Foraging of FDA approved botanicals

[RoyaleDistillery]

Hi,

I've been through every posts till 2015 and havent find anything on foraged botanicals so here is my question:

Let's say I forage wild botanicals in a foreign country and make a spirit with these botanicals abroad then import everything bulk to be bottled in the US; 

knowing that every botanical is on the FDA list, do I have a chance for my formula to be approved even if the botanicals don't come from a certified provider?

 

Thanks a lot!!

[dhdunbar]

I'm not sure what you are asking.  Forage is not the issue.  Whether you forage or purchase an ingredient does not matter.  Whether it comes from Estonia or Brooklyn does not matter.  What matters is the ingredient, botanical or not.  What matters is whether TTB can document that FDA has determined that the ingredient is GRAS at the concentrations you propose.

Not all botanicals are on the FDA list of ingredients that are generally recognized as safe (GRAS) for use in foods (alcoholic beverages are foods under FDA rules).  Nightshade leaps to mind.

There is no single FDA list of ingredients that FDA has determined to be GRAS.  FDA gave up on making its own determinations years ago.  They allow self-certification, but the conditions for self-certifying are stringent.  The person who self-certifies must do so using the same sort of rigorous guidelines the FDA would use if it were still self-certifying.  If you can't afford to hire an attorney to advise you about that, you can't afford to make the tests necessary.  That is a kind, not mocking answer.  It is the plain truth.  That's been on the forum before, I think. 

So you are stuck with the lists that do exist.  See:  https://www.fda.gov/food/generally-recognized-safe-gras/fdas-approach-gras-provision-history-processes.  I'm not competent to comment beyond that reference.  Call the FDA for further guidance.

You must disclose all botanicals on your TTB formula and TTB will check what it knows to be GRAS.  If it does not know that what you propose to use is GRAS, then it should, by its rules, not approve the formula you submit. 

If you want to know if TTB can find your ingredient on an FDA list, call the formulations division.  Leave a message.  My experience is that they will call back in a day or two.

[RoyaleDistillery]

Thanks a lot @dhdunbar. I read somewhere that foraged botanicals weren't allowed unless foraged in the USA.

[dhdunbar]

   

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38 minutes ago, RoyaleDistillery said:

I read somewhere that foraged botanicals weren't allowed unless foraged in the USA

That could be.  I just don't know.  You got my curiosity up, so I went onto the internet.  It appears that USDA may play a role in determining what you may and may not import.  Probably Customs too.  So you've got an alphabet soup  - USDA - USCBP - FDA -TTB

But to add more letters to the soup - GRAS is certainly an issue.  If the plant material you have in mind isn't GRAS, whether you can import it is moot.

 

[RoyaleDistillery]

right ... so in other words : a red tape nightmare!

But thanks a lot, it does help a lot!

[dhdunbar]

It is not necessarily a red tape nightmare.  It may be; it may not be.  But even if it does require jumping through hoops, control over imported plant materials can help to protect against importing invasive species that wreak havoc on the environment, diseases that can decimate domestic crops , and foods that can harm those who consume them.  Some red tape is the cost of that protection. 

 

 

 

 

[RoyaleDistillery]

I totally agree with you, but my goal is to distill the botanicals on site (abroad) so all I'm going to bring back to the US is the actual flavoured spirit!