Controlled Supplements


The Dietary Supplement Safety Act of 2010 was introduced by Senators
John McCain and Byron Dorgan (D-ND) "to amend the Federal Food Drug and
Cosmetic Act to more effectively regulate dietary supplements that may
pose safety risks unknown to consumers." If passed, the bill would
overturn the 1994 Dietary Supplement Health and Education Act (DSHEA),
which determined that dietary supplements are to be regulated as food,
not as drugs.  This meant that dietary supplements were not
held to the same FDA standards as pharmaceuticals and could be marketed
without FDA approval. McCain proposes to end the supplement industry's
self-regulation by bringing it under FDA supervision. S. 3002 would
require that supplement manufacturers register the locations of their
facilities, a list of all products and ingredients, and copies of all
supplement labels with an FDA secretary as well as maintain a
"scientifically reasonable substantiation file" with evidence that
their products are "reasonably expected to be safe." This shifts the
burden of proof from the FDA to the supplement companies themselves.
In addition, the bill requires manufacturers to submit "adverse event
reports" documenting "non-serious adverse events," and greatly expands
the FDA's recall authority. To ensure compliance, dietary supplement
facilities must "obtain adequate written evidence" of registration "for
review and inspection by the Secretary upon request."

Although
McCain assured Congress that "legitimate dietary supplement companies
should have nothing to fear from this legislation," organizations like
the Alliance for Natural Health and the Natural Products Association
are sounding the alarm about this "capricious war against food
supplements." Opponents of S. 3002 say that the bill doesn't address
the problem of illegal steroids as McCain purports, but does create
unnecessary and cumbersome administrative hurdles for supplement
suppliers. The Alliance for Natural Health states that the end result
is "the consolidation of the supplement industry into a few big
companies . . .[that would] very likely be owned by drug companies."
More objections to the bill suggest that the creation of "voluminous
safety dossiers" and an "approved list of ingredients" gives the FDA
authority to arbitrarily ban supplements or reclassify them as drugs in
order to be more closely scrutinized. There is even concern that
imposing restrictions on supplements is a step towards harmonizing the
United States with the Codex Alimentarius, an internationally
recognized food code backed by the World Trade Organization and
agribusiness giants.

In short, the Dietary Supplement Safety
Act of 2010 increases federal oversight of supplements ostensibly to
protect consumers from dangerous substances. While it's true that
regulations on the supplement industry are lax under DSHEA, it is
uncertain whether increased regulation will actually protect consumers
or simply hamper the sale of alternative health products. Given its
history of approving questionable drugs (such as Vioxx and Rezulin),
its rejection of medical marijuana research, and its financial ties to
the pharmaceutical industry, it is important to question the FDA's
partiality and of course, follow the money. You can read the bill here,
McCain's introduction here, and sign the petition to stop the DSSA from
passing here.

Image: "CRW_5121" by Teresa Stanton on Flickr courtesy of Creative Commons licensing.