Report: #1174949
Complaint Review: Plexus Worldwide - Scottsdale Arizona
Ripoff Report on CBS 19
Ripoff Report on CBS 19 - Global Marketing Alliance
Ripoff Report on ABC 15 - Smart Shopper
Ripoff Report - Girls Gone Wild
Ripoff Report on Fox 11 - Car Repair
- Author Not Confirmed
Why?
- Plexus Worldwide 7025 East Greenway Parkway Scottsdale, Arizona USA
- Phone: 4809983490
- Web: www.plexusworldwide.com
- Category: Weightloss Programs
Plexus Worldwide Plexus Pink, Plexus Wireless, Plexus Worldwide inc, Plexus holdco, plexus holdings, plexus pima centre, tarl robinson, alfred pettersen, alec clark, FDA Warning Letter - not generally recognized as safe Scottsdale Arizona
*Consumer Comment: Not quite what it says....
Business Rating:
Tell us has your experience with this business or person been good?
Show customers why they should trust your business over your competitors...
← Is this
willing to make a
commitment to
customer satisfaction
Click here now..
Report about YOU
listed on other sites?
Those sites steal
Ripoff Report's
content.
We can get those
removed for you!
Find out more here.
listed on other sites?
Those sites steal
Ripoff Report's
content.
We can get those
removed for you!
Find out more here.
How to fix
Ripoff Report
If your business isRipoff Report
willing to make a
commitment to
customer satisfaction
Click here now..
fda.gov/iceci/enforcementactions/warningletters/2014/ucm411287.htm
Plexus Worldwide Inc 7/30/14
| 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 |
Department of Health and Human Services
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 #(((redacted))) 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
This report was posted on Ripoff Report on 09/06/2014 02:22 PM and is a permanent record located here: https://www.ripoffreport.com/reports/plexus-worldwide/scottsdale-arizona-87413/plexus-worldwide-plexus-pink-plexus-wireless-plexus-worldwide-inc-plexus-holdco-plexu-1174949. The posting time indicated is Arizona local time. Arizona does not observe daylight savings so the post time may be Mountain or Pacific depending on the time of year. Ripoff Report has an exclusive license to this report. It may not be copied without the written permission of Ripoff Report. READ: Foreign websites steal our content
Search for additional reports
If you would like to see more Rip-off Reports on this company/individual, search here:
Report & Rebuttal
Respond to this report!
Also a victim?
Repair Your Reputation!
#1 Consumer Comment
Not quite what it says....
AUTHOR: Adam - ()
SUBMITTED: Tuesday, September 09, 2014
Actually the letter from the FDA says the wording Plexus Worldwide used is against their policy. Most (if not all) of the products I have seen say this has not been evaluated by the FDA, etc.
I don't see the problem.
It is not FDA approved....ok, so what?
Respond to this report!
Related Reports
1, Report #1280238
Jul 22 2016
01:21 PM
01:21 PM
2, Report #1301215
Jun 16 2016
11:26 AM
11:26 AM
3, Report #1296816
Mar 30 2016
12:42 PM
12:42 PM
Author: Dallas, Georgia
4, Report #1293867
Mar 15 2016
02:16 PM
02:16 PM
Author: Denver, Colorado
5, Report #1264074
Oct 27 2015
06:55 PM
06:55 PM
Author: McKinney, Texas
6, Report #1233330
Jun 03 2015
07:10 PM
07:10 PM
7, Report #1193347
Dec 05 2014
01:01 PM
01:01 PM
Author: thousand palms, California
8, Report #1175177
Sep 08 2014
08:25 AM
08:25 AM
9, Report #1171288
Aug 21 2014
08:34 AM
08:34 AM
10, Report #1131282
Mar 24 2014
04:05 PM
04:05 PM
Author: Palm Desert, California
Legend
New 
Updated Rebuttal 
Photo 
Featured Reports
Featured Reports
Advertisers above have met our
strict standards for business conduct.
