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New food ingredients are a “complete black box,” one expert says
by
Sophie Putka, Enterprise & Investigative Writer, MedPage Today
September 9, 2024
After a ground-beef substitute sickened nearly 400 customers in 2022, an investigation found that the illnesses were most likely from a new ingredient called tara flour, bringing to light an alarming truth: food manufacturers are not required to clear new food ingredients with the FDA.
Because of this, it’s almost impossible to know if a given ingredient added to the food supply is safe, wrote Pieter Cohen, MD, of Harvard Medical School, and Emily Broad Leib, JD, of Harvard Law School, in a perspective in the New England Journal of Medicine .
This recently became even more clear to consumers after over 150 people fell ill from mushroom-containing candy and chocolate bars.
The FDA’s Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) in 1958 required that all food ingredients be vetted for safety before being sold. But to keep commonly used substances that were “generally recognized as safe,” or GRAS, like vinegar and baking powder, on the market, an alternate regulatory pathway was created.
GRAS substances are not considered food additives, and, according to the FDA, for an ingredient to be considered generally safe, “all data necessary to establish safety must be publicly available and its safe use must be generally recognized by qualified experts.”
However, Cohen and Broad Leib wrote, “the GRAS exception has increasingly been applied to not only well-known food ingredients but also various new substances used to affect the flavor, texture, or shelf life of products or used as substitutes for meat, eggs, or nuts.”
Over time, they argued, this pathway has served as a loophole for manufacturers to circumvent FDA scrutiny. Under its framework, “the approach taken by a company to determine that a substance is GRAS is left to the firm’s discretion; evidence isn’t required to be shared with the FDA or the public,” they noted, adding that while manufacturers may assemble an expert panel to assess the safety of an ingredient, they aren’t required to do so.
In the 1960s, the FDA would review the safety of ingredients and publish a list of GRAS substances in the Federal Register. But in 1972, the agency eliminated independent evaluation and began letting companies voluntarily inform them of a GRAS determination.
The Center for Food Safety and Applied Nutrition filed more than 600 GRAS notices from 1998 through 2015, for an average of approximately 34 GRAS notices per year, including 69 GRAS notices filed during 2014 and 51 GRAS notices filed during 2015.
Cohen told MedPage Today that these notices were likely a small fraction of the total number of new food ingredients that entered the market.
He also noted that the companies that submit their safety information to the FDA are likely those that serve large portions of the market, with the resources to assemble an independent safety panel, and a legal team to uphold their reputation.
Daily Harvest, the mail-order company behind the illnesses from the ground-beef substitute, which was comprised of French lentil and leek crumbles, may not have had this kind of infrastructure. “Tara flour is typical in terms of that process, because, like … why would a company ever want to spend the time and energy to submit something formally to the FDA when they don’t need to?” Cohen said.
Even if a company does submit a notice to the FDA and the agency asks for more safety data, the company may withdraw their notification and introduce the new ingredient anyway, Cohen and Broad Leib pointed out.
When consumer advocacy groups sued the FDA in 2021, arguing that the pathway “allows FDA to abdicate its core duty under the FDCA … to be responsible for the safety of the food supply,” the court upheld the GRAS legal framework. In essence, they determined, the FDA was within its discretion to decide to compel companies to share safety information or not.
Cohen suspects this lack of oversight may be behind worrying long-term health trends. “Our thinking is that most of the time the new ingredients are going to do things that are subtle and long term,” he added.
He pointed to a recent rise in colon cancer among younger people. “But tying it back to figure out what’s going on is literally impossible these days,” he said, “because no one’s tracking what new ingredients are being introduced in the food supply and how much of those new ingredients are being consumed by individuals.”
States like California and New York have already begun to take matters into their own hands, banning certain food additives and attempting to gather more safety information from food manufacturers.
Cohen and Broad Leib argued that the FDA should be more proactive in its approach, requiring manufacturers to share all new GRAS determinations with them, and to base determinations on high-quality studies.
However, Cohen pointed out that even high-quality studies might not be enough to identify contributors to long-term health trends.
The agency could also periodically review the safety of previously introduced GRAS substances, similar to the Dietary Guidelines Advisory Committee, they added. Another option is for Congress to pass new laws on food safety.
“Neither of those two scenarios — more proactive FDA in this space, or new laws regarding new food ingredients — are anywhere in the near horizon,” Cohen said, but “we need to at least acknowledge, as clinicians, as U.S. consumers, that whenever you’re buying something that’s not traditional food … it’s [a] complete black box in terms of what kind of safety evaluation was done of new ingredients.”
Sophie Putka is an enterprise and investigative writer for MedPage Today. Her work has appeared in the Wall Street Journal, Discover, Business Insider, Inverse, Cannabis Wire, and more. She joined MedPage Today in August of 2021. Follow
Disclosures
Cohen reported financial relationships with the CDC, Consumer Reports, and Pew Charitable Trusts.
Broad Leib reported no conflicts of interest.
Primary Source
New England Journal of Medicine
Source Reference: Cohen PA, Broad Leib EM “Ingesting risk — the FDA and new food ingredients” N Engl J Med 2024; DOI: 10.1056/NEJMp2403165.
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