Jump to content

  • Quick Navigation
Photo
- - - - -

Diluting concentrated raw ingredient used in tinctures and vape pens

cannabis; raw materials

  • You cannot start a new topic
  • Please log in to reply
4 replies to this topic

#1 twiley

twiley

    Grade - Active

  • IFSQN Active
  • 11 posts
  • 0 thanks
0
Neutral

  • United States
    United States

Posted 31 August 2020 - 06:14 PM

Hello, we use flavoring terpenes in our manufacturing lab. These are very concentrated, natural fruit or herbal flavors and we dilute them a great deal in the final product (tinctures, vape pens). Prior to using the terpenes, we send them for testing and analyze for pesticides and residual solvents. Normally we send them "straight" in their concentrated form and they fail horribly for both analytes. Because we always cut them, we decided to send them diluted to 10% as the highest concentration we use them in any final product is around 7%. I figured 10% was a good safety net and they pass testing fine at this level. 

I know the the CFR essentially says, you can't 'dilute out' a contaminant in a food product, but this is the cannabis industry, not food and not so black and white...do you think my 10% is logical and fair or should I be testing this material concentrated?

Thanks in advance for your help!
 



#2 TimG

TimG

    Grade - MIFSQN

  • IFSQN Member
  • 247 posts
  • 91 thanks
101
Excellent

  • United States
    United States

Posted 31 August 2020 - 06:27 PM

Hey Twiley, we deal with similar issues in the food grade chemical industry. Do you know if there are any GRAS guidelines or manufacturer recommendations for the terpenes? What you want to look for is something on paper that says "this is safe in food as long as we don't exceed X or use it for Y" and then you would test accordingly to make sure you maintain those safety parameters in production. Once that's in place, you wouldn't be diluting to pass, but rather matching your analysis to a level controlled in production.

 

We make FCC  and USP grade salts (not table salt) out of two highly toxic substances. It was a treat to figure out how best to meet FDA supplier/ingredient requirements. The GRAS statement and FCC monograph were my saving grace documents in that one.



#3 twiley

twiley

    Grade - Active

  • IFSQN Active
  • 11 posts
  • 0 thanks
0
Neutral

  • United States
    United States

Posted 31 August 2020 - 06:43 PM

Hey Twiley, we deal with similar issues in the food grade chemical industry. Do you know if there are any GRAS guidelines or manufacturer recommendations for the terpenes? What you want to look for is something on paper that says "this is safe in food as long as we don't exceed X or use it for Y" and then you would test accordingly to make sure you maintain those safety parameters in production. Once that's in place, you wouldn't be diluting to pass, but rather matching your analysis to a level controlled in production.

 

We make FCC  and USP grade salts (not table salt) out of two highly toxic substances. It was a treat to figure out how best to meet FDA supplier/ingredient requirements. The GRAS statement and FCC monograph were my saving grace documents in that one.

Interesting, thanks for your insight! The company we purchase the terps from does have food safe and GRAS statements available but all they say is the "product is safe for use in food when used properly" so maybe I should see if they can give me some actual numbers. I should have mentioned that when we test the terps ourselves and they fail, we're testing them to cannabis regulation action limits, which didn't really seem to make sense since these regs are much more stringent than many other industries. 

Thanks again!



#4 TimG

TimG

    Grade - MIFSQN

  • IFSQN Member
  • 247 posts
  • 91 thanks
101
Excellent

  • United States
    United States

Posted 31 August 2020 - 07:29 PM

They should be able to provide info on what is considered 'proper' use.

I want to warn you though, be prepared for some bad news. It sounds like you are using it for something not originally considered in the scope of the GRAS testing, which means you might have to do some testing of your own or find other means of validation.

 

My next step were I in your shoes would be to get with my global regulatory guy and make sure you're on the same page about the statement you made "I know the the CFR essentially says, you can't 'dilute out' a contaminant in a food product." I'm allowed certain amounts of heavy metals in my product by the FCC monograph (measured in PPM), and to meet that I am allowed to set my own ingredient heavy metal limits.

If you are your global regulatory guy, it might be worth getting a consultant in to explain to you what's allowed and what isn't. Then pay them to write up a rock solid argument in defense of your process.



#5 pHruit

pHruit

    Grade - FIFSQN

  • IFSQN Fellow
  • 1,471 posts
  • 623 thanks
330
Excellent

  • United Kingdom
    United Kingdom
  • Gender:Male
  • Interests:Composing/listening to classical music, electronics, mountain biking, science, sarcasm

Posted 01 September 2020 - 07:47 AM

I'm less familiar with the US CFR than with the equivalent EU regs, but IIRC it includes a provision that, for concentrated products made from a single ingredient, the residue limits are applicable for the product as reconstituted to single strenght - i.e. it recognises that this is not a "dilution" per se.

Again I can really only talk from an informed position from the EU perspective, but to me 10% seems somewhat arbitrary and may thus be difficult to specifically defend?
I'd contact the suppliers of the various components to see if they can give you an effective concentration factor for the product - for example, if it takes 100kg of the starting botanical to make 1kg of extracted oils then this is arguably a nominal 100-fold concentration factor. You should then be able to advise the lab of this when sending the samples for analysis, so they can take into account when preparing the report. If they can't/won't do this for you then try other labs, as it's something I've seen very routinely for various products with a known concentration factor - you'll get e.g. a table of direct actual results, and a second column showing the result taking the concentration factor into account, and the latter would then be used for the conclusion/opinion section (if they're including one).

 

Edited to add: From a very quick scan, 40CFR180.1 (h)(10) looks like it could be helpful here: 

(10) For processed foods consisting primarily of one ingredient and sold in a form requiring further preparation prior to consumption (e.g., fruit juice concentrates, dehydrated vegetables, and powdered potatoes), the processed food to be examined for residues shall be the whole processed commodity after compensating for or reconstituting to the commodity's normal moisture content, unless a tolerance for the concentrated or dehydrated food form is included in this part. If there exists a tolerance for a specific pesticide on the processed food in its concentrated or dehydrated food form, for the purpose of determining whether the food is in compliance with that tolerance, the processed food to be examined for residues shall be the whole processed commodity on an “as is” basis.


Edited by pHruit, 01 September 2020 - 07:50 AM.





0 user(s) are reading this topic

0 members, 0 guests, 0 anonymous users