9 replies to this topic

[matthewcc]

This proposed rule from the U.S. Food and Drug Administration (FDA) aims to amend regulations to make the submission of a Generally Recognized as Safe (GRAS) notice mandatory for human or animal food substances. The change seeks to increase transparency and strengthen the oversight of additives in the food supply.

 

 

https://www.reginfo....&RIN=0910-AJ02 

 

 

What do we think about how this will affect food safety and regulatory compliance in the food industry? 

 

I've read some of this but I am unsure how much it will affect our company and others in the food industry.

 

Matthew

[TimG]

That link goes to a page that says it's not published in a unified agenda.

I remember reading about some info on here about it but can't recall what the main points from the law were going to be. No self-proclaimed GRAS was what I kind of remember. It would have to be backed up by published science?

[matthewcc]

Sorry, my bad! If this link does not work then this attachment should. The main point is that it would be a mandatory submission to FDA.

 

https://www.reginfo....0&RIN=0910-AJ02

 

That link goes to a page that says it's not published in a unified agenda.

I remember reading about some info on here about it but can't recall what the main points from the law were going to be. No self-proclaimed GRAS was what I kind of remember. It would have to be backed up by published science?

 

Attached Files

•  Mandatory GRAS proposal.pdf   563.14KB   7 downloads

[Bo16]

"GRAS notices will be required for certain uses of substances in human and animal food"  

 

not very clear.  what uses, what substances, how are they going to handle all the current self-GRAS products?

 

more questions than answers.

 

The FDA always had the power to require a manufacture to actually file a notice if they believed there was an issue with the ingredient, even if it was "self-GRAS", they just didn't know what was being added and when.  

[G M]

It doesn't seem to substantively change anything.  No proof required, no disclosure of evidence to back the claim up.  Just requiring the claim before using it.

 

Someone at FDA gets to say, "look! we made a decision!" and get a pat on the head.

[MDDF]

Vague enough so that they can ding ya for whatever, and weasel their way out of any responsibility.   Pretty standard, lol.

[TimG]

And the amount of food companies who use a product that really should have a GRAS study on an ingredient or processing aid would probably shock you.

 

Storytime: I worked for a (now defunct) food/pharma supplying manufacturer that used something as a processing aid which remained in small quantity in the final product. Tried to get a GRAS statement from the supplier, they wouldn't provide one. I believe they told me 'we don't suggest or guarantee this product as a food safe chemical.' Supplier stopped making it and gave us the recipe because we were the last customers still using it (probably because BASF wouldn't touch a GRAS statement for it).

Anyway, I told plant management to stop using it and find a safe alternative or we need to pay for some studies, because I had NO clue if there were health risks. I got the ole 'suuure quality guy we'll get on that' look. Tried to appeal to their humanity, "how do we know some kid isn't going to develop some type of chronic health issue from this?" 

I'm sure that type of stuff happens more frequently than the average Joe thinks it does.

[G M]

And the amount of food companies who use a product that really should have a GRAS study on an ingredient or processing aid would probably shock you.

 

...

I'm sure that type of stuff happens more frequently than the average Joe thinks it does.

 

The numbers I've seen are pretty horrifying for how many chemicals are listed as GRAS that the FDA has never really bothered to look at, and those are just the ones being voluntarily disclosed.  Then of course there are the ones that made it onto the list, then got banned elsewhere in the world after they were proven detrimental, but are still "generally recognized as safe" by the FDA and continue being used here.

 

Not to worry, I'm sure FDA will patch up those colossal loopholes, they're well known for making quick and effective decisions. /s

[MDDF]

 

Not to worry, I'm sure FDA will patch up those colossal loopholes, they're well known for making quick and effective decisions. /s

[Danny123]

Does anyone have insight into how this may affect the herbal industry? Many botanical herbs are not included on the FDA’s GRAS list, yet some of our customers use them in finished food products. Will those customers need to stop using these herbs until they are added to the list?