1. Bioterrorism. In June 2002, Congress passed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“The Bioterrorism Act”). On January 29, 2003, FDA issued proposed regulations totaling 256 pages detailing new requirements for the registration of all food and supplement manufacturers, distributors and packers as well as rules governing prior notification of food and supplement shipments coming into the U.S. These rules, while clearly intended to help reduce bioterror risks to the food supply, will likely have a dramatic and long-term effect on the ability to source and import new ingredients from overseas. The procurement and planning processes for new products must now take these new regulations into account or risk missing delivery deadlines and detention of goods at U.S. ports, all of which would wreak havoc on an otherwise exciting new product launch.
2. Proposition 65. Proposition 65 really means 65 ways to ruin your new product launch in California. With increased imports of foreign raw materials, there has been a parallel increase in litigation, “bounty hunter” lawsuits, and state action taken against foods and dietary supplements which contain ingredients thought to violate Prop. 65 limits (such as heavy metals). Increased vigilance in selection and analysis of raw materials must be Standard Operating Procedure (SOP) for all companies. Thoughtful consideration must be given in the early planning stages to determine if certain raw materials present inherent compliance problems with Prop. 65 and, if so, to find substitute ingredients to minimize the unwanted and unpleasant experience that only those who have been sued under Proposition 65 can appreciate.