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FDA sampling finds milk allergens in four of 52 dairy-free dark chocolate products
02 October 2020
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."