Are B2B Bulk Ingredients Exempt from FDA Labeling Requirements?

Good Morning IFSQN, we manufacturer breading's, dry batters and dry seasoning blends in bulk form. We sell to other businesses that use it as an ingredient for further processing. We sell 50lb brown bags and cases containing multiple 5lb plastic sacks.

 

1) Are we required to follow FDA Labeling Guidance and Rules if we are only selling B2B? (are we required to follow the PDP positioning, Net Weight - stating US and Metric -placed at 30% of bottom of PDP, Statement of Identity Rules, Font Size, Prominence, "Manufactured By", etc.). More specifically, Title 21, Chapter 1, Subchapter B, Part 101, Subpart A:

 

§ 101.1 Principal display panel of package form food. § 101.2 Information panel of package form food. § 101.3 Identity labeling of food in packaged form. § 101.4 Food; designation of ingredients. § 101.5 Food; name and place of business of manufacturer, packer, or distributor. § 101.7 Declaration of net quantity of contents. § 101.8 Vending machines.

 

2) The only exemption I could find is within subsection 101.9 (9) (j) which I believe is only in regard to the Nutritional Info, not all the other PDP FDA requirements. Meaning we are exempt from a Nutrition Facts panel. Can anyone confirm this?

 

§ 101.9 Nutrition labeling of food.

 

Subsection 101.9 (9) (j) states "Food products shipped in bulk form that are not for distribution to consumers in such form and that are for use solely in the manufacture of other foods or that are to be processed, labeled, or repacked at a site other than where originally processed or packed."

 

3) If we are selling B2B, who can possibly penalize our product labeling other than the business buying our product?

 

4) Would it make most sense that an agreement between both businesses would satisfy any labeling "requirements", does the FDA have any other B2B requirements listed somewhere?

 

Thank you for your help and answers!

 

 

The basic ones still apply.  Net weight, manufacturer, product name, expiration/use by date.  Customers still need to be able to accurately identify what they're getting/using.

 

Most of our dry ingredients come in with a simple 3~5" label or card, whether its a 5# baggy or an 1100# supersack.

What GM said, almost exactly what we did for bulk spice packaging when I started my food career.  If you're doing cases, each case needs to be identified and then a pallet label gets applied because shrink wrapping can block view of the case labels.  A lot of the FDA Labeling requirements are focused on the final packaging going to a retail consumer, it's really hard to find specific guidance on bulk products for B2B purposes.  There's variation around the industry from what I've seen in a few different operations, it's worth checking with your customers to find out what their expectations are for bulk labeling.

 

Only think I didn't see on his list was the lot coding for traceability (yours and your downstream customer's).  Additionally, we had a simple ingredient list on the labels as well (because the list was short and easy), but at a bare minimum I'd say you need to identify allergens.  Helps your own staff identify allergen containing when they're warehousing the stuff, and your customers need to know they're receiving allergens at the dock.  Most dock operators are not going to have access to a spec sheet to check themselves.

The basic ones still apply.  Net weight, manufacturer, product name, expiration/use by date.  Customers still need to be able to accurately identify what they're getting/using.

 

Most of our dry ingredients come in with a simple 3~5" label or card, whether its a 5# baggy or an 1100# supersack.

 

 

What GM said, almost exactly what we did for bulk spice packaging when I started my food career.  If you're doing cases, each case needs to be identified and then a pallet label gets applied because shrink wrapping can block view of the case labels.  A lot of the FDA Labeling requirements are focused on the final packaging going to a retail consumer, it's really hard to find specific guidance on bulk products for B2B purposes.  There's variation around the industry from what I've seen in a few different operations, it's worth checking with your customers to find out what their expectations are for bulk labeling.

 

Only think I didn't see on his list was the lot coding for traceability (yours and your downstream customer's).  Additionally, we had a simple ingredient list on the labels as well (because the list was short and easy), but at a bare minimum I'd say you need to identify allergens.  Helps your own staff identify allergen containing when they're warehousing the stuff, and your customers need to know they're receiving allergens at the dock.  Most dock operators are not going to have access to a spec sheet to check themselves.

Thank you G M and jfrey for taking the time to read my questions and offer your help and experience, it's much appreciated. These responses make sense to me as well, just as a courtesy to the business you're selling to and what seems to be industry standard. Also, in the event our customers are audited, with the label information you both provided, they would be able to properly identify their raw material ingredient(s) to an auditor or FDA inspector.

 

I'm hoping to back this industry standard up with references/legal codes for complete compliance. I understand what I'm looking for specifically may not be available easily. Thank you again!

Yes, allergen labeling on B2B is mandatory.

Yes, allergen labeling on B2B is mandatory.

Hi Bo16, thank you for your response and confirming.