If you've been following the FDA's enforcement actions lately, you may notice that the agency has been very busy dealing with recalls, warning letters, and new rules that would require tighter regulatory oversight of products.
For example, according to LA Times, warning letters for misleading labeling and other violations issued by the FDA's Center for Drug Evaluation and Research jumped from 24 in 2005 and 21 in 2006, to 103 in 2009. Additional warning letters also come from FDA regional offices and from other agency offices responsible for the safety and effectiveness of food, biologics, medical devices, cosmetics and other products.
That new activity hasn't gone unnoticed in political circles. David Acheson, the FDA's top food safety official during the George W. Bush administration, contends that the agency is overzealous in pursuing allegedly bogus health claims made by food producers. However, he had to admit that "on balance, it's been mainly science."
I have advised many of my clients (especially small and medium sized businesses) that, no matter how "right" you think you are to do or say something (or how "wrong" you think the FDA is), you would have to stop doing or saying it once the FDA asked you to stop, unless you have the resources to fight it. In light of the FDA's stepped-up regulatory activities, it is especially important to seek experienced FDA counsel in the early stage of product development to minimize your risks.
