Dietary supplements: A round-up of bad news
The bad news about dietary supplements pours in. Most of them are harmless, but this industry is largely unregulated and the lack of oversight shows.
Here’s a brief summary of recent reports and an old one I’ve been saving for an occasion like this:
Some supplements do more harm than good
A lengthy investigative report in the New York Times describes the death of a 22-year-old Army private attributed to taking a recommended dose of a workout supplement, Jack3d, bought at a GNC store on the base.
Jack3d contains a powerful stimulant called dimethylamylamine, or DMAA for short, which has similar effects as amphetamines, but claims to produce “ultra-intense muscle-gorging strength, energy, power and endurance.”
Some supplement companies don’t report problems to FDA
The Government Accountability Office (GAO), in Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products, reports a doubling of the number of adverse event complaints to the FDA since 2008. It attributes the increase to FDA’s enforcement efforts and to lawsuits publicizing situations in which supplement firms are not reporting problems.
Some supplement companies can’t back up health claims
Last year, the Department of Health and Human Services’ Office of Inspector General (OIG) issued two reports examining health claims on immune support and weight loss supplements, both fast-growing segments of the industry.
In its first report, Structure/Function Claims Fail To Meet Federal Requirements, the OIG points to FDA’s limited enforcement authority over such claims. As a result, supplement companies cut corners and ignore requirements for such claims.
Some supplement companies make it hard to complain
In its second report, Dietary Supplements: Companies May Be Difficult To Locate in an Emergency, OIG says that many supplements do not put information about where to file adverse event reports on their labels. Many companies fail to register with the FDA. And when companies do register, they neglect to provide required information. About 20% of dietary supplement labels dd not provide telephone numbers or addresses where consumers can report adverse events.
The supplement industry brought this on itself
A year or so ago, the New York Times published a long article about the cozy relationship between Senator Orrin Hatch (Rep-Utah) and the supplement industry.
If you want to understand how the supplement industry gets away with ignoring regulations, read how “Senator Orrin G. Hatch has helped the nutritional supplement industry, and been rewarded with donations.”
He was the chief author of a federal law enacted 17 years ago that allows companies to make general health claims about their products, but exempts them from federal reviews of their safety or effectiveness before they go to market. During the Obama administration, Mr. Hatch has repeatedly intervened with his colleagues in Congress and federal regulators in Washington to fight proposed rules that industry officials consider objectionable.
When Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, it effectively deregulated the industry, allowing it to use a new category of vague health claims (“structure-function”), to use Supplement Facts labels, and to escape much in the way of oversight.
Even if we assume that most supplement manufacturers are honest about what’s in their products and what the products can and cannot do, some are not. DSHEA gave the less honest manufacturers plenty of room to cause trouble, and so they do.
We will be seeing more such reports, no doubt.