We all know labeling a supplement for prevention or treatment of the H1N1 flu virus makes that product an unapproved drug. And we all know making H1N1 claims for products you sell on a Web site is asking for at least a letter from FDA or FTC. But what if you’re a bricks and mortar retailer who has to respond to customers (e.g., moms) who ask about natural products that would keep their children safe from the H1N1 threat? Surely you can tell them that All Natural ViraNuke Liquid drops will stop those H1N1s in their tracks like a Kevlar vest? Right? WRONG!
Since 1938, it has been a crime under the Federal Food, Drug and Cosmetic Act to do any “act with respect to, a food, . . . if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.”(21 USC 331[k]). FDA has enforced this provision against retailers by posing as consumers and letting retailers “walk the plank” by answering their inquiries, or simply listening to or recording retailers as they respond to real consumers.
In the old days, FDA inspectors like Kenny Milstead would go into a retail store accompanied by a colleague who would listen to the conversation with the retailer. After the retailer made drug or disease claims about the food supplements they were selling, Milstead and his colleagues would go down to the nearest U.S. courthouse and swear out a warrant of arrest for the products that had been offered, relying on the commentary of the retailer to allege the products were unapproved drugs. Then, they would seize the products. According to Milstead, he and others would do many of these kinds of small seizures annually. At the time, this kind of enforcement was important to FDA. This was the way FDA removed products from the market that were being sold with drug or disease claims.
When I was in law school, I read books on eavesdropping written by my criminal law professor, Sam Dash. His books detailed early government efforts at wiretapping and recording conversations. As I recall them, many of the examples of recording were reports of FDA inspectors making recordings of conversations in retail outlets.