Ullman Expresses Suspicion of FDA Warning Letters

May 10, 2022 | Compliance Investigations & White Collar

Marc Ullman, quoted in the NutraIngredients-USA article, “FDA cites 10 firms for use of ingredients flagged as illegal,” expressed his suspicion of the recent warning letters that the FDA sent to 10 dietary supplement companies using ingredients that have been added to its Ingredients Advisory List.

The FDA has marked some of these potentially harmful because of cardiovascular risks and in other cases maintains they don’t fit the definition of a dietary ingredient.

Ullman said gathering the 11 letters together means FDA has been mulling the action for a while, and he found the timing potentially suspect, as it comes only days after the introduction in late April of the Dietary Supplement Listing Act of 2022​​.

“How long have they been sitting with this information? Is it just a coincidence that they waited until after Durbin dropped his bill?” ​ Ullman asked.

“And if these are ingredients that they’ve said are dangerous, why is the ‘enforcement response’ just a letter?  I submit that this amounts to ‘enforcement theater,’” ​he concluded.

Ullman questioned just how ‘dangerous’ the Agency considers these ingredients to be, given the fact that end users have been consuming them in the meantime.

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