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WARNING LETTER

Rena's Organic MARCS-CMS 613036 —

Delivery Method:
Via Email
Product:
Animal & Veterinary
Dietary Supplements
Drugs
Food & Beverages
Recipient:
Recipient Name
Ms. Rena S. Greenberg
Recipient Title
Registered Agent
Rena's Organic

414 26th St West
Bradenton, FL 34205-4926
United States

SUPPORT@renasorganic.com
Issuing Office:
Office of Human and Animal Food Operations East Division IV

United States

WARNING LETTER

22-HAFE4-WL-02/CMS No. 613036

Dear Ms. Greenberg:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.renasorganic.com in February 2022 and has determined that you take orders there for the products “300 mg CBD Full Spectrum Oil Cannabinoid Tincture”, “600 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “1500 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “500 mg Pain Relief Cream,” “1000 mg Pain Relief Cream,” “1000 mg CBD Anti-Aging Beauty Cream,” “CBD Super Cider,” “CBD Super Food,” and “Rena’s Organic For Pets 300mg CBD,” all of which you promote as products containing cannabidiol (CBD). We have also reviewed your social media websites at www.facebook.com/RenasOrganic and www.instagram.com/renasorganic; these websites direct consumers to your website, www.renasorganics.com to purchase your products. The claims on your website and social media websites establish that your “300 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “600 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “1500 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “500 mg Pain Relief Cream,” “1000 mg Pain Relief Cream,” “1000 mg CBD Anti-Aging Beauty Cream,” “CBD Super Cider,” and “CBD Super Food” 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 “Rena’s Organic For Pets 300mg CBD” 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.

Unapproved New Human Drugs

Based on our review of your website and your social media websites, your “300 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “600 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “1500 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “500 mg Pain Relief Cream,” “1000 mg Pain Relief Cream,” “1000 mg CBD Anti-Aging Beauty Cream,” “CBD Super Cider,” and “CBD Super Food” 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 https://renasorganic.com and your social media website https://www.facebook.com/RenasOrganic/ that establish the intended use of your products as drugs include, but may not be limited to, the following:

On the Blog post, “3 Reasons to Be Excited About CBD!” dated January 15, 2021:
• “Cancer-Fighting Capabilities . . . recent studies have shown that CBD can act as a direct antitumor agent for a variety of aggressive cancers and can even prevent the spread of cancer cells in the body.”
• “Potential for Neurodegenerative Disorders and Brain Injury . . . CBD has various neuroprotective effects that have shown effectiveness against neural cell damage related to various neurodegenerative disorders such as Alzheimer’s. CBD consumption can limit or prevent the damage caused by the advancing disease and even slow down the progression of degenerative brain diseases. Studies are also being conducted to conclusively prove the benefit of administering CBD immediately after traumatic brain injuries or spinal cord injuries to prevent the release of harmful mediators that often lead to permanent brain damage in such scenarios.”

On the webpage titled, “CBD Oil: Can It Treat Opioid Dependency?” linked from your Facebook post dated October 10, 2020 (which states “Opioid addiction kills 130 people in the USA every day. The medical community believes that CBD can curb opioid dependence in the country.”):

• “CBD is being touted as a safer alternative to opioids in the market. Unlike opioids, CBD isn’t addictive and doesn’t have psychoactive properties. Preliminary studies show that CBD can reduce opioid cravings, and that it breaks the addiction cycle.”

• “Seeing how CBD effectively manages pain, many healthcare providers have started recommending it to patients suffering from chronic pain and undergoing chemotherapy.”

• “Prevents Relapse . . . According to preclinical studies, the therapeutic properties of CBD can reduce cravings for psychostimulants, opioids and hard drugs like cocaine. CBD also rewires the brain’s programming to lower the intensity of cravings, making it easier to break the opioid addiction.”

On the Blog post, “How CBD Can Help You Quit Smoking” dated August 27, 2020:

• “CBD can help you with smoking cessation. There’s mounting evidence that suggests that CBD can decrease the urge to smoke, until it disappears altogether.”

• “According to studies, CBD oil can help weaken habitual triggers and breaks the addictive association with time, allowing smokers to quit.”

• “Preventing Relapse . . . While there still isn’t enough research to confidently say that CBD oil can eliminate nicotine addiction, ongoing studies have proven that it can be used to prevent relapses when quitting cocaine and morphine.”

• “Combating Nicotine Withdrawal . . . CBD triggers the release of serotonin by reacting with 5-HT1A receptors in the brain (just like antidepressants) and prevents anxiety, stress and moodiness caused by quitting smoking.”

On the webpage titled, “CBD Oil: Can it Help ADHD Patients?” linked from your Facebook post dated October 23, 2020:

• “CBD is especially useful in releasing serotonin in the body to combat feelings of anxiety and stress. Increased levels of serotonin in the body help us feel more relaxed and boost concentration—this is why many patients believe CBD can treat ADHD.”

• “CBD is a much safer alternative to conventional ADHD treatment. It’s all-natural, and it reacts with our bodies inbuilt receptors to promote optimal functionality.”

On the webpage titled, “Curing Insomnia with CBD” linked from your Facebook post dated October 24, 2020:

• “Anxiety and insomnia go hand in hand. People who suffer from anxiety usually struggle with insomnia. Treating anxiety through therapy, medication, or CBD can help people sleep better.”

On the webpage titled, “What is CBD?”:

• “At Rena’s Organic, I want you to share with you the truth about CBD and its amazing properties. That’s because I want you and your loved ones to have an alternative to risky and debilitating pills and opioids.”

On the Blog post, “How to Use CBD to Combat Holiday Stress” dated January 22, 2021:

• “Reduced Anxiety and Depression . . . Studies show that cannabidiol has anxiolytic-like and anti-depressant-like effects, which can help reduce anxiety and depression in many people. While more research is required to prove the therapeutic effects of CBD, there are several studies that suggest that CBD can help alleviate some symptoms of depression and make the condition easier to manage.”

On the webpage titled, “Using CBD Oil for the Symptoms of Fibromyalgia” linked from your Facebook post dated February 9, 2021:

• “CBD oil has helped countless patients gain relief from the debilitating symptoms of fibromyalgia.”

• “According to a 2020 review, CBD oil has proven to . . . reduce inflammation, and relieve chronic pain. CBD also helps with . . . anxiety, which can keep people from achieving a state of complete rest.”

On the product page for “CBD Super Cider”:

• “Curbs Cravings”

• “Helichrysum [an ingredient in CBD Super Cider] is a powerful compound that works on your Endo-cannabinoid system. It is know [sic] to be a potent:
  o Anti-depressant
  o Mood stabilizer
  o Inflammation Fighter”

• “Orange Essential Oil [an ingredient in CBD Super Cider] may naturally relieve anxiety, . . . depression and inflammation of the body.”

Your “300 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “600 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “1500 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “1000 mg CBD Anti-Aging Beauty Cream,” “CBD Super Cider,” and “CBD Super Food” are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

External Analgesic Drug Products

Based on the above labeling claims, “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” are topical products intended for use as external analgesics, among other uses. As described below, these external analgesic drug 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).

As previously noted, in general, a drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not 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, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” drug products.

“500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” are external analgesic drug products 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 without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. In particular, topical products intended for use as an external analgesic are deemed to be GRASE and not a “new drug” if, among other things, they conform to the tentative final monograph (TFM) that is the most recently applicable proposal or determination for such drug issued under 21 CFR Part 330. We note that OTC topical external analgesic products were addressed in the TFM for External Analgesic Drug Products for Over-the-Counter Human Use (external analgesic TFM; 48 FR 5852, February 8, 1983) and subsequent rulemakings. The 1983 external analgesic TFM, in combination with subsequent determinations, was deemed to be a final administrative order by section 505G(b)(8) of the FD&C Act. However, your “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” products do not conform to the conditions of use specified in the final administrative order, because the products’ active ingredient, CBD, is not an active ingredient in such order (nor in any applicable final monograph or TFM).

Although CBD is listed as an inactive ingredient in the labels of your “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” products, 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 labels and website repeatedly highlight the use of CBD for various conditions (see above claims), include numerous references to CBD with images of cannabis plants; and prominently feature CBD on the principal display panels of all of your “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” products. CBD is not a permitted active ingredient under the 1983 TFM.

Even if CBD could be considered an inactive ingredient in your “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” products, these products would still need an approved drug application to be legally marketed because they would not meet the requirements for marketing under section 505G of the FD&C Act. In particular, these products would not meet the conditions under section 505G(a)(1), insofar as they would not conform with the general requirement in 21 CFR 330.1(e) that inactive ingredients must be safe and suitable.1 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).2 CBD has no known functional role as an inactive ingredient in a finished drug product. Additionally, an inactive ingredient should not exert pharmacological effects3 and must be safe when used at the intended dosage.4 CBD, however, has known pharmacological activity with demonstrated risks.5 It is unknown whether the levels of CBD used in your “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” products 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 “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” product, that product would not meet the general requirements for nonprescription drugs needed for legal marketing under sections 505G(a)(1). Thus, “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” do not meet requirements under section 505G of the FD&C Act, under which they would be deemed to be GRASE and not a new drug.

In addition, FDA is not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling. Moreover, there is no evident basis under the FD&C Act under which these products would be legally marketed without an approved application. Accordingly, “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” are unapproved new drugs marketed in violation of section 505(a) of the FD&C Act, 21 U.S.C 355(a). Introduction or delivery for introduction of such products into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. 331(d).

Misbranded Human Drugs

Your “300 mg CBD Full Spectrum Oil Cannabinoid Tincture”, “600 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “1500 mg CBD Full Spectrum Oil Cannabinoid Tincture,” “500 mg Pain Relief Cream,” “1000 mg Pain Relief Cream,” “1000 mg CBD Anti-Aging Beauty Cream,” “CBD Super Cider,” and “CBD Super Food” 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).

Furthermore, your “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” products are also misbranded under section 502(a) of the FD&C Act because the labeling of these products is false and misleading for several reasons. First, the labeling for these products identifies CBD as an inactive ingredient but represents CBD as having purported active pharmacological properties such as pain relief, among others. Even if CBD could be considered an inactive ingredient in these products, the prominent featuring of CBD on the labeling of your “500 mg Pain Relief Cream” and “1000 mg Pain Relief Cream” products causes the products to be misbranded under section 502(a) of the FD&C Act, which deems a drug to be misbranded if its labeling is “false or misleading in any particular,” and under 21 CFR 201.10(c)(4). Under 21 CFR 201.10(c)(4), “[t]he labeling of a drug may be misleading by reason . . . [of] the featuring in the labeling of inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation.”

301(ll) and Adulterated Foods

We note that some of your products appear to be promoted or labeled as conventional foods. For example, your “CBD Super Cider” product is promoted as having a “delicious taste” and that it will not “have that sickeningly, sweet taste that most drinks offer.” Additionally, your “CBD Super Cider” and “CBD SuperFood” products are labeled with a Nutrition Facts label. Your “300 mg CBD Full Spectrum Oil Cannabinoid Tincture”, “600 mg CBD Full Spectrum Oil Cannabinoid Tincture” and “1500 mg CBD Full Spectrum Oil Cannabinoid Tincture” products, which are taken sublingually, also bear a Nutrition Facts label. However, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food, including animal food, to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.6 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.

According to your product labeling, your “CBD Super Cider” and “CBD SuperFood” 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.7

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 conventional food 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. 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 website, www.renasorganic.com, and your social media websites, www.facebook.com/RenasOrganic and www.instagram.com/renasorganic, FDA determined that your firm is marketing the unapproved new animal drug “Rena’s Organic For Pets 300mg CBD.” Based on our review of your website and social media websites, your “Rena’s Organic For Pets 300mg CBD” 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 an animal. 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 website www.renasorganic.com, and your social media websites, www.facebook.com/RenasOrganic and www.instagram.com/renasorganic, that establish the intended use of your “Rena’s Organic For Pets 300mg CBD” as a drug include, but are not limited to, the following:

On your product webpage for “Rena’s Organic For Pets 300mg CBD” at https://renasorganic.com/products/renas-organic-for-pets/:

• “Whatever ailment your pet is suffering from, CBD or Cannabidiol, has shown extremely promising results.”

On your blog post titled “4 Uses for CBD for Your Pets” at https://renasorganic.com/4-uses-for-cbd-for-your-pets/:

• “Small scale studies have shown that CBD can help calm anxious pets without compromising their health, so they’re easier to manage.”

• “Let’s look at some of the uses of CBD for your pets:

1. CBD as a Painkiller
CBD is known for its anti-inflammatory properties that make it an effective painkiller for humans and animals. If your pet was injured in an accident, try massaging the effective area with potent CBD oils to reduce the
inflammation and pain. . . .

2. CBD is an Anticonvulsant
It’s not very common, but pets can have seizures too. Seeing your pet have a seizure is the traumatizing, to say the least. If your pet has a condition that causes seizures or tremors, use CBD to reduce them. CBD is an anticonvulsant; it’s proven to be very effective at treating epilepsy and other similar conditions.

3. CBD for Anxiety and Stress
Owners struggling to manage an anxious pet can use CBD to calm them down. Both dogs and pets can suffer from anxiety in the same way humans do. If you notice that your pet hides in one corner of the house or gets aggressive when you’re trying to leave the house, you can use CBD to put them at ease. CBD relaxes animals by reducing stress and anxiety.

4. CBD as an Antiemetic
Is your pet vomiting everywhere due to certain illnesses? Try giving them some CBD brands ; it’s a known antiemetic and can help control nausea and vomiting. Your “Rena’s Organic for Pets” website metadata includes the following tag:
• “product_tag-dog-cancer-cbd”

On your webpage titled, “What is CBD?” at https://renasorganic.com/what-is-cbd/:

• “Many pet owners are faced with watching their pets suffer from many of the same diseases that humans are inflicted with. There are more and more reports of animals being treated for these and other ailments successfully with CBD.”

On your January 12, 2021 Facebook post www.facebook.com/RenasOrganic:

• “If something is making your pet anxious or tense, use our organic CBD Pet Product to help soothe them:”

On your January 6, 2021 Instagram post at www.instagram.com/renasorganic:

• “Try using our CBD product for pets. It can help reduce anxiety and calm down your furry companions. #CBD #CBDProducts #CBDforPainRelief #CBDforAnxiety #CBDforArthritis #CBDforStress #StressRelief #Anxiety”

Your “Rena’s Organic For Pets 300mg CBD” product is a “new animal drug” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because it is 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. 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).

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that 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.

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 this office 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 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 written response should be directed to the Food and Drug Administration, attention to: Mr. Ramon Hernández, District Director, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding this letter, please contact, Ms. Marilyn Santiago, Compliance Officer, at (787) 729-8707 or via email at Marilyn.santiago@fda.hhs.gov.

Sincerely,
/S/

Ramon A. Hernandez
District Director | FDA San Juan District
Program Division Director
Office of Human and Animal Food Operations-
East Division

________________________________

1 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".

2 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.

3 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)).

4 See 21 CFR 330.1(e).

5 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.

6 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.

7 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 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.

 
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