Since we last reported on enforcement actions in March 2015, FDA
posted warning letters to seafood processors, juice processors,
dairies, and other food companies or violations related to CGMP
(current good manufacturing practice), commodity-specific
regulations, labeling, illegal drug residues, unapproved drug
claims, and cosmetics, among others.
FDA warned two juice manufacturers for failing to comply with
juice hazard analysis and critical control points regulations, for
CGMP violations, and for insanitary conditions. Three seafood
processing facilities were cited for failing to comply with hazard
analysis and critical control points regulations and for various
CGMP violations, and two of the facilities were additionally warned
for processing seafood in insanitary conditions. FDA also warned
two dairy farms for selling cattle adulterated with illegal drug
residue for slaughter. One acidified foods manufacturer, located
overseas, was warned for various violations of the Acidified Foods
and Emergency Permit regulations.
FDA continues to review product labels for incorrect or incomplete
claims. FDA cited a Japanese manufacturer of soy sauce for
improperly formatted nutrition information and failure to use the
common or usual name of ingredients on the label. An American
cereal manufacturer was cited for bearing an unauthorized health
claim related to whole grains.
FDA cited only two dietary supplement manufacturers since our
March 2015 issue. One manufacturer of eye care products was warned
for marketing unapproved drugs because its product is promoted for
therapeutic claims. Another manufacturer was warned for using
melatonin, an unsafe food additive, in a beverage product that was
improperly marketed as a dietary supplement.
Finally, in a rare warning letter to a cosmetics manufacturer, FDA
warned a skin care products manufacturer that therapeutic claims on
its website rendered the products unapproved new drugs.
View FDA's Warning Letters Home
page (scroll down for listing of recently posted Warning
Letters).
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