80 Unexpected Consequences
like sorbic acid, already had a long history of use. Congress exempted
these from further review, since they were widely recognized as safe. All
others were to undergo a rigorous FDA evaluation using scientific data.
Today, more than ten thousand substances are allowed. Why so
many? When the growth in new additives surpassed FDA’s capacity
to assess safety, the agency came up with a new approach—let the
companies decide if they were safe. In essence, the original exemption
in the law became the new rule. Companies would self-determine
whether their additives were GRAS—“generally recognized as safe.”
If the companies said they were safe, FDA could not overturn their
decision without first substantiating the harm to consumers. When the
Government Accountability Office evaluated FDA’s rule, they looked
for similar approaches in other countries. None was found.
Several years ago, the Pew Charitable Trusts wanted to know whether
the GRAS provision was working. Among their findings: food compa-
nies had no obligation to even notify FDA of their determinations. An
estimated one thousand substances were introduced into food without
FDA being informed. It was unclear how the agency could investigate
such substances with no direct knowledge of their existence.
Pushing their investigation further, and knowing that many food
companies rely on third parties in making their determinations, Pew
looked at 45 findings where FDA did receive voluntary notifications.
To evaluate whether third parties were free of conflicts of interests that
could bias the results, Pew used criteria developed by the National
Academies’ Institutes of Medicine. Their conclusion: none of the third
parties met the criteria.
In practice, even when a substance is identified as harmful, removing
it from the food supply can take decades. Artificial trans fat, or partially
hydrogenated oil, is made by adding hydrogen to solidify liquid vege-
table oils. It was covered by the original 958 exemption. Because trans
fat is inexpensive, tasty, keeps food from spoiling, and can be used mul-
tiple times in deep fryers, food providers love it. But for consumers, trans
fat raises bad cholesterol (LDL) and lowers good cholesterol (HDL), a
one-two punch against good health. Despite decades of research con-
sistently pointing out its dangers, FDA did nothing until a petition and
lawsuit were filed in 009.