The American supplements industry has backed a congressional effort to create a mandatory adverse-event reporting system, but the ?devil will be in the details,? which are still being hammered out, said David Seckman, CEO of the National Nutritional Foods Association.
?People want to make sure they see it, and the specific language hasn?t been developed yet. There are several concepts we will find essential (in this legislation).?
Other industry groups that have come out in support of an AER system include the American Herbal Products Association (AHPA), the Council for Responsible Nutrition, the Coalition to Preserve DSHEA, the Utah Natural Products Alliance, the Consumer Healthcare Products Association and the American Medical Association.
It is also being supported by the nonprofit American Botanical Council.
The bipartisan effort is being spearheaded by Republican Senator Orrin Hatch, and Democratic Senators Tom Harkin and Richard Durbin, who have been working for months with the Food & Drug Administration and industry leaders on the exact language of the bill.
The industry hopes the legislation will be added as an amendment to the anabolic steroids bill sponsored by Democratic Senator Joe Biden.
Industry leaders hope the bill will contain several key components:
- That it will require makers of both dietary supplements and over-the-counter products to report serious adverse events to the FDA;
- That it will include a pre-emption clause requiring any related state bills to conform to the federal act;
- And that the new law will apply only to products manufactured or sold in the US.
?It is rare for an industry to ask for more regulation,? said Michael McGuffin, president of the AHPA, which spearheaded the push for an AER system in 2002. ?But this industry is confident that it is selling a class of goods with a remarkable safety record and that there is nothing to hide. An effective reporting system will confirm industry?s view that consumers can use their supplements safely.?
In 2003 there were 370,887 reports to the FDA of suspected serious adverse events related to pharmaceutical use.
Industry leaders hope the AER system will model the system already in place for the pharmaceutical industry in at least one way—its definition of a ?serious? event.
The FDA Code of Federal Regulations for Food and Drugs defines a serious event as: ?Any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life-threatening drug experience, in-patient hospitalisation or prolongation of existing hospitalisation, persistent or significant disability/incapacity or a congenital anomaly/birth defect.?
?We certainly don?t want it to be more restrictive than this,? McGuffin said.