CRN discusses AERs on Capitol Hill
support for potential legislation that would mandate reporting of
serious adverse events for dietary supplements and
over-the-counters to the Federal Drug Administration.
At meetings on Capitol Hill, CRN member companies and staff are discussing the issue with over 40 legislative offices and a bi-partisan senatorial group, including the US Senator for Utah Orrin Hatch, that has been at the forefront of the issue.
While dietary supplement companies may voluntarily report adverse events to the FDA, they are not presently required by law to do so.
With the aim of more industry transparency, CRN and other trade associations have been calling for companies to be legally obliged to notify the FDA if a consumer submits a serious adverse event.
A 'serious adverse event' is defined by CRN, in its position statement on the issue, as: "An event that is associated with the use of a product that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity or a congenital anomaly or birth defect."
CRN insists, however, that if a company puts forth a consumer's adverse event from a supplement to the FDA it does not imply proof of causation or, in other words, does not imply the company is 'guilty'.
Rather than pointing the finger at the supplement industry, CRN says the potential new legislation would make the industry it represents more credible.
"We pride ourselves on the responsible positions that we take," CRN spokesperson Judy Blatman told NutraIngredients-USA.com. "It's important to us that we have visibility."
The regulatory framework for the supplement industry is set out in the Dietary Supplement Health and Education Act (DSHEA), enacted following a bill co-authored by Senator Hatch in 1994.
Requiring the industry to report serious adverse events to the FDA would entail modifying the law through an amendment.
The DSHEA was to provide a legal foundation to negotiations between dietary supplement companies and the FDA after the industry sought protection from what it saw as the agency's tradition of animosity towards them.
But 12 years later critics say that DSHEA still does not go far enough in its regulation. Industry advocates have defended the law as a good one, and said that the FDA has not properly enforced it, nor has it been properly funded to do so.
"DSHEA: It makes sense - Let's make it work!" states a CRN ad running this week in the Capitol Hill publications, Roll Call and Congress Daily AM.
Senator Hatch has reason to champion the cause of the supplement industry - a large revenue earner for his home state.
Supplement companies represent Utah's third largest industry, according to the Utah Natural Products Alliance, and bring in $2.5 to 4 billion annually. Pharmanex, Nature's Way, Nature's Sunshine, Nature's Herbs and Tahitian Noni International are among the companies headquartered in the state.
