iVillage Member
Registered: 03-26-2003
Thu, 09-25-2003 - 10:41am
seems it's not hard to get fda approval nowadays...

To begin with, Wyeth asked for GRAS status for DHA and AA. They were refused. see

Back then, the rules for GRAS approval were different than they now are.

The new rules are a notification procedure not an affirmation process!! Therefore,

GRAS status is simply the industry affirming that they believe their product

is GRAS. Approval or rejection is based on research provided by the *industry*

not independent research. It has made the process much faster. The items

that were approved prior to this "notification" program underwent a more

rigorous process.

"FDA is also proposing to replace the current GRAS affirmation process with a

notification procedure whereby any person may notify FDA of a determination

that a particular use of a substance is GRAS. Under the proposed notification

procedure, the agency intends to evaluate whether the submitted notice provides

a sufficient basis for a GRAS determination and whether information in the

notice or otherwise available to FDA raises issues that lead the agency to

question whether use of the substance is GRAS. This proposal reflects FDA's

commitment to achieving the goals for the Reinventing Food Regulations part of the

President's National Performance Review(herein after referred to as Reinventing

Food Regulations). The proposed notification procedure would allow FDA to

direct its resources to questions about GRAS status that are a priority with

respect to public health protection."

Claire Hope Cummings, who was a lawyer for the USDA during the Carter Administration, traces the history of the deregulation of the biotech industry. She also states at one

point in her commentary that:

"any 'novel' substances in food must be tested and perhaps labeled. However,

if something can be 'generally regarded as safe' (GRAS), as most conventional

foods are, then they are exempt. Since GMOs are 'substantially equivalent'

to conventional food, they are considered GRAS and thus they do not require

testing or labels."

The FDA has gotten out of the responsibility to monitor the food industry. The responsibility has fallen to the industry itself. The FDA views foods made through biotechnology as functional equivalent to the real thing. We are introducing many novel ingredients into our population, without rigorous, unbiased research to their safety. My concern is in the case of infant formula, for the health and well-being of

infants, which is a more vulnerable population. There are some experts such as Dr. Vyvyan

Howard of the University of Liverpool who mentions in the UK Daily Mail of

March 1999 that experiments have raised questions of the possibility that GM

foods migh harm the immune systems and internal organs of infants and babies.