WARNING LETTER
Naturally Infused LLC
MARCS-CMS 628036 —
November 16, 2022
Delivery Method:
Via Overnight Delivery
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Gaetano Venezia
Naturally Infused LLC
6813 State Road 54
New Port Richey
,
FL
34653-6019
United States
Guy@NaturallyInfused.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
Center for Drug Evaluation and Research
Center for Veterinary Medicine
WARNING LETTER
November 16, 2022
RE: # 628036
Dear Mr. Venezia:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.naturallyinfused.com in October 2022 and has determined that you take orders there for various human and animal products, which you represent as products containing cannabidiol (CBD) or Delta-8 tetrahydrocannabinol (THC). We have also reviewed your social media websites at https://www.instagram.com/naturallyinfusedcbd/ and at https://www.facebook.com/Naturally-Infused-CBD-CBG-335285106887519/; these websites direct consumers to your website www.naturallyinfused.com to purchase your products.
FDA has determined that your CBD Lollipops, CBD Infused Sugar, CBD Gummies, CBD Infused coffees, D8 THC Infused coffees, and Delta-8 THC Gummies products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce your CBD Lollipops, CBD Infused Sugar, CBD Gummies, and CBD Infused coffees products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).
Further, the claims on your website and social media websites establish that all strengths and varieties of CBD Lollipops, CBD Infused Sugar, CBD Gummies, CBD Infused coffees, CBD Isolate in MCT Oil, CBD Plus CBG in MCT Oil, CBD/CBG/CBN Isolates in MCT Oil, CBD/CBG/CBN/Delta 8 THC, Full Spectrum Oil CBD, Roll & Rub CBD Oil, and Spray & Rub CBD (hereinafter referred to as “your CBD-containing 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-containing products for humans are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).
As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov
. You can find specific information about how FDA regulates CBD at
https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd
.
Over the past several years, FDA has warned the public on various illegally marketed CBD-containing products. FDA has also observed a proliferation of products containing another cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. See https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc. This letter is to inform you that your firm markets Delta-8 THC-containing products that may pose a serious health risk to consumers.
As stated above, the Agency is particularly concerned that some of your products are in forms that are appealing to children. For example, your CBD Lollipops, CBD Gummies, and Delta-8 THC Gummies are in forms that would be attractive to children and could easily be mistaken for traditional foods that are commonly consumed by children. Furthermore, you market other products that consumers may confuse with traditional foods for humans, including CBD Infused Sugar and CBD and Delta-8 THC Infused coffees. Therefore, there is a risk that consumers of these products, including children, will unintentionally consume CBD or Delta-8 THC ingredients. Additionally, we note that the CBD coffee products appear to contain caffeine. Evidence suggests that CBD may affect caffeine metabolism and may increase and/or prolong caffeine’s effects.
Your products have not been evaluated by the Agency for safety, effectiveness, and quality. As discussed below, CBD has been studied as a drug, and it is the active ingredient in the approved drug product Epidiolex. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations, such as children. For example, children may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites.
The Agency has also collected and analyzed samples of your CBD Lollipops and CBD Infused Sugar products and has confirmed the presence of cannabinoids in the products. We have particular safety concerns with the CBD Lollipops product, which was purchased from your website and did not have a label on the packaging indicating that the lollipops contain CBD. A consumer, including a child, could easily mistake the product for a traditional lollipop candy.
301(ll) and Adulterated Human Foods
According to your product labeling, your CBD Lollipops, CBD Infused Sugar, CBD Gummies, and CBD Infused coffees products are foods to which CBD has been added.
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.
1
Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act (21 U.S.C. 348(a)) and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
There is no food additive regulation which 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 CBD Lollipops, CBD Infused Sugar, CBD Gummies, and CBD Infused coffees 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 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 which authorizes the use of Delta-8 THC. We are not aware of any information to indicate that Delta-8 THC is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that Delta-8 THC is GRAS for use in conventional foods. FDA's regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).
We know of no basis for general recognition of safety for Delta-8 THC based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of Delta-8 THC in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from Delta-8 THC. Our review of published scientific literature identified potential for adverse effects on the central nervous and cardiopulmonary systems. In addition, studies in animals have suggested that gestational exposure to Delta-8 THC can interfere with neurodevelopment. Therefore, based on our review, the use of Delta-8 THC in your products does not satisfy the criteria for GRAS status under 21 CFR 170.30.
FDA is not aware of any other exception to the food additive definition that would apply to Delta-8 THC for use as an ingredient in a conventional food. Therefore, Delta-8 THC added to a conventional food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Delta-8 THC is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Therefore, your D8 THC Infused coffees and Delta-8 THC Gummies are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act because they bear or contain an unsafe food additive. Introduction of these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
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.
2
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.
According to your product labeling, your 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 a prohibited act under section 301(ll) of the FD&C Act.
Unapproved New Human Drugs
Based on our review of your website and social media websites listed above, your CBD-containing 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 website and social media websites that establish the intended use of your CBD-containing products for humans as drugs include, but may not be limited to, the following:
From your 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 your social media website https://www.facebook.com/Naturally-Infused-CBD-CBG-335285106887519/:
• August 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 your firm’s retail store]” followed by an image of a store window displaying the text, “CBD.”
• September 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”
3
Your 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” 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 the 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 CBD-containing products for humans.
Misbranded Human Drugs
Your 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. See 21 CFR 201.5. The aforementioned 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. 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, under 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved applications are in effect for them. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates 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.
Additionally, we have the following comment:
We are concerned that it appears your firm is marketing the following products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals: Canine and Feline Comfort, CBD Plus CBG in organic MCT Oil, and CBD/CBG/CBN Isolates in organic MCT Oil. These products are marketed on your social media website for intended uses including, but not limited to, the treatment of anxiety, seizures, and pain. There are FDA approved animal drugs to treat these conditions. If not treated appropriately, these conditions can have detrimental health and welfare consequences for animals.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the time within which you will do so. 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.
Your response should be sent to CFSANResponse@fda.hhs.gov. Please include “CMS 628036” in the subject line of your email.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling 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
_________________________
1
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.
2
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.
3
Your January 29, 2020 post on your social media website at https://www.instagram.com/p/B7576EJALfM/ contains similar claims.
Content current as of:
11/21/2022
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages