TAX FRAUD

Alfred Pettersen admits that his partnership agreement with Tarl Robinson, Plexus Worldwide was a TAX FRAUD. Please read the comments sections on the pages and posts. They contain some great info from other readers. This Blog is freedom of speech, makes no money aside from a few cents a year in affiliate linking. Reports and information contained were accurate at time of posting and nobody will correct them as they are an archived history of events. Changes may have been made, but we don't care.

Covid 19 cured

 Does Plexus cure Covid 19?

Where are the outbreaks in your area?

We want to know.

Court Documents

Court Documents 

"Defendant Robinson's goal was to get full control of the company"

Here for you to view.
Not sure where they came from or who screwed who.

""22. Defendant Robinson knew that his treatment of Plaintiff at the || company's yearly convention would embarrass, humiliate and demean Plaintiff, and, in order to assure that that occurred, Robinson told many PLEXUS personnel and ambassadors that he had to send Plaintiff home due to Plaintiff's misconduct with Brittany Gaines and also due to Plaintiff being drunk. Defendant Robinson's ||"story" was communicated by Robinson to all the PLEXUS staff and, in a matter of
hours, all the PLEXUS Ambassadors (distributors).
23. As a result of Defendant Robinson's conduct and statements at the
convention in Dallas, Plaintiff sent an e-mail to Defendant Robinson, on the following Monday, saying that Plaintiff was taking a six-month sabbatical from the company. About 10 days later, Defendant Robinson had a meeting with Plaintiff, and said to Plaintiff: "Here are the terms of your sabbatical." I was thinking, you arrogant SOB. It is MY sabbatical not yours.""

Have a nice read. Here is the link: 





Tax Fraud

Tax Fraud.

The IRS sates:

""You may deduct charitable contributions of money or property made to qualified organizations if you itemize your deductions. Generally, you may deduct up to 50 percent of your adjusted gross income, but 20 percent and 30 percent limitations apply in some cases.""



Where there is money, there is tax.  Most everyone knows that.  Work hard, pay the tax man, grumble.

They more you make, the more you pay, some say.

Taking some of your money, contributing to a charity and then being able to deduct that contribution sounds like a good thing.

Everyone loves a do-gooding philanthropist!

Nobody ever criticised a persons goodwill or desire to help others. Gifted money is never questioned or turned downed. Happiness all around! Mission accomplished.

Gift to charity. Sounds like the one solution to an average tax payers woes. Money Money Money. What happens if you aren't an average tax paying citizen, and this solution is not enough to meet your needs. You want and need to keep as much as you can, right?  Some don't really want to gift away hundreds of thousands of dollars, to be left with warm fuzzy feelings and a lower tax bracket. They don't. So, they get crafty and find loopholes. Charities have an enormous benefit to a tax situation, especially if the charity is your own and allows one to hide income within.

It's still tax fraud, right?









Lawsuit Links

Information regarding Plexus lawsuits:

Alfred Pettersen and Tarl Robinson found here

Marriott Hotel found here
Marriott Hotel is seeking $1,000,000.  in damages for a contract breach by Plexus.

Environmental Research Centre - Lead in products - found here

Rex Powers found here

Elsenrath found here

TruVisoin Health found here and found here and found here

Angel Fletcher found here

Ryan Higgins found here

Patty Swan found here

Carrie Sterma found here

Your name: found here

Class Action Lawsuit found here

Breach of Contract - Who's the quilty one?

2015 -  Top Plexus Ambassadors flee, following products that don't work, many hidden legal issues, customers making claims that the products are harmful and after FDA investigation.
Dave Brown lies about ownership of TruVision Health, yet Plexus Ambassadors follow him and secretly join.
Secrets keeps you sick and always have a way of showing the truth, even years later.

When the pink drink scam was taking place, I contacted several ambassadors, one of which was Robin Elsenrath
_____________
08/28/2014

Hi Robin, I'm curious, and it is not my business.. Why did you leave Plexus?

08/28/2014

Robin Naquin Elsenrath

I am not sure how you know me or where your info came from but I have not left Plexus and am not planning to leave. I am happy where I am and my family and I have been blessed.   I hope your day Is great so far.  R
______________________

She registered the domain.. Truvision.org.

have a peek:

NOW.. Legal Battles show all the truth..






Health Fraud


Plexus Worldwide, the company known for a Pink Drink, has been accused of Health Fraud, violations of the FTC and the FDA,  just to name a few.

Truth in Advertising posted their independent investigation here.

I want to thank them for their hard work.

For the sceptics, naysayers and those that were just down right dirty over the years... well.. you know.





Complaints Against Plexus Worldwide

Recent Complaints Against Plexus Worldwide 

  1. False, misleading or deceptive advertising (Section 9, Food and Drugs Act)
  2. Complaint regarding the advertising of unauthorized products
  3. Prohibited advertising to the general public as treatment or cure for any Schedule A disease (Section 3, Food and Drugs Act) and False, misleading or deceptive advertising (Section 9, Food and Drugs Act)

Complaints source:

  1. Social Media
  2. In Person, Print, Website

Source: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/complaint-plaintes/index-eng.php



Found by A Woman Scammed:

Randolph Road resident reported to Deputy Mark Allen someone tried to make an unauthorized purchase on her American Express card.
According to the report, American Express called the resident in regard to a purchase that was charged to her card, but was delivered to another address.
The resident stated the purchase was made with Plexus Worldwide but was declined by American Express due to different addresses for the mailing and billing addresses.
According to the report, the resident has since cancelled and shredded the card.

Source: http://www.panolian.com/2016/08/05/sheriffs-report-tragedy-claims-man-at-cypress-point/

Plexus Mega X

Plexus Worldwide released another new product at their convention in Arizona. "Plexus Mega X"

This products main ingredient ""Ahiflower oil, has never been consumed by humans before""   that is until mid 2014 when Researchers at the University of Moncton got to perform some clicinal trials.

This new product, Plexus Mega X is going to be plastered all over social media in the next few weeks to come. The company will declare that their sales have sky-rocketed and try to deceive people into thinking they are the company to be with! NOT.



‪#‎oneplexus‬ showed their new product, Mega X. New products mean that companies are phasing out non-selling products and hope that the pink drink sheep will get back on board and bust open their wallets to try this. As we know, Alfred is suing Tarl, so I guess Plexus may be facing financial difficulties. Please don't go buy this sh*t ..

Human trials of this product took place in PEI Canada in mid 2014, so this product and the long term effects aren't known, good or bad. There are several reports and documents talking about this.


Breast Health

Breast Health by Plexus Worldwide

Healthy breasts and general overall health is not something that should be taken lightly.

I'm in a playful mood today and wanted to share the label of the 'Original' Breast Cream, that Plexus Pink sold to distributors.

As with all Plexus products, please be aware, Plexus Worldwide is constantly changing products, product ingredients, and product names.

At least we know they have, or at least had, their heart in it.


I think it would be safe to assume that Dr. Spencer and Plexus lost that loving feeling after their out of court settlement.


Clinical Studies

Plexus Clinical Studies‎

"Plexus is so confident in the power of their products that they guarantee you will notice a difference in your life. There is no risk. "

Plexus Worldwide has thousands of cult minded individuals that regurgitate information passed on to them from someone else.
This second hand information tends to be spewed down the pipeline from a person that has a high rank as an Ambassador of Plexus Worldwide.
Their source isn't always known or given, and typically, nobody will question a person with this sort of "celebrity status".


The Ambassadors of  Plexus Worldwide will not question or dispute information, as they are Afraid.


Pink Drink Fraud

Pink Drink Fraud


Definition of Fraud is: 





"wrongful or criminal deception intended to result in financial or personal gain"




"a person or thing intended to deceive others, typically by unjustifiably claiming or being credited with accomplishments or qualities"

For purposes of this blog, we have decided to publicly identify the names of faces of those associated with operating any sort of Pink Drink fraud.

You have already been introduced to the owners, past and present, of Plexus. You've been told about the Dirty Diamonds. What you haven't been told about, are those snakes that lurk in the dark, some calling themselves your friend, some you may think of as these pink drink fraudsters as family, while others won't have a clue that snakes exist.

Let's help shine some light on these snakes.

Edge does it work?

Edge -  Plexus Egde Energy Supplement




Another new product, to replace an old one!

Typical business operations for this company.




Still sold on ebay. Buyer Beware


Who remembers the product 'Plexus Slim Accelerator'?

Who can recall what countries banned this product from crossing their border into their country?

Probably just the Plexus Ambassadors that are at the top of this MLM food chain. Not many new recruits will know about all of the health complaints that customers and plexus ambassadors were making and reporting about products that Plexus Worldwide preached as safe, effective and natural.  There are a few complaints about Plexus products in the product review page.





Why did Plexus Holdings aka Plexus Worldwide need a product replacement for the Plexus Slim Accelerator?





Plexus Accelerator contained DMAA, which is an illegal ingredient found in this and many dietary supplement, mislabelled as a 'natural stimulant'





Untold Secrets of MLM Uplines



Untold Secrets

MLM Uplines must maintain a friendly public persona at all times.





I wonder if she shared this in the "jewels training" that Plexus provides?

Did you fall for the 'products just sell themselves' line? That's ok, we all did!

Products don't just sell themselves, especially Plexus products.


Read more Untold Secrets here: 


Pink Drink

Pink Drink
What is it about a 'pink drink' that has women going crazy for it!

This blog was originally started to share info about a crooked company, Plexus Worldwide.

Many other pink drinks have popped up, Starbucks has a pink drink!

OMG !
If you are on pinterest, twitter or youtube, or other social media platforms, you will see this pink drink everywhere!

Not only can you purchase a pink drink from 'Starbucks' but you can make one yourself!


A DIY pink drink!



Plexus product review

Plexus Product Review






Want to know what Plexus customers really think? 


Click here:  Plexus Worldwide Product Reviews


Plexus Scam

Plexus Scam

Is this company another MLM Scam?

There have been many visitors asking the same question and looking here for an answer.

I have a question for those that visit this site.

Why is this blog frequently monitored by the following companies, if Plexus is not a scam?


  1. Plexus and their numerous 'plexus police' pimps
  2. Sonya Dudley, Helen McFadden, Sheila Medina and other top dollar money making #IamPlexus Plexus Ambassadors and their perspective lawyers.
  3. United States Government agencies - including and not limited to:
    1. US Department of Defence
    2. The FDA
    3. The FTC
    4. The IRS
    5. The Department of Homeland Security
    6. United States Senate
  4. Past and Present people involved with TruVision Health
  5. Government Agencies within Canada and Australia

As it states on the blog.. there is a tracker.. there are a few actually .. I like to see who you are. 

Thank you for visiting and please connect with me if you have questions.

Remember: Plexus Worldwide is still under investigation by many government agencies and Tarl Robinson will settle out of court should one decide to pursue that route.






Supplements Claiming to be Cures

Supplements Claiming to be Cures

Promises for a quick cure or solution for a serious health problem may be hard to resist — but supplements claiming to shrink tumors, cure insomnia, cure impotency, treat Alzheimer's disease, or prevent severe memory loss aren't proven. Besides cheating you out of your money, they also may hurt your health.

Under Federal law, dietary supplements can't be promoted for the treatment of a disease because they aren't proven to be safe and effective.

Treat weight loss products with suspicion, too. Claims that you can eat all you want and still lose weight effortlessly just aren't true. To lose weight — and keep it off — you have to eat fewer calories and increase your activity.

Other tip-offs to a fraud include:

Claims that one product does it all and cures a wide variety of health problems.
"Proven to treat rheumatism, arthritis, infections, prostate problems, ulcers, cancer, heart trouble, hardening of the arteries and more."

Suggestions the product can treat or cure diseases.
"Shrinks tumors," "Cures impotency," or "Prevents severe memory loss."

Words like scientific breakthrough, miraculous cure, exclusive product, secret ingredient, or ancient remedy.
"A revolutionary innovation formulated by using proven principles of natural health-based medical science."

Misleading use of scientific-sounding terms.
"Molecule multiplicity," "glucose metabolism," "thermogenesis," or "insulin receptor sites."

Phony references to Nobel Prize winning technology or science.
"Nobel Prize Winning Technology," or "Developed by two times Nobel prize winner."

Undocumented testimonials by patients or doctors claiming miraculous results.
"My husband has Alzheimer's disease. He began eating a teaspoonful of this product each day. And now, in just 22 days, he mowed the grass, cleaned out the garage, weeded the flower beds, and we take our morning walk again."

Limited availability and a need to pay in advance.
"Hurry. This offer will not last. Send us a check now to reserve your supply."

Promises of no-risk "money-back guarantees.
"If after 30 days you have not lost at least 4 pounds each week, your uncashed check will be returned to you."

Read more here: 



        

Does Plexus Work



this was sent this way



Comment below and share your thoughts

Listen to her refer to the study.. it's a scam  

Did she say the products are safe.. if you like lead in your chocolate

Shut down


Tarl Robinson, "Hopes you can still be friends" after has your business shut down!

That's right, shut down.

If you thought that you were in charge of your own business, that you owned and/or operated your own Plexus business, that you had any control over your business, you were duped!

Those high up on the food chain want you to think that, the company wants you to think that,
but it's wrong.
They know that, and they know that you don't know that.

One cannot be in business for oneself if they have no control over incoming sales.

Don't bother calling, it goes to an automated voice message!

Don't call Sonya Dudley either to ask her how this is effecting her business, she will just hang up on you, or well, maybe it's just me that she will hang up on. Either way..

Plexus Worldwide claims to have 220,000 Ambassadors
All screwed.

Ah well, Ambassadors aren't smart enough to realize the cost to them.



Plexus Lawsuit

Plexus Lawsuit to be one of the biggest in MLM history. 

Inside court documents reveal Alfred Pettersen "alleges fraud, fraudulent transfer, breach of fiduciary duty and violation of the
2012 shareholders’ agreement". 

?? 2012 





We already knew that this company was build on a foundation of lies, deceit and fraud! 




OMNIHEALTH

Have you seen this product for sale at WalMart? 











Did you wonder what Plexus had to do with this and why their name is on the label?













Plexus gives money away

What I find incredibly funny, is an email sent to someone that is NOT involved in the company that says:

 "Plexus Worldwide has loaded USD $2.00 to your account at 01-22-2016.. "

I wonder how many times they have "given" money away like that.

let's think....

over 200,000 ambassadors at one count (unverified, of course)

Why would they create an expense in the tune of $400,000+ like that?



I can think of many reasons. How about you?


I'm sure the company's papers would like rather interesting to the IRS of the FTC.


Maybe Alfred Pettersen is not aware of this, what would it do his civil lawsuit against Tarl Robinson and Plexus Worldwide.


WHAT IF THIS COULD CHANGE EVERYTHING?





 

Have you heard about the new changes taking place in Plexus?


Some may say the company is growing, some may say that the company has been selling products that are harmful, some may say that this is their way out, and even still, others may say they are shutting their doors!

We did some research and have found some information, and wondered:

What if this could change EVERYTHING?


Plexus is Out of Business

Is Plexus out of Business? Have they shut down their doors permanently? It looks like a Change is in the works. Did they tell you?

Plexus has cheated you

Plexus has cheated you, or have they?

It's not often that you will hear the President of a company suggest that they have cheated you.


Depending on how you interpret his words.. that is what he could be suggesting.. 
Have a listen..


Dear Plexus Ambassador

Dear Plexus Ambassador , J. Doe et al

Whether you go by Jane Doe, John Doe, Tarl Robinson, Sonya Dudley, Helen McFadden, Sheila Medina, Coach Cuevas, Ambassador # 12345 and every other Plexus Ambassador, Plexus employee, Plexus distributor, or persons such as Dennis Harris, Alfred Petterson and Dave Brown.

Plexus products are harmful

Selling them serves no purpose other than to line your bank account and make you feel better about yourself.



Oops, my mistake, you already know that!



Some of you make videos to prey on the emotions of others. You include things such as storms, floods, fires and natural disasters to try to have that impact on people and then tell them how blessed you are that you found Plexus. Blessed my ass!

Some of you show how hard done by you were, before Plexus came along. You may very well have been, but you are a snake. You are not interested in helping others have a better life. You are interested in helping you have a better life. If you wanted to help those people, why do you charge them?

Many of you, almost all of you, say you use the product. You don't. What if you did?

You would have subjected yourself to the list of medical issues that your customers have been complaining to you about. You must have, if you really did use these products.

I wonder if you are even concerned about the civil suit that ERC's Executive Director Chris Heptinstall has filed in the State of California claiming that several of the products Plexus Worldwide sells contain over the allowable limit for Lead.

If you use plexus products, have used the fast relief capsules that you allege, you may very well have: Possible Lead poisoning!


But Hey! We all know the truth. What do you care... you had your boob job so that you might finally meet a man,  you are selling products for your wife so that she won't be around so much; we all know why.. you have finally hit the mark for a new facebook page, you went to Hawaii,  were able to pay off your mortgage and your youtube account is bringing you in money that you haven't declared. You feel special now.

Please don't be confused. I'm not jealous or pathetic or have a grudge. I want you to remember me.

I want you to tell everyone that you talk to about plexus what I have to say, then ask them if they still want to buy your product or join your team.

Wonder how that will work out for you? I think most of us already know the answer.

Ambassadors, you are all potentially liable in a court of law. 

Are you going to keep selling Plexus products?




Sonya Dudley has a YouTube channel, she makes a few thousand a month off it.
She claims:

""This channel was created to help as many as I can in the Plexus world learn from my lessons and mistakes! Hope that you enjoy learning from them...""

Sonya Dudley says:

""This is my true story of pain to peace.... And how even in a small town who had the highest unemployment rate a few years ago in the nation can have many many doing Plexus and helping so many.. ""

Debra Lawson says:

"FAST RELIEF will help you live happier, healthier, and pain free" 


Don't feel left out or singled out, I'm busy and Sonya Dudley will be joined by others here. I have contacted her numerous times to ask to speak with her about Plexus, she hangs up the phone.


I've been busy, here are some interesting reads, Gee .. hope your not worried:

FTC Sues Marketers Who Used “Gag Clauses,” Monetary Threats, and Lawsuits to Stop Negative Consumer Reviews for Unproven Weight-Loss Products
https://www.ftc.gov/enforcement/cases-proceedings/142-3255/roca-labs-inc


Sealed Document

Sealed Documents



Case Information
Case Number:CV2015-051936Judge:Anderson, Aimee
File Date:5/15/2015Location:Northeast
Case Type:Civil 
Party Information
Party NameRelationshipSexAttorney
Alfred Pettersen  Plaintiff Male Philip Nathanson 
Tarl Robinson  Defendant Male Joshua Ernst 
Plexus Holdco L L P  Defendant  Joshua Ernst 
Plexus Holdings Inc  Defendant  Joshua Ernst 
Plexus Worldwide L L P  Defendant  Joshua Ernst 
Plexus Worldwide L L C  Defendant  Joshua Ernst 
Plexus Worldwide Inc  Defendant  Joshua Ernst 
Case Documents
Filing DateDescriptionDocket DateFiling Party
2/5/2016 MTC - Motion To Compel 2/5/2016  
NOTE: Defendants' Motion to Compel Arbitration 
2/5/2016 MTT - Motion To Transfer 2/5/2016  
NOTE: Motion to Transfer to Commercial Court 
2/5/2016 CAN - Credit Memo Appearance Fee Paid 2/5/2016  
NOTE: Credit Memo/Appearance Fee Paid 
1/29/2016 ORD - Order 1/29/2016  
NOTE: ORDER ON PLAINTIFFS’ MOTION FOR LEAVE TO FILE PLAINTIFF’S FIRST AMENDED COMPLAINT. 
1/29/2016 SDD - Notice: Sealed Document 2/1/2016  
NOTE: PLAINTIFFS FIRST AMENDED COMPLAINT 
1/7/2016 ORD - Order 1/7/2016  
NOTE: ORDER ON PLAINTIFFS’ MOTION TO SEAL PLAINTIFF’S PROPOSED FIRST AMENDED COMPLAINT, AND THE MOTION FOR LEAVE TO FILE SAME. 
1/7/2016 ORD - Order 1/8/2016  
NOTE: ON PLAINTIFFS MOTION TO SEAL COURT RECORDS 
1/4/2016 SDD - Notice: Sealed Document 1/5/2016  
NOTE: PLAINTIFF'S MOTION TO SEAL PLAINTIFF'S PROPOSED FIRST AMENDED COMPLAINT, AND THE MOTION FOR LEAVE TO FILE SAME 
12/31/2015 SDD - Notice: Sealed Document 1/4/2016  
NOTE: PLAINTIFFS’ MOTION FOR LEAVE TO FILE HIS FIRST AMENDED COMPLAINT. PLAINTIFF ASKS FOR ACCELERATED CONSIDERATION OF THIS MOTION. 
12/28/2015 MOT - Motion 12/29/2015  
NOTE: TO SEAL COURT RECORDS 
10/21/2015 311 - ME: 150 Day Minute Entry 10/21/2015  
9/8/2015 WSS - Waiver Of Service Of Summons 9/8/2015  
NOTE: Waiver of Service of Summons ALL DEFENDANTS 
8/19/2015 322 - ME: Notice Of Intent To Dismiss 8/19/2015  
5/15/2015 COM - Complaint 5/19/2015  
5/15/2015 CCN - Cert Arbitration - Not Subject 5/19/2015  
5/15/2015 CSH - Coversheet 5/19/2015  

TruVision Health


TruVision Health LLC 9/21/15


Department of Health and Human Services logoDepartment of Health and Human Services

Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740 


WARNING LETTER
SEPT 21, 2015 
VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Derek Bailey, Founding Partner
Shawn Gibson, Founding Partner
Travis Martin, Founding Partner
TruVision Health LLC
12244 S Business Park Drive
Ste. 115
Draper, UT 84020-6522 US
Re: 461315 
Dear Mr. Bailey, Mr. Gibson, Mr. Martin and:
This letter concerns your product tru Weight & EnergyTM, which is labeled and/or offered for sale as a dietary supplement. The Supplement Facts panel on your product label appears to declare AMP as a dietary ingredient. This ingredient is also called, among other names, 1,3-Dimethylbutylamine, DMBA, 2-amino-4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine, and will be referred to in the rest of this letter as DMBA.  In addition, the Supplement Facts panel on your product label appears to declare Bitter Orange Extract (synephrine 30%) as a dietary ingredient. 
The term “dietary supplement” is defined in section 201(ff) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321(ff)). Given that you appear to declare DMBA as a dietary ingredient in the labeling of your product, we assume you have a basis to conclude that DMBA is a “dietary ingredient” under section 201(ff)(1) of the Act (21 U.S.C. 321(ff)(1)). Assuming that DMBA is a “dietary ingredient,” it would also be a “new dietary ingredient” for which a notification is required under section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6.
Under section 413 of the Act (21 U.S.C. 350b), a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under section 402(f) of the Act (21 U.S.C. 342(f)) unless it meets one of two requirements:
1.    The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
2.    There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
DMBA
To the best of FDA’s knowledge, there is no information demonstrating that DMBA was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. In the absence of such information, DMBA is subject to the notification requirement in section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6. Because the required notification has not been submitted, your product is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)).
Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that DMBA, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, tru Weight & EnergyTM is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)) because it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Introduction of such a product into interstate commerce is prohibited under sections 301(a) and (v) of the Act (21 U.S.C. 331(a) and (v)). To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that DMBA will reasonably be expected to be safe when used as a dietary ingredient. 
It has come to our attention that DMBA used in products in the dietary supplement marketplace may be produced synthetically. Section 201(ff)(1) of the Act (21 U.S.C. 321(ff)(1)) defines “dietary ingredient” as a vitamin, mineral, amino acid, herb or other botanical, or dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract or combination of any dietary ingredient from the preceding categories. Synthetically produced DMBA is not a vitamin, mineral, amino acid, herb or other botanical. To the best of FDA’s knowledge, synthetically produced DMBA is not commonly used as human food or drink. Further, synthetically produced DMBA is not a concentrate, metabolite, constituent, extract or combination of the preceding categories. Therefore, synthetically produced DMBA is not a dietary ingredient as defined in section 201(ff)(1) of the Act.
Bitter Orange Extract (synephrine 30%)
Bitter orange (C. aurantium) is a dietary ingredient under sections 201(ff)(1)(C) and 201(ff)(1)(E) of the Act and has a history of use by man intended to supplement the diet. However, the levels of synephrine in Bitter Orange Extract (synephrine 30%) have been modified from naturally occurring levels. The natural p-synephrine content in dried bitter orange ranges from 0.012%-0.25%[1] and the content of p-synephrine in concentrated extracts or commercial products are standardized to 4-6%[2],[3],[4]
To the best of FDA’s knowledge, there is no information demonstrating that Bitter Orange Extract (synephrine 30%) was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is there information demonstrating that this ingredient has been present in the food supply as an article used for human food in a form in which the food has not been chemically altered. In the absence of such information, Bitter Orange Extract (synephrine 30%) is subject to the notification requirement in section 413(a)(2) of the Act (21 U.S.C. 350b(a)(2)) and 21 CFR 190.6. Because the required notification has not been submitted, your product is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)).
Even if the required notification had been submitted, we know of no evidence that would establish that your product is not adulterated. In the absence of a history of use or other evidence of safety establishing that Bitter Orange Extract (synephrine 30%), when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe, your tru Weight & EnergyTM is adulterated under sections 402(f)(1)(B) and 413(a) of the Act (21 U.S.C. 342(f)(1)(B) and 350b(a)) because it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. To the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that Bitter Orange Extract (synephrine 30%) will reasonably be expected to be safe when used as a dietary ingredient. In fact, there is evidence from short term human and animal studies suggesting that the consumption of products containing a high dosage of bitter orange extract and synephrine could lead to a significant increase in systolic blood pressure, diastolic blood pressure, and heart rate.  Similarly, products containing Bitter Orange Extract with high doses of p-synephrine and caffeine, also an ingredient in your product may be of potential safety concern. The combination of these substances is likely to enhance their potential cardiovascular effects and could contribute to a significant increase in heart rate and blood pressure[5].
We request that you take prompt action to correct the violations cited above, as well as any other violations associated with your tru Weight & EnergyTM product or other dietary supplement products marketed by your firm, including any that contain DMBA and/or Bitter Orange Extract (synephrine 30%). We also remind you that the new dietary ingredient notification requirement applies to all dietary supplements that contain new dietary ingredients that have not been present in the food supply as articles used for food in a form in which the food has not been chemically altered. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
Failure to immediately cease distribution of your tru Weight & EnergyTM product and any other products you market that contain DMBA and/or Bitter Orange Extract (synephrine 30%) could result in enforcement action by FDA without further notice. Sections 302 and 304 of the Act provide for seizure of violative products and injunction against the manufacturers and distributors of violative products [21 U.S.C. §§ 332 and 334]. 
We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace. Your response should also include an explanation of each step taken to ensure that similar violations do not recur, as well as documentation to support your response. Your written reply should be directed to Mr. Rob Genzel, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Mr. Genzel atrob.genzel@fda.hhs.gov.
Sincerely,
/S/                                                                                               
William A. Correll
Director
Office of Compliance
Center for Food Safety
  and Applied Nutrition


[1] Rossato, L. G.; Costa, V. M.; Limberger, R. P.; Bastos, M. d. L.; Remião, F., Synephrine: From trace concentrations to massive consumption in weight-loss. Food and Chemical Toxicology 2011, 49, (1), 8-16.
[2] Kubo, K.; Kiyose, C.; Ogino, S.; Saito, M., Suppressive Effect of <i>Citrus aurantium</i> against Body Fat Accumulation and Its Safety. Journal of Clinical Biochemistry and Nutrition 2005, 36, (1), 11-17.
[3] Nguyen, D. T.; Bui, L. T.; Ambrose, P. J., Response of CEDIA amphetamines assay after a single dose of bitter orange. Ther Drug Monit 2006, 28, (2), 252-4.
[4] Penzak, S. R.; Jann, M. W.; Cold, J. A.; Hon, Y. Y.; Desai, H. D.; Gurley, B. J., Seville (sour) Orange Juice: Synephrine Content and Cardiovascular Effects in Normotensive Adults. The Journal of Clinical Pharmacology2001, 41, (10), 1059-1063.
[5] Health assessment of sports and weight loss products containing synephrine and caffeine. www.bfr.bund.de

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