“Faux-Tox? Fraudulent Versions of Botox Found in the United States
As a member of the top 1% of Botox Cosmetic users in the United States (and the largest solo injector of Botox cosmetic in the State of Virginia), I have always purchased my Botox from a single company and that is Allergan Inc.; the only legitimate produce of Botox in the USA. In this day and age when anyone can purchase fake designer watches, handbags and about anything else, it is not surprise that someone is trying to sell fake Botox and injectable fillers. Unfortunately, many U.S. doctors purchase Botox and or injectable fillers from sources outside the USA. They do this for one reason, and that is profit. It sounds pretty benign on the surface as the web sites are listed as “Canadian Pharmacy”, etc, but they may be from China or other countries. First they may not actually be Botox at all, possibly just water. The real reason for concern is that if they are in fact actually botulinum toxin A (the most deadly poison on the planet), then you really don’t know what you are getting. Too little won’t help your wrinkles and too much can kill you. This happened about 6 years ago when several patients almost died after receiving research grade toxin instead of the real deal. There is only one legitimate manufacturer of Botox Cosmetic and that is Allergan Inc. in Irvine, California. If you are getting Botox Cosmetic injections make sure your provider is only purchasing Botox from Allergan. The FDA maintains a list of doctors that are known purchasers from outside the USA and you would be surprised that some very famous docs are not buying the real deal Botox. It never hurts to ask! Your surgeon should be able to give you the name of their Botox rep and or account number. The article below is straight from the FDA website and discusses the dangers of imported Botox.
FDA is alerting health care practitioners and the public that fraudulent versions of Botox that are not approved by the FDA are being sold to U.S. medical practices. The outer carton is counterfeit, while the vial inside is labeled as a foreign version of Botox, which is not FDA-approved for sale in the United States. These products are being sold by unlicensed suppliers who are not part of the legitimate U.S. supply chain. FDA cannot confirm that the manufacture, quality, storage, and handling of these products follow U.S. standards. These fraudulent products are considered unsafe and should not be used.
The company selling the fraudulent versions of Botox goes by the names “Online Botox Pharmacy,” “Onlinebotox.com,” and “Onlinebotox.” At the time this alert was issued, the company did not appear to be selling its products over the internet. Instead, the company has been using “blast faxes” to solicit sales from medical practices, typically selling products at prices below those of FDA-approved products. As is the case with many companies that sell fraudulent products, Online Botox Pharmacy uses a U.S. return address when sending packages to medical practices, even though the products are from foreign sources.
Medications purchased from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are putting patients’ health at risk, as patients may not be getting proper treatment.
FDA-approved Botox for injection (100 units/vial), manufactured by Allergan, displays the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial. Currently, there is no indication that Allergan’s FDA-approved version is at risk, and this product should be considered safe and effective for its intended and approved uses.
Suspect fraudulent products can be identified as follows:
- the outer carton displays the active ingredient as “Botulinum Toxin Type A”; or
- the lot numbers and expiration dates on the outer carton and accompanying vial do not match.
Thus far, the following examples have been confirmed as fraudulent Botox. Products with any of these lot numbers and expiration dates should be considered suspect.
|Lot #||Exp Date|
|C3016 C3 (carton)||10-2014|
|C3121 C3 (vial)||04-2015|
|Lot #||Exp Date|
|C3060 C3 (carton)||01-2015|
|C3121 C3 (vial)||04-2015|
FDA is asking the public to report suspect Botox products obtained from Online Botox Pharmacy or other questionable sources:
- Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or
- Report to OCI at www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm1, or
- Email – DrugSupplyChainIntegrity@fda.hhs.gov
Health care professionals and patients should report adverse events related to the use of any suspect medications to FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Health care professionals and consumers can either:
- Complete and submit the report online: www.fda.gov/MedWatch/report.htm2, or
- Download form3 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
FDA has issued a series of alerts and letters to practitioners about the risk of buying medicines from foreign or unlicensed sources. (http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm330610.htm4 and http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm299920.htm5 )
The Food and Drug Administration is committed to protecting public health by securing the drug supply chain against counterfeit and unapproved medications that enter the United States through fraudulent sources.
As more information becomes available, this webpage will be updated.
For more information about cosmetic facial surgery by Dr. Joe Niamtu, III visit www.lovethatface.com