WARNING LETTER
The Dragontree Apothecary LLC
MARCS-CMS 592743 —
April 28, 2020
Delivery Method:
Overnight Delivery
Product:
Dietary Supplements
Recipient:
Recipient Name
Briana Borten/Peter Borten
Recipient Title
Member and Owner
The Dragontree Apothecary LLC
1521 Pearl Street
Boulder
,
CO
80302
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
April 28, 2020
In reply, refer to CMS 592743
WARNING LETTER
Dear Ms. and Mr. Borten:
The U.S. Food and Drug Administration conducted an inspection of your facility, located at 12011 NE Marx Street, Portland, Oregon, from August 12, 2019, through August 21, 2019. Based on the inspection and a review of your product labels and your websites, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You may find the Act and related regulations through links in FDA's home page at www.fda.gov.
We received your email correspondence dated September 5, 2019, written in response to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection and items discussed with you during the inspection. We address your response below, in relation to each of the noted violations.
Dietary Supplement Labeling
Although you intend to market CBD Inflammation Relief, CBD Headache Relief, and CBD Sleep Support as dietary supplements, FDA has concluded that based on available evidence that CBD products cannot be dietary supplements because they do not meet the dietary supplement definition under section 201(ff) of the Act [21 U.S.C. § 321(ff)]. Further, FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) and (ii) of the 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 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.
1
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 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 CBD products are excluded from the dietary substance definition under section 201(ff)(3)(B)(i) and (ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(i) and (ii)], but you may present FDA with any evidence bearing on this issue. For more information on FDA’s regulation of CBD products, see our webpage at https://www.fda.gov/news-events/public-health-focus/fdaregulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your websites at the internet addresses https://dragontreeapothecary.com and https://dragontreecbd.com in April 2020, and has determined that you take orders there for Cold & Flu Relief, Inflammation Relief, Anxiety Relief, Sleep Support, Muscle Melt Liniment, Muscle Melt Balm, Muscle Melt Patch, CBD Headache Relief, CBD Sleep Support, and CBD Muscle Melt Balm. FDA also reviewed your product labels collected during the August 2019, inspection. The claims on your product labels and websites establish that your products are drugs under section 201(g)(1) of the 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 function of the body.
Examples of some of the claims on your websites and product labels that provide evidence your products are intended for use as drugs include the following:
Cold & Flu Relief
Statements that appear on the product label:
“[R]elief of cold & flu symptoms”
“For cold symptoms including sore throat, headache, runny nose, fever, and cough, take at the absolute first sign.”
Statements that appear on the website, https://dragontreeapothecary.com:
“[A]ddresses all facets of cold and flu symptoms”
“Some of our favorite herbs in this formula are: Honeysuckle— this is one of the primary anti-viral herbs . . . Elder berry and flower— long relied upon in American and European herbal medicine for colds and flus, new research now confirms the ability of this herb to destroy flu viruses. Ligusticum . . . is used to . . . treat headaches, sinus pain, and body aches. Isatis root— probably the strongest of anti-viral herbs in Chinese medicine, isatis and honeysuckle are in high demand during epidemic diseases, such as SARS.”
Inflammation Relief
Statements that appear on the website, https://dragontreeapothecary.com:
“Counters damaging inflammation in the body caused by . . . injury . . . and exposure to toxins.”
“[C]hronic inflammation is the root cause of many serious illnesses . . . including heart disease, many cancers, diabetes, and Alzheimer’s disease . . ..”
“Some of the powerful herbs [in Inflammation Relief] are . . . Honeysuckle— a valued herb for alleviating viral and bacterial infections and inflammation. . . Coptis root . . . anti-infective agent . . . potent anti-inflammatory herb.”
Anxiety Relief
Statements that appear on the product label:
“For acute anxiety, take 1 to 3 dropperfuls as needed.”
Statements that appear on the website, https://dragontreeapothecary.com:
“[M]ost effective, natural solution for your anxiety”
“Our Anxiety formula . . . eases anxiety without making you sedated”
“This formula is a combination of 18 synergistic herbs that address a full range of possible anxiety patterns. Some of those herbs are: . . . Zizyphus . . . for anxiety and insomnia . . . Passionflower . . . for anxiety and insomnia.”
Sleep Support
Statements that appear on the product label:
“For ongoing sleep problems, best taken not only at bedtime, but also midday and evening”
Statement that appears on the website, https://dragontreeapothecary.com:
“Some users with chronic insomnia have found that after taking the formula for several weeks or months, they can gradually discontinue it and continue sleeping well”
Muscle Melt Liniment
Statements that appear on the website, https://dragontreeapothecary.com:
“Reduces inflammation, release spasms, alleviates soreness, and increases circulation”
“Lobelia . . . anti-spasmodic” [Lobelia is an ingredient in Muscle Melt Liniment]
“Frankincense . . . anti-inflammatory” [Frankincense is an ingredient in Muscle Melt Liniment]
“Rhubarb root . . . anti-inflammatory” [Rhubarb root is an ingredient in Muscle Melt Liniment]
“Drynaria . . . to treat fractures, bruises, and sprains” [Drynaria is an ingredient in Muscle Melt Liniment]
Muscle Melt Balm
Statements that appear on the website, https://dragontreeapothecary.com:
“[M]assage into sore muscles and joints”
“[S]oothe uncomfortable muscles and joints more quickly and safely than oral pharmaceuticals”
“Here are a few of the 17 precisely chosen ingredients [in Muscle Melt Balm]: Helichrysum . . . anti-inflammatory and antimicrobial properties. Chamomile . . . anti-inflammatory and pain relieving effects. Clove . . . alleviate pain . . . antiinflammatory. . .”
Muscle Melt Patch
Statement that appears on the product label:
“Natural relief for muscles and joints”
Statements that appear on the website, https://dragontreeapothecary.com:
“Fast-acting and effective relief for your sore muscles and joints”
“[C]ooling/warming sensation eases your tension and pain away”
CBD Headache Relief
Statement that appears on the product label:
“Herbal formula for headache & migraine relief”
Statement that appears on the website, https://dragontreecbd.com:
“This powerful tincture . . . includes a wide range of herbs that address pain in all parts of the head – front, sinuses, jaw, eyes, sides, top, and back of the skull.”
CBD Sleep Support
Statement that appears on the website, https://dragontreecbd.com:
“Some users with chronic insomnia have found that after taking the formula for several weeks or months, they can gradually discontinue it and continue sleeping well.”
CBD Muscle Melt Balm
Statement that appears on the website, https://dragontreecbd.com:
“[S]oothe uncomfortable muscles and joints more quickly and safely than oral pharmaceuticals”
Your Cold & Flu Relief, Inflammation Relief, Anxiety Relief, Sleep Support, Muscle Melt Liniment, Muscle Melt Balm, Muscle Melt Patch, CBD Headache Relief, CBD Sleep Support, and CBD Muscle Melt Balm products are not generally recognized as safe and effective for the above referenced uses and, therefore, they are “new drugs” under section 201(p) of the 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 FDA, as described in sections 301(d) and 505(a) of the 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 products.
In addition, your Inflammation Relief product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “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). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner. The aforementioned product is offered for conditions that are not amenable to self-diagnosis and treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use this drug safely for its 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 product is not exempt from the requirement that its labeling bear adequate directions for use, 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved application is in effect for it. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
We note that we received your email correspondence dated September 5, 2019, in which you stated that you have retained legal counsel to assist in a comprehensive review of product claims and that you anticipated having the review and revisions to marketing materials completed by April 6, 2020. To date we have received no communication from your firm about this issue.
Adulterated Dietary Supplements
Your dietary supplement products are adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practice (CGMP) requirements for dietary supplements (21 CFR Part 111). Additionally, even if your Sleep Support, Anxiety Relief, Cold & Flu Relief, and Inflammation Relief products did not have therapeutic claims that make them drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
During the inspection, we found the following violations of CGMP requirements for dietary supplements:
1. You failed to establish specifications for your dietary supplements in accordance with, 21 CFR 111.70, such as the following:
a. Identity specifications for each component that you used in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1);
b. Component specifications, for each component that you use in the manufacture of a dietary supplement, that are necessary to ensure that the specifications for the purity, strength and composition of the dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2); and
c. Product specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e).
Specifically, during the inspection our investigator asked if specifications have been established for ingredients used to manufacture the supplements, any in-process steps affecting the quality of the supplements, the finished supplement products, packaging components like bottles and caps, and labels for the finished product. Your Apothecary Director stated that there is a recipe for each product, but specifications have not been established for finished products, ingredients, bottles and caps, or in-process parameters.
We reviewed your email correspondence dated September 5, 2019, which states you are in discussion with two potential consulting firms. While we acknowledge the action of using a consulting firm to assist you in developing your quality system, your response did not provide any interim measures you were planning to take before your anticipated completion date of April 6, 2020, nor have we received a communication from your firm as it relates to this matter after your anticipated completion date.
2. You did not prepare and follow a written master manufacturing record (MMR) for each unique formulation of your dietary supplements that you manufacture, and for each batch size, to ensure uniformity of the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, your firm has not established a written MMR that includes the identity specifications for any points, steps, or stages in the manufacturing process where control is necessary and to establish controls and procedures to ensure that each batch of dietary
supplement that you manufacture meets such specifications. During the inspection, your Apothecary Director stated there has not been any master manufacturing records created to meet the requirements because they did not understand that the requirements were so specific for manufacturing dietary supplements.
We reviewed your email correspondence dated September 5, 2019, which stated that you were planning to hire a consulting firm to assist you in developing your quality system. However, to date we have received no information upon which to evaluate whether you have taken corrective actions.
3. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, during the inspection, the Apothecary Director provided the investigator a document titled “Quality Control” in response to the investigator’s request for your written quality control procedures. However, this document does not satisfy the requirements
for quality control as listed in 21 CFR 111, Subpart F, including:
a. Ensuring that required representative samples and reserve samples are collected and held (21 CFR 111.105(f) and (g));
b. Requirements for conducting a material review and making a disposition decision (21 CFR 111.113);
c. Quality control operations for equipment, instruments and controls (21 CFR 111.117);
d. Quality control operations for components, packaging and labeling (21 CFR 111.120);
e. Quality control operations for MMRs, batch production records, and manufacturing operations (21 CFR 111.123);
f. Quality control operations for returned dietary supplements, including any dietary supplement that is reprocessed (21 CFR 111.130);
We reviewed your email correspondence dated September 5, 2019, in which you state you are using a consulting firm to assist you in developing your quality control operations. However, to date we have received no information upon which to evaluate whether you have taken corrective actions.
4. You failed to establish and follow written procedures to fulfill the requirements of this Subpart O (Product Complaints), as required by 21 CFR 111.553.
Specifically, during the inspection, the Apothecary Director provided our investigator with an untitled written procedure document, with a subsection titled “Complaints,” in response to the investigator’s request for your written complaint procedures. However, this document does not provide a procedure to have quality control personnel review and approve decisions about whether to investigate a product complaint and review and approve the findings and followup action of any investigation performed (see 21 CFR 111.560).
We reviewed your email correspondence dated September 5, 2019, in which you stated you are using a consulting firm to assist you in developing your complaint procedures. However, to date we have received no information upon which to evaluate whether you have taken corrective actions.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your 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, but not limited to, seizure and/or injunction.
Additionally, we have the following comment. Under 21 CFR 111.75(a)(1)(i), you must conduct at least one appropriate test or examination to verify the identity of the dietary ingredient prior to its use. As explained previously in this letter, you need to establish identity specifications for components in your dietary supplements, including dietary ingredients. During the inspection, the Apothecary Director explained to the investigator that botanical ingredients received in plant form undergo visual examination and
(b)(4)
exams such as
(b)(4)
and
(b)(4)
. However, your firm has no records of these examinations. Your Apothecary Director also explained that powdered ingredients undergo organoleptic examination. While organoleptic analysis may be an appropriate identity test for whole or coarsely-cut botanical parts, it may not be an appropriate identity test for powdered or extracted botanicals because of decreased reliability, or in those instances where misidentification of botanicals is known to occur. Organoleptic testing has limitations and may not be adequate or appropriate for verifying the identity of dietary ingredients in powder form in contrast to whole herbs or botanicals.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
Your firm’s response should be sent to: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of CDR Joshua Wireman, Compliance Officer. If you have any questions regarding this letter, please contact CDR Wireman at
425-302-0345
.
Sincerely,
/S/
Miriam R. Burbach
District Director
Program Division Director
cc: Matthew E. Moore, Apothecary Director
Dragontree Apothecary LLC
12011 NE Marx Street
Portland, Oregon 97220
_____________________
1
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.
Content current as of:
06/02/2020
Regulated Product(s)
Dietary Supplements