FSMA PC for Brand Owners who use co-packers

December 2017

Disclaimer:  This is a best effort interpretation of FDA FSMA rules and guidance.  This information should not substitute for competent legal counsel.  Please report factual errors and instances where FDA is interpreting this differently.  I will update this note.   

As a brand-owner, what part of the new FSMA regulations (mostly Preventive Controls for Human Foods) must I be in compliance with?  That is a great, straightforward question.  However, like all governmental regulation questions, the answer is not straightforward.

We start with the fact that only those facilities that are required to register as a food facility must be in compliance with FSMA rules.  FDA says that 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.  [21 CFR 1.226 lists exemptions from the requirement to register, such as farms and foodservice].  Therefore, if you are a brand owner of a food or beverage that is in a co-packaging arrangement, then the co-packer is the manufacturer and packager of the food.

Caveats.  As a brand owner, what is the level of involvement in the co-manufacturing/packaging arrangement? Do you get directly involved in any aspect of the purchasing, processing, packaging, holding of food arrangement? If yes, then you are required to register as a food facility and be in compliance to relevant parts of the FSMA rules. One less than obvious involvement is labeling.  If the brand owner applies labels or stickers to the food container, the FDA has said that is “manufacturing” (1).

Do you require specific suppliers’ ingredients be purchased for your product(s)? Or, do you buy the ingredients for delivery to the co-packer? If yes, then you may need to apply “Supplier Preventive Controls” regarding purchasing. If the ingredient would require a Supplier Preventive Control by the food manufacturer (your co-packer), then you must ensure that the same control is applied (whether by you or by the co-packer as a contractual agreement).

Do you provide labels or labeling instructions to the co-manufacturer?  In a similar manner to the above question, if you are in control of any part of the labeling process, then you must have (or you ensure the co-packer has) a food safety plan covering those controls.  Or, you can arrange by contract to have your co-packer ensure controls are in place.  Keep in mind that business contracts will dictate who pays for a recall if there ever is a need for one.  At the very least, a brand owner should verify food safety controls, especially those that could lead to foodborne illness or recall$$.