CRN: Sen. Blumenthal’s proposed NDAA amendment is ‘duplicative’ for adverse event reporting

20-Jun-2019 - Last updated on 20-Jun-2019 at 15:56 GMT

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An amendment to the National Defense Authorization Act (NDAA) introduced to Congress would require the creation of a reporting system for adverse events that may be associated with dietary supplements use in the military. Trade group CRN is pushing back, saying that it is duplicative.

The amendment was introduced by Sen. Richard Blumenthal (D-CT) in the senate version of the NDAA a couple weeks ago, Steve Mister, president and CEO of CRN, told audience at the CRN/ACI Annual Legal, Regulatory and Compliance Forum on Dietary Supplements on Tuesday.

NDAA is the name of a series of US federal laws that specify budgets and expenditures of the US Department of Defense.

According to the amendment proposed by Blumenthal, if passed, the Department of Defense would be required to have electronic medical records of servicemen and women include their dietary supplement use, particularly adverse events associated with their supplements.

The amendment also requires the “reporting of adverse event report data regarding dietary supplement use by members of the Armed Forces to the Food and Drug Administration,” according to a PDF file of the Bill, supplied to NutraIngredients-USA by CRN.

Industry pushes back

“The problem is we already have an adverse event reporting law that passed ten years ago, it seems to be a pretty good job in catching things,” Mister said.

“It’s duplicative in many ways of current adverse event reporting system, and it’s likely to do redundant reporting,” he added. “If FDA is already doing this and then every so often it gets this data dump from DOD, I think you’re going to get a lot of repetitive reports, where you’re going to need a lot of money to look through which ones have been reported to FDA and which ones haven’t.”

Mister argued that if the bill passes with the amendment, it would discourage members of the military from reporting adverse events to their healthcare practitioner “because of the possible ramifications of having that on their electronic medical record.”

“It discourages the candor we want customers to have with their healthcare providers,” he added.

The provision now only exists in the Senate version of the bill. “The NDAA is going through the House to get the House version of the Bill, and then it goes to conference,” where Mister said he hopes this provision will be stripped off.

In 2016, Blumenthal introduced amendments to the NDAA that would similarly track adverse events but also limit the sale of dietary supplements at military exchanges and commissaries, though it never passed into law.

“It’s a reminder that the supplement industry is always under attack,” even through seemingly unrelated legislation, Mister said.