Implementing adverse events reporting begins, UNPA
bill by President Bush, many dietary supplement manufacturers will
need to begin implementing or changing their reporting practices
within the upcoming year before the legislation comes into effect.
Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was introduced in June 2006 as a means of obliging supplement manufacturers, packers and distributors to notify the Food & Drug Administration (FDA) of any serious adverse events reports (AERs). The bill is applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers.
To make the implementation process more clear to supplement manufacturers and distributors, the United Natural Products Alliance (UNPA) is conducting a seminar on January 11th in Salt Lake City.
The bill requires supplement labels to include a telephone number for the reporting of serious adverse events, and obliges supplement companies to pass on these reports to FDA within 15 days.
But in order for this process to be implemented effectively, companies need to understand the legislation and all its subtleties, according to UNPA.
"My hope is for the industry to be fully prepared by this time next year," UNPA executive director Loren Israelson told NutraIngredients-USA.com. "We want to have a robust system in place."
To begin with, a company has to be able to define and identify what constitutes a serious adverse events report. This then triggers the 15-day process of getting information to the FDA.
Some issues still need to be ironed out according to Israelson. For instance, the extent to which companies other than the manufacturer should be involved in the reporting process.
"One issue that will be increasingly important is how to address the combination of a supplement with other ingredients, food or drugs," said Israelson.
Labelling is another issue Israelson highlighted.
"When should you label something?" asked Israelson, refering to adverse events that may have occurred involving a product. "Or how do you advise people on your labelling?"
Israelson said labelling any adverse event warning on supplements is tricky because the supplement may not even be the culprit in the root culprit.
For instance, he cited the example of what he calls the "caffeinization" of society, in reference to the abundance of caffeine in beverages, which he claims can unknowingly cause problems for consumers if they ingest a lot of caffeine and then take a weight loss supplement, for example, that may have a high caffeine content.
In a case like this, Israelson said, the supplement could get blamed for the high caffeine content.
Smaller companies will not have to worry about taking on all the responsibility for setting up an adverse events reporting system, said Israelson, as contract manufacturers can take calls for companies.
However, companies will also have to work out themselves who is responsible for receiving and investigating that call said Israelson - be it manufacturer, distributor or marketer.
"That should be causing companies to question who they are working with," he added. According to Israelson there will no new penalties for adverse events and that, if infringed, penalties will be administered according to current legislation for misbranding or mislabelling.
