"We are very concerned that by continuing to promote BOTOX® COSMETIC in a false and misleading manner these materials are raising significant public health concerns."

"Allergan continues to promote BOTOX® COSMETIC in a way that misrepresents approved indications."

"... minimizes important risks associated with the use of BOTOX®..."

"... minimizes the data from the clinical trials which document that almost one-half of all BOTOX® COSMETIC subjects exhibited adverse events."

"The [FDA's] Advertising and Promotional Labeling Branch ...has identified promotional materials for your product, BOTOX® COSMETIC Botulinum Toxin Type A, that are in violation of the Food, Drug and Cosmetic Act..."

"... has reviewed several direct-to-consumer (DTC) promotional and broadcast ... pieces and has concluded that these materials contain misleading statements about BOTOX® Cosmetic."

"Allergan should immediately stop all broadcasts of these ads and all other promotional activities [that violate FDA rules]..."

"... your promotional activities and materials ... are misleading and lacking in fair balance..."

"... you have repeatedly included favorable ... conclusions from nonclinical studies ... in a way that suggests they have clinical significance when, in fact, no such clinical significance has been demonstrated."

"You minimize the side effects of BOTOX..."

"You fail to present all of the serious and important risks associated with BOTOX..."

"The violations noted in this letter represent continuing examples of violative promotion ... by Allergan."

"We have previously objected to these activities in Review Memoranda dated December 12, 1998 and September 25, 2000, and untitled letters dated November 7, 2000, February 14, 2001, and April 12, 2001..."