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What the FDA’s new draft guidance means for food manufacturers

For years, undeclared allergens have been a leading cause of food recalls in the United States. And now, those fearful of facing blame for not doing enough to protect consumers are demanding quicker and broader food recalls.

This month, The U.S. Food and Drug Association (FDA) issued draft guidance encouraging food manufacturers to include sesame as an ingredient on food labels. According to the guidance, “many Americans are allergic or sensitive to sesame, and they need the ability to quickly identify products that might contain sesame.”

While the Food Allergen Labeling and Consumer Protection Act (FALCPA) requires foods containing one of the eight “major food allergens” – milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans – to clearly display the allergen on its label, sesame is not included.

Despite approximately 1.5 million Americans allergic to sesame, the ingredient is oftentimes omitted on labels when used as a flavor or spice. For example, ingredients like tahini are made from sesame, but manufacturers are not required to list sesame on the product label. Many consumers containing this allergen may not be aware of certain products containing sesame, leading to possibly fatal allergic reactions.

The FDA says this draft guidance is “intended to help individuals who are allergic to sesame identify those foods that may contain sesame as an ingredient.” And as we look ahead, this guidance is likely to be the forerunner to officially expanding the allergens list to nine.

How should manufacturers respond?

While the guidance is intended to be viewed as a recommendation or suggestion, it’s important that food manufacturers take note and begin coordinating their action plan. By voluntarily making the label change, manufacturers can keep regulators and consumers happy while remaining confident and prepared.

Manufacturers should view this as a requirement to get ahead of the situation and avoid future litigation. Down the line, lawyers will undoubtedly point to this guidance on behalf of consumers claiming to have allergic reactions to unlabeled sesame ingredients.

Smart companies will take proactive steps to comply with proposed rules and draft guidance as if they were official policy positions. Such action will lessen regulatory pressure on companies and undoubtedly help prevent litigation.

It’s better for companies to be safe than sorry, and by making the label change now, food manufacturers can remain confident, prepared, and protect consumers.

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