Ex FDA commissioners say their hands were tied while they were at agency

By Hank Schultz contact

- Last updated on GMT

Ex FDA commissioners say their hands were tied
Dietary supplement regulations are insufficient to adequately regulate the industry, according to a report about what was said at a meeting of six former FDA commissioners.

The six former commissioners were brought together at a recent annual event sponsored by The Atlantic ​magazine in Aspen, CO.  The headline of the online report by Atlantic​ writer James Hamblin about the meeting said: “Six former FDA commissioners regret inabilities to ensure safety and legitimacy of products.”​  The six commissioners were: Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan, Andrew von Eschenbach, and Frank Young.

Pointed comments by Kessler

According to Hamblin’s report​, ex commissioner Kessler made the most pointed comments. He called the system of declaring ingredients as GRAS as “a joke.”​ And when asked by an audience member who was identified as a psychiatrist, “will the FDA ever regulate this industry?”​ Kessler replied, “We tried.” ​He added that, “We have ​some authority.”

Despite the general tone of the meeting that the regulations governing the industry are too weak and the FDA hands are tied, other ex-commissioners did mention areas in which FDA was able to take action. Ex-commissioner McClellan said that he was able to get ephedra removed from during his tenure.  And former commissioner Hamburg was quoted as saying, “When there's a problem, FDA does take action, and usually it's when there is a contaminant.”

“I think the tenor of that meeting came mostly from Dr Kessler,” ​said Dan Fabricant, CEO and executive director of the Natural Products Association. Fabricant is former chief of the Division of Dietary Supplements at FDA.  Fabricant’s tenure was noted for an uptick in the tempo of enforcement activities.

“Dr Kessler is a very smart guy but he hasn’t been at the agency in a long time,” ​Fabricant told NutraIngredients-USA. 

Kessler’s tenure, 1990-1997, coincided with the advent of the Dietary Supplement Health and Education Act, which was signed into law in 1994.  Industry observers who helped get the law written and passed have often said that under Kessler the agency was slow to use the tools that DSHEA provided.

It is widely believed that the unprecedented public support for DSHEA had much to do with Kessler’s vigorous views on enforcement, and some actions taken against dietary supplement marketers and manufacturers that were seen as being over the top. Kessler, who was trained as a pediatrician and also holds a law degree, was the youngest FDA commissioner ever at the time of his appointment in 1990. In a Chicago Tribune ​article written in 1991, Kessler was quoted as saying, “If the FDA is to restore its reputation as a strong consumer protection agency, it must demonstrate its willingness to enforce the law.” ​ In an article in The New York Times ​that same year, Kessler was quoted as saying, “If there is a safety problem demonstrated, if harm has occurred, the agency can step in. But that's awfully reactive and one of the fundamental tenets of this agency is to prevent harm, not to deal with harm once it has occurred.”

Learned helplessness

Fabricant disputed the notion that Kessler had in a way discredited DSHEA by shoving it onto the back burner once it became law.

“I don’t think there was any underhanded plan that we are going to usurp the law,” ​he said. “I think you can point to a more of a learned sort of helplessness. There are enforcement tools, and I think some of those were dormant until I got to the agency.”

Despite the ex-commissioners' air of consternation during the meeting in Aspen, other federal officials have said in the past that FDA has sufficient authority to regulate this sector.  In testimony before Congress in 2006, Robert E Brackett, PhD, then director of the Center for Food Safety and Nutrition, had this to say: “DSHEA is intended to strike the right balance between providing consumers access to safe dietary supplements that they may choose to help maintain and improve their health, and giving the Food and Drug Administration (FDA or the Agency) regulatory authority to take action against supplements and supplement ingredients that present safety problems, have false or misleading claims, or are otherwise adulterated or misbranded.”

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