On November 12, the US Food and Drug Administration (FDA) issued a recall notice on its website entitled: ILG International Trading Inc. Issues Alert on Undeclared Sulfites in “Natural Delight Collection” Natural Dried Apricots.
Recalls of this type are unremarkable because they occur often; over 36 recalls were announced on the FDA website in the past 30 days alone. But the sheer banality of this notice is instructive and warrants a closer look.
Here’s an excerpt from the recall announcement, warning about the potential for anaphylaxis:
No illnesses or allergic reactions involving this product have been reported to date.
The recall was initiated after routine sampling by the New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in the 500 g (17 oz) packages of “Natural Delight Collection” Natural Dried Apricots, which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites. Analysis of “Natural Delight Collection” Natural Dried Apricots revealed they contained 23.49 milligrams per serving.
To summarize, a significant quantity of sulfites was found in the product — more than enough to trigger life-threatening anaphylaxis — despite no mention on the label that sulfites are an ingredient. This means one of two things: either (1) ILG routinely adds sulfites to this product and the product is mislabeled, or (2) the sulfites were inadvertently introduced into this product via cross-contact.
Cross-contact is the unintentional transfer of an allergen from a food or contact surface containing an allergen to a food that should not contain the allergen.
We’re guessing cross-contact is the culprit in this recall as sulfites are routinely used by ILG in their other products.
Should cross-contact ever happen? In theory, no: the Food Safety Modernization Act enacted in 2011 introduced the concept of Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (cGMP). cGMP is meant to assure the opportunities for cross-contact are absolutely minimized. But in reality, they happen often as is indicated by the FDA recall page.
Some in the food allergy community whose lives may be threatened by cross-contact are often cavalier about the chances their food might be contaminated, believing the FDA will quickly discover such instances and take action when necessary to protect the allergic. But let’s look at the wording of the FDA’s announcement.
The cross-contact was discovered by the New York State Department of Agriculture (NYSDA) during a routine inspection. This begs further questions: How often does the NYSDA perform such inspections and how many products are they able to screen in a year? How long was this contaminated product on the shelves and how many people were affected by it before the problem was discovered and the recall issued? How effective are other states at finding contaminated products?
According to the FDA, the federal agency itself oversees some 222,490 registered facilities that manufacture food products for human consumption, and according to Live Science, the FDA typically conducts about 8,400 routine food inspections annually. That’s less than 4% of facilities inspected each year and doesn’t include thousands of smaller facilities not required to be registered with the FDA.
How pervasive is cross-contact? We don’t know. What we do know is determining the source of an allergic reaction is often difficult — if not impossible — because reactions to an allergen can occur minutes, even hours after ingestion. And even if the source of a reaction can be attributed to a specific product, it’s unlikely the incident will be reported to the FDA and rise to the level of a recall. (How many times have you or a family member suddenly broken out in hives with no explanation?)
Looking back on the FDA’s recall page, we can see for ourselves that cross-contact happens with regularity, but we don’t know how many contaminated products are currently sitting on shelves that have yet to be identified by routine inspection or reports of reactions.
What common sense does tell us is that cross-contact with a specific allergen is much more likely to occur in facilities where that allergen is processed.
So as consumers, is it possible for us to know which allergens are processed in the facility where a product is manufactured so we are better able to gauge the risk for cross-contact ourselves? The answer is a resounding no, not in the US.
The reason why provides insight into a major weakness of the regulations that govern how allergens must be disclosed on food products sold in the US known as FALCPA.
FALCPA requires manufacturers to disclose when any of the top eight allergens are ingredients of a product but says nothing about whether and how a product must disclose the potential for cross-contact with those allergens.
Precautionary allergen warning statements like “May contain traces of peanuts” or “Manufactured on equipment that also processes soy” can’t provide insight into the risk a product contains traces of an allergen because the FDA provides no guidelines for how they should be worded and when they should be used.
Likewise, the absence of such a warning does not mean the product is safe from containing traces of the allergen! Despite the lack of a warning, your allergen may be processed on the same equipment as your product and the manufacturer is not required to warn you — and many, including well-known brands, don’t.
What we need are stronger allergen disclosure regulations that help consumers determine which products have a higher risk of cross-contact. We have an opportunity to do so right now by amending legislation already making its way through Congress known as the Food Label Modernization Act of 2021, an opportunity that may not come again for years.
In the interest of your own safety and that of your family, please read, sign, and share this petition on Change.org calling for three simple and easy-to-implement regulations to be added to the legislation to help better safeguard the allergic community from cross-contact:
- ILG International Trading Inc. Issues Alert on Undeclared Sulfites in “Natural Delight Collection” Natural Dried Apricots — FDA
- Fact Sheet: FDA at a Glance — FDA
- What the Slowdown in FDA Food Inspections Means for You (Spoiler: Don’t Panic Yet) — Live Science
- Recalls, Market Withdrawals, & Safety Alerts — FDA
- Strengthen the Food Labeling Modernization Act to Protect the Allergic Community — Change.org