Public Health Service Food and Drug Administration
Los Angeles District
Irvine, CA 92612
VIA UNITED PARCEL SERVICE
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:
“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 will typically provide the following results…jock itch, migraine headaches, recurring cystitis/vaginal infections…”
“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
Food and Drug Administration
Los Angeles District
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.