US Health and Human Services Secretary Robert F Kennedy Jr wants to end a long-standing programme allowing companies to include new additives – and artificial dyes – into their food products without being vetted by the Food & Drug Administration (FDA).
He has told industry executives he wants artificial dyes out of American foods by the end of his term, reports Everyday Health.
The HHS said that companies should no longer be able to self-certify that ingredients are “generally recognised as safe” (GRAS) and instead should submit those products for FDA safety review.
“For far too long, ingredient manufacturers and sponsors have exploited a loophole allowing new ingredients and chemicals, often with unknown safety data, to be introduced into the US food supply without notification to the FDA or the public,” he said.
Loophole in the system
At least 99% of the chemicals that have been introduced to the food supply since 2000 have not undergone FDA review because of the GRAS loophole, according to a 2002 analysis by the Environmental Working Group (EWG), an advocacy group based in Washington with a long history of criticising additives in food and personal care products.
Over this period, companies sought FDA approval to use new chemicals, including dyes, in foods just 10 times, according to the analysis.
The FDA has approved 36 food dyes, of which nine are artificial colour additives used in foods and beverages, according to Michigan State University.
They include: Blue No 1, Blue No 2, Green No 3, Orange B, Red No 2, Red No 3 (now banned), Red No 40, Yellow No 5 and Yellow No 6.
Because of the GRAS rule, food companies basically decide for themselves whether artificial food dyes and other additives are safe – and they’re not even required to notify the FDA when they do this, said Marion Nestle, PhD, MPH, a professor emerita of nutrition and food studies at New York University.
“The companies appoint their own experts to decide. This allows potentially unsafe additives into the food supply,” saide Nestle, who has written about the influence of industry in food research and regulation in her books Food Politics and Unsavory Truth.
‘Generally recognised as safe’
The GRAS loophole was part of the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act, and said that “any substance intentionally added to food is a food additive and is subject to premarket approval by FDA unless the use of the substance is generally recognised as safe (GRAS; the GRAS provision) (or otherwise excepted from the definition of food additive, e.g, colour additive)”.
This “loophole” was originally intended to make it easier for companies to manufacture and sell products containing food additives that had a history of safe use (like vinegar, for example) without seeking FDA review, said Jerold Mande, MPH, chief executive of Nourish Science, a non-profit nutrition research organisation, and an adjunct professor of nutrition at the Harvard TH Chan School of Public Health in Boston.
“Companies later became unhappy with how long it was taking the FDA to review new food additives, so they started abusing the GRAS exemption, claiming that new chemical additives without a history of safe use were nevertheless generally recognised as safe,” he said.
At the same time, the main reason FDA reviews took so long is because companies used their political power to limit FDA funding that would be necessary to accelerate this process.
“Allowing companies to make this decision rather than FDA is a problem because companies have a conflict of interest – their focus is making money,” he added.
The banning process
Kennedy can’t remove artificial food dyes from products overnight, but there’s a good chance the regulatory process he’s kicked off at the FDA can ultimately succeed, Mande said.
“This type of rulemaking typically takes at least two years, plus an additional year or more for companies to reformulate their products. Some companies will choose to change their products much faster, to be seen as leading a change they know is coming.”
In January, the FDA banned the artificial colouring Red Dye 3, after years of public concern over data showing it causes cancer in rats.
There is no research suggesting the food dye causes cancer in humans.
Food makers have two years to remove it from their products. Drug manufacturers have three years.
Everyday Health article – RFK Jr. Asks Food Companies to Stop Using Artificial Dyes (Open access)
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