FDA announced Thursday (October 1) that it has found potentially hazardous levels of milk allergens in four dark chocolate products claiming to be dairy-free.

The products that tested positive for milk were all dark chocolate bars bearing dairy-free claims and all have been recalled, FDA said.

And while products that tested positive represented a small percentage of dairy-free dark chocolate available on the market, the finding has put FDA on alert, causing the agency to advise consumers with milk allergies to be extra vigilant if they choose to eat chocolate products bearing dairy-free claims.

"Consumers with milk allergy who choose to eat dairy-free chocolate may wish to contact the manufacturers and inquire about how the product is made, including whether the product is made on equipment dedicated to making dairy-free chocolate, whether the ingredients used are free of milk, and whether the manufacturer tests its products with dairy-free claims for the presence of milk," the agency said on Thursday.

FDA also suggested it planned to step up surveillance of both domestic and imported dark chocolate "as warranted to detect dark chocolate with undeclared milk allergen and help ensure its removal from the marketplace."

"The FDA is concerned about the presence of milk in dark chocolate claiming to be dairy-free because it can cause serious health consequences to consumers with milk allergy," the agency added.

The agency's findings come as a result of a new sampling assignment, which was conducted over the 15-month period between July 2018 and October 2019 and was designed to help FDA determine the extent to which dairy-free dark chocolate products available on the market could contain milk allergens.

FDA focused on milk because it is the most common undeclared food allergen, and it has cropped up in more than a third of all food recalls caused by undeclared allergens over the past decade. Milk is the leading cause of adverse reactions in foods recalled because of undeclared allergens and in the past, these foods have included dark chocolate products, the agency explained.

FDA finds milk in levels likely to trigger a reaction

FDA released a report on the results from the assignment, in which FDA tested 119 samples representing 52 different dairy-free products and found that four of those products (or 12 samples) tested positive for milk allergens.

According to the report, FDA collected samples from 88 dark chocolate bars and 31 packages of dark chocolate chips sold online or at US stores.

While the sampling found that the majority of products were free of allergens, FDA also found that the levels of milk in the products that tested positive ranged from 600 parts per million (ppm) to 3,100 ppm and were hazardous for people allergic to milk.

"The agency determined that, at these levels, the four products held the potential to cause severe reactions in consumers with milk allergy," FDA said in the findings.

According to the report, two of the products found positive for allergens were produced by the same manufacturer.

FDA also detected a lower level of milk allergen in a fifth product - also a chocolate bar. That product generated three samples that tested negative for milk allergens and one sample that detected milk allergen at 90 ppm.

The assignment resulted in recalls for all products that had contained high levels of milk allergens. For the fifth product, FDA decided not to pursue a recall, but instead notified the manufacturer of the result, so the firm could take appropriate action.

FDA identifies cross-contaminated equipment as one potential source of the allergen

FDA also conducted follow up inspections, which suggested that the milk allergen in the products may have come from chocolate ingredients that companies sourced from third-party suppliers or from cross-contamination of equipment that may have also been used to make milk chocolate, FDA said in the report.

This is not the first time that FDA has detected the presence of milk allergens in products that claim to be dairy-free. The agency conducted a limited survey in 2013-14, which found that two out of 14 dark chocolate products with dairy-free or lactose-free claims and no allergen advisory statement had detectable levels of milk ranging from 1,100 ppm to 1,900 ppm.

"The presence of undeclared milk allergen in dark chocolate products with dairy-free claims remains a concern to the FDA in light of these FDA findings and the history of recalls caused by undeclared milk in dark chocolate products, including those labeled as dairy-free," FDA said in the report.

While FDA stressed that it will "continue to research, evaluate and monitor the issue," the sampling report urged greater vigilance from both consumers and chocolate manufacturers.

FDA urges chocolate makers to follow FSMA rules on cross-contamination, ensure that "dairy free" claims are truthful

The report also stressed that except for "gluten-free," FDA does not define claims of absence such as "dairy-free," "milk-free" or other "absence" claims. Those claims are voluntary, but when used on products they must be truthful and not misleading, FDA reminded companies.

When FDA finds milk allergens in products claiming to be dairy-free, FDA may conduct an investigation and pursue enforcement action through warning letters, seizures, injunctions, and even mandatory recalls, the report warned.

Considering the assignment's findings of potential cross-contamination, the agency also reminded manufacturers that under the Food Safety Modernization Act's (FSMA) Preventive Controls Rule, dark chocolate makers who produce chocolate on shared equipment with milk chocolate are required to "address allergen cross-contact through preventive controls and CGMPs [Current Good Manufacturing Practices] to prevent or significantly minimize the potential for allergen cross-contact."

FDA's inspections of facilities producing dark chocolate already include a review of companies' controls for cross-contamination prevention and may lead to testing, the agency said.

"The agency will take appropriate regulatory action when investigators find that a firm is not adequately controlling allergen cross-contact or when milk allergens are detected in dark chocolate products due to allergen cross-contact or other means," FDA stressed. "Adherence to the FDA's preventive controls rule, as applicable, is critical to help protect consumers with milk allergy."

This article was published by S&P Global Commodity Insights and not by S&P Global Ratings, which is a separately managed division of S&P Global.