Food Supplements FSMA Exemption?

Hi all,

I've been asked by a European dietary supplements manufacturer who is going to export to Canada if they have to meet FSMA without the exemption to subparts C (hazard analysis and risk-based preventive controls) and G (suply chain program); in the USA, dietary supplements manufacturers have an exemption to those subparts (they have to comply with 21 CFR part 111 instead). I've checked this link:

https://laws-lois.ju...-7.html#docCont

...where it says:

46 (1) Unless otherwise specified, the requirements of this Part apply in respect of

• (a) any foods that are to be exported or sent or conveyed from one province to another; Not the case

• (b) any edible meat products (not the case) that are imported, during their storing and handling in their imported condition, for the purpose of the exercise of an inspector’s powers under the Act; and 

• © any food animals from which meat products that are to be exported or sent or conveyed from one province to another may be derived (not the case)

I'm not an expert on Canadian regulations, so I'm not sure at all if I'm properly understanding this; I'm not even sure about how FSMA is applied in Canada  :crybaby:. The summary of my question would be:"Does a food supplement manufacturer who is going to export to Canada have to comply with HARPC and supply chain program of 21 CFR 117?".

Thank you in advance for your help!

Kind regards.

Surely FSMA and the US Code of Federal Regs don't apply at all in Canada?

Hi Phruit, thank you for your answer.

I think it applies somehow; I have read in several places that Canada adopted FSMA preventive controls...but as I'm not in contact with Canada,regulations, I'm not sure to which extent...

Canada is revamping their FS regs to look like ours, but our regulations have nothing to do with theirs (other than some parity agreements).

Use https://www.inspecti...1/1526653035700 as your resource and ignore the US stuff if you're doing business in Canada.

Hi FurFarmandFork,

Thank you very much for your answer, that sounds reasonable :spoton: . The confusion comes because they use the term "preventive controls", the same as the FDA uses. I've been reading the Canadian preventive controls provisions, and well, yes, they pursue the same goal as the FDA ones...but I find the Canadian ones more open, more flexible. My perception (maybe wrong; please is there any Canadian in the room? :shades: ) is that as long as you have a HARPC, or HACCP, or whatever that follows the Codex guidelines, everything will be ok. 

Apart from that, I haven't find anything specific for dietary supplements...is there anything of that sort in the Canadian regulations? 

Regards.

Health Canada regulates natural health products which might include food supplements. This link might help you,

https://www.canada.c...escription.html

https://www.canada.c...regulation.html

This is the Food and drug regulation table of contents

https://laws.justice..._870/index.html

Of course requirements such as safety, labeling, licensing, GMP etc is a must to be able to export products here in Canada.