The trade group analyzed 598 AERs received by the US Food and Drug Administration (FDA) between January 1 and June 30 2008, which highlighted potential adverse health effects of dietary supplement products.
However, although 25 per cent of these were for mainstream multivitamins and minerals, the findings must not be misinterpreted as identifying this as the most dangerous class of products, said Michael McGuffin, director AHPA.
“This is not a cause and effect reporting system, it’s an association system. So although a large part of the AERs are linked to multivitamins, this does not mean that they are dangerous. It simply reflects usage patterns, and the most used dietary supplements are multivitamins,” McGuffin told NutraIngredients-USA.com.
To listen to brief comments by McGuffin, click here.
Common brands
The AER reports were obtained by AHPA via Freedom of Information (FOI) requests with FDA. AHPA revealed its analysis of these reports at the recent SupplySide East trade show in Secaucus, New Jersey.
A number of supplement brands or products were repeatedly flagged up in the AERs. The most common single product reports were for:
· Total Body Formula (93 reports)
· Bayer One a Day (all formulas) (81 reports)
· Centrum (all formulas) (25 reports)
· Flintstones Vitamins (all formulas) (24 reports)
· Mainstream calcium products (25 reports)
However, McGuffin again cautioned that this does not implicate these brands or products as being dangerous. It reflects the frequency of reporting by a select number of companies, which have put systematic reporting systems in place, he explained.
Indeed, the 600 reports from the first sic months of 2008 were submitted by around 50 companies.
Fear factor
He highlighted the importance for all companies to put AER systems in place, stressing that filing a report does not identify a cause-effect relationship between the product and the adverse event.
“Not every company understands that they have this reporting burden – we need to help educate them and make them understand that they have this obligation. And we need to remove the ‘fear factor’; making a report does not implicate a company, it doesn’t mean your products are doing harm,” he said.
However, in some cases, AERs do identify real problems, raising an alarm that allows products to be investigated.
For example, AERs received last year for the Total Body Formula product identified repeated symptoms of hair loss, muscle cramps, diarrhea, joint pain and fatigue. Once the signals were raised, FDA was able to investigate the supplements and found that the company had accidentally overdosed on selenium. Consequently, the agency issued a consumer warning for the products.
More findings
Out of the 600 AERs reviewed by AHPA, 44 percent were for combination products, 25 percent were for vitamins and minerals, 10 percent were for ‘other primary ingredients’ products, and 5 percent were for herbals.
The majority (almost 60 percent) of reports had been submitted by companies, while just under a third (30 percent) were submitted by consumers. Around 10 percent were sent in by health professionals.
The majority of cases (73 percent) were female consumers, and 54 percent of reports were for people aged between 50 and 79. Again, this reflects supplement usage, said McGuffin.