FDA WARNING_LETTER - Plexus Worldwide Inc - July 31, 2014

The FDA issued a Warning Letter to Plexus Worldwide, Inc. on July 30, 2014, following a review of their website (www.plexusworldwide.com) in April and July 2014. The FDA determined that the products Fast Relief, ProBio5, and BioCleanse are promoted for conditions that cause them to be unapproved new drugs and misbranded drugs under the Federal Food, Drug and Cosmetic Act.

Specific violations include therapeutic claims on the website that establish the products as drugs intended for the cure, mitigation, treatment, or prevention of disease. Examples cited are Fast Relief for nerve damage symptoms, ProBio5 for jock itch, migraine headaches, and recurring infections, and BioCleanse for addressing viruses, bacteria, fungi, and preventing diseases like flu and chronic fatigue by increasing oxygen levels.

These products are considered "new drugs" because they are not generally recognized as safe and effective for their claimed uses, and they lack prior FDA approval, violating sections 201(p), 505(a), and 301(d) of the Act. Furthermore, they are misbranded under section 502(f)(1) and 301(a) because they are offered for conditions not amenable to self-diagnosis and treatment, meaning adequate directions for layperson use cannot be provided.

Plexus Worldwide, Inc. is required to take prompt action to correct these