Does this plant need to be FDA registered to become SQF certified?

Hello,

 

I have a quick question about SQF. A co manufacturing plant that only processes Direct to consumer products is not FDA registered. Does this plant need to be FDA registered to become SQF certified? My thoughts were no but some clarity on this would be much appreciated! 

If the facility/products fall under FDA oversight they need to be registered.

This may change soon however for now it's the requirement.

The facility is producing plant based products. Does is still need to be registered even though the product goes directly to consumer?

Can you elaborate on this?

 

They are your co man, but what they produce is sold via a retail store and/or online?  Farmers Markets?   and you?  or some of the above

 

 

does their product cross state lines?

Yes- they are our co-man. They have their own DTC brand as well. Both our brand and their brands consist of meal kits via internet purchase that are delivered directly to the consumer. Yes, the product passes State lines.

Then yes, they should be registered

 

Once a manufacturer is selling across state lines, state certification is no longer enough  while they may not specifically mention this type of sales, the regulatory land will catch up quickly

https://www.fda.gov/...ng-address-food

Thank you for the insight. We are trying to hold them accountable and follow our FSQA standards. This will be the gateway! 

Will SQF ask for a FDA registration number? I can't remember from previous audits. 

Will SQF ask for a FDA registration number? I can't remember from previous audits. 

 

 

 

if they go through the SQF audit process, the auditor will seek proof that they are registered.   Unless they do not need to be registered by some exemption.  

 

your SQF auditor will not normally ask to see their "proof",  but will seek information on how you approved them (see 2.3.3)

 

What explanation do they give for not registering?

 

if they go through the SQF audit process, the auditor will seek proof that they are registered.   Unless they do not need to be registered.   

 

They are trying to say they are exempt from registering due to being a DTC brand. However, I explained to them that they manufacture food and are packaging food thus shall be registered - 21 CFR 1.227

It always pays to know and understand the regulations

https://www.fda.gov/...seventh-edition

 

On October 10, 2003, the Food and Drug Administration (FDA or we) issued an interim final rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) (68 FR 58894). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. This guidance was developed to answer frequently asked questions relating to the registration requirements of section 415 of the FD&C Act.

 

If you are the owner, operator, or agent in charge of either a domestic or foreign facility that is engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the United States, you must register with FDA, unless you are exempt under 21 CFR 1.226 from the requirement to register. If you are an owner, operator, or agent in charge of a domestic facility, you must register your facility whether or not the food from the facility enters interstate commerce (21 CFR 1.225(b)). If you are the owner, operator, or agent in charge of a facility, you may authorize an individual to register your facility on your behalf (see 21 CFR 1.225© and 1.230(a)). A foreign facility’s U.S. agent may, but is not required to, register the facility (21 CFR 1.230).

B. Who is Exempt from Registration? 1. Farms

https://www.fda.gov/.../85043/download

They are trying to say they are exempt from registering due to being a DTC brand. However, I explained to them that they manufacture food and are packaging food thus shall be registered - 21 CFR 1.227

 

 

Oh, I get it now.   They are calling themselves a "retail establishment" and trying to use that exemption.  

 

To your original question and thought - I believe you could be correct.   The SQF requirement is that they need to follow all relevant legislation. If they are operating within the law, SQF should have no issues.  

 

I guess we can all speculate / argue / discuss if they are properly interoperating & applying the law.   

 

Retail food establishment - means an establishment that sells food products directly to consumers as its primary function. The term “retail food establishment” includes facilities that manufacture, process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. A retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The term “consumers” does not include businesses. A “retail food establishment” includes grocery stores, convenience stores, and vending machine locations. A “retail food establishment” also includes certain farm-operated businesses selling food directly to consumers as their primary function.

They are trying to say they are exempt from registering due to being a DTC brand. However, I explained to them that they manufacture food and are packaging food thus shall be registered - 21 CFR 1.227

Being a DTC - they still need to be state inspected. I would ask for that proof. Depending on the state - you may be able to find the results of their last inspection on-line.