The self-affirmed GRAS (Generally Recognized as Safe) process is flawed, says a new white paper from the Alliance for Natural Health (ANH) USA. But reforming it, rather than ditching it, is the best way to address legitimate concerns without creating a “massive regulatory bottleneck.”
The paper was released after US Health & Human Services secretary Robert F. Kennedy Jr instructed the FDA to explore ways to “eliminate the self-affirmed GRAS pathway,” a move that sent shockwaves through the food industry.
The GRAS designation applies to substances added to food that are considered safe under the conditions of their intended use. Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards as approved food additives.
Currently, companies can independently determine their ingredient is GRAS through self-affirmation after convening an expert panel to review relevant safety data. Alternatively, they can submit a dossier (a “GRAS notification”) to the FDA for formal review, which can take up to 18 months or more. In many cases, companies will first self-affirm their ingredient is GRAS in order to get into the market in a timely fashion, and then submit a dossier to the FDA at a later date, often because some large customers will only accept ingredients that have been reviewed by the agency.
Should the FDA be satisfied with the submission, it will come back with a “no questions” letter, which is publicly available on the FDA website along with the applicant’s GRAS notice.
In cases where a company has self-affirmed its ingredients as GRAS, however, there is no requirement to notify the FDA and no public database of self-GRAS ingredients, something some commentators have long argued is a “loophole” that needs closing.
‘Disproportionate application of the precautionary principle is not appropriate’
According to the ANH-USA, this loophole can be addressed without throwing the baby out with the bathwater.
“We support Secretary Kennedy’s intention to remove the most toxic substances from our food supply,” said Jonathan Emord, J.D., ANH general counsel and co-author of the white paper. “However, the government should avoid complete elimination of self-GRAS, which would create a massive regulatory bottleneck, potentially removing thousands of safe ingredients from the market along with those that are unsafe.”
Self-GRAS has enabled “unscrupulous companies to place ingredients of dubious safety in the food supply,” claimed Emord. However, “disproportionate application of the precautionary principle is not appropriate and contravenes the intended purpose of the GRAS program,” he claimed.
Meanwhile, requiring every ingredient self-affirmed as GRAS to suddenly submit a GRAS notification “would create a massive regulatory bottleneck as thousands of substances, for which there is a reasonable basis for safe use, would clog FDA GRAS notification channels, along with those lacking such reasonable basis,” he warned.
“The agency would thus labor for years, perhaps even decades, to discern which ones meet the new approval standards.”
The ANH-USA white paper instead proposes “reforming GRAS to keep safe products on the market while targeting and ensuring evaluation only of those for which sound scientific evidence suggests a significant or unreasonable risk of illness or injury.”
The solutions proposed include:
- Using adverse event reporting data and peer-reviewed toxicity data to prioritize a subset of GRAS ingredients “for which there is proof of a significant or unreasonable risk of illness or injury.” The FDA would then “require the ingredients not be used unless and until notices seeking FDA GRAS have been accepted without objection.” Examples of ingredients the ANH USA believes should be on such a list include potassium bromate, propylparaben, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), sodium benzoate, and brominated vegetable oil (BVO).
- Requiring companies with self-affirmed GRAS to supply the FDA with those determinations so that they can be posted online.
- Permitting ingredients with a long history of safe use in food for 60-plus years to be recognized by the FDA as “historically safe.”
- Requiring warnings for certain GRAS food ingredients to which a subset of the population is vulnerable to adverse effects (such as allergic reactions) from an otherwise safe substance.
- Implementing a four-tier system that calibrates evidence requirements based on an ingredient’s history of use and safety profile. Substances with 30-plus years of safe use would face minimal requirements, for example.
Further reading:
RFK Jr takes aim at self-GRAS process, but what does it mean in practice?
