Stronger FDA oversight could significantly improve food safety, provided that the agency implements the changes required as laid out by a new directive from the new U.S. Health and Human Services Secretary Robert F. Kennedy, Jr., who aims to close food safety loopholes in the current FDA rules that allow companies to self-approve food additives.
Secretary Kennedy wants the HHS to once again be a revered scientific institution, and everyone who works there to be proud of their work, with renewed inspiration and responsibility for success in restoring America to good health. The current streamlining of HHS is part of the shift to new priorities and eliminating redundant inefficiencies that have been failing the American public, especially when it comes to “ending the chronic disease epidemic with clean water, safe food, effective medicine, good science, radical transparency, and a healthy environment.” He states that what we have been doing hasn’t worked, a radical overhaul is needed to improve the health of the entire nation to Make America Healthy Again.
As part of the overhaul, Secretary RFK Jr. is asking for the FDA to explore changes to how new ingredients in food are categorized as safe. The March 10th order specifically targets rules that relate to “Substances Generally Recognized as Safe” or “GRAS” designations. The GRAS designation was created by Congress in 1958 to allow substances to bypass FDA review before going to market if they had a long history of use or had “information generally available to scientists” to assure their food safety.
GRAS Designation
Until 1997, companies had to petition the FDA for the GRAS designation for substances not already approved for the designation for the specific way that the company intended to use it. However, a new rule created in 1997 allowed manufacturers to independently determine, using experts of their own to self-regulate/affirm new substance safety without prior GRAS designation without even notifying or sharing their findings/information with the FDA.
“This is regarded as a GRAS loophole and has become the norm,” said Kris DeAngelo, JD, LLM, associate director of the Institute for Food Laws and Regulations at Michigan State University. “Manufacturers are permitted to determine if substances are GRAS independent of or absent from the FDA’s review or approval as long as the determination aligns” with the agency’s established regulations for determining an additive is safe to be used in a specific way.
“Generally speaking, this [rule change] was beneficial for the companies because they could enter the market faster with their food products and ingredients,” said Bryan Quoc Le, PhD, a food science consultant. “Otherwise, by the time the GRAS determination was completed by the FDA, they would have lost the window to be competitive as other companies would find alternatives.”
Pew Charitable Trust Report
Of the notices the FDA receives, the agency evaluates an average of 75 per year, which can be viewed by searching the agency’s website. There are at least 1000 chemicals with GRAS designation that made it to market without notifying the FDA, according to a 2013 Pew Charitable Trust Report. The report also found that most of the additives are not tested for safety in accordance with the FDA’s established recommendation, as well as revealed ubiquitous conflicts of interest in the GRAS self-designation process.
“General recognition of additive safety requires consensus in the scientific community,” the report stated. “There can be no such consensus if the chemical’s use is unknown to the scientific community and to the FDA.”
Lack of Transparency in Food Safety
Fast forward to the present day, and this lack of transparency in food safety is still in place. Now, Secretary Kennedy is taking important steps to revise the GRAS rules to update and potentially eliminate the practice that is in the sole best interest of manufacturers and their profit margins, to instead enhance the oversight of the FDA to protect the best interest of food safety for public health.
“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” said Secretary Kennedy. “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”
Currently the FDA “strongly encourages” manufacturers to submit GRAS notices, but the industry can self-affirm without notifying the agency which maintains a public inventory of all GRAS notices along with supporting data, and the FDA’s final response letter which are available for public review and download.
Safeguarding Food Safety
Eliminating the self-affirmation loophole process would mean that companies would be required to notify the FDA and publicly seek approval to introduce new ingredients into food, and submit their intended use of the ingredients, along with underlying safety data, before they can introduce the ingredients into the food supply chain to significantly improve transparency and food safety.
More thorough FDA oversight and approval processes may be more necessary now than ever before because food ingredients are increasingly being produced using genetically modified and synthetic biology, of which the long-term safety risks are not known, and scientists are still studying.
“If the self-affirmed GRAS determination were eliminated and the FDA received adequate funding and personnel for all food safety and nutrition operations, both the U.S. and the world would benefit,” DeAngelo said. “However, without sufficiently skilled and educated staff and proper funding, it could simply become another grand gesture aimed at fixing a problem without the necessary people or resources to do so.”
Moreover, now under Secretary Kennedy, the HHS is committed to working with Congress to explore ways that legislation can be more transparent and completely close GRAS loopholes. Creating this legislation protecting public health and food safety rather than corporate profits, in tandem with potential future new rulemaking, are critical steps towards safeguarding the food supply chain and Making America Healthy Again.
“The FDA is committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with food,” said Acting FDA Commissioner Sara Brenner, M.D., M.P.H. “The FDA will continue to follow our authorities and leverage our resources to protect the health of consumers to ensure that food is a vehicle for wellness.”
As with anything you read on the internet, this article om food safety should not be construed as medical advice; please talk to your doctor or primary care provider before changing your wellness routine. WHN does not agree or disagree with any of the materials posted. This article on food safety is not intended to provide a medical diagnosis, recommendation, treatment, or endorsement. Additionally, it is not intended to malign any religion, ethnic group, club, organization, company, individual, or anyone or anything. These statements have not been evaluated by the Food and Drug Administration.
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This article was written by TJ Webber at the WHN News Desk
https://worldhealth.net/news/healthy-has-been-redefined-for-food-labels/
