Botox, also known as botulinum toxin type A, is made from the bacterium that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity. In terms of being used in a cosmetic procedure, Botox is mostly used to lessen the appearance of facial wrinkles by being injected into a patient in extremely small concentrations and works by preventing signals from the nerve cells reaching muscles which leave the muscles without instructions to contract, therefore paralyzing them.
While usually a safe procedure, the Food and Drug Administration has come across situations where counterfeit versions of Botox were found in the United States. The counterfeit product may have been sold to doctors' offices and medical clinics nationwide meaning that patients were at risk of being injected with a foreign substance. In some instances, health care professionals misrepresented the counterfeit product to patients, leading them to believe they were receiving the real Botox Cosmetic. Some of the tactics used included:
- advertising in brochures, magazines, and on Web sites that they specialized in treating facial wrinkles with Botox Cosmetic
- asking patients to sign a consent form indicating they would be receiving injections of FDA-approved Botox Cosmetic
- displaying a certificate indicating staff had received training by the Botox Cosmetic manufacturer, when they did not
- informing patients they would be receiving Botox Cosmetic when a different substance was administered
- failing to tell patients they were getting a drug not approved for human use
The counterfeit products were considered to be unsafe since the FDA could not confirm that the manufacture, quality, storage, and handling of the products followed the acceptable standards held within the United States.
If you are a Botox patient, it is important talk with your doctor to make sure that the product you are being injected with is legitimate. A counterfeit product can be identified by one or more of the following:
- the vial is missing the lot number
- the outer carton does not have any entries next to the LOT: MFG: EXP:
- the outer carton and vial display the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”
In addition, your doctor should make sure that the distributor that they purchase from is authorized to distribute Botox.
If you are your doctor come across a counterfeit Botox product, the FDA is asks that you report the product in one of the following ways:
- Calling the FDA's Office of Criminal Investigations (OCI) at 800-551-3989
- Report to OCI at www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm,
- Email - [email protected]
Punishments for sample Botox cases Investigated by FDA's Office of Criminal Investigations include:
- Indicted for mail fraud, misbranding a drug, making false statements to a federal agent; sentenced to 27 months in prison, restitution of $98,426, fine of $1,000
- Indicted for fraud, misbranding a drug, tampering with documents; sentenced to 1 year and 1 day in prison, restitution of $65,265, fine of $3,000
- Indicted for mail fraud, misbranding a drug; sentenced to 14 months in prison
- Indicted for mail fraud, misbranding a drug; sentenced to 6 months in prison, 6 months home detention, restitution of $88,000, fine of $40,000, 300 hours community service
- Indicted for misbranding a drug; sentenced to 1 year in prison
- Indicted for mail and wire fraud, misbranding a drug; sentenced to 9 years in prison, restitution of $345,567, forfeiture of $882,565