On May 18, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release announcing the voluntary recall of certain dietary supplements marketed as male enhancements. West Coast Nutritionals, Ltd., the firm responsible for the supplements, initiated the recall after an FDA laboratory analysis uncovered the presence of undeclared Tadalafil in an assortment of the Company’s products. Tadalafil is the active ingredient in Cialis, the popular drug approved by the FDA to treat Erectile Dysfunction (“ED”). Because of the presence of the undeclared pharmaceutical ingredient, the FDA warns that the Company’s products are considered unapproved new drugs under the Federal Food, Drug and Cosmetic Act (“FFDCA”).
In the past, the FDA has issued statements to consumers and industry concerning the presence of undeclared active ingredients in dietary supplements, and with the recent recall it appears that this issue remains a high priority for the FDA. For more information about maintaining compliance with FDA regulations, contact us at firstname.lastname@example.org.