The FOIA sometimes drives me bonkers, and FDA & NAC is Exhibit A

The Freedom of Information Act can serve as a wonderful tool for journalists.

I’ve often used it and similar state laws over the years to obtain various data—ranging from a coroner’s report regarding white mulberry (following a bombshell story in the mainstream media) to data on FDA foreign inspections of manufacturers of dietary supplement products.

Sometimes, though, the FOIA can be a real drag on the “news,” with government agencies taking months or even many years to respond.

I’ve filed a few administrative appeals over the years when agencies have dragged their heels on responses or redacted documents to such a degree that they are essentially worthless. But beyond an administrative appeal of a FOIA request, the other remedy is to eventually haul a government agency into federal court, and that’s a financial burden and time suck that most media organizations aren’t likely elated to assume.

A few days ago, on Dec. 15, 2023, I received a substantive response to a FOIA request I made to FDA on Aug. 4, 2021. I had requested “all records (including electronic and paper format) from the office of the commissioner to Amazon related to the following: NAC (N-acetyl-L-cysteine) in dietary supplements.”

As many of our readers may recall, Amazon in the spring of 2021 had confirmed its plans to remove from its website NAC-containing supplements.

The e-commerce titan’s decision followed FDA’s pronouncements in July 2020 warning letters that NAC was excluded from the definition of a dietary supplement because it was approved as a new drug in 1963 before being marketed as a supplement or food.

We broke the Amazon story at the time and wanted to know whether top brass at FDA—namely the office of the FDA commissioner—had tipped off Amazon regarding its position that NAC could not be lawfully marketed in supplements.

FDA’s position at the time was extremely controversial within industry, since NAC had been on the market in supplements for decades, and it prompted the Natural Products Association (NPA) to file a lawsuit against FDA.

In August 2022, FDA issued final enforcement discretion guidance that essentially paved the way for Amazon to resume sales of NAC.

Few industry stakeholders are talking much about NAC these days, at least as it relates to FDA. However, the agency recently completed its review of safety information concerning NAC, noting in a constituent update the assessment will now be subject to a peer review process.

As a journalist, I would have preferred to report in the late summer or fall of 2021—or early 2022 at the latest—whether then-FDA Acting Commissioner Janet Woodcock or colleagues in her office had communicated with Amazon regarding NAC.

We now know the answer is “no,” according to FDA’s search. The precise answer was, "We conducted a search and found no records responsive to your request for records from the office of the commissioner to Amazon related to the following: NAC (N-acetyl-L-cysteine) in dietary supplements."

Of course, one of my lawyer sources with whom I shared the FOIA response noted he wouldn’t be surprised if FDA’s Office of Chief Counsel communicated with Amazon.

I could send another FOIA request to find out the answer to his question. If you’re interested in the results, perhaps check back with me in 2026.