WARNING LETTER
EarthLab, Inc., dba Wise Woman Herbals
MARCS-CMS 634872 —
April 27, 2023
Delivery Method:
Overnight Delivery
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Bryan C. Bast
Recipient Title
Interim Chief Executive Officer
EarthLab, Inc., dba Wise Woman Herbals
1389 Center Drive, Suite 200
Park City
,
UT
84098
United States
Issuing Office:
Division of Human and Animal Food Operations West VI
United States
April 27, 2023
In reply, refer to CMS 634872
AMENDED
1
WARNING LETTER
Dear Mr. Bast:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, EarthLab, Inc., DBA Wise Women Herbals, located at 185 North Mill Street, Creswell, Oregon, from April 4 to April 14, 2022. Based on inspectional findings and a review of your websites www.wisewomanherbals.com and www.facebook.com/WiseWoman Herbals, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Unapproved New Drugs
We reviewed your website at www.wisewomanherbals.com in September and November 2022, and we determined you take orders for your products Green Tea Solid Extract, Curcuma Spp. Organic Turmeric, PSA Capsules, Healthy Prostate, Turmeric Gold Capsules, Joint Support, Upper Respiratory Support, and Elderberry Plus Syrup. We also reviewed your social media website at www.facebook.com/WiseWoman Herbals in September and November 2022, and we determined you direct consumers from your social media website to your website at www.wisewomanherbals.com, where you take orders for those products.
The claims on your websites establish these products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Green Tea Solid Extract
https://wisewomanherbals.com/blogs/news/supplements-for-stroke-preventions-helpreduce-stroke-risk
“Studies also show that green and black tea are helpful. Drinking three cups or more daily can reduce stroke risk by as much as 21% . . .. The antioxidants and anti-inflammatory properties in tea help prevent intracerebral hemorrhages from occurring. It is believed that compounds such as catechins also provide some protection against strokes.
Another option is to consider a green tea solid extract, which can also be used as a tea concentrate.”
Curcuma Spp. Organic Turmeric
https://wisewomanherbals.com/blogs/news/supplements-for-stroke-preventions-helpreduce-stroke-risk
“Can Turmeric Help Reduce the Risk of Strokes?
Curcumin, which is extracted from turmeric, may reduce the risk factors of stroke by reducing total cholesterol and improving vascular function . . .. In a study done on stroke-prone spontaneously hypertensive rats, curcumin delayed the onset of stroke and increased the rats’ survival time. Curcumin also increased relaxation of carotid artery response. All these factors help reduce stroke risk.”
PSA Capsules
https://wisewomanherbals.com/blogs/news/top-5-mens-health-supplements-for-mens-health-month
“PSA Capsules contain a blend of adaptogenic herbs like reishi…
The reishi mushroom, also known as ganoderma lucidum, has been shown to have anticancer effects, especially in those with prostate cancer. It does this primarily by suppressing the migration and invasion of prostate cancer cells.”
Healthy Prostate
“Healthy Prostate … includes herbs like saw palmetto, cleavers, pipsissewa, and stinging nettle . . .. Pipsissewa is another herb that can benefit men by ... promoting anti-inflammation that can benefit the prostate glands.”
Turmeric Gold Capsules
https://wisewomanherbals.com/blogs/news/how-to-improve-your-joint-health-naturally
“… if you suffer from chronic joint pain, then you know how simple activities like walking, using a computer or even carrying grocery bags can become daunting and unenjoyable. In this article we’re going to dive deep into what joint pain is and how you can improve your joint pain with natural herbal remedies and supplements”
“Another way to naturally improve joint pain is to incorporate certain supplements and herbal remedies into your daily health regimen. Wise Woman Herbals Turmeric Gold Capsules are a great option for those looking for a natural alternative to over-the-counter pain relievers. In fact, studies show that turmeric is just as – if not more – effective in reducing inflammation and joint pain than NSAIDs”
“Turmeric contains the active compound curcuminoid, which when taken in a therapeutic dose can support joint comfort, maintain joint mobility and even improve digestive health by acting on our inflammation response pathways”
“[A] 2016 study showed that taking a high dose of 1000 mg of curcumin each day for an average of 8-12 weeks helped reduce inflammation and joint pain.”
Upper Respiratory Support
https://www.facebook.com/WiseWomanHerbals (April 28, 2022)
“[T]hyme [an ingredient in Upper Respiratory Support] has been shown to exhibit antimicrobial … anti-carcinogenesis, anti-inflammatory … properties.”
“[T]hyme is a strong antimicrobial that can help promote relief and healing from sore throats and other respiratory infections. It is why you’ll see this healing herb in Wise Woman Herbals Upper Respiratory Support tincture.”
Elderberry Plus Syrup
https://www.facebook.com/WiseWomanHerbals/ (January 26, 2020)
“In a study aimed to determine the mechanism of action of elderberry and its primary active compound, cyanidin 3-glucoside (cyn 3-glu), against influenza virus, elderberry exhibited multiple modes of therapeutic action against influenza infection.”
“The Study showed that Elderberry extract is effective in treatment of flu.”
https://wisewomanherbals.com/blogs/news/supplements-for-stroke-preventions-help-reduce-stroke-risk
“Studies show that increasing vitamin C [an ingredient in Elderberry Plus Syrup] can reduce stroke risk.”
Your social media website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Joint Support for the cure, mitigation, treatment, or prevention of disease. Specifically:
Joint Support
https://www.facebook.com/WiseWomanHerbals/ (July 20, 2021)
Facebook image post:
“Joint Support Capsules … Amazing. Really works. Muscle pain and nerve pain.”
Your 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 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.
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 (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.
Your products Green Tea Solid Extract, Curcuma Spp. Organic Turmeric, PSA Capsules, and Elderberry Plus Syrup are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Green Tea Solid Extract, Curcuma Spp. Organic Turmeric, PSA Capsules, and Elderberry Plus Syrup fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Adulterated Dietary Supplements
FDA’s above-mentioned inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). Based on the inspection, we determined that these violations cause certain of your dietary supplements to 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 requirements for dietary supplements. Additionally, even if your Elderberry Plus Syrup and your Curcuma Spp. Organic Turmeric were not unapproved new drugs and misbranded drugs, they would be adulterated dietary supplements under section 402(g)(1) of the Act.
Your significant violations of CGMP requirements are as follows:
1. Your firm failed to establish a specification for every point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (MMR), as required by 21 CFR 111.70(a). Specifically, you have not established certain required written specifications for the components you use in your dietary supplement products or for the finished dietary supplement products. As required by 21 CFR 111.70, you must (among other requirements):
a. Establish an identity specification for each component used in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). You do not maintain written specifications for dietary ingredients such as Vitamin C and Zinc for your Elderberry Plus Syrup product. In addition, your purported identity specifications for the dietary ingredients Kava Kava Root (
Piper methysticum
) and
Echinacea purpurea
Dry Root Powder, ingredients in your Kava Capsules and Echinacea Glycerite products, respectively, state the ingredients must have a “chemical identification” of “>
(b)(4)
%”; however, such chemical identification cannot confirm the identity of the components at issue because near-infrared spectroscopy (NIR), which you use to analyze samples, requires establishing different standards of wavelength and absorption for different components and materials to support distinctions within and between components and materials. Such a standard can be represented by a reference chromatogram that has been characterized. Your purported identity specifications for Kava Kava Root (
Piper methysticum
) and
Echinacea purpurea
Dry Root Powder do not contain reference standards; therefore, they cannot confirm the identity of the ingredients at issue.
b. Establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). For example, you do not have such component specifications for your dietary ingredients Kava Kava Root (
Piper methysticum
) and
Echinacea purpurea
Dry Root Powder as you do not have any purity, strength, and composition specifications for Kava Capsules or Echinacea Glycerite, the finished products that respectively use those dietary ingredients.
c. Establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). For example:
Your purported finished product specifications for your Curcuma Spp. Organic Turmeric, Elderberry Plus Syrup, Kava Capsules, Echinacea Glycerite, Goldenseal (Hydrastis) Glycerite and Ginkgo biloba Liquid Extract state that the product must have a “chemical identification” of >
(b)(4)
%, and you purport to use NIR to confirm the identity of the finished product. However, identification by NIR requires establishing different standards of wavelength and absorption for different components and materials to support distinctions within and between components and materials. Such a standard can be represented by a reference chromatogram that has been characterized. Your purported specifications for the above finished products do not contain reference standards; therefore, they cannot confirm the identity of the finished product. Even if your purported specification could confirm the identity of the finished product, we also note inconsistencies in your records for the purported specification. For example, for your Kava Capsules product, your document titled “Confidential Finished Product Specification” states the chemical identification is a minimum value of
(b)(4)
%, a target value of
(b)(4)
%, and a maximum value of
(b)(4)
%. However, your document titled, “QC Laboratory (QCL) Report” states “NIR Identification - Specification
(b)(4)
%.” Further, your document titled “Quality Testing Matrix” states “NIR: >
(b)(4)
%.” It is unclear what you intend this specification to be.
Your purported finished product specifications failed to include specifications for the purity, strength, and composition of your finished dietary supplement. For example, your Elderberry Plus Syrup product is formulated to contain Vitamin C, Zinc, elder (berry), echinacea pur. (root), echinacea ang. (root) and osha (root); however, you have not established specifications for the purity, strength, and composition in the finished batch of dietary supplement.
You stated that for the approximately
(b)(4)
finished liquid herbal products manufactured at your facility, none have specifications for purity, strength, or composition.
Once you have established specifications as required by 21 CFR 111.70, you must verify that the established specifications are met, as required by 21 CFR 111.75. You must also make and keep records for established specifications, as required by 21 CFR 111.95(b)(1). With regard to your component and finished product identity specification, to the extent you establish identity specifications that are capable of confirming the identity of the components and/or finished products at issue through the use of NIR or other laboratory procedures, you must also establish and follow laboratory control processes that are reviewed and approved by quality control personnel, including the use of criteria for selecting standard reference materials used in performing tests and examinations, to determine whether your specifications are met (21 CFR 111.315(d)).
We have reviewed your responses dated May 5, 2022, June 6, 2022, July 6, 2022, August 8, 2022, and September 23, 2022. In your response dated June 6, 2022, you provided copies of the Quality Testing Matrix for Ascorbic Acid and Zinc Picolinate as a raw material specification, and the draft Finished Product Testing Against Specification Sheets (FTPASS) for Elderberry Plus Syrup and Potassium Sorbate Solution as a finished good specification. You subsequently stated in your response dated July 6, 2022, that your raw material specification template will be applied to your other materials. Further, you stated in your responses dated July 6, 2022, August 8, 2022, and September 23, 2022, that the implementation of your finished good specifications is still ongoing. We cannot evaluate the adequacy of your corrective actions because you did not provide documentation to support that you have established and made effective the required component and finished product specifications, in accordance with 21 CFR 111.70(a), (b), and (e).
2. Your quality control personnel neither rejected a component or dietary supplement when that component or dietary supplement failed to meet a specification established in accordance with 21 CFR 111.70, nor did they approve a treatment, an in-process adjustment, or reprocessing as permitted in 21 CFR 111.77, as required by 21 CFR 111.113(b)(2). Specifically:
a. You established a component specification on microbial load to limit contamination that may adulterate or lead to adulteration of the finished batch of a dietary supplement. In 2016, your firm received a shipment of Kava root, lot number
(b)(4)
, that failed to meet your microbial load specification for Total Plate Count (TPC). TPC testing for this material resulted in 1,285,000 cfu/gram, exceeding your specification of <
(b)(4)
cfu/gram. Your quality control unit failed to reject this component. In addition, the quality control unit did not approve a treatment, in-process adjustment, or reprocessing that would have ensured the quality of the finished supplement. Instead, you reassigned it to lot numbers
(b)(4)
and
(b)(4)
and subsequently incorporated it into various finished products, including certain lots of Kava Glycerite and Kava Capsules.
b. You established component specifications on lead to limit contamination that may adulterate or lead to adulteration of the finished batch of a dietary supplement. Your incoming dietary ingredients failed to meet established specification for lead as a contaminant; however, your quality control personnel failed to reject the component or approve a treatment, in-process adjustment, or reprocessing, as permitted in 21 CFR 111.77. Examples include, but are not limited to, the following:
Your
Ruscus aculeatus
root powder lot number
(b)(4)
testing resulted in 1.45 ppm of lead, exceeding your specification limit of
(b)(4)
ppm. You also did not approve a treatment, in-process adjustment, or reprocessing of the root powder that would have ensured the quality of the finished supplement. This ingredient was used to produce Bottoms Up Capsules lot number 17893, which was subsequently distributed to your customers.
Your
Ruscus aculeatus
root powder lot number
(b)(4)
testing resulted in 1.91 ppm of lead, exceeding your specification limit of
(b)(4)
ppm. You also did not approve a treatment, in-process adjustment, or reprocessing of the root powder that would have ensured the quality of the finished supplement. This ingredient was used to produce Bottoms Up Capsules lot numbers 17972, and 18083, and lot number 17972 was subsequently distributed to your customers.
Your
Echinacea purpurea
root powder lot number
(b)(4)
testing resulted in 1.40 ppm of lead, exceeding your specification limit of
(b)(4)
ppm. You also did not approve a treatment, in-process adjustment, or reprocessing of the root powder that would have ensured the quality of the finished supplement. This ingredient was used to produce GI Caps lot numbers 17975 and 17706, which were subsequently distributed to your customers.
We have reviewed your responses dated May 5, 2022, June 6, 2022, July 6, 2022, August 8, 2022, and September 23, 2022. In response to the FDA sample results, you recalled certain lot numbers of Kava Capsules as well as various other finished products made from the Kava root component. You stated in your response dated June 6, 2022, that you will conduct a material review for microbial and heavy metals limits for your over
(b)(4)
raw materials that will be completed by January 2023. You also stated in your response dated June 6, 2022, that your internal review identified the materials that were improperly released with OOS results, and that you have destroyed these materials as of May 4, 2022. However, we cannot fully evaluate the adequacy of these corrective actions because you did not provide a summary of the materials identified, a summary of which (if any) finished products contained such materials, and documented proof of destruction for the components or finished product destroyed. Further, you stated in your response dated June 6, 2022, that you have issued a directive that no OOS material will be used unless a “valid rework” is found. However, we cannot evaluate the adequacy of this corrective action because you also did not include in your procedures how you plan to evaluate rejected ingredients and you have not established criteria for “valid rework.”
3. You failed to follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met, as required by 21 CFR 111.303. Specifically, you have established a standard operating procedure (SOP) titled Micro Testing: Quantification for quantifying and documenting results of your microbiological program. This procedure states that initial OOS results should be confirmed by analyzing
(b)(4)
. You did not adhere to this procedure in conducting retesting of OOS test results of TPC testing of your Kava Capsules lot number 17764 obtained on July 22, 2021. Your retesting procedure included testing
(b)(4)
of the product, but you did not retest
(b)(4)
, as required by your written procedure.
We have reviewed your responses dated May 5, 2022, June 6, 2022, July 6, 2022, August 8, 2022, and September 23, 2022. You stated in your response dated May 5, 2022, that your Micro Testing: Quantification SOP conflicts with another SOP titled Deviations and Investigations, which instructed to retest the
(b)(4)
that yielded the OOS result. You also stated that you would update your SOPs to ensure they would no longer conflict. In your response dated June 6, 2022, you provided your revised written procedure for Micro Testing: Quantification, which now instructs staff to reference your Deviations and Investigations SOP when OOS results are received. We acknowledge your revised written procedure; however, your response does not address what actions you have taken with personnel to prevent reoccurrence.
This letter is not intended to be an all-inclusive statement of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
We also offer the following comment: You are conducting identity tests by NIR on your multi-ingredient finished products; however, the NIR does not identify the dietary ingredients that are present in the finished product. For example, you conducted identity tests by NIR for Immune Glycerite lot number 17921, which is a multi-ingredient dietary supplement product. This product’s finished product specification states that it contains Echinacea Glycerite,
(b)(4)
, Eriodictyon Glycerite, Hydrastis Glycerite, Ligusticum Glycerite, Verbascum Glycerite, Zingiber Glycerite, and Bitter Orange Essential Oil. However, the NIR material report does not show this. You must verify that NIR and the associated method is appropriate for its intended use, as required by 21 CFR 111.320(a).
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington, 98021-4421, to the attention of Mark Babbitt, Compliance Officer.
If you have any questions concerning this letter, you can contact Mark Babbitt at (509) 353-2136 ext. 107, or by email at mark.babbitt@fda.hhs.gov.
Sincerely,
/S/
Miriam R. Burbach
Program Division Director
Office of Human and Animal Food Operations
West – Division 6
____________________________________
1
The Amended Warning Letter includes changes to the date of the letter and the named addressee(s) as well as to the title of the letter, and to page headers. The original Warning Letter was issued to an individual who was no longer employed by the firm at the time of issuance, and a new responsible individual has been identified. No other material changes were made to the amended letter. For FDA tracking purposes, the original Warning Letter date of November 10, 2022, continues to serve as the date of issuance.
Content current as of:
05/16/2023
Regulated Product(s)
Drugs
Food & Beverages