What supplement companies need to know about new FDA allergens guidance

By Hank Schultz contact

- Last updated on GMT

©Getty Images - tttuna
©Getty Images - tttuna

Related tags: allergens, Labelling, plant-based, Protein, Dairy, tree nuts, regulations

A new FDA draft guidance on food allergens lays out the factors the Agency will use to evaluate the risk posed by substances beyond the nine major allergens now on or soon to be added to the list.

The guidance, titled Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act: Guidance for FDA Staff and Stakeholders,​ was issued earlier this week.  A 120-day public comment period is now open.

Nine major allergens aren't end of story

The current major food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.  At the time those eight substances were categorized into law in 2004 they accounted for more than 90% of the serious allergic reactions adverse events among consumers, FDA said.  Sesame was added to this list in 2021, an action that becomes formally effective in 2023.

But the Agency noted that more than 160 food ingredients in total are known to cause allergic reactions.  The draft guidance lays out what kind of scientific evidence the Agency will use to determine the status of these substances in the future.  It also specifies how FDA personnel will evaluate and weight that evidence, and by extension what stakeholders using these ingredients should be aware of.

Why supplement firms need to take notice

While dietary supplements don’t often contain any of the major food allergens, Larisa Pavlick, vice president of regulatory and compliance for the United Natural Products Alliance, said the new guidance is something that manufacturers need to be familiar with, considering that supplements are regulated as a subset of foods.

Pavlick said dietary supplements are cited by name only twice in the 51-age guidance.  But she noted that nine warning letters citing non compliance on allergen labeling were issued to dietary supplement firms in the period from December 2017 to May 2020.  In addition, she said at least three supplement recalls in recent years have been driven by allergen concerns, including probiotics that contained almonds, crustaceans, milk, casein, eggs and peanuts and a case of a multivitamin that contained vitamin A partially derived from fish liver oil.

“It is important to remember that raw materials and dietary ingredients are also regulated as foods unless they meet the definition of an in-process dietary supplement,”​ Pavlick told NutraIngredients-USA.

“Why do we care about allergens? Food allergens are a chemical food safety hazard under the Food Safety Modernization Act (FSMA) and they must be identified and managed in a Food Safety Plan. Allergens typically cannot be removed once introduced into food as an ingredient, via a sub-ingredient or an ingredient, or via cross-contamination, and reactions by sensitive individuals can range from anaphylaxis to minor health-related irritations,”​ she added.

“The nine major food allergens don’t currently represent all foods nationwide that people are allergic to or that cause food hypersensitivities,”​ said Susan Mayne, PhD., director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN). “This draft guidance is part of the FDA’s efforts to evaluate emerging evidence about other non-listed food allergens that can cause serious reactions in a consistent and transparent manner, which can inform potential future actions to better help protect the health of consumers.” 

Details that can trip companies up

Pavlick noted that supplement manufacturers get into trouble when they don’t take into account the base sources of ingredients or some of the processing steps that can occur before the totes land on the loading dock.  Among the ingredients that have tripped companies up in past she listed:

  • Glucosamine which can be ‘vegetable’ or shellfish derived
  • Milk for any chocolate coated products 
  • MCT from coconut without evidence of ‘highly refined’ 
  • Soybean lecithin from soy with no evidence of ‘highly refined’
  • Colostrum with no milk disclaimer
  • Vitamins derived from a major food allergen
  • Herbs that are traditionally soaked in milk before extraction or processing.

Click here​ to see a full version of the guidance.

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