A lack of leadership at FDA, the Dietary Supplement Labeling Act of 2015, and a ‘tenderized’ industry: Mister’s State of the Union
Speaking to a packed room at The Carlton Hotel in New York City at the 3rd Annual Legal, Regulatory and Compliance Forum on Dietary Supplements, Mister also said that the retirement of Senator Harkin has created an “opportunity for mischief from the industry’s detractors”. The event was organized by the American Conference Institute in collaboration with CRN.
In his ‘State of the Union’ presentation, Mister asked if attendees had heard of the Dietary Supplement Labeling Act of 2015. “Well, it hasn’t been introduced yet but the industry expects Senator Durbin to introduce this,” he said. “His staff has indicated to us that they are working on something.”
Mister acknowledged the industry’s “legitimate problems” like spiking and questionable stimulants, which may or may not be legitimate dietary supplements but certainly are new dietary ingredients (NDIs), he said.
The industry has also been on the focus of negative media, which began around December 2013 with the Enough is enough editorial in the Annals of Internal Medicine, he said. “We’ve been on a downward journey since then.”
Feeding into this media environment has been Dr Oz. The cardiothoracic surgeon was hauled in front of a Senate subcommittee in June 2014 to answer questions about claims made on his show, and was recently the subject of an April 2015 letter from 10 physicians to Columbia University expressing their ‘dismay’ that he was still on faculty.
“Dr Oz is a double-edged sword for the industry,” said Mister. “The ‘Dr Oz Effect’ has definitely benefited certain companies, but the flip side of this is that less scrupulous companies have jumped in to meet the increased demand with lower quality products.”
And now the good news…
“The good news is that dietary supplement use continues to grow, and many consumers use at least one type of product,” he said. “And, despite a blip in sales during the first week of February at the start of the NY AG affair, sales have remained strong.”
Mister also noted that survey data also reveals that consumer confidence in the product remains strong. “The vulnerability comes from potential users entering the category who may now think twice about purchasing the products.”
Another positive is the strength of the Dietary Supplement Caucus in Congress, he said, which is at an all-time high.
“We don’t have a direct replacement for Senator Harkin, and this represents a change from one clear Republican champion (Senator Hatch, who remains in office) and one clear Democratic champion (Senator Harkin). What we have now are a lot of situation allies who may not come to the industry’s defense each and every time but will support when appropriate.”
Mister also hailed the passage of the Designer Anabolic Steroid Control Act (DASCA) during the last Congress. “DASCA is significant because it passed during a ‘do-nothing’ Congress that was paralyzed by partisanship,” he said.
An article in CQ Weekly titled the Herbal Swat Team has noted: “The supplements industry knows how to work the Hill and usually gets its way”.
“That’s good for politicians to read,” said Mister.
Ongoing vacancies at high levels of the US Food and Drug Administration are also have an impact on the industry, he said. “FDA is not showing any leadership.” And this lack of leadership may also delay progress on new dietary ingredient (NDI) guidance. “I don’t see FDA doing this without a strong leadership to champion its position,” he said.
And while GMP inspections are continuing and the Agency is continuing to find violations (which the industry’s critics highlight as evidence of problems), there is no policing beyond the letters.
More resources could be coming to the Division of Dietary Supplement Programs if it is elevated to the level of an office, said Mister.
Time to rewrite DSHEA?
One topic of conversation that has increased in frequency over recent months is whether it is time to rewrite DSHEA with stakeholders discussing how to strengthen the regulations.
“What would that look like?” he asked. “Could we have NDIs spelled out in the statute and not left to FDA? Are there things the industry is willing to give, like product registration? But if the industry ‘gives’ what are the ‘gets’? With all the advances in the science, could we revisit structure-function claims?”