Importation of Cosmetic Injectables Can Be a Felony
Coalition Urges Reporting Of Suspected Illegal Solicitation or Use of Botox®, Restylane®, RadiesseÂ® and Others
New York, NY (September 10, 2009) - One year in prison and up to $100,000 in fines; it’s a potential steep penalty to pay for importing cosmetic injectables. As recently as August 2009, five physicians, one nurse and a practice manager all from the same New York medical practice pled guilty to charges stemming from the purchase of non-FDA approved cosmetic injectables from on-line pharmacies. Each faces monetary penalties and jail time. Since 2004 the U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) entered into more than 210 investigations that led to arrests and convictions.
“Physicians fax machines and email accounts are filled with offers to buy off-shore, or unbranded cheaper injectables,” said coalition leader Mark L. Jewell, MD of Eugene, OR. “Buying from such sources is not a naïve or innocuous act simply for cost savings on the product. It’s a dangerous act that can cause unexpected adverse events, and ultimately land the physician in prison.”
“Genuine U.S. FDA approved cosmetic injectables have a safe and predictable record of outcomes. There is simply no excuse to cut corners, import or buy cheaper unbranded and illegal substances,” said coalition leader Robert Weiss, MD of Baltimore. “Illegal injectables can be readily distinguished from the real thing (see listing of tips below),” said coalition leader Ira Papel, MD of Baltimore. “The Coalition urges anyone, physician or consumer, who suspects the criminal act of soliciting non-approved, off-shore, counterfeit or illicit injectables in the U.S. to anonymously report the suspected crime to the FDA.”
Information on reporting a suspected crime to the FDA can be found at HYPERLINK "http://www.fda.gov/consumer/updates/oci072307.html"http://www.fda.gov/consumer/updates/oci072307.html. Warning signs of counterfeit or illegal product include:
- Misspelled brand names, unknown or unfamiliar names, and catchy marketing names like “Freeze”
- Generic packaging that does not include serial and lot numbers for injectables that correspond to serial and lot number on actual vials and syringes
- Foreign language writing on packaging, a lack of trademarks and identifying holograms
- Logos and type and packaging that are inconsistent with those of U.S. FDA approved injectables
Logos, packaging, brand names and other identifiers for genuine, approved product are all available, at-a-glance, at HYPERLINK "http://www.injectablesafety.org"www.injectablesafety.org. In addition, the complete list of legal distributors for all currently FDA approved brands is also available at HYPERLINK "http://www.injectablesafety.org" http://www.injectablesafety.org.
The Physicians Coalition for Injectable Safety is an alliance of specialty physician organizations including the American Society for Aesthetic Plastic Surgery, American Academy of Facial Plastic and Reconstructive Surgery, the American Society of Ophthalmic Plastic and Reconstructive Surgery, the American Society of Plastic Surgeons, the International Society for Aesthetic Plastic Surgery, the International Federation of Facial Plastic and Reconstructive Surgeons, and the Canadian Society for Aesthetic Plastic Surgery. The mission of the Coalition is to provide the public with unbiased and necessary information on injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical procedures. Our goal is to promote treatment supervised by properly qualified and trained, board-certified doctors and to promote only the use of U.S. FDA-approved, appropriately administered product. More information can be found at http://www.injectablesafety.org.