Since we last reported on enforcement actions in January 2015,
FDA posted warning letters to seafood processors, dairies, dietary
supplement manufacturers, and other food companies for violations
related to CGMP (current good manufacturing practice),
commodity-specific regulations, labeling, illegal drug residues,
and unapproved drug claims, among others.
FDA warned two food manufacturing facilities for various CGMP
violations, including packaging food in insanitary conditions and
failure to protect against contamination of food by pests. Two
seafood processing facilities were cited for failing to comply with
hazard analysis and critical control points regulations, for
various CGMP violations, and for processing seafood in insanitary
conditions. FDA also warned eight dairy farms for selling cattle
adulterated with illegal drug residue for slaughter. A manufacturer
of medicated animal feeds was cited for various CGMP violations,
including failing to properly identify, store, handle, and control
drugs in the mixing areas.
FDA continues to review product labels for incorrect or incomplete
claims. FDA cited a Japanese manufacturer of dumpling skin products
for labeling violations related to serving size, saturated fat
content, and calcium, iron, and calorie declarations. The
manufacturer was further cited for failing to use the common or
usual name on the label and for failing to include all required
information in English.
Dietary supplement manufacturers have been the subject of
increased enforcement action on several fronts. In early February
2015, a federal court granted summary judgment in favor of FDA and
entered a permanent injunction against a dietary supplement
manufacturer, effectively shutting it down for making
unsubstantiated claims that its products could treat
Alzheimer's disease, autism, fibromyalgia, and other medical
conditions. In New York, the Attorney General issued letters to
four major retailers "for allegedly selling store brand herbal
supplement products in New York that either could not be verified
to contain the labeled substance, or which were found to contain
ingredients not listed on the labels" and is requesting that
these retailers submit detailed information on each of the
products. Finally, FDA posted seven warning letters to dietary
supplement manufacturers. Four supplement manufacturers were cited
for CGMP violations, and five supplement manufacturers were warned
for marketing unapproved drugs because the products are promoted
for therapeutic claims. Four of the dietary supplement
manufacturers were also warned for insufficient labels, such as
incorrect serving sizes, failure to include all required
information in two languages, failure to identify the part of the
plant from which ingredients are derived, failure to properly
format a "Supplement Facts" label, and failure to include
adequate directions for the supplement's intended use.
View FDA's Warning Letters Home page (scroll
down for listing of recently posted Warning Letters).
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