WARNING LETTER
MB Solutions, LLC/BioSpectrum CBD
MARCS-CMS 610649 —
July 22, 2021
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Food & Beverages
Recipient:
Recipient Name
Frederic A. Melius, MD
MB Solutions, LLC/BioSpectrum CBD
5980 Executive Dr. Suite A
Madison
,
WI
53719
United States
Info@biospectrumcbd.com
Issuing Office:
Center for Drug Evaluation and Research
United States
WARNING LETTER
July 22, 2021
RE: 610649
Dear Dr. Melius:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at www.biospectrumcbd.com and www.nasadol.com from April 2021 through July 2021 and has determined that you take orders there for several products, including “Regular Strength Nasadol CBD Nasal Spray,” “Extra Strength Nasadol CBD Nasal Spray,” “Pain Relief Roll-On,” “CBD Oil Tincture” (500 mg and 1500 mg), “Sour Gummy Worms” (250 mg and 500 mg), “CBD Gummy Worms” (250 mg and 500 mg), “CBD Peach Rings” (250 mg and 500 mg), “Watermelon Slices” (250 mg, 500 mg, and 1000 mg), “CBD Gummy Bears” (500 mg and 1000 mg), “1,000mg Canine CBD Oil,” and “CBD Dog Treats,” all of which are represented as containing cannabidiol (CBD).
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We have also reviewed your social media websites at www.facebook.com/BioSpectrumCBD and www.instagram.com/biospectrum.cbd/; these websites direct consumers to your website www.biospectrumcbd.com to purchase your products.
Claims on your websites establish that your “Regular Strength Nasadol CBD Nasal Spray,” “Extra Strength Nasadol CBD Nasal Spray,” and “Pain Relief Roll-On,” are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Furthermore, your “Pain Relief Roll-On” product is misbranded in violation of section 502(ee), 21 U.S.C. 352(ee). In addition, your “Regular Strength Nasadol CBD Nasal Spray” and “Extra Strength Nasadol CBD Nasal Spray” are misbranded under 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). The introduction or delivery for introduction into interstate commerce of a misbranded drug is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
In addition, your “1,000mg Canine CBD Oil,” and “CBD Dog Treats,” 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).
Currently, a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. As explained below, nonprescription drug products that include CBD as an active ingredient are not generally recognized as safe and effective (GRASE) and are new drugs that require an approved application to be legally marketed. Furthermore, even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements for nonprescription drug products under section 505G of the FD&C Act. In particular, such product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1(e).
Your “Nasadol CBD Nasal Spray” products are intended to be sprayed into the nose and absorbed into the bloodstream. For example, from your website http://nasadol.com/, you state “Our water soluble CBD in the nose is immediately and efficiently absorbed, and directly transferred to within the brain. When you spray Nasadol into your nose, you will start to feel the health effects of our precise dosing right away.” Further, on your website https://www.biospectrumcbd.com/, you state “[T]he product that revolutionized the way CBD is delivered to the brain . . . requires less product for greater relief . . . [w]orks within 30 seconds . . . [i]mproved [b]ioavailability of CBD . . . [b]ypasses blood brain barrier in seconds.” These products are especially concerning from a public health perspective because intranasal drug products may be rapidly absorbed through the highly vascularized nasal mucosa directly into systemic blood circulation, where they may exert undesirable systemic effects such as increased heart rate or elevated blood pressure. If toxic substances are introduced directly into the nose, harmful local effects such as bleeding, ulceration, or nasal septal perforation may occur.
FDA has also determined that your “Sour Gummy Worms,” “CBD Gummy Worms,” “CBD Peach Rings,” “Watermelon Slices,” “CBD Gummy Bears,” “CBD Oil Tincture,” and “CBD Dog Treats” 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 “Sour Gummy Worms,” “CBD Gummy Worms,” “CBD Peach Rings,” “Watermelon Slices,” “CBD Gummy Bears,” “CBD Oil Tincture”, and “CBD Dog Treats” 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 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
.
Unapproved New Drugs
Based on a review of your websites, your “Regular Strength Nasadol CBD Nasal Spray,” “Extra Strength Nasadol CBD Nasal Spray,” and “Pain Relief Roll-On,” 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 websites www.nasadol.com and www.biospectrumcbd.com that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:
From www.nasadol.com
• A webpage that features a graphic of Nasadol CBD Nasal Sprays states that “[c]linical trials and other scientific research illustrate CBD’s usefulness in treating pain, anxiety, inflammation, depression, addiction and many other conditions.”
From www.biospectrumcbd.com
• “Regular Strength Nasadol CBD Nasal Spray”
• “Benefits
o Supports sense of calm*
o For Focus and Anti-Anxiety*
o Manage Stress*
o Relieves Headaches*
o Relieves Sinus Pressure*
o Allergy relief*
o Maintain and aid healthy sleep cycles*”
• “BioSpectrum CBD engineered this Pain Relief Roll-On to provide powerful long lasting relief from aches and pains. By using FDA approved pain relievers; Lidocaine, Menthol, Camphor, along with Broad Spectrum CBD Distillate, this product is truly unique and effective.”
Based on the above labeling claims, your “Regular Strength Nasadol CBD Nasal Spray,” “Extra Strength Nasadol CBD Nasal Spray,” and “Pain Relief Roll-On” products are drugs. We are not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that any of these products are GRASE for use under the conditions prescribed, recommended or suggested in their labeling. Thus, “Regular Strength Nasadol CBD Nasal Spray,” “Extra Strength Nasadol CBD Nasal Spray,” and “Pain Relief Roll-On” are “new drugs” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). New drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a), unless they are nonprescription drugs governed by and lawfully marketed under section 505G
2
of the FD&C Act, among other exceptions not applicable here. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for “Regular Strength Nasadol CBD Nasal Spray,” “Extra Strength Nasadol CBD Nasal Spray,” or “Pain Relief Roll-On,” nor do they meet the requirements for marketing without an approved application under section 505G of the FD&C Act, as described below. 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).
We note that section 505G of the FD&C Act governs nonprescription drugs marketed over-the-counter (or "OTC") without an approved drug application, such as your “Pain Relief Roll-On” product.
3
Under section 505G, certain nonprescription drug products may be lawfully marketed without an approved application if applicable requirements are met. However, your “Pain Relief Roll-On” product does not meet the requirements for marketing under section 505G. Specifically, it does not meet the applicable conditions under section 505G(a)(1) or (2) of the FD&C Act, 21 U.S.C. 355h(a)(1), (2), under which nonprescription drugs marketed without an approved application are deemed GRASE and not considered “new drugs” by operation of law. Among these conditions is that a drug conforms with the general requirements for nonprescription drugs and that it conforms with the requirements for nonprescription use of a final monograph issued under 21 CFR part 330 or, for drugs classified in Category I for safety and effectiveness under a tentative final monograph (TFM), that a drug conforms with the proposed requirements of such TFM. Your “Pain Relief Roll-On” does not meet these conditions, notably because its active ingredient CBD is not an active ingredient in any applicable final monograph or TFM.
4
Although CBD is not explicitly identified as the active ingredient in your “Pain Relief Roll-On,” the product labeling clearly represents CBD as an active ingredient, which is a component of a drug intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body (see 21 CFR 201.66(b)(2)). For instance, your product label for “Pain Relief Roll-On” prominently highlights on the principal display panel that it contains “1000mg CBD,” the company name on the label is Bio Spectrum CBD, the product is available on your website under the subheading “Shop CBD,” and your product page includes a lab analysis highlighting the product’s CBD content.
We note that you list CBD as an “other ingredient” on your “Pain Relief Roll-On” product label. Drug products only contain “active ingredients” or “inactive ingredients.” To the extent that CBD is intended to be an inactive ingredient in your “Pain Relief Roll-On” product, it would still need an approved drug application to be legally marketed because it does not meet the conditions under section 505G of the FD&C Act. In particular, the product would not meet the conditions under section 505G(a)(1) or (2) insofar that the product does not conform to the general requirement in 21 CFR 330.1(e) that inactive ingredients must be safe and suitable.
5
A suitable inactive ingredient generally provides a beneficial formulation function, such as a tablet binder or preservative, or improves product delivery (e.g., enhances absorption or controls release of the drug substance).
6
CBD has no known functional role as an inactive ingredient in a finished drug product. Additionally, an inactive ingredient should not exert pharmacological effects
7
and must be safe when used at the intended dosage.
8
CBD, however, has known pharmacological activity with demonstrated risks.
9
It is unknown whether the levels of CBD used in your “Pain Relief Roll-On” have pharmacological activity or pose any concern for safety events. Accordingly, CBD cannot be considered a safe and suitable inactive ingredient as required under 21 CFR 330.1(e). Consequently, if CBD is intended to be an inactive ingredient in your “Pain Relief Roll-On” product, this product would not meet the general requirements for nonprescription drugs needed for legal marketing under section 505G(a)(1) of the FD&C Act.
In addition to not meeting section 505G(a)(1) of the FD&C Act, your “Pain Relief Roll-On” product does not meet the other conditions under section 505G under which nonprescription drug products can be lawfully marketed without an approved application. Specifically, it does not satisfy the requirements under sections 505G(a)
10
nor is its marketing permitted by an order issued under section 505G(b).
11
In addition, your “Regular Strength Nasadol CBD Nasal Spray” and “Extra Strength Nasadol CBD Nasal Spray” also do not meet the conditions under section 505G for legal marketing without an approved application.
12
For the reasons described above, your Regular Strength Nasadol CBD Nasal Spray,” “Extra Strength Nasadol CBD Nasal Spray,” and “Pain Relief Roll-On” 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), 331(d).
Misbranded Drugs
Your “Regular Strength Nasadol CBD Nasal Spray,” “Extra Strength Nasadol CBD Nasal Spray,” and “Pain Relief Roll-On” are misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 502 and 301(a) of the FD&C Act, 21 U.S.C. 352 and 331(a).
OTC External Analgesic Drug
In particular, your “Pain Relief Roll-On” product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section, and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355. Accordingly, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).
Nasal Spray Drugs
In addition, your “Regular Strength Nasadol CBD Nasal Spray” and “Extra Strength Nasadol CBD Nasal Spray” products are misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. See 21 CFR 201.5. The aforementioned products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, including depression, anxiety, and addiction; 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 “Regular Strength Nasadol CBD Nasal Spray” and “Extra Strength Nasadol CBD Nasal Spray” 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 misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
301(ll) and Adulterated Human Foods
Furthermore, 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.
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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 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 “Sour Gummy Worms,” “CBD Gummy Worms,” “CBD Peach Rings,” “Watermelon Slices,” “CBD Gummy Bears,” and “CBD Oil Tincture” 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 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.
14
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. 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 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, “Sour Gummy Worms,” “CBD Gummy Worms,” “CBD Peach Rings,” “Watermelon Slices,” “CBD Gummy Bears,” and “CBD Oil Tincture” are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. 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, www.biospectrumcbd.com, and your social media websites, www.facebook.com/BioSpectrumCBD and www.instagram.com/biospectrum.cbd/, FDA determined that your firm is marketing the unapproved new animal drugs “1,000mg Canine CBD Oil” and “CBD Dog Treats”. Based on our review of your website and social media websites, your “1,000mg Canine CBD Oil” and “CBD Dog Treats” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act.
Examples of claims observed on your social media websites that establish the intended use of your “1,000mg Canine CBD Oil” and “CBD Dog Treats” as drugs include, but are not limited to, the following:
• On your Facebook and Instagram social media websites at www.facebook.com/BioSpectrumCBD and www.instagram.com/biospectrum.cbd/ respectively, March 22, 2021 postings with a photograph of your “1,000mg Canine CBD Oil” and “CBD Dog Treats” products:
o “We have CBD products your pups will be begging for! Did you know CBD may help reduce anxiety, pain and inflammation in dogs? CBD isn’t just for humans anymore!”
Your “1,000mg Canine CBD Oil” and “CBD Dog Treats” products are “new animal drugs” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-l. These product are not approved or index listed by the FDA, and therefore these products are considered unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). Introduction of these adulterated drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
301(ll) and Adulterated Animal Foods
Furthermore, it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any animal food, to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD, as described above.
According to your product labeling, your “CBD Dog Treats” product is an animal food to which CBD has been added. Specifically, your product label depicted on your website, www.biospectrumcbd.com, refers to this product as a “Dog Treat” and as “Steak Bites.” Additionally, the product label includes a “Guaranteed Analysis” section, which promotes the product as a source of protein, fat, and fiber. Therefore, the introduction or delivery for introduction into interstate commerce of this product is a prohibited act under section 301(ll) of the FD&C Act.
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.
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Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in animal food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the animal food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
There is no food additive regulation that authorizes the use of CBD in animal food. We are not aware of any information to indicate that CBD is the subject of a prior sanction (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal food. FDA’s regulations in 21 CFR 570.30(a)-(c) describe the criteria for eligibility for classification of an animal food ingredient as GRAS. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food (see 21 CFR 570.30).
We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958. Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal food are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity. Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30.
FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in animal food. Therefore, CBD added to animal food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act, 21 U.S.C. 348. Under section 409 of the FD&C Act, 21 U.S.C. 348, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any animal food. Animal food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Therefore, your “CBD Dog Treats” is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of this adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
* * *
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 any violations and for preventing their recurrence or the occurrence of other violations. According to your website, you manufacture many other types of CBD containing products. 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 address the violations cited in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
This letter notifies you of our findings and provides you an opportunity to address the above violations. Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any the violations. Include an explanation of each step being taken to prevent the recurrence of any 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 completely address any violations within fifteen working days, state the reasons for the delay and your schedule for completion.
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 FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
/S/
Michael Dutcher
Acting Director of Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine
Food and Drug Administration
/S/
Michael W. Roosevelt
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
_______________________________
1
From your website, www.nasadol.com, when you click “BUY NOW,” it directs to biospectrum.com and all of the products available on that website.
2
Section 505G of the FD&C Act was added under title III, subtitle F ("Over-the-Counter Drugs") of the CARES Act, Pub. L 116-136 (March 27, 2020).
3
We note that your “Pain Relief Roll-On” is made available for purchase by consumers without a prescription and that the label for that product includes ostensible "Drug Facts," which is part of the content and format required for OTC drug labeling under 21 CFR 201.66.
4
We note that OTC drug products such as your “Pain Relief Roll-On,” intended for external analgesic indications, such as the relief of pain, were addressed in the Tentative Final Monograph (TFM) for External Analgesic Drug Products for Over-the-Counter Human Use (external analgesic TFM; 48 FR 5852, February 8, 1983). CBD was not included as an active ingredient under this TFM.
5
21 CFR 330.1(e) requires that "the product contains only suitable inactive ingredients which are safe in the amounts administered and do not interfere with the effectiveness of the preparation or with suitable tests or assays to determine if the product meets its professed standards of identity, strength, quality, and purity".
6
See e.g., "Using the Inactive Ingredient Database" Guidance for Industry (July 2019), p. 1 at https://www.fda.gov/media/128687/download, and "Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients" Guidance for Industry (May 2005), pp. 1-2 at
https://www.fda.gov/media/72260/download
.
7
See e.g., 21 CFR 314.3(b) and 21 CFR 210.3(b)(7), which define an active ingredient as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man.” All other components of a finished drug product are considered inactive ingredients (see CFR 314.3(b), 21 CFR 210.3(b)(8)).
8
See 21 CFR 330.1(e).
9
For example, the labeling for Epidiolex (cannabidiol) prescription oral solution includes risks for the drug such as liver injury, interactions with other drugs or supplements, potential for male reproductive toxicity, somnolence, insomnia, diarrhea, decreased appetite, abdominal pain, upset stomach, changes in mood, irritability, and agitation. See
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210365s005s006s007lbl.pdf
.
10
Under 505G(a) of the FD&C Act, drugs in a final monograph and drugs that were classified as Category III for safety and effectiveness in a TFM that is the most recently applicable proposal or determination issued under 21 CFR Part 330 -- and that were not classified in such a TFM as Category II for safety or effectiveness -- are not required to have an approved application under section 505 in order to be marketed, as long as they are in conformity with the relevant conditions of use outlined in the applicable final monograph or TFM, including labeling conditions, and comply with all other applicable requirements for nonprescription drugs. Drugs containing CBD as an active ingredient were not classified under any final monograph or any TFM as Category III for safety and effectiveness. Thus, your “CBD Containing Products” do not meet the conditions under section 505G(a) for lawful marketing absent an approved application.
11
Your “Pain Relief Roll-On” product is not the subject of an order issued under section 505G(b)(1) of the FD&C Act, 21 U.S.C 355h(b)(1), under which it is considered GRASE and can be lawfully marketed without an approved application.
12
As noted above, CBD, the active ingredient in “Regular Strength Nasadol CBD Nasal Spray” and “Extra Strength Nasadol CBD Nasal Spray,” is not an active ingredient in any applicable final monograph or TFM. Moreover, the website labeling for these products includes indications such as depression, anxiety, and addiction, which are indications not covered under any applicable final monograph or TFM.
13
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 Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and 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.
14
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.
15
Under section 201(s)(5) of the FD&C Act (21 U.S.C. 321(s)(5)), new animal drugs are excluded from the food additive definition. If a new animal drug is unsafe within the meaning of section 512 because it is not approved for use in animal food, then the animal food is adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.
Content current as of:
07/29/2021
Regulated Product(s)
Animal & Veterinary
Drugs
Food & Beverages