Warning on Counterfeit Alli

On Monday, the FDA issued a warning regarding counterfeit supplies of our over-the-counter weight loss product, alli.  Our own statement, posted on the alli website, follows below.

GlaxoSmithKline Consumer Healthcare alerts consumers that a small quantity of fake weight loss product, falsely packaged and labeled as alli®, has been sold on online auction websites, such as eBay. The falsely packaged and labeled products are the 60mg, 120ct refill packs only. The products are sold on online auction sites directly to consumers and are falsely represented as the genuine alli product. We do not have any evidence that counterfeit alli products have penetrated other distribution channels.

Preliminary testing confirms that the counterfeit products do not contain the active ingredient orlistat, which is found in the authentic alli product. The prescription drug sibutramine has been detected in the fake product. Sibutramine is the active ingredient in the prescription drug Meridia. Sibutramine could potentially interact with other medications the consumer may be taking and there are dosing differences between alli (three times a day) and Meridia (once a day).

While many of these counterfeit products may look similar to GSK's products, they are illegal and have no connection with GSK or FDA. GSK Consumer Healthcare, along with FDA, has initiated efforts to identify those responsible for counterfeit products.

HOW TO IDENTIFY THE FAKE PRODUCT:

• The LOT code information is missing from the top of the box.
• The expiration date includes month, day and year (example: 06162010); the authentic alli expiration date includes only the month and year (example: 05/12).
• The seal on the bottle should read "SEALED FOR YOUR PROTECTION" in white ink on the GSK alli bottle; this statement is not present on the fake product.
• The capsule size is slightly larger in the counterfeit and the content inside of the capsule is different--the counterfeit content is powdery and the genuine product is more of a pellet shape.

WHAT CONSUMERS SHOULD DO:

• Buy alli only from reputable retailers or from their branded online websites. When purchased from these reputable retailers, consumers can have confidence the product is genuine and they should continue use.
• Consumers who suspect they have purchased counterfeit alli are urged to contact the FDA at http://www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm
• Consumers can visit www.myalli.com for more information.