Food manufacturers are routinely exploiting a “legal loophole” that allows them to use new chemicals in their products, based on their own safety studies, without ever notifying the Food and Drug Administration, according to a new report by an environmental and consumer advocacy group.
Natural Resources Defense Council identified 56 companies that were marketing products using 275 chemicals that the company’s hired experts decided met federal safety standards, known as Generally Recognized as Safe (GRAS). However, the science behind those safety findings and the use of the chemicals was disclosed to the FDA in only six instances. The New York-based NRDC called its report “Generally Recognized as Secret” and said the lack of transparency with the GRAS process is a public health threat.
“If you don’t know when (an additive) is being used, how can you determine if it’s safe?” said Thomas Neltner, a chemical engineer and co-author of the study that was presented Monday at a Grocery Manufacturers Association’s Science Forum at Washington.
In a prepared statement, the GMA defended the GRAS process, saying, “It is a very thorough and comprehensive process that has, under the current law provided FDA with authority to challenge the improper marketing of an ingredient as GRAS, and if necessary, act to remove products containing that ingredient from the food supply.”
The FDA said that although the law allows for food manufacturers to make their own safety determinations, the agency “encourages companies to consult with the agency when developing new ingredients.” Ultimately, the FDA said, manufacturers “are responsible for ensuring that their food products are safe and lawful.”
NRDC said that Food Additives Amendment of 1958 was enacted, the GRAS process was meant to apply to innocuous additives like vinegar. Instead, it is commonly used for chemicals that are potentially dangerous and have never before been in the American food supply. For example, until recently, artificial transfats were considered GRAS but the FDA has now deemed them dangerous, saying they cause as many as 7,000 deaths from heart disease each year.
The organization said its findings are “likely the tip of the iceberg,” since the scientific work and GRAS determinations are not publicly disclosed and therefore difficult to track down. The organization spent more than a year reviewing trade journals and talking to food additive consultants to identify the 56 companies that frequently make their own safety determinations.
The FDA’s food additive process allows companies to take several paths to determine the safety of new chemicals or other ingredients.
The most transparent and rigorous path involves companies submitting a food additive petition – along with the science behind why they think the ingredient is safe — to the FDA in an effort to gain formal approval from the agency. Companies use the FDA approvals to promote the safety of their products.
The other, non-public path that NRDC examined allows companies to determine GRAS status on their own without notifying the FDA.
A third path allows companies to voluntarily submit their own GRAS determinations for FDA review and sign off, but they may withdraw the petition if the agency is worried about the safety of the additive. The agency announces the withdrawal but does not disclose whether it had safety concerns. The company may then go ahead and use its own GRAS determination to use the additive in products anyway. The NRDC found that one in every five GRAS petitions were either rejected by the FDA or the company voluntarily withdrew their petition.
NRDC’s report also calls on the FDA to petition Congress for a new law that would require manufacturers to submit their safety determinations to the agency for review and approval. The council said it is encouraging consumers to “demand” that their grocery stores and their favorite brands sell only food products with ingredients that the FDA has found to be safe.
At Monday’s event, the Grocery Manufacturers Association also announced a new food additive research center it has helped create at Michigan State University, which will be called the Center for Research on Ingredient Safety (CRIS). GMA’s chief science officer, Leon Bruner, said the center will operate independent of the association and will review the safety of ingredients, train future food toxicologists and serve as an “independent and credible source” for the public, news organizations and the industry.