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WARNING LETTER

Red's Kitchen Sink at Bourbon Street Ice MARCS-CMS 611873 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Ms. Dionne C. Netus
Red's Kitchen Sink at Bourbon Street Ice

1635 Old 41 Hwy NW Ste 107
Kennesaw, GA 30152-4481
United States

Issuing Office:
Office of Human and Animal Food Operations – East Division 3

United States


03/02/2021

Reference: CMS Case # 611873

WARNING LETTER

Dear Ms. Netus:

This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.redskitchensink.com in January and February 2021 and has determined that you take orders there for the products Pressure Be Gone, Cell Defense Shield, Bony-Barony Detox Tea, and Cell Fuel 102 capsules, powder, and gel. We have also reviewed your Facebook and YouTube social media websites at https://www.facebook.com/Reds-Kitchen-Sink-Natural-Hair-Care-Skin-Care-and-Supplements-149163638454086/
and https://www.youtube.com/user/RedsKitchenSink; these websites direct consumers to your website www.redskitchensink.com to purchase your products. The claims on your websites establish that the products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (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. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

Pressure Be Gone
(contains hawthorn berries and matricaria flowers as ingredients)

(b)(4)

Cell Defense Shield
(contains blackseed oil, wild oregano oil, and turmeric oil as ingredients)

On the Cell Defense Shield product webpage at www.redskitchensink.com:
• “Black Seed Oil…Naturally high in powerful compounds Thymoquinone (TQ) and Nigellone - an anti-histamine…to help fight and prevent diseases and inflammation…”
• “Wild Oregano Oil…known for its anti-viral, antimicrobial and anti fungal properties…[f]ound to provide support in the relief of respiratory conditions such as colds and flu, urinary tract infections…yeast infections and more….”
• “Turmeric Oil…ability to provide support with anti inflammatory, pain relieving disease fighting properties.”
• “Fight Back against viruses, bacteria and fungi/yeasts.”

An October 26, 2020 Facebook post at https://www.facebook.com/Reds-Kitchen-Sink-Natural-Hair-Care-Skin-Care-and-Supplements-149163638454086/ states about Cell Defense Shield:
• “[F]ights inflammation, bacteria, viruses and more…#colds…#flu…#inflammation…”

Bony-Barony Detox Tea
(contains sorrel and ginger root as ingredients)

On the Bony-Barony Detox Tea product webpage at www.redskitchensink.com:
• “Sorrel… use it to lower blood pressure and lower LDL (bad cholesterol) and triglycerides…”
• “Ginger Root is anti-inflammatory…”

Your Bony-Barony Detox Tea product webpage at www.redskitchensink.com also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Bony-Barony Detox Tea for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
• “After two months of using my Bony Barony tea blend…my allergies almost completely disappeared and my blood pressure medication became so strong til [sic] my dose had to be reduced to half…”

Cell Fuel 102 capsules
(contains organic sea moss powder, bladderwrack, and burdock root as ingredients)

On the Cell Fuel 102 capsules product webpage at www.redskitchensink.com:
• “Joint Pain Relief…”
• “[F]or those struggling with a sluggish thyroid…”
• “Organic Sea moss powder and Bladderwrack has been used…for its role in alleviating the symptoms of the common cold and flu. Why? Because it contains antimicrobial and antiviral compounds…This blend makes Cell Fuel an essential herbal supplement … for whenever you’ve come down with a sore throat…”
• “STRENGTHENS JOINTS… [B]urdock root is rich in compounds that have shown promise as anti-inflammatory agents for use in those with arthritis, osteoporosis, aches and joint pains.”

Cell Fuel 102 powder
(contains organic sea moss powder, bladderwrack, and burdock root as ingredients)

On the Cell Fuel 102 powder product webpage at www.redskitchensink.com:
• “Joint Pain Relief…”
• “Adding high-potassium foods like Sea Moss to the diet can significantly improve behaviour and mental functioning (such as with ADHD children) …very helpful for fibromyalgia…depression and anxiety disorders.”
• “Sea Moss…helps to heal the body of ulcers, indigestion, gastritis, and constipation.… it can provide relief to all inflamed mucus membranes … helps to alleviate acid reflux…”
• “Sea Moss contains Algin…a phytonutrient which has therapeutic value . . . also used as a medicine for the prevention and treatment of high blood pressure…”
• “STRENGTHENS JOINTS… [B]urdock root is rich in compounds that have shown promise as anti-inflammatory agents for use in those with arthritis, aches and joint pains.”
• “It has been proven that there is a link between auto-immune thyroid disease and vitiligo. Use of this product … provides support for vitiligo.”
• “Sea moss has been used … for its role in alleviating the symptoms of the common cold and flu. Why? Because it contains antimicrobial and antiviral compounds…This makes Cell Fuel 102 an essential herbal supplement … for whenever you’ve come down with a sore throat …. Sea moss also is a source of potassium chloride, …which helps reduce inflammation and phlegm in the mucous membranes, which cause congestion.”
• “The bladderwrack and sea moss combination makes for a potent supplement for those struggling with a sluggish thyroid. The Thyroid is mainly responsible for regulating hormones, an imbalance can lead to…fibroids…extreme fatigue and other ailments...”

Cell Fuel 102 gel
(contains sea moss, bladderwrack, and burdock root as ingredients)

On the Cell Fuel 102 gel product webpage at www.redskitchensink.com:
• “STRENGTHENS JOINTS… [B]urdock root is rich in compounds that have shown promise as anti-inflammatory agents for use in those with arthritis, aches and joint pains.”
• “Sea moss has been used … for its role in alleviating the symptoms of the common cold and flu. Why? Because it contains antimicrobial and antiviral compounds…This makes the Organic Sea Moss, Bladderwrack & Burdock Root Powder an essential herbal supplement … for whenever you’ve come down with a sore throat…”
• “The bladderwrack and sea moss combination makes for a potent supplement for those struggling with a sluggish thyroid.”
• “It has been proven that there is a link between auto-immune thyroid disease and vitiligo. Use of this product … provides support for vitiligo.”

Your Pressure Be Gone, Cell Defense Shield, Bony-Barony Detox Tea, and Cell Fuel 102 capsule, powder, and gel 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) and 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 Pressure Be Gone, Cell Defense Shield, Bony-Barony Detox Tea, and Cell Fuel 102 capsule, powder, and gel products are intended for treatment of one or more diseases that are not amenable to self-diagnosis 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, Pressure Be Gone, Cell Defense Shield, Bony-Barony Detox Tea, and Cell Fuel 102 capsule, powder, and gel 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)].

This letter is not intended to be an all-inclusive statement of violations that may 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.

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 note that you display the FDA logo on your Cell Fuel 102 capsules and powder products. The FDA logo is for the official use of the FDA and not for use on private sector materials. To the public, such use would send a message that FDA favors or endorses a private sector organization or the organization’s activities, products, services, and/or personnel (either overtly or tacitly), which FDA does not and cannot do. Unauthorized use of the FDA logo may violate federal law and subject those responsible to civil and/or criminal liability.

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 action within fifteen (15) 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.

Your written response should be sent to N’Jere P. English, Ph.D., Compliance Officer, U.S. Food and Drug Administration, 60 8th Street, NE, Atlanta, GA 30309. If you have any questions regarding the content of this letter, please contact N’Jere P. English at 404-669-4450 or by email at Njere.English@fda.hhs.gov.

Sincerely,
/S/

Ingrid A. Zambrana
District Director, FDA Atlanta District
Program Division Director
Office of Human and Animal Food Operations – East Division 3

 
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