On June 6, 2012, the U.S. Food and Drug Administration (“FDA”) announced the seizure of various drug products from a Portland, Maine facility. According to the FDA, U.S. Marshals seized the drug products upon the Agency’s request after it was discovered that the firm was making improper claims in various promotional materials, including the products’ labels and the firm’s website. The Press Release announcing the recent seizure may be accessed here.
Global Biotechnologies, Inc., the firm targeted in the seizure, had been cited by the FDA before for the same type of deficiencies. In particular, the FDA issued a Warning Letter to the company on February 8, 2006, after a November 2005 inspection uncovered the use of improper drug claims. According to the FDA’s recent Press Release, the Company responded to the 2006 Warning Letter by committing to the removal of all offending claims from its marketing materials and product labeling. However, during a recent inspection the FDA found that the Company had not made the requisite changes. Rather than issue an additional warning letter, the government secured a warrant and seized the offending drug products from Global Biotechnologies’ facility.
Under the Federal Food, Drug and Cosmetic Act (“FFDCA”) and accompanying FDA regulations, products that intended to be used in the diagnosis, cure, treatment or prevention of a disease or condition are considered drugs. As shown in the Warning Letter issued to Global Biotechnologies, Inc., found here, the Company marketed its products for the maintenance of immune system functioning and the control of insulin levels, specifically linking the products to cancer and diabetes. Although the Warning Letter did not allege the products themselves contained active pharmaceutical ingredients, it was the statements made in marketing that caused the products to be deemed unapproved new drugs.
In sum, the lessons that may be gleaned from this case are twofold. First, it is important to ensure that the marketing materials of FDA-regulated products, including websites, print media and product labels, are properly worded because statements made in marketing play a key role in determining how a particular product is regulated. Second, this case illustrates the importance of being responsive and remaining committed to taking all necessary corrective actions after deficiencies are alleged. For more information about establishing compliance with federal regulations, please contact us at firstname.lastname@example.org.