The month of November, with five federal agencies announcing sweeping action against supplement companies and the National Association of Attorneys General laying out a blueprint for state-by-state enforcement, could be the dawn of a post-FDA age for supplement regulation, says United Natural Products Alliance President Loren Israelsen.
The FDA will obviously still be enforcing supplement regulations, but the administration is just one player on a much larger and more organized team now, Israelsen notes. “If you look at the Department of Justice press conference and what was said at the attorneys general conference, the common line appears to be that FDA regulation of dietary supplements is a failed concept,” Israelsen says. “It is clear that the FDA is unable to tackle the companies masquerading as purveyors of dietary supplements. The industry itself can't do that, as frustrating as that is.” A year that began with huge questions raised by the New York attorney general moving against major retailers and supplement makers is ending with a clear message that the rules are going to be enforced more widely by more people, Israelsen explains.
Last week, the Department of Justice staged a press conference announcing 117 criminal and civil actions against supplement companies, most prominently USP Labs, makers of the notorious sports supplement Jack’d. On Nov. 2, the attorneys general group presented a program highlighting spiking issues in supplements, bringing in experts that included perennial supplements critic Pieter Cohen.
Israelsen says there is more than a dotted line connecting the two: “You see the same language, the same litany of complaints, the same syntax, calls to action, restatement of the same issues, literally using the same references and citations.” All of this, the UNPA president notes, clearly sets the stage for revisiting and rethinking DSHEA. A paper released in conjunction with the NAAG meeting, “Breaking the gridlock: Regulation of dietary supplements in the United States,” lays out that agenda, Israelsen says.
UNPA welcomes more enforcement, and the Alliance's response to last week’s federal sweep remains “Carry on,” but the industry has to be prepared to fully engage with enforcement and lawmakers who might see revamping DSHEA to be a necessity. In particular, the industry should be pointing to proposals in the “Gridlock” paper that the supplement makers asked for in the buildup to DSHEA, Israelsen says, explaining that supplement makers sought measures like a botanical monograph system back in 1992. Such history is critical for all sides in the debate.
Retelling the story that the industry was ready for and actually asked for that kind of regulation will be essential as the new coalition of critics emerges, Israelsen says. “Part of it is we have to shift the perception of the new regulatory players. If they want to engage, we’ll go point by point, and say ‘Let’s talk.'"
Whether policy of that depth is ever proposed, Israelsen says, the industry needs to see the NAAG meeting and Department of Justice press conference for what they are: the beginning of a new era. “What’s interesting is the clarity of the message of critics of the industry, not just their attention to the tactics and strategies,” Israelsen says. “That should inform industry in taking decisive action.”