FDA Warning - GermBullet Is An Unapproved Flu Remedy

FDA warns company over unapproved flu remedy - US News and World Report:

"The Boca Raton, Fla.-based company advertises the product as a "proprietary blend of 11 organic botanicals." The company's website claims that "an FDA recognized virology lab" tested the formula and "confirmed that it has the potential capability to kill cold and flu viruses."

But FDA regulators say the mixture has never been reviewed as safe and effective and the company is violating drug safety regulations. All new drugs marketed in the U.S. must be submitted for approval to the FDA before they can be sold to consumers. The GermBullet is sold online through retailers like CVS.com and at a handful of small pharmacies and natural food stores in Florida."

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FDA Unapproved Drugs Initiative

There are prescription and over-the-counter (OTC) drugs marketed illegally without FDA approval. The manufacturers of drug products have not received FDA approval and do not conform to a monograph for making OTC drugs. These manufacturers circumvent the FDA approval process. The lack of evidence demonstrating that these unapproved drugs are safe and effective is a significant public health concern. The FDA has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. Therefore, the FDA has crafted an entire suite of web pages that help manufacturers of unapproved drugs navigate the regulatory landscape, Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval. 

Here's what you can find: FDA's Concerns About Unapproved Drugs Background Information Unapproved Drugs Initiative Compliance Policy Guide Enforcement Actions Important Documents Publications Industry Information Unapproved Drug Decision Tree Unapproved Drugs Coordinator Letter to Branded Pharmaceutical Association Regarding Unapproved Drugs Coordinator Marketed Unapproved Drugs Workshop Required reporting of adverse events Health Care Professional Information Determining if a drug is FDA approved Orange Book NDC Directory http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ssLINK/ucm119742.htm#drugsatfda Legal mechanisms to access unapproved drugs Reporting of adverse events Consumer Information But best of all, they offer a FDA WebLearn Course: Bringing an Unapproved Drug into Compliance. You can get a sense of the content by scanning the companion FDA's Bringing an Unapproved Drug into Compliance - Course Script (PDF). 

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