Is the FDA 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.
What Is DSHEA?
That’s why Congress felt pressured to pass the 1994 Dietary Supplement Health and Education Act (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 (GMP) of all such products and gives FDA the power to enforce GMP.
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.
FDA Is Not Checking on Supplement Makers
As far as we can tell, the agency does not routinely visit supplement manufacturers 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 recently in a New York Times article. BMPEA is a stimulant similar to amphetamine that has been included in some products marketed to body builders. Health Canada required its removal from the Canadian market late last year because animal research shows 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 nor 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, 2015).
How the FDA Handled Ephedra
This is not the first time the FDA has moved very slowly on supplement dangers. 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 US market in April, 2004.
Other Supplements Fall Short
Even supplements that are acknowledged as helpful rather than hazardous may not meet quality standards. Scientists in Portland, Oregon, reported in 2013 that vitamin D pills off pharmacy shelves had enormous variability (JAMA Internal Medicine, April 8, 2013).
As we have written, some had as little as 9 percent of the labeled dose, while others had 140 percent, a huge spread. This clearly demonstrated a lack of attention to GMP on the part of the FDA as well as the makers of the supplements.
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. Taking supplements seriously would not have to mean taking them away from American consumers.
