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Get The Tea: FDA INSPECTION / WARNING LETTER
The Ghost Of LOP
Registered User
User ID: 539565
03-27-2020 07:00 AM

Posts: 26,623




Post: #1
Get The Tea: FDA INSPECTION / WARNING LETTER
Advertisement
WARNING LETTER

Get The Tea
MARCS-CMS 538965 — MARCH 22, 2018


Mr. Ronald K. McMullen, Co-Owner and President
Get The Tea
781 Airpark Way Ste A1
Cottonwood, AZ 86326-4090


Ref #: HAF4W(DEN)-18-06-WL

Dear Mr. McMullen:

From September 14, 2017, through September 15, 2017, an investigator from the U.S. Food and Drug Administration (FDA or we) conducted an inspection of your facility located at 781 Airpark Way Ste A1, Cottonwood, Arizona. During the inspection our investigators identified significant violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulations, Title 21 Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (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.

We have also reviewed your website at http://www.getthetea.com in March 2018 and determined that you take order there for the products Allicin Advanced, Ceylon Cinnamon, Life Change Power Cleanse, Life Change Tea Super Strength, Life Change Tea Regular Strength, Eighth Element, G.I. Joy, Wild Alaska Sockeye Omegas, Hawthorn Berry Syrup, PotentSea Marine Aminos, Ocean Sleep, Tea Tree Lavender Balm, and Wildflower West Sun Damage Serum. Additionally, we have reviewed the product labels for these products. The claims on your product labels and website establish that the products are drugs under section 201(g)(1)(B) and/or (g)(1)© of the Act [21 U.S.C. 321(g)(1)(B) and/or (g)(1)©] because they are intended for use in the cure, mitigation, treatment, or prevention of disease, and/or to affect the structure or any function of the body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

We have also reviewed the labeling for your Life Change Tea Super Strength, Moringa Leaf capsules, Moringa Extract, Grapeseed Extract, Ceylon Cinnamon, and Astaxanthin Max, including product labels and your website http://www.getthetea.com. Based on our review, we have concluded that your products are in violation of section 403 of the Act [21 U.S.C. 343] and its regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101.

You can find the Act and FDA regulations through links on FDA’s website http://www.fda.gov.

Unapproved New Drugs and Misbranded Drugs

Examples of some of the claims that provide evidence that your Allicin Advanced, Ceylon Cinnamon, Life Change Power Cleanse, Life Change Tea Super Strength, Life Change Tea Regular Strength, Eighth Element, G.I. Joy, Wild Alaska Sockeye Omegas, Hawthorn Berry Syrup, PotentSea Marine Aminos, Ocean Sleep, Tea Tree Lavender Balm, and Wildflower West Sun Damage Serum are intended for use as drugs include:


more at link
https://www.fda.gov/inspections-complian...5-03222018
(This post was last modified: 03-27-2020 07:03 AM by The Ghost Of LOP.) Quote this message in a reply
The Ghost Of LOP
Registered User
User ID: 539565
03-27-2020 07:01 AM

Posts: 26,623




Post: #2
RE: Get The Tea: FDA WARNING : The crazy stuff you hear being sold on radio ads
Just found this online
thought some people might be interested in it...

USE CAUTION ON THIS STUFF
Quote this message in a reply
Boop
【GROOVERIFIC BABY】
User ID: 540086
03-27-2020 07:04 AM

Posts: 12,470




Post: #3
RE: Get The Tea: FDA INSPECTION / WARNING LETTER
The Ghost Of LOP  Wrote: (03-27-2020 07:01 AM)
Just found this online
thought some people might be interested in it...

USE CAUTION ON THIS STUFF

Why. Whos using it and why

~~~~~~~~~~~~
[Image: HLQpp3f.gif]

・VENI VIDI CASTRATAVI ILLEGITIMOS・

[Image: DmahCLp.gif]
Quote this message in a reply
The Ghost Of LOP
Registered User
User ID: 539565
03-27-2020 07:06 AM

Posts: 26,623




Post: #4
RE: Get The Tea: FDA INSPECTION / WARNING LETTER
IToldYouSo  Wrote: (03-27-2020 07:04 AM)
The Ghost Of LOP  Wrote: (03-27-2020 07:01 AM)
Just found this online
thought some people might be interested in it...

USE CAUTION ON THIS STUFF

Why. Whos using it and why

A lot of radio shows / podcasts and such sell these products
some of us stream the shows... I am starting to hate these sell pitches so just kinda googled it and this came up.

Shows like

Ground Zero with clyde lewis
Pastor Paul Begley on youtube
Coast To Coast am with Gorge Noory

Some other Talk Shows and such.....
(This post was last modified: 03-27-2020 07:07 AM by The Ghost Of LOP.) Quote this message in a reply
PENDULUM
Registered User
User ID: 483520
03-27-2020 07:07 AM

Posts: 1,362




Post: #5
RE: Get The Tea: FDA WARNING : The crazy stuff you hear being sold on radio ads
The Ghost Of LOP  Wrote: (03-27-2020 07:01 AM)
Just found this online
thought some people might be interested in it...

USE CAUTION ON THIS STUFF

I'm very careful of the quality and quantity of anything I ingest.
I don't take multi V for this reason.
Give your body what it needs when it needs it.
For now, taking liposomal C, vitamin d3 on days where i can't get out, whey protein and getting exercise.
Too much stuff burns the kidneys.
Stagger your supplements throughout the day.
Quote this message in a reply
The Ghost Of LOP
Registered User
User ID: 539565
03-27-2020 07:08 AM

Posts: 26,623




Post: #6
RE: Get The Tea: FDA INSPECTION / WARNING LETTER
PENDULUM  Wrote: (03-27-2020 07:07 AM)
The Ghost Of LOP  Wrote: (03-27-2020 07:01 AM)
Just found this online
thought some people might be interested in it...

USE CAUTION ON THIS STUFF

I'm very careful of the quality and quantity of anything I ingest.
I don't take multi V for this reason.
Give your body what it needs when it needs it.
For now, taking liposomal C, vitamin d3 on days where i can't get out, whey protein and getting exercise.
Too much stuff burns the kidneys.
Stagger your supplements throughout the day.

I just am really starting to hate these kinds of ads.

What makes it worse they are on other wise good shows at times.
Quote this message in a reply
Your Worst Nightmare
Registered User
User ID: 310624
03-27-2020 10:58 AM

Posts: 2,646




Post: #7
RE: Get The Tea: FDA INSPECTION / WARNING LETTER
The Ghost Of LOP  Wrote: (03-27-2020 07:01 AM)
Just found this online
thought some people might be interested in it...

USE CAUTION ON THIS STUFF

No because the problem isn't the product. The problem is the FDA.
Quote this message in a reply
Boop
【GROOVERIFIC BABY】
User ID: 540121
03-27-2020 11:40 AM

Posts: 12,470




Post: #8
RE: Get The Tea: FDA INSPECTION / WARNING LETTER
The Ghost Of LOP  Wrote: (03-27-2020 07:06 AM)
IToldYouSo  Wrote: (03-27-2020 07:04 AM)
Why. Whos using it and why

A lot of radio shows / podcasts and such sell these products
some of us stream the shows... I am starting to hate these sell pitches so just kinda googled it and this came up.

Shows like

Ground Zero with clyde lewis
Pastor Paul Begley on youtube
Coast To Coast am with Gorge Noory

Some other Talk Shows and such.....

Products like that ruined part of my livelihood.
Years ago.
Idiots trying to make money off Chinese herbs, using them in stupid ways.
So I just ignore it all

~~~~~~~~~~~~
[Image: HLQpp3f.gif]

・VENI VIDI CASTRATAVI ILLEGITIMOS・

[Image: DmahCLp.gif]
Quote this message in a reply
Luvapottamus
Registered User
User ID: 372884
03-27-2020 01:56 PM

Posts: 16,580




Post: #9
RE: Get The Tea: FDA INSPECTION / WARNING LETTER
The Ghost Of LOP  Wrote: (03-27-2020 07:01 AM)
Just found this online
thought some people might be interested in it...

USE CAUTION ON THIS STUFF

lol

Company needs to relabel their products as "not drugs."

They should have done that in the first place.

These are herbal supplements, not dangerous FDA approved drugs.

If you are taking any FDA approved drugs, check this website for possible interactions:

https://www.medicinenet.com/herbs__toxic.../views.htm

chuckle

https://reference.medscape.com/drug-interactionchecker

There is no such thing as sovereign debt. Reinstate Greenbacks.
http://www.youtube.com/watch?v=Vb5OQUElilo
Tax Wallstreet Party
United Front Against Austerity
(This post was last modified: 03-27-2020 01:58 PM by Luvapottamus.) Quote this message in a reply
The Ghost Of LOP
Registered User
User ID: 539565
03-27-2020 01:58 PM

Posts: 26,623




Post: #10
RE: Get The Tea: FDA INSPECTION / WARNING LETTER
Luvapottamus  Wrote: (03-27-2020 01:56 PM)
The Ghost Of LOP  Wrote: (03-27-2020 07:01 AM)
Just found this online
thought some people might be interested in it...

USE CAUTION ON THIS STUFF

lol

Company needs to relabel their products as "not drugs."

They should have done that in the first place.

These are herbal supplements, not dangerous FDA approved drugs.

If you are taking any FDA approved drugs, check this website for possible interactions:

https://www.medicinenet.com/herbs__toxic.../views.htm

chuckle

Anon
Quote this message in a reply
Luvapottamus
Registered User
User ID: 372884
03-27-2020 02:02 PM

Posts: 16,580




Post: #11
RE: Get The Tea: FDA INSPECTION / WARNING LETTER
The Ghost Of LOP  Wrote: (03-27-2020 07:01 AM)
Just found this online
thought some people might be interested in it...

USE CAUTION ON THIS STUFF

You should use caution on everything you put in your body.

If you eat right, you shouldn't need many supplements.

I take magnesium and iodine.

The magnesium because my chiropractor recommended it, and it worked...no major back issues since.....

Iodine because I don't salt my food much.(And because a lot of presalted foods now use sea salt that's non-iodized.

But I had both levels checked while I was taking it, and my doctor told me to keep doing whatever it was I was doing.

There is no such thing as sovereign debt. Reinstate Greenbacks.
http://www.youtube.com/watch?v=Vb5OQUElilo
Tax Wallstreet Party
United Front Against Austerity
(This post was last modified: 03-27-2020 02:03 PM by Luvapottamus.) Quote this message in a reply
Luvapottamus
Registered User
User ID: 372884
03-27-2020 02:05 PM

Posts: 16,580




Post: #12
RE: Get The Tea: FDA INSPECTION / WARNING LETTER
The Ghost Of LOP  Wrote: (03-27-2020 01:58 PM)
Luvapottamus  Wrote: (03-27-2020 01:56 PM)
lol

Company needs to relabel their products as "not drugs."

They should have done that in the first place.

These are herbal supplements, not dangerous FDA approved drugs.

If you are taking any FDA approved drugs, check this website for possible interactions:

https://www.medicinenet.com/herbs__toxic.../views.htm

chuckle

Anon

Turnabout it fair play.

If they want to play the drug card, play it back.

Plus people should take cautions on herbs even if they aren't taking drugs.

(the second link was better, I added it after you quoted me)

There is no such thing as sovereign debt. Reinstate Greenbacks.
http://www.youtube.com/watch?v=Vb5OQUElilo
Tax Wallstreet Party
United Front Against Austerity
(This post was last modified: 03-27-2020 02:06 PM by Luvapottamus.) Quote this message in a reply
Boop
【GROOVERIFIC BABY】
User ID: 529377
03-27-2020 07:15 PM

Posts: 12,470




Post: #13
RE: Get The Tea: FDA INSPECTION / WARNING LETTER
Luvapottamus  Wrote: (03-27-2020 02:02 PM)
The Ghost Of LOP  Wrote: (03-27-2020 07:01 AM)
Just found this online
thought some people might be interested in it...

USE CAUTION ON THIS STUFF

You should use caution on everything you put in your body.

If you eat right, you shouldn't need many supplements.

I take magnesium and iodine.

The magnesium because my chiropractor recommended it, and it worked...no major back issues since.....

Iodine because I don't salt my food much.(And because a lot of presalted foods now use sea salt that's non-iodized.

But I had both levels checked while I was taking it, and my doctor told me to keep doing whatever it was I was doing.

Jhikpghf

But I use some supplements in lieu of medications.
Some for inflammation, some for general heart health, general gun health , some for anti cancer prophylaxis et al.

Not all foods can do some of these things.

~~~~~~~~~~~~
[Image: HLQpp3f.gif]

・VENI VIDI CASTRATAVI ILLEGITIMOS・

[Image: DmahCLp.gif]
Quote this message in a reply
Boop
【GROOVERIFIC BABY】
User ID: 529377
03-27-2020 07:18 PM

Posts: 12,470




Post: #14
RE: Get The Tea: FDA INSPECTION / WARNING LETTER
Ghostie, are you on Patrick Stewart's Facebook?
He's doing these lovely daily readings for the house bound.

https://www.facebook.com/678442918910284...352751085/

~~~~~~~~~~~~
[Image: HLQpp3f.gif]

・VENI VIDI CASTRATAVI ILLEGITIMOS・

[Image: DmahCLp.gif]
Quote this message in a reply








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