“Me, FDA, and Maybe the Mafia”--A Tribute to the FDA Inspectors Who Keep Us Safe
One of FDA Matters’ recurring themes is the importance of FDA inspections and enforcement activities (here, here, and here).
Product approvals get most of the public attention, but the agency would quickly fail without a robust, committed inspection staff. They need more resources--now and in the future--to maintain their vigilance.
For those interested or affected by inspections, I highly recommend reading former FDA Associate Commissioner Michael Rogers’ article (here), which reviews recent changes in FDA’s approach to foreign inspections and its efforts to balance the need for well-trained specialists with the need for flexible generalists.
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Today’s column (“Me, FDA, and Maybe the Mafia”) focuses on a personal story and is dedicated to the brave inspectors and investigators who never know what they will find or who they will be dealing with during an inspection or criminal enforcement.
The story reflects FDA’s history as a struggle of competing interests. Sometimes reasonable people disagree. At other times, it is obvious that indifference or greed are the driving forces.
Both the good and the bad are part of everyday life at FDA and in the FDA-regulated world.
Here is my own little story. After all of these years, I still can’t say for sure whether it involved reasonable people or dark forces.
My first recollection of the artificial sweetener, saccharin (distributed under the brand name “Sweet‘N Low”) was a 1977 visit to the House health subcommittee’s staff office. It was overflowing with boxes that contained letters begging Congress to prevent FDA from removing saccharin from the marketplace.
Later that year, Congress passed the Saccharin Study and Labeling Act. This prevented FDA from removing saccharin from the market for two years and required a warning label on the packaging that said, “This product contains saccharin, which has been determined to cause cancer in laboratory animals.” The law was extended seven times until the issue disappeared in the 1990’s.[1]
After I became a Senate staffer in 1979, I was responsible for shepherding through the 1981 and 1983 extensions and probably the 1985 extension, which occurred just before I left the Hill.
These were simple bills—short, totally clear in their meaning, and noncontroversial. The only issue (and not a large one) was that one committee member refused to consent to its unanimous adoption, which slowed the bill at the committee level and later on the Senate floor. I can’t remember any Senator expressing actual concerns about these bills.
Sometime around 1983, I started receiving regular visits and calls from Joseph Asaro, Vice President of Governmental Affairs for Cumberland Packing, makers of Sweet‘N Low. I remember him as pleasant, but terribly anxious that nothing should stand in the way of extending the moratorium every two years.
He never seemed to accept that passage of the extension was routine business of the most ordinary sort. The more I reassured him (so he wouldn’t call as often), the more solicitous he became. Then one afternoon, I received a call from my family—who lived on Long Island, maybe twenty miles from Cumberland Packing’s headquarters, which were on the Brooklyn docks.
That morning, a delivery truck had arrived with multiple cartons of Cumberland products, including several 1000-packet boxes of Sweet’N Low, and a message that essentially said: let us know when you run out. My family was delighted by the unexpected gift.[2]
Although it was probably meant as a generous gift (and didn’t violate any Senate rules), I was quite upset. I had mentioned to Mr. Asaro that I had grown up on Long Island, but never mentioned family names or where they lived. (At that time, pre-Internet, identifying someone’s address was a difficult task without such information.)
In my imagination (or maybe in reality), I was being reminded that he knew where my family lived… and that I needed to pay more attention to the legislation. Despite all efforts on my part to banish such thoughts, I considered the possibility that Cumberland was involved in some way in organized crime, and I had been threatened.
In 2006, an unauthorized history of Cumberland Packing was published, which showed that my concern may have been justified. According to the book, a 1994 Washington Post article stated that Joseph Asaro had been “identified as an associate of the Bonanno crime family in a prosecution memo….” Subsequently, a New York Times article reported that federal prosecutors and Mr. Asaro’s attorneys denied there was any connection.[3]
Threats, even implicit ones, are inherently scary—even if the goal was to make me do something that I was planning to do anyway and for which there was strong Congressional and public policy support. Even at the time, I didn’t really think my family was in “harm’s way.” Still, it made me anxious and self-conscious about what was otherwise a routine task.
Other than being an interesting tale, I hope it is a small reminder to every reader that there are employees of the FDA (inspectors and staff in the Office of Criminal Investigations) and their colleagues at the FBI and Customs—who do put themselves in “harm’s way” in order to protect us. These threats are invisible to most of us. They are no less real because we cannot see them.
We should salute and remember those who take these risks on our behalf so that we can enjoy the benefits of a safe food and drug supply.
[1] Subsequent studies never strengthened the connection to cancer in humans. In 1985, FDA supported extension of the moratorium and in 1991 withdrew the proposal to ban saccharin from food. It was delisted as a possible carcinogen in 1997, and the warning label requirement was repealed in 2000.
[2] Thanks to my mother and sister for their memories of that day, still quite vivid in 2012, when I first authored this story.
[3] Sweet and Low: A Family Story</b> by Rich Cohen. Published by Farrar, Straus and Giroux, 2006. The material on the possible linkage with organized crime is a footnote on page 144. https://www.amazon.com/Sweet-Low-Family-Rich-Cohen/dp/0312426011