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Have you read about changes to U.S. food manufacturing practices? Are you confused? In this post, we explain some of the changes and what it means if you have food allergies.

What Are Good Manufacturing Practices?

The U.S. has rules that establish “Good Manufacturing Practices” (GMP) for food manufacturers to follow. These practices help to lessen the risk of danger to the public. They require manufacturers to follow good food hygiene and handling methods. Most facilities that manufacture food products in the U.S. must follow these practices.

Are Rules for Manufacturing Practices Changing?

These practices have been in place since 1986 with little change. In 2011, Congress passed the Food Safety and Modernization Act (the FSMA) to update and improve the rules.

In September 2015, the FDA created the rules for the FSMA. The GMP is now called the “Current Good Manufacturing Practices” (CGMP).

As we now know, the number of people with food allergies has been rising. Undeclared allergens are the top reason for food recalls. The number of recall events has increased since 2006. With this in mind, the FDA wrote the new CGMP to include provisions intended to reduce the number of allergen recalls.

The Difference Between the Old Rules and the New Rules

This table helps to explain some of the changes in the updated manufacturing practices. The main one is that the FDA can now force a recall of mislabeled food, rather than wait for a food manufacturer to do it.

Updated Manufacturing Practices

Previous Manufacturing Practices

FDA has ability to force a recall for mislabeled products.

Manufacturer decides whether to recall a mislabeled product.

Food imported from other countries must list the source of all ingredients.

Importers liable for false or misleading labels of their products.

No official mandates or requirements.

Facilities must have procedures in place to ensure that their products are not cross contaminated with allergens.

Detailed plans must analyze risk and include controls designed to prevent cross contamination, known as “Hazard Analysis and Risk-Based Preventative Controls.” 

Staff oversee the plans and review them every three years.

Plans must include scientific evidence to show that they are effective.  

No official mandates or requirements for preventing cross contact with allergens.

Voluntary “May Contain” Language Remains the Same

Even though manufacturers must now be more careful to avoid cross contact with allergens, these new rules do not require any changes to the labeling of foods. The new rules do not address the use of advisory statements such as “may contain” or “made in the same facility as.” Such statements are still voluntary and up to the manufacturer to decide whether to use them. It is hoped that the new procedures to ensure against cross contact will reduce the need for such statements.

When Do the New Rules Take Effect?

The new rules take effect in September 2016. Small businesses with fewer than 500 full-time employees do not have to follow the new rules until September 2017. Even smaller businesses have until September 2018 to comply.

The Asthma and Allergy Foundation of America applauds the FDA for developing more allergy-friendly rules. We look forward to more detail about how these rules will protect consumers with food allergies.


Kennedy, P. "North American Food Recalls Headed by Allergens." Food Safety & Quality Blog, Mérieux NutriSciences. Retrieved May 20, 2016.

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food 80 FR 55907 Retrieved May 20, 2016.

It is important to stay up-to-date on news and food allergy recalls. By joining our community and following our blog, you will receive important updates about food recalls and other food allergy news.


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It is encouraging to see these changes being made, and I hope we start to see a decline in the number of recalls we see along with better management and education of allergens within manufacturing facilities.  

I did not know that the FDA didn't have the ability to force a recall for mislabeled products and that it was up to the manufacturer, this is a move in the right direction for sure.

 To the facilities have to have procedures in place to ensure that their products are not cross contaminated with allergens.

Katie D
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