The FDA was established as a regulatory overseer to ensure implementation of the 1906
Pure Food and Drugs Act, a law a quarter-century in the making that
prohibited interstate commerce in adulterated and misbranded food and
drugs. Its official title 'Food and Drug Administration' was given in 1930.
Since then FDA has been entrusted with the task of " protecting the public health by assuring the safety, efficacy and
security of human and veterinary drugs, biological products, medical
devices, our nation’s food supply, cosmetics, and products that emit
radiation" ( as defined on the FDA website)
But it is starting to become apparent that some food product manufacturers have found ways around the regulations that ensure public safety, most commonly used is a legal loophole, introduced in 1958, that allows use of additives in food products if deemed by them as 'generally recognized as safe' (GRAS). The most well known example of GRAS is partially hydrogenated fats.
As defined on the FDA site: "Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic
Act (the Act), any substance that is intentionally added to food is a
food additive, that is subject to premarket review and approval by FDA,
unless the substance is generally recognized, among qualified experts,
as having been adequately shown to be safe under the conditions of its
intended use, or unless the use of the substance is otherwise excluded
from the definition of a food additive."
Thus these additives may not require FDA approval or oversight if declared as safe by industry experts. It is at the food companies' discretion whether to ask for FDA for approval or declare them harmless using the GRAS loophole. Such an evaluation by the food company is not required to be reviewed by the FDA, yet again the decision lies with the food companies.
What is worrisome is that in recent years several safety of such GRAS ingredients has been disputed by scientists and consumer groups. There have been documented cases where some GRAS additives have led to serious allergic reactions or other health issues.
The fact is that American consumers are ingesting food products with ingredients that have not be scrutinized and approved by the FDA. The long term effects of such ingredients on general health are not known or understood.
As pointed out in the NPR news article "Why The FDA Has Never Looked At Some Of The Additives In Our Food "
This is true of one of the most known — and vilified — GRAS additives:
partially hydrogenated oil, a form of trans fat. Widely used in food
products including fried foods and cake mixes, trans fats have been
named by public health experts as a contributor to heart disease, stroke
and Type 2 diabetes. Despite strong pushback from industry, the FDA in
November 2013 made a tentative determination that artificial trans fats should not have GRAS status, and the agency is likely to make that determination final this summer.
The general assumption that these GRAS ingredients are safe is no longer being accepted by major consumer groups. These are now pushing for higher standards of review and scrutiny by FDA.
Researchers for the Pew Charitable Trusts and the Natural Resources
Defense Council say that allowing companies to make safety
determinations without telling the FDA makes it nearly impossible to
identify whether there are health effects caused by long-term exposure
to certain ingredients.
Their concerns are heightened because
safety decisions often rest in the hands of a small group of scientific
experts selected by companies or consulting firms with a financial
incentive to get new ingredients on the market. Several of these
scientists, a Center for Public Integrity investigation found,
previously served as scientific consultants for tobacco companies during
the 1980s and 1990s, when the tobacco industry fought vigorously to
defend its products.
Unfortunately the steps being taken to control the increasing number of GRAS ingredients being used by food companies are lagging behind, as mentioned in the article;
In the past five decades, the number of food additives has
skyrocketed — from about 800 to more than 10,000. They are added to
everything from baked goods and breakfast cereals to energy bars and
carbonated drinks.
Meanwhile, the FDA's food additive approval
system has slowed to a crawl — the average review takes two years, but
some drag on for decades.
Many industry experts feel these concerns are exaggerated, but as a consumer we need to take time to read food labels and try to make informed decisions of our own. After all the consequence of what we put in our bodies will primarily effects us and our families.
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