The American Council on Science and Health has often been critical of the dangerous law giving free rein to "dietary supplements" known as the Dietary Supplement Health Education Act (DSHEA) of 1994, which essentially removed supplements from FDA oversight.
Because of our concern about public health and the risks of supplements, we have heaped praise on others who share the same goal. One example is Harvard physician Dr. Pieter Cohen, who has made exposing the hypocrisies and misrepresentations of the dietary supplement industry's marketing tactics his life's work. Here is a good summary of Dr. Cohen's positions on DSHEA and supplements. The last several of our paeans to Dr. Cohen can be found here and here.
Flaws in the way that dietary supplements are monitored and reported are causing potentially life-threatening delays in how long dangerous products linger on store shelves, said Cohen recently. They are also setting the stage for similar episodes to occur again. In his recent editorial in The New England Journal of Medicine, he noted that one of the more significant problems in such instances is that many cases of harm are reported to doctors and poison control centers but are either delayed in reaching the United States Food and Drug Administration or do not make it to the agency at all.
We ve all been working under the premise that once a dangerous supplement is identified, the F.D.A. will swiftly remove it from the market, he said. But what I ve come to realize over the last several years is that dangerous supplements remain on store shelves sometimes indefinitely or much longer than they should be.
He has co-authored a new study of supplement dangers, this time in the journal Drug Testing and Analysis and seeking and finding evidence of widespread contamination/adulteration of supplements with potentially toxic ingredients, some of which are actually pharmaceuticals.
Supplements might contain actual medicine? That should be good, right?
Not when they are mislabeled and improperly used. Cohen and colleagues found "the amphetamine isomer Î²-methylphenylethylamine (BMPEA) was detected in dietary supplements labelled as containing Acacia rigidula." More specifically, over one year after the FDA announced the adulteration, "more than half (11/21; 52.4%) of the Acacia rigidula supplement brands contained BMPEA."
Shortly after that study, supplement manufacturer Hi-Tech Pharmaceuticals sued Cohen for $200 million. Cohen was not deterred, nor was the FDA, and sent warning letters to Hi-Tech and four other companies selling products with the adulterant. Will that be a deterrent? It seems not to be, since lack of ethical purpose, lax standards and misleading marketing tactics have grown worse.
But it doesn't have to be that way.
As Cohen told Science magazine, There s so many things the FDA could be doing that they re not doing, such as removing supplements from store shelves when companies don t fully pass FDA inspections.
They could simply be overwhelmed by the sheer volume of supplements that the DSHEA law, and co-sponsor Senator Tom Harkin's creation of the National Center for Complementary and Alternative Medicine that attempts to legitimize them, made possible.
When it comes to pulling a supplement ingredient, the FDA seems to have given up until someone can show us the dead bodies, Cohen says.
Senator Orrin Hatch, the other sponsor of the DSHEA law, has been scrambling for cover along with the supplements industry. An HBO "Real Sports" story linked him to the deaths of military personnel who had taken supplements containing DMAA, which was casus belli for the FDA to ban it. Where are an alarming number of supplement companies located? Utah, the home of Senator Orrin Hatch.
Caveat emptor, especially when it comes to supplements and your health. The labels must state, "This product has not been evaluated by the FDA" and since we know a dangerous ingredient won't be banned until there are bodies on the floor, you want to make sure one of those bodies is not your own.