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WARNING LETTER

 

November 22, 2019

RE: 593395

 

Dear Mr. Hu:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.mrpinkcbd.com in September 2019 and has determined that you take orders there for the products “CBD Oil Drops” (various sizes and flavors), “CBD Gummies,” "CBD Vape Pen," and “Mr. Pink Natural CBD Oil for Pets” (also referred to as “Vegan Bacon Flavored Pet CBD Oil”), all of which you promote as products containing cannabidiol (CBD). We have also reviewed your social media websites at www.facebook.com/MrPinkCBD/ and www.instagram.com/mrpinkcbd/, and your firm’s YouTube video published on December 21, 2018, titled “11 Benefits of CBD – Mr. Pink CBD”;[1] these websites direct consumers to your website at www.mrpinkcbd.com to purchase your products. The claims on your website and social media websites establish that your “CBD Oil Drops,” “CBD Gummies,” and "CBD Vape Pen" products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your “Mr. Pink Natural CBD Oil for Pets” product is an unapproved new animal drug that is 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).

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.

Dietary Supplement Labeling

Information on your website at www.mrpinkcbd.com suggests that you intend to market your “CBD Oil Drops” and “CBD Gummies” products as dietary supplements. For example, your “CBD Oil Drops” product label contains a Supplement Facts panel and your website labeling refers to your “CBD Gummies” product as a dietary supplement in the product information section. 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.[2] 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 the evidence available to FDA, 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 bearing on this issue.[3]

Unapproved New Drugs

Based on our review of your website, your “CBD Oil Drops,” “CBD Gummies,” and "CBD Vape Pen" products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. 

Examples of claims observed on your website www.mrpinkcbd.com and social media websites www.facebook.com/MrPinkCBD/ and www.instagram.com/mrpinkcbd/ that establish the intended use of your products as drugs include, but may not be limited to, the following:

On a webpage on www.mrpinkcbd.com titled “How CBD Affects Your Immune System”:

• “CBD is a natural deterrent to inflammation which is known to suppress modern diseases such as depression, anxiety, arthritis and allergies.”
• “CBD can let diseased cells participate in a natural process called apoptosis meaning "suicide of the cells." Apoptosis provides the body with the ability to concentrate its energy and forces it function [sic] more efficiently, becoming a natural deterrent to cancerous cells . . ."

On a webpage on www.mrpinkcbd.com titled “How to Choose the Best Hemp CBD Oil”:

• “[H]emp CBD oil continues to be in high demand as a growing number of chronic pain patients look for alternatives to opioids and drugs with troubling side effects.”

On a webpage on www.mrpinkcbd.com titled “What is CBD Oil? How it works, and is it legal?”:

• “CBD oil can be used to treat common health issues such as acne, anxiety, depression, and help cancer patients.”

On your Facebook page at www.facebook.com/MrPinkCBD/:

• "[P]revious studies concluded that CBD oil is a promising treatment for numerous forms of anxiety, including social anxiety disorder, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder, and post-traumatic stress disorder."

On your Instagram page at www.instagram.com/mrpinkcbd/:

• “Known Benefits of CBD Oil . . . Used for chronic pain management . . . Used for treating depression . . . Arrests cancerous growth . . . Treats Irritable Bowel Syndrome . . . Topical therapy for Glaucoma . . . Has anti-inflammatory properties"

Captions on your video published on YouTube titled “11 Benefits of CBD – Mr. Pink CBD”:

• “Pain Relief – CBD interactions with receptors in the brain & immune system to reduce inflammation & alleviate pain.”
• “CBD protects against the vascular damage caused by a high glucose environment, inflammation, or the induction of type 2 diabetes.”
• “Has Antipsychotic effects – CBD benefits include producing antipsychotic effects, & is effective in open case reports & clinical trials in patients w/ Schizophrenia”
• “Improve Cholesterol”
• “CBD oil has been shown to repair damage from free radicals like UV Rays & pollutants.”

Your “CBD Oil Drops,” “CBD Gummies,” and "CBD Vape Pen" products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). 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-named products. 

Misbranded Drugs

Your “CBD Oil Drops,” “CBD Gummies,” and "CBD Vape Pen" products 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, 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).

301(ll) and Adulterated Human Foods

We note that your “CBD Gummies” product also appears to be promoted as a conventional human food. Specifically, your website labeling suggests that this product is food. To the extent that you market any of your products containing CBD as conventional food, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD. 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 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 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.[4]

Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(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 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. 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 our review, the use of CBD in conventional food products does not satisfy the criteria for GRAS status under 21 CFR 170.30.

FDA is not aware of any other exemption from 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).

Unapproved New Animal Drugs

During our review of your firm’s website www.mrpinkcbd.com, FDA determined that your firm is marketing the unapproved new animal drug “Mr. Pink Natural CBD Oil for Pets.” Based on our review of your website, your “Mr. Pink Natural CBD Oil for Pets” product (also referred to as “Vegan Bacon Flavored Pet CBD Oil”) is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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, this product is an unapproved new animal drug and marketing it violates the FD&C Act.

Examples of claims observed on your firm’s website www.mrpinkcbd.com that show the intended uses of this product include, but are not limited to, the following:

On your product webpage for “Mr. Pink Natural CBD Oil for Pets”:

• “CBD oil is known to promote relaxation and calmness, help with anxiety, reduce stress.”
• “[Mr. Pink CBD oil] helps in situations when an animal is being relocated, is put in an unfamiliar setting, which can cause stress, anxiety, and irritation.”
• “Pet CBD oil is great for making your pet relaxed in public places, before seeing a vet, or simply as a daily supplement that would help balance the nervous system of the animal as well as stabilize its metabolism.”

Your “Mr. Pink Natural CBD Oil for Pets” product is not generally recognized as safe and effective for the above referenced uses and, therefore, this product is a “new animal drug” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v). 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-l. This product is not approved or index listed by the FDA, and therefore this product is 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 this adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

301(ll) and Adulterated Animal Foods

Moreover, to the extent that you market any of your products containing CBD as animal food, 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 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.

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.[5] 

There is no animal 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 (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 foods. 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 foods 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.

Under section 409, 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.  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).

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above 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.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, 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, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 or by email to [email protected].

 

Sincerely,

/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

 

/S/
Eric Nelson
Director of Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine
Food and Drug Administration

 

/S/
William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration