Plexus FDA

Health and Testimonials

Plexus Worldwide Inc 7/30/14

  

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

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612
 
Telephone:      949-608-2900
FAX:    949-608-4415

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE                                                                     
SIGNATURE REQUIRED
 
July 30, 2014                                                                                                     
WL # 28-14
Tarl Robinson, Chief Executive Officer
Plexus Worldwide, Inc.
15649 N. Greenway Hayden Loop
Scottsdale, AZ 91356
 
Dear Mr. Robinson:
 
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.plexusworldwide.com in April and July 2014 and has determined that you take orders there for the products Fast Relief, ProBio5 and BioCleanse, which the website promotes for conditions that cause these products to be 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)]. The therapeutic claims on your website establish that your products are drugs 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 may 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: 
 
Fast Relief
 
  • “Nerve damage is present to some degree in most cases of chronic pain, especially neck and back pain. Nerve damage can occur due to trauma, medication side effects, or other metabolic issues.” 
  • “Features & Benefits…[m]ay reduce the associated symptoms from nerve damage of pain, numbness, tingling, ‘pins and needles’ sensations, and weakness.”
 
ProBio5
 
  • ProBio5 will typically provide the following results…jock itch, migraine headaches, recurring cystitis/vaginal infections…”
 
Bio Cleanse
 
  • “Why do you need Plexus Bio-Cleanse? Many people are in a low oxygen/toxic state….[v]iruses, bacteria, fungi, and other pathogenic microbes thrive in this condition, and can lead to disease such as flu, Candida, chronic fatigue, etc.   Plexus Bio-Cleanse can increase the oxygen levels around these microbes, causing them to die due to their high-oxygenated environment.”
 
Your Fast Relief, ProBio5 and BioCleanse 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)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. The FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
 
Furthermore, your Fast Relief, ProBio5 and BioCleanse are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that their labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist 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 all products marketed by your firm comply with all requirements of federal law and FDA regulations.
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. 
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 working days, state the reason for the delay and the time within which you will complete the correction. 
 
Please submit your response to:
 
Nancy Schmidt, Acting Director
Compliance Branch
Food and Drug Administration
Los Angeles District
19701 Fairchild
Irvine, CA 92612
 
Include Special Identifier FEI #3010151057 on all correspondence. If you have any questions please contact Dr. Raymond W. Brullo at (949) 608-2918.
 
Sincerely,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc: 
 
Harlan Loui, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435
The company issued this request in April 2013:
""To protect our company, our future & stay in compliance with FTC (federal trade commission) we've been asked to make a few verbage changes.
1) We can no longer post Dave Brown's videos publicly. He makes medical claims in them relating the product to diseases, We can post them privately in messages or in these groups for educational purposes only but should never be showed to a person "proving" a cl
aim that has been made.
2) When posting testimonies, please do not put your website link in the post. Simply put "Contact me for additional information". If you put any info about how to order the product with the testimony you are saying that you have products that will do the same for them.
3) We can no longer publicly say that our product is safe for pregnant or lactating women. Even though it is, our compliance dept. would like for us to change this to legally protect the company. Women should always consult with their doctors first taking a list of the product ingredients.
4) We can no longer say that Plexus was originally created for those with Type II Diabetes (diagnosis of disease) We CAN say, Plexus has been proven to help those with Type II Diabetes to stabilize their blood sugars or is diabetic friendly and again should take a list of ingredients to their physician.""
A quick google search shows us the following information for Plexus Slim Side Effects.
Listed here are ones pertaining to "Plexus Slim" and "Plexus Slim Accelerator"

The company does not list anything in their database for customers or the people selling the products.
This site will be updated when time allows.



Side effects/Precautions:
No clinical research has evaluated Plexus Slim for safety or side effects. The ingredients in Plexus Slim can result in side effects like nausea, gastrointestinal discomfort, and headache, and can interact with a variety of medications.

The bottom line: Although the ingredients in Plexus Slim have been shown to help with appetite control, blood sugar levels, and/or weight loss, the supplement facts label doesn't disclose how much of each of these ingredients are in a serving, so it's impossible to know if there's enough of each ingredient to be effective. Until there is more research (or a better disclosure of what is actually in the supplement),
Source: http://www.nola.com/health/index.ssf/2013/09/post_42.html
__________________________________________________________________________
Hazard identified
The Australia Therapeutic Goods Administration (TGA) warned consumers not to use these products as they were found to contain 1,3-dimethylamylamine (DMAA), a drug that is not approved for sale in Canada.
Health Canada received one Canadian report of a serious adverse reaction suspected to be associated with a "Plexus Slim Accelerator" product. Due to limited information at this time, Health Canada is unable to determine whether the product reported is the same as the product that is the subject of the TGA alert, or what role, if any, the product may have played in the adverse reaction. It is not known where the product was purchased. Health Canada is currently following up on this report. Place of origin
Unknown Side effects
Side effects associated with DMAA include high blood pressure, shortness of breath, chest pain, stroke and psychiatric disorders.
Source: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2014/37721a-eng.php
___________________________________________________________________________
Side Effects
Even though the parent companies official website claims that there are no side effects, you do have to be careful. Here are some of the side effects that could occur, based on the ingredients inside of Plexus Slim.
Gas, due to the number of fibers in the drink. Some people with liver problems could have issues due to a couple of the ingredients in the drink.
Heart disease may be related to a couple of the lesser acids in the drink. Some of the ingredients cause low low blood sugar levels, and in those who already have low blood sugar, that could be dangerous.

As you can see, many of the side effects listed here are ones that are related to specific issues.
In people who are not pregnant or do not have any of the above issues, it’s probably fine to try, even though there isn’t really a lot of proof that the ingredients in Plexus Slim are going to do anything for weight loss.

Source: http://www.ncourages.org/plexus-slim-review-ingedients-and-side-effects/
___________________________________________________________________________
Side Effects
There are a number of side effects reported by users on Amazon.com.
The most common one is bloatedness and constipation.

Others have reported side effects such as:

Heartburn. Jittery. Nautious. Headache. Dizzy. Chest pain.
These side effects are most likely caused by Accelerator+ which has caffeine in it. You should avoid Accelerator+ if you are sensitive to caffeine.
Source: http://www.bestdietpillreviewsforwomen.com/plexus-slim-reviews-side-effects/
_________________________________________________________________________________
According to Plexus Worldwide the answer is simply NO.
They claim that “extensive clinical research” has shown no side effects with any medications or supplements. That’s a fairly big claim and clearly they can’t have tested their supplement with EVERY medication out there. So we would urge caution if you’re taking any prescription medication and suggest you speak to your medical professional first before taking!
Source: http://www.dietpillswatchdog.com/plexus-slim/
____________________________________________________________________
Plexus Slim Side Effects
Although the companies that promote the product claims of its zero side effects, there is still a need to be extra careful. There are still some side effects in the product that depend on its ingredients. Here are the following side effects attributed to Plexus slim:
1. Gas. This is due to a lot of fibers contained in Plexus Slim.
2. Other people who already have liver problems may suffer from issues because of its ingredients.
3. Heart disease is also related in the intake of Plexus Slim.
4. Other ingredients result for lower levels of blood sugar. Those who already have their lower blood sugar may find it dangerous to take this product.

Source: http://healthresearchfunding.org/plexus-slim-side-effects/
_______________________________________________________________________________
This site is worth the time to read:
Source: http://networkedblogs.com/RSE9n
_____________________________________________________
Not known for sure
Plexus Slim has several products, and since they are not medications approved by the FDA, Plexus Slim products are probably not tested for interactions and side effects like real medicines are. So, that means nobody really knows what side effects there are. If an Plexus Slim user hears of some interaction or thinks she is getting a side effect, she can visit her primary care doctor.

Source:
 https://www.healthtap.com/topics/is-plexus-slim-fda-approved_____________________________________________________________


Here is the Alert issued via Health Canada. 

Health Canada
 issues this Alert for two Products sold via Plexus Worldwide
Foreign Product Alert:
Plexus Slim Accelerator capsules, and Plexus Slim Accelerator 3
 Day Trial pack
Starting date: February 7, 2014
Posting date: February 7, 2014
Type of communication:Foreign Product Alert (FPA)
Subcategory: Natural health products
Source of recall: Health Canada
Source of alert: Australia Therapeutic Goods Administration
Issue: Undeclared Substance
Audience: General PublicIdentification number:RA-37721

These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.
Affected products Plexus Slim Accelerator capsules Plexus Slim Accelerator 3 Day Trial pack Plexus Slim Accelerator capsules, and Plexus Slim Accelerator 3 Day Trial pack Product description
These products are promoted for weight loss. Hazard identified The Australia Therapeutic Goods Administration (TGA) warned consumers not to use these products as they were found to contain 1,3-dimethylamylamine (DMAA), a drug that is not approved for sale in Canada. Health Canada received one Canadian report of a serious adverse reaction suspected to be associated with a "Plexus Slim Accelerator" product.
Due to limited information at this time, Health Canada is unable to determine whether the product reported is the same as the product that is the subject of the TGA alert, or what role, if any, the product may have played in the adverse reaction. It is not known where the product was purchased. Health Canada is currently following up on this report.
Place of origin Unknown S
ide effects Side effects associated with DMAA include high blood pressure, shortness of breath, chest pain, stroke and psychiatric disorders.
What you should do
Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find either of the products listed above in the Canadian marketplace.
Canadians who have these products are advised not to use them, and should consult with a health care professional if they have concerns about their health related to the use of these products.
Background Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.
As of December 31, 2013, Health Canada has received one report of an adverse reaction suspected to be associated with the use of these products. Report a health of safety concern

To report a side effect to a health product to Health Canada:
Call toll-free at 1-866-234-2345
Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax
http://www.youtube.com/watch?v=kvwpZwXpJ-M
Found on the Company webpage... This has been on the page, prior to the company changing products. This is false advertising as the company does not sell the products that resulted in this.  ""Lost 26 lbs. and 4 Sizes. I started taking Plexus Slim with Accelerator four months ago and I have lost 26 pounds. I went from a size 12 to a size 8. Even during the holidays when the food craving was at its worst, I was able to enjoy and eat what I wanted without gaining a pound. Plexus Slim helps me maintain my weight loss. It started working so great that my husband tried the products and has lost 20 pounds. Today I am happier, healthier, and feeling my all-time best. Thank you Plexus! - Hope S. Disclaimer: These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.""

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