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#1 Paula da Silva

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Posted 05 June 2019 - 09:44 AM

Hi everyone!
 
so...I'm preparing a label for the US for a product containing glycerine, which is considered a sugar alcohol.
 
From the FDA website I can see that only  "foods that contain the sugar alcohols sorbitol or mannitol must include a warning on their label that states "excess consumption may have a laxative effect." (doc attached)

 

does this mean that my product which only contains glycerine as sugar alcohols doesn't have to have this warning?

 

In the EU, we would still have to place the warning on pack that's why I'm a little bit confused... :helpplease:

 

thanks for your help : )

 

Paula

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#2 SQFconsultant

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Posted 05 June 2019 - 01:12 PM

Glycerin is in the Polyols category, this category includes Sugar alcohols, like sorbitol, Malitol, erythritol, etc. It is like a sugar alcohol, but not a sugar alcohol. Glycerin does taste sweet and does have calories, but interestingly enough only has the sweetness of about 60-70% of white table sugar.  Glycerin is used in foods, but not that often. Glycerin is used in cosmetics most because it attracts and maintains moisture. This is why it is used mixed with wax as a suppository as it attracts water into the colon and thus creates the need to go.

 

While Glycerin does have calories and sometimes more so than white table sugar it does not cause a rise in blood sugar - but it can create a laxative effect depending on amount of consumption, for some it is low and others high.

 

Did the FDA say that Glycerin is a sugar alcohol?  It is not by definition, of course the FDA  puts out stuff that is just wrong many times.

 

Glycerin is required to be declared on the label and since it does create a laxative effect with excess consumption it does need to be declared that way on the label - but, guess what I had a product with Glycerin in it and it did not contain that warning.


Kind regards,

 

Glenn Oster
 
 
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#3 Paula da Silva

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Posted 06 June 2019 - 10:03 AM

Glycerin is in the Polyols category, this category includes Sugar alcohols, like sorbitol, Malitol, erythritol, etc. It is like a sugar alcohol, but not a sugar alcohol. Glycerin does taste sweet and does have calories, but interestingly enough only has the sweetness of about 60-70% of white table sugar.  Glycerin is used in foods, but not that often. Glycerin is used in cosmetics most because it attracts and maintains moisture. This is why it is used mixed with wax as a suppository as it attracts water into the colon and thus creates the need to go.

 

While Glycerin does have calories and sometimes more so than white table sugar it does not cause a rise in blood sugar - but it can create a laxative effect depending on amount of consumption, for some it is low and others high.

 

Did the FDA say that Glycerin is a sugar alcohol?  It is not by definition, of course the FDA  puts out stuff that is just wrong many times.

 

Glycerin is required to be declared on the label and since it does create a laxative effect with excess consumption it does need to be declared that way on the label - but, guess what I had a product with Glycerin in it and it did not contain that warning.

thank you!  FDA is definitely not clear on this one!



#4 pHruit

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Posted 06 June 2019 - 10:27 AM

Glenn, as I like to learn things and am far less familiar with US regs than with the EU equivalents, where would one find this info from the FDA?

I had a look at the eCFR site, and found:

§182.1320 lists Glycerin as GRAS, with the only condition of use being that it is done so in accordance with GMP.

§184.1835 puts Sorbitol in the "substances affirmed as GRAS" category, including the specific provision of clause (e) that: The label and labeling of food whose reasonably foreseeable consumption may result in a daily ingestion of 50 grams of sorbitol shall bear the statement: “Excess consumption may have a laxative effect.”

 

Where does one find the equivalent requirement for Glycerin?!
 



#5 Charles.C

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Posted 06 June 2019 - 03:23 PM

Glenn, as I like to learn things and am far less familiar with US regs than with the EU equivalents, where would one find this info from the FDA?

I had a look at the eCFR site, and found:

§182.1320 lists Glycerin as GRAS, with the only condition of use being that it is done so in accordance with GMP.

§184.1835 puts Sorbitol in the "substances affirmed as GRAS" category, including the specific provision of clause (e) that: The label and labeling of food whose reasonably foreseeable consumption may result in a daily ingestion of 50 grams of sorbitol shall bear the statement: “Excess consumption may have a laxative effect.”

 

Where does one find the equivalent requirement for Glycerin?!
 

 

Hi pHruit,

 

Perhaps the FDA haven't validated the Glycerine Laxative Potency as yet. Waiting for Volunteers ?.

(albeit seems well-recognised, eg -

https://www.webmd.co...-rectal/details


Kind Regards,

 

Charles.C


#6 pHruit

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Posted 07 June 2019 - 08:28 AM

Oh yes, I quite agree about the reality of the effect. I was just curious as to the slightly opaque nature of the formal CFR requirements - entry for glycerine makes no apparent mention of labelling being required but from Glenn's post (and I don't doubt he is massively more familiar with the US position than I am!) it does seem to be needed, whereas it's very clear for the sorbitol case.

I don't deal with US regs much so it's not really critical to me in a professional capacity, but it was more a question as to whether I'd missed something / was looking in the wrong place. It bugs me if I haven't fully understood something!



#7 moskito

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Posted 11 June 2019 - 04:26 PM

Hi Charles,

 

I have been looking for informations on laxative properties of glycerine some years ago - not found.

 

Rgds

moskito



#8 pHruit

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Posted 12 June 2019 - 09:31 AM

Hi Charles,

 

I have been looking for informations on laxative properties of glycerine some years ago - not found.

 

Rgds

moskito

 

Have a look at hyperosmotic laxatives - glycerine is one of the substances that can be used for this purpose (draws water into the bowel IIRC)



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