Major Allergen Labeling Issues Lead To Warning Letter

There are three lessons in this Warning Letter Wednesday post. Labeling major allergens, avoiding label mix-ups, and hazard analyses are required for conventional food.

The specific type of allergen is needed for tree nuts, crustacean shellfish, and fish. This is still a common error that I see when reviewing dietary supplement labels.

• The specific species of fish (e.g., bass, flounder, tilapia, salmon or cod)

• The specific species of Crustacean shellfish (e.g., crab, lobster, or shrimp)

• The specific type of tree nut (e.g., almond, pecans, or walnuts)

I review 10+ dietary supplement labels each month at my consulting company, Supplement Advisory Group. Contact me to learn more about this and my website/content compliance review services. I love this stuff.

Proper labeling and packaging control can prevent dangerous and expensive mix-ups. This company put the wrong labels on which resulted in recalls and the warning letter. Proper packaging process control and documentation are critical in manufacturing, and up-front organization can prevent expensive issues. I use consultants like Nate Call & Blake Ebersole for Quality Management System development and implementation. If you want an introduction, please let me know.

Conventional food companies must comply with all subparts of 21 CFR 117, which include a risk-based hazard analysis. There are so many warning letters about this essential aspect of food safety. As a side point, dietary supplements need to only comply with some of the 21 CFR 117 subparts.

Here is a good FDA resource that includes directions on listing major allergens and common seafood names. If you know of a better allergen resource, please do share.

Read the full warning letter here. 

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.