In honor of FDA Matters’ third anniversary, I am sharing a personal story. It reflects FDA’s history as a struggle of competing interests—where sometimes reasonable people disagree, often vehemently, while at other times it is obvious that indifference or greed are the driving forces.
Both are a fact of everyday life at FDA and in the FDA-regulated world. Here is my own little story and 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 saccharine from the marketplace.
Later that year, Congress passed the Saccharin Study and Labeling Act. This prevented FDA from acting for 2 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 The law was extended seven times until the issue disappeared in the 1990’s. The labeling requirement was repealed in 2000.*
After I became a Senate staffer in 1979, I was responsible for shepherding through the 1981 and 1983 extension 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 very large one) was that one committee member refused to consent to its unanimous adoption—which slowed the bill at committee and when it got to 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 and a business located near the Brooklyn docks. I remember him as pleasant, but terribly anxious that nothing stand in the way of extending the moratorium every two years.
It never seemed to sink in to him 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 20 miles from Cumberland Packing’s headquarters. That morning, a delivery truck had arrived with multiple cartons of Cumberland products, including several 1000-packet boxes of Sweet’N Low, and the message: let us know when you run out.**
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 my family’s names or where they lived (and 30 years ago, pre-Internet, identifying people’s connections was a difficult task without such information.)
In my imagination (or maybe in actuality), I felt that I was being reminded that he knew where my family lived….and I needed to pay more attention to the legislation. Despite all efforts on my part to banish such thoughts, I admit 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 and I found that my concern was well-founded, although perhaps not true. 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.***
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—sometimes inspectors, but more often 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, but are no less real because we don’t 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.
Steven
* 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 saccharine from food. It was delisted as a possible carcinogen in 1997 and the warning label requirement was repealed in 2000. http://www.icarus-japan.com/pdf/Saccharin_English.pdf
** Thanks to my mother and sister for their memories of that day, still quite vivid nearly 30 years later.
*** Sweet and Low: A Family Story 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.