We have learned about a new “study” that will be released at 5 pm ET today that, among other things, suggests that 23,000 people per year visit an emergency room due to dietary supplements. Despite being funded in part by FDA and being co-authored by FDA officials, this number was NOT derived from the official AER reporting data (which showed about 3,300 AERs in 2012), a point we are stressing to media. We will forward the study as soon as it is made public. Other points the study tries to make is to suggest that all supplements should come in childproof packaging and that supplements in pill form should conform to the 22 mm standard for pharmaceuticals. We are saying that many supplements including iron already come in childproof packaging so additional requirements are unnecessary.
We know that USA Today will be writing a story on the study and have already conducted an interview with the reporter, Liz Szabo. Our main points will be reflected in our official NPA news release, but these are some of the views we shared with the reporter this morning:
“The facts are that adverse events from supplements are extremely low given their widespread usage, and most of these are the result of three factors: accidents, people not consulting with their doctor, or misuse of a product combined with other health factors. Supplements are safe, which is why millions of Americans use them every day.”
- Dietary supplements have a mandatory serious adverse event reporting requirement and those data are available – be happy to show that to you.
- The official AER data shows a much different picture, with fewer than 3,300 happening in 2012.
- Hospitals are ADDING supplements to formularies – if hospitals thought there were legitimate concerns this wouldn’t be happening.
- Weight loss, body building and sexual enhancement are the top three problem areas in our industry, because that’s where we see the most internet, fly-by-night outfits that don’t adhere to good manufacturing practices.
- Everyone needs to consult with their doctor or caregiver, and especially those who use some of the products in these areas.
- Supplements are safe, which is why millions of Americans use them every day.
- The facts are that adverse events from natural supplements are extremely low especially compared to pharmaceuticals, which is why demand for natural alternatives is growing.
- The facts are that adverse events from supplements is extremely low given the widespread usage, and most of these are the result of three factors: accidents, people not consulting with their doctor, or misuse of a product combined with other health factors.
As always, we are happy to answer any questions about this and will share information as soon as it becomes available.
CEO & Executive Director, NPA
1773 T Street, NW
Washington, DC 20009