Government researchers warn that certain dietary supplement manufacturers, which are not obliged to follow federal safety guidelines for pills, are making products that are too large and pose a choking hazard for elderly consumers.
The U.S. Food and Drug Administration (FDA) published a letter this week in the Annals of Internal Medicine, warning about the risks of large dietary supplement pills for adults aged 65 years and older.
According to those researchers, thousands of people over the last several years have reported serious issues swallowing large dietary supplement pills and tablets, and they are blamed for at least three deaths.
The study looked at data from adverse event reports filed with the FDA, indicating that 21,000 reports involving dietary supplement problems were received from 2006 through 2015. Nearly 4,000 of those were linked to swallowing, and more than three quarters involved consumers over the age of 65. In addition, nearly 86% of the reports were from women.
The FDA has issued guidance, which is not binding on manufacturers, indicating that generic pills and capsules should not exceed 17mm in a single dimension. If a brand-name pill exceeds 17 mm, then the generic version should not be any larger than that.
However, even if the guidance were solid rules, they would not apply to dietary supplements. The FDA does not have the authority to regulate dietary supplements unless they pose a public health threat or are revealed to be unadulterated drugs.
The findings add to many recent concerns that suggest dietary supplements may do more harm than good, and should be more closely regulated. A study published last month in the same journal reported that most dietary supplements claiming to have heart benefits or decrease the risk of death, do not do what they claim.
Another study published in the Journal of the American Medical Association in 2018 echoed these findings, indicating most people gain no benefit from taking vitamins or dietary supplements.
Estimates indicate roughly 52% of Americans take at least one vitamin or dietary supplement every day. Some estimates indicate nearly three-quarters of Americans take dietary supplements. Americans spend nearly $31 billion on supplements each year.
While there is some evidence certain supplements can positively impact the risk of death and cardiovascular outcomes, not all supplements do. Most supplements carry no benefit at all, experts say.