. There is no food additive regulation that authorizes the use of CBD.
Therefore, their CBD Lollipops, CBD Infused Sugar, CBD Gummies, and CBD Infused coffees products are adulterated because they bear or contain an unsafe food additive. Introduction of these adulterated foods into interstate commerce is prohibited.
Further, according to the firm’s product labeling, their D8 THC Infused coffees and Delta-8 THC Gummies are foods to which Delta-8 THC has been added.
There is no food additive regulation that authorizes the use of Delta-8 THC.
In addition, studies in animals have suggested that gestational exposure to Delta-8 THC can interfere with neurodevelopment. Therefore, based on FDA review, the use of Delta-8 THC in their products does not satisfy the criteria for GRAS status.
According to the firm’s product labeling, their CBD Lollipops, CBD Infused Sugar, CBD Gummies, and CBD Infused coffees are foods to which CBD has been added. Therefore, the introduction or delivery for introduction into interstate commerce of these products is prohibited.
Unapproved New Human Drugs
Based on FDA review of the firm’s website and social media websites listed above, their CBD-containing products for humans are drugs 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 their website and social media websites that establish the intended use of their CBD-containing products for humans as drugs include, but may not be limited to, the following:
From their website https://naturallyinfused.com/articles.html, webpage titled, “Articles,” that lists links to pages with articles and blog posts, including:
• A link to an article entitled, “A Primer About Cannabidiol and the Benefits of CBD,” which contains claims such as, “CBD is a powerful anti-epileptic, anti-depressant . . . muscle relaxant, sedative . . .”
• A link to an article entitled, “CBD and Bipolar Disorder,” which contains claims such as, “research suggests that certain cannabinoids found in marijuana, i.e. THC and CBD, may have significant mood-stabilizing properties that could be beneficial for patients with bipolar disorder. . . CBD seems to counter the psychoactive effects produced by high doses of THC and may also possess anti-anxiety, hypnotic and anticonvulsant properties of its own.”
From their social media website https://www.facebook.com/Naturally-Infused-CBD-CBG-335285106887519/:
• Aug. 20, 2021 post: “Recommended by primary care physicians, cardiologist [sic], chiropractors, pain management doctors and more! If you want help to stop taking opioids, stop on by! 6813 State Road 54 New Port Richey [the street address for their firm’s retail store]” followed by an image of a store window displaying the text, “CBD.”
• Sept. 27, 2017 post: An image of a banner displaying the text, “Alzheimers [sic] – Anxiety . . . Autism – Auto Immune Disorder – Cancer – Depression – Diabetes – Epilepsy . . . NATURALLY INFUSED CBD . . . Spray & Rub . . . Roll & Rub . . . Tinctures . . . NATURALLYINFUSED.COM[,] Fibromyalgia – Glaucoma . . . M.S. . . . Psoriasis – Seizures”
• June 2, 2017 posts: Images of a T-shirt with the text “Got CBD?” on the front of the shirt and the following text on what appears to be the back of the shirt: “HAVE THESE? . . . Auto Immune Disorder . . . M.S. . . . Cancer . . . Depression . . . Psoriasis . . . Epilepsy . . . Seizures . . . Fibromyalgia . . . Go To: NaturallyInfused.com”
The firm’s CBD-containing products for humans are not generally recognized as safe and effective for their above referenced uses and, therefore, these products are “new drugs.” With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA.
Misbranded Human Drugs
The firm’s CBD-containing products for humans are also 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.
The full warning letter can be viewed here.
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