Is the Food and Drug Administration doing its job of protecting the public health when it comes to vitamins, herbs and dietary supplements? Recent evidence has emerged suggesting that the agency has let us all down.
There are many people who would prefer to keep the FDA out of the supplement-regulating business. They worry that the government will keep them from accessing the vitamins, minerals and other supplements they rely on to stay healthy.
That’s why Congress felt pressured to pass the 1994 Dietary Supplement Health and Education Act, or DSHEA, which seems to limit the FDA’s authority over this booming marketplace. Many have assumed that this legislation tied the FDA’s hands when it comes to supplements, and that is how the FDA has acted.
The reality is quite different, however. DSHEA specifically calls for good manufacturing practices regarding all such products and gives the FDA the power to enforce those practices. Not only must all vitamins, herbs and dietary supplements meet such quality standards, but the labels of these products must clearly and accurately state what is in the pills.
If quality control is lacking, the FDA can take action, but that requires inspections, monitoring and enforcement. As far as we can tell, the agency does not routinely visit manufacturers of supplements or test products for quality assurance.
Worse yet, when the agency detects a danger, it may not follow up and require changes to the supplement. A glaring example of this came to light this month in New York Times reports on BMPEA, a stimulant similar to amphetamine that has been included in some products marketed to bodybuilders.
Health Canada required the removal of BMPEA from the Canadian market late last year because animal research shows that it raises blood pressure and heart rate dangerously. But although the FDA has known about nine supplements containing BMPEA for two years, it has done nothing to warn the public or to have the products recalled. In many cases, this designer stimulant is hidden on the label as the Mexican plant Acacia rigidula (Drug Testing and Analysis online, April 7).
This is not the first time the FDA has moved very slowly on the dangers of supplements. The FDA dawdled over the herbal weight-loss and energy booster ephedra while gullible consumers experienced strokes or heart attacks. In the 1990s, there were reports of serious cardiovascular complications associated with this stimulant herb. We received several reports of healthy young people in their 20s or 30s being seriously harmed by this herb, which they believed to be safer than a drug. A report in the New England Journal of Medicine documented 140 cases occurring in less than two years, between June 1997 and March 1999 (Dec. 21, 2000). The FDA finally moved to remove ephedra from the U.S. market in April 2004.
Even supplements that are acknowledged as helpful not meet quality standards. Scientists in Portland, Ore., reported in 2013 that vitamin D pills purchased off pharmacy shelves had enormous variability (JAMA Internal Medicine, April 8, 2013). Some had as little as 9 percent of the labeled dose, while others had 140 percent, a huge spread. This demonstrated a lack of FDA attention to good manufacturing practices.
It’s past time for the FDA to use the power it has to ensure the safety and quality of dietary supplements. Americans deserve the kind of protection that other developed countries enjoy.