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  1. Compliance Actions and Activities

WARNING LETTER

Green Water, LLC MARCS-CMS 564081 —

Product:
Drugs

Recipient:
Recipient Name
Keith B. Baruch
Recipient Title
Owner/President
Green Water, LLC

25797 Conifer Road
Unit B102, Mailbox #11
Conifer, CO 80433
United States

Issuing Office:
Denver District Office

United States


January 31, 2019

WARNING LETTER

 

Via UPS Overnight

 

Keith B. Baruch

Owner/President

Green Water, LLC

25797 Conifer Road

Unit B102, Mailbox #11

Conifer, CO 80433

 

Ref #: HAF4W(DEN)-19-05-WL

 

Dear Mr. Baruch:

From June 25 to July 26, 2018, the U.S. Food and Drug Administration conducted an inspection of your manufacturing facility located at 25797 Conifer Rd., Unit B102, Conifer, Colorado.  During the inspection, we also collected labeling for your products. Based on the inspectional findings, a subsequent review of the product labels and promotional material collected during the inspection, and a subsequent review of your website at the Internet address https://taspens.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov.

To date, we have not received a response to the FDA-483, Objectionable Conditions, issued at the close of our inspection on July 26, 2018 to indicate any corrective actions you are planning to implement.

 Unapproved New and Misbranded Drugs

The FDA reviewed your website at the Internet address https://taspens.com in August 2018 following an inspection of your facility at the address above between June 25, 2018 and July 26, 2018. We have determined that you take orders there for the products listed in this paragraph. The claims on your product labels, promotional material, and website establish that these products are drugs under Section 201(g)(1)(B) of the Act [21 USC § 321(g)(1)(B)] for the reasons stated below. The products Sleep Ease Tincture, Calm Child Tincture, Teething Tincture, Digestive Ease Tincture with Peppermint, Headache Ease Tincture are intended for use in the cure, mitigation, treatment, or prevention of disease. The products Migraine Relief, No More Aches PLUS Cream, Breathe Easy, Restore & Revive PLUS Cream, and Sun Cream are intended for use in the cure, mitigation, treatment, or prevention of disease and/or to affect the structure or any function of the human body. 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 claims on your product labels, promotional material, and website https://taspens.com that provide evidence these products are intended for use as drugs, include:

On your product labels:

Headache Ease Tincture product label:

“Headache…”

“This is a wonderful blend of herbs that may help reduce headaches…”

Calm Child Tincture product label:

“This herbal tincture is a wonderful nerve and digestive calmer which may help to alleviate sickness…It may be especially helpful…when ill…”

Digestive Ease Tincture product label:          

“Catnip is a calming digestive aid generally used for: indigestion, diarrhea, colic & a fever reducer. Fennel…relieves cramps, constipation, diarrhea…”

Teething Tincture product label:

“A gentle & effective herbal blend that helps…including…sore gums…tummy aches…fever…”

Migraine Relief product label:

“A unique … blend of our original anti-inflammatory herbs with the added therapeutic benefit of five essential oils that assist in relieving … migraines…”

Face Cream Lavender product label:

“Formulated with…SPF containing oils, it provides…sun protection…”

“SPF…”

Restore & Revive PLUS Cream product label:

“Ailments such as eczema, psoriasis, … burns, wounds, bug bites and any skin irritation and eruptions…”

 Sun Cream (Water Resistant) SPF product label:

“Equivalent to 30+ SPF…”

“SPF…”

 No More Aches PLUS Cream product label:

“These organic herbs can reduce inflammation…”

“The anti-inflammatory herb blend…can help with Arthritis, tendonitits [sic], bursitis, …”

Restore & Revive PLUS Cream product label:

“Ailments such as eczema, psoriasis,…burns, wounds, bug bites and any skin irritation and eruptions…”

Breathe Easy Roll-On product label:

“A blend of oils known to assist the body with sinus congestion & inflammation. Opens airways & alleviates…allergies…”

 On the webpage https://taspens.com:

On the product page for Headache Ease Tincture:

“This is a wonderful blend of herbs that may help reduce headaches and prevent migraines…”

On the product page for Sleep Ease Tincture:

“Valerian Root and Skullcap…Both work well for insomnia…”

On the product page for Calm Child Tincture:

“This tincture…may help to alleviate sickness…”

“Calm Child is a wonderful way to deal with…fevers…”

On the product page for Digestive Ease Tincture:

“Catnip is … generally used …as a fever reducer…”

On the product page for Teething Tincture:

“A gentle and effective herbal blend that helps reduce the discomforts associated with teething, including: sore gums…tummy ache…fever and colds…”

On the product page for Facial Moisturizing Cream:

“Formulated with…SPF containing oils, it provides natural…sun protection…”

“Provides Natural and Mild Sun Protection...”

On the product page for Restore & Revive Cream PLUS:

“An amazing product for a vast variety of skin ailments, such as: Eczema, …Wounds, …Rashes...including Diaper Rashes, Psoriasis, Cracked Lips, Irritated and/or Itchy Skin, Burns, Acne, Rosacea,…and More!..”

On the product page for Sun Cream (Water Resistant) SPF:

“Provides safe, effective, chemical free, broad spectrum UVA-UVB protection for all ages…”

“These minerals [Zinc Oxide and Titanium Dioxide] provide a physical barrier, reflecting and scattering damaging UVB and UVA rays before they reach your skin…”

“Equivalent to 30+ SPF…”

On the product page for Migraine Relief:

“This blend of pure, therapeutic grade essential oils is perfect for migraine headaches...”

On the product page for No More Aches PLUS:

“Our No More Aches Line encourages the body to repair naturally by applying to any area with pain and inflammation...”

“The organic herbs…are known for inflammation reduction…”

“PLUS: Our amazing cream blended with Therapeutic Grade Essential Oils to offer…while assisting with…Plantar Fasciitis, Swelling & Inflammation, arthritis and tendonitis…”

“Sciatica…”

On the product page for Breathe Easy Oil (Chest & Sinus Relief):

“Use as an expectorant, immune booster and for it's [sic] antiviral properties...”

On your Taspen’s Organics promotional brochure:

Migraine Relief – pamphlet comments:

“Migraine…oils blended to assist the body with the affects from migraines…”

 Face Cream – pamphlet comments:

“Formulated with…natural SPF containing oils...”

No More Aches Line – pamphlet comments:

-     “NO MORE ACHES Line encourages the body to repair naturally by applying to any area with pain and inflammation…known to reduce inflammation…”

-     “PLUS: …assisting with…Plantar Fasciitis, Swelling & Inflammation, Back & Knee pain...”

-     “OIL: …great for assisting the body to alleviate headaches, migraines…”

Restore & Revive Remedy – pamphlet comments:

“SALVE: …herbs that assist the body’s innate ability to reduce symptoms of eczema, psoriasis, …rashes….”

“CREAM: …soothing cream that protects and alleviates the skin from the itchiness, pain and irritation of skin ailments such as psoriasis, eczema and rashes…”

“PLUS CREAM: …blended with Therapeutic Grade Essential Oils beneficial for burns and cuts…break outs from acne to rashes….”

“OIL [Roll-On]: …great for fungal infections, warts, acne, scalp….”

Sun Cream – pamphlet comments:

“Sun Cream Equivalent to 30+ SPF – Provides…broad spectrum UVA-UVB protection….”

“These minerals [Zinc Oxide and Titanium Dioxide] provide a physical barrier, reflecting and scattering damaging UVB and UVA rays before they reach your skin…”

Breathe Easy Line – pamphlet comments:

“Use as an expectorant, immune booster and for its anti-viral properties…”

Your Calm Child Tincture, Digestive Ease Tincture, Teething Tincture, Headache Ease Tincture, Sleep Ease Tincture, Face Cream, Restore & Revive Remedy, Sun Cream (Water Resistant) SPF, Migraine Relief, No More Aches Line, and Breath Easy Line 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 USC § 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 USC §§ 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 Sleep Ease Tincture product is intended for the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, your Sleep Ease Tincture product fails to bear adequate directions for its intended use and, therefore, the product is misbranded under Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].

Further, Face Cream, No More Aches PLUS Cream, Restore & Revive PLUS Cream, and Sun Cream Water Resistant contain silver ingredients. According to 21 CFR 310.548, any Over The Counter (OTC) drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a new drug within the meaning of section 201(p) of Act for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the Act [21 U.S.C. § 352]. The introduction or delivery for introduction into interstate commerce of misbranded drugs violates Section 301(a) of the Act [21 U.S.C. § 331(a)].

Dietary Supplement CGMP Violations

Our investigators observed the following significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which render your dietary supplement products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Additionally, even if your Sleep Ease Tincture, Calm Child Tincture, Teething Tincture, Digestive Ease Tincture, and Headache Ease Tincture products did not have therapeutic claims which make them unapproved new drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] for the reasons described below.

The significant violations documented during the inspection include, but are not limited to, the following:

1.    You failed to establish a specification for any 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, as required by 21 CFR 111.70(a). Specifications include those that must be established for components that you use in the manufacture of a dietary supplement (21 CFR 111.70(b)), for in-process production (21 CFR 111.70(c)), for dietary supplement labels and packaging (21 CFR 111.70(d)), and to ensure the quality of the dietary supplement (21 CFR 111.70(e)). Specifically:

a.    You failed to establish the following required component specifications under 21 CFR 111.70(b) for each component that you use in the manufacture of a dietary supplement:

·    Identity specifications, as required by 21 CFR 111.70(b)(1);

·    Component specifications that are necessary to ensure that 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

·    Limits on those types of contamination that may adulterate or 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(b)(3).

b.    You failed to establish 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).

We note that once you have established these specifications, you must determine whether the specifications that you establish under 21 CFR 111.70 are met, as required by 21 CFR 111.73 and 21 CFR 111.75(c). Specifically, once you have established component specifications and before using a component, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing. You must also confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). Further, you must verify that your finished batch of the dietary supplement meets product specifications for the identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.75(c).

You must also make and keep records, including records for the specifications you establish, in accordance with 21 CFR 111.95.

2.    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 and 21 CFR 111.140(b)(1). Specifically, you have no written procedures for the responsibilities of the quality control operations and you do not perform or document any of the required quality control operations for the manufacturing, packaging, labeling, and holding of your dietary supplements.

Further, we note that once you have established written quality control procedures, you must implement quality control operations into your manufacturing, packaging, labeling, and holding operations for producing dietary supplements to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, in accordance with 21 CFR 111.65.

3.    You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch as required by 21 CFR 111.205(a).

Specifically, during the inspection, you stated you had not established MMRs for any of the approximately fifty dietary supplement products you produce.

4.    You failed to prepare a batch production record (BPR) every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a). Specifically, your firm manufactures twenty herbal tinctures that you identify as intended for use as dietary supplements under the “Taspen’s Organics” label and you did not prepare batch production records during the manufacturing of any of these products to document their production.

5.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you have not established written procedures for handling product complaints. In addition, we note you must ensure product complaints are reviewed and investigated as required by 21 CFR 111.560 and written records of every product complaint that is related to good manufacturing practice and subsequent investigations are made and kept, as required by 21 CFR 111.570(b)(2).

6.    You failed to provide handwashing facilities that are designed to ensure that an employee’s hands are not a source of contamination of components, dietary supplements or any contact surface by providing facilities that are adequate, convenient and furnish running water at a suitable temperature as required by 21 CFR 111.15(i). It was observed during the inspection that the sink used to clean/sanitize production equipment utensils is the same sink provided for handwashing. 

Misbranded Dietary Supplements

The dietary supplement products discussed below are misbranded within the meaning of Section 403 [21 U.S.C. § 343] of the Act because they fail to comply with the regulations implementing the food labeling requirements of the Act for dietary supplements, found in 21 CFR Part 101. Additionally, even if your products Sleep Ease Tincture, Calm Child Tincture, Teething Tincture, Digestive Ease Tincture, Headache Ease Tincture did not have therapeutic claims which make them unapproved new drugs and misbranded drugs, these products would be misbranded within the meaning of Section 403 of the Act for the reasons described below. 

1.    Your Digestive Ease, Teething, Sleep Ease, and Headache Ease herbal tincture products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because the label is false and misleading in that the label claims “No alcohols” whereas the label lists “gluten free cane alcohol” as one of the ingredients.

2.    Your Calm Child, Digestive Ease, Teething, Sleep Ease, and Headache Ease herbal tincture products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343 (q)(5)(F)] in that the presentation of the nutrition information on the labeling of your products does not comply with 21 CFR 101.36. For example:

a.  Your Calm Child, Digestive Ease, Teething, Sleep Ease, and Headache Ease herbal tincture product labels fail to present nutrition information in the form of a “Supplement Facts” panel, as required by 21 CFR 101.36.

b.  Your Calm Child, Digestive Ease, Teething, Sleep Ease, and Headache Ease herbal tincture product labels fail to include the quantitative amount by weight per serving of all the dietary ingredients as required by 21 CFR 101.36(b)(2)(i)(A) and (b)(3)(ii).

3.    Your Calm Child, Digestive Ease, Teething, Sleep Ease, and Headache Ease herbal tincture products are misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labels fail to identify the products by using the term “dietary supplement” as a part of the product’s statement of identity, as required by 21 CFR 101.3(g).

4.    Your Calm Child, Digestive Ease, Teething, Sleep Ease, and Headache Ease herbal tincture products are misbranded within the meaning of Section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)], in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Specifically:

  • Your Calm Child herbal tincture product fails to include the part of the plant from which catnip, chamomile, lemon balm, and hawthorn are derived;
  • Your Digestive Ease herbal tincture product fails to include the part of the plant from which peppermint is derived;
  • Your Teething herbal tincture product fails to include the part of the plant from which catnip, lemon balm, lavender, and chamomile are derived;
  • Your Sleep Ease herbal tincture product fails to include the part of the plant from which skullcap is derived;
  • Your Headache Ease herbal tincture product fails to include the part of the plant from which feverfew, lemon balm, chamomile, and skullcap are derived.

Misbranded Cosmetics

1.    Your “Face Cream,” “Restore & Revive (Cream, PLUS Cream, Salve, Roll-On, or Stick),” “Water Resistant Sun Cream SPF,” and “Eye Cream” products are misbranded under section 602(c) of the Act [21 U.S.C. § 362(c)] in that the declaration of ingredients for these products includes ingredients listed as “Silver Solution”. The declaration of ingredients must contain the common or usual names of the cosmetic ingredients as required in 21 CFR 701.3(c). “Silver Solution” should be listed as “Silver” or “Colloidal Silver.”

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or 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 or implement corrections to the violations cited in this letter.  Failure to do so may result in legal action without further notice, including, without limitation, seizure and/or injunction.

We offer the following comment:

1.    Please note if the “Silver Solution” imparts color to your “Face Cream,” “Restore & Revive (Cream, PLUS Cream, Salve, Roll-On, or Stick),” “Water Resistant Sun Cream SPF,” and “Eye Cream” products, it may be considered a color additive. Silver is listed under 21 CFR 73.2500 for use as a color additive in fingernail polish. The color additive silver may be safely used for coloring fingernail polish at a level not to exceed 1 percent of the final product. If the Silver does not impart color, it may meet the requirement in 21 CFR 70.3(g) for exemption from section 721 of the Federal Food, Drug, and Cosmetic Act.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct these violations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken.  If your firm’s planned corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed. If you do not believe that your products are in violation of the FD&C 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 re-inspection-related costs.  A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection 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 re-inspection related costs.

Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Nancy G. Schmidt, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Schmidt at (303) 236-3046 if you have any questions about this matter.

 

Sincerely,

/S/ 

LaTonya M. Mitchell

Program Division Director

Office of Human and Animal Foods –

Division IV West