So in this week’s installment of the Food Basket Topics, I was doing a little project for a school based assignment about the Additive Approval Process. Upon which, I stumbled into the U.S. Food and Drug Administration’s (FDA) website for further details. In their Q&A page for industries, the process can be summarised into companies filing for a petition with an extensive assessment of the additive’s safety via the company, FDA’s scientists and external bodies .
The entire process can average out to 2 years depending on the additive and two questions that occurred was to me was, would companies wait 2 years for an additive to be approved for use? Could there be anyway this process might be exploited? A quick intro to the topic can be seen in WebMD’s video below.
WebMD mentioned in the video above about the Generally Recognised as Safe (GRAS) status that allows companies to conduct their own research and if approved, they can bypass the stringent default process for additives.
In an article by Martha Rosenburg, an investigative reporter from the HuffingtonPost, she had mentioned that at times food companies or additive makers can bypass both the GRAS and additive approval process of the FDA by making self-declaration if its safety – even more so if the additives are imported overseas . This poses a concern, if the FDA is unaware, these additives can appear in food products with or without labeling, much less warnings and can cause unreported reactions in consumers.
The GRAS Status
The creation of the GRAS status can be traced back to the 1958 Food Additives Amendment act which was formed when the realisation occurred that not all additives required strict safety assessments. This was to better utilise the FDA’s resources than having common ingredients such as a salt or vinegar to be approved. The notion of was also brought out how can a food additive be defined, the first was any substance that affects the characteristic of a food product either directly or indirectly and the other as a substance generally recognised by scientific experts as safe or with long experience with their common usage .
But what is the GRAS approval process like? In 1962, the FDA has contracted with the Life Sciences Research Office (LSRO) to select qualified scientists in reviewing the information of the GRAS ingredients. The scientists’ evaluations are kept independent from FDA and other bodies that are involved in conducting safety reviews for these substances. The FDA then uses this data and comments from the public about its proposal and approve the substance as GRAS if its strongly supported [ibid].
The few concerns over this process lies that not all the substance in the GRAS list may have had went through the procedure above if the manufacturer’s independent conclusion had claim if it was GRAS. Secondly, the petition of a GRAS status need not necessarily go through the reviews of the FDA’s agency with the LSRO’s scientists and can be done with the FDA itself. Lastly, the FDA had proposed for the process to be a notification procedure rather than a affirmation petition, this means companies would voluntarily report to the FDA for a final conclusion of the GRAS status [ibid].
In a 2014 report by the National Resources Defence Council (NRDC), they had criticised the FDA’s handling of the GRAS status that despite their strict assessment for the procedure, the fact that it is voluntary for manufacturers had resulted in a deterioration of the quality of risk and safety reviews. Made worse when despite the FDA’s rejection of a GRAS status, it does not mean that it is not allowed to be marketed. This can be evident from their study with 56 companies pertaining to undisclosed GRAS safety assessments for 275 chemicals. Upon which, were unable to provide the GRAS safety studies with 21 not responding at all .
The report’s concerns can be summarised in this video as well.
I had brought up a question earlier in this article, “Would companies wait 2 years for its approved used?” This creates difficulties for the manufacturers for, in that time, the potential profits of the product would be on hold, as with investments and additional costs incurred for its assessments. A concern evident in the report by the NDRC when the companies mentioned why they would forgo the FDA’s review. Others include an additional dietary review included or a misinterpretation of the status – needing both efficacy and a toxicology study [ibid].
In addition, some bias may hold if the companies are held responsible for providing their own safety/ risks assessments. It lacks the independent body present when the FDA is reviewing it or via its initial petition as a food additive [ibid].
Another criticism was made in Kimberly Kindy’s article in the Washington Post of the evaluation of safety studies such as Marlows Food for mycoprotein, a protein-rich fungus. Not all studies had to be cited completely and its approval had resulted in severe allergic reactions to the protein. The FDA had mentioned that the continued responsibility was on Marlows and not theirs .
A different case was a company Kemin, based in Iowa and its green tea powder containing Epigalocatechin-3-gallate (EGCG) which had bypass the FDA as a GRAS status despite Kao Coporations’s rejection of EGCG from the FDA’s toxicologist scientists indicating its toxicity in various organs like the kidneys and liver [ibid].
The takeaway message is that despite the FDA’s rigorous studies and procedures readied in its petition application or GRAS reviews, the organisation needed a larger body of manpower and resources to take on the growing influx of food additives into the market.
I argue that a very large problem lies with transparency of additives not known and recorded by the FDA than the weak or potentially bias claims made by the food manufacturers themselves. This is because if an adverse reaction to happen, to however small the inflicted maybe (in the case of allergies), product recalls would be harder if these ingredients aren’t steadily tracked down.