District Court Enters Permanent Injunction against Miami Dietary Supplement Manufacturer and its Two Owners to Stop Distribution of Adulterated Products
The U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction against Miami-based Sunset Natural Products Inc. and the firm’s co-owners, Teresa Martinez and Elsy Cruz, to prevent the distribution of adulterated dietary supplements, the Department of Justice announced today.
The department filed a complaint in the U.S. District Court for the Southern District of Florida at the request of the U.S. Food and Drug Administration (FDA), alleging that the defendants violated the law by manufacturing and distributing dietary supplements that were deemed to be adulterated. Under the law, dietary supplement manufacturers are required to have systems in place to ensure that their products meet specifications for identity, purity, strength and composition.
According to the complaint, several FDA inspections between 2012 and 2014 allegedly revealed that Sunset failed to conduct at least one appropriate test or examination to verify the identity of every dietary ingredient before using the ingredient, and that the firm failed to establish product specifications for the identity, purity, strength and composition of finished batches of dietary supplements. The defendants allegedly failed to use equipment and utensils of appropriate design, construction and workmanship to enable them to be adequately cleaned and properly maintained.
The firm and its owners agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing further violations of the federal Food, Drug and Cosmetic Act. The consent decree requires Sunset to cease all operations and requires that if the defendants seek to resume manufacturing and distributing dietary supplements, the FDA first must determine that the firm’s manufacturing practices have come into compliance with the law. The consent decree also requires the defendants to recall all dietary supplements that the defendants manufactured, prepared, processed, packed, labeled, held and/or distributed at any time since April 2014. The defendants are then required to destroy all dietary supplements in their possession, custody and/or control.
“Manufacturers of dietary supplements who do not follow the appropriate federal regulations put the public at risk,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work with FDA to protect consumers from adulterated products.”
On March 19, 2013, the FDA issued a warning letter to Martinez, detailing numerous violations of current Good Manufacturing Practice (cGMP) regulations the FDA observed during the 2012 inspection. According to the complaint, all of the cGMP violations described in the warning letter were the same as, or similar to, the violations the FDA observed during the April 2014 and September 2014 inspections. As noted in the complaint, the warning letter stated that it was the defendants’ responsibility to ensure compliance with the law and cautioned that failure to take prompt action to correct the deviations, and prevent their recurrence, may result in legal action.
According to the complaint, Martinez responded to the 2013 warning letter with promises to correct the cGMP violations. However, according to the allegations, the defendants either did not follow through on their promises to correct and/or failed to fully correct these violations, as shown by the FDA investigators’ observation and documentation of ongoing, significant cGMP deficiencies during the subsequent inspections in 2014.
The government is represented by Counsel Melanie Singh of the Civil Division’s Consumer Protection Branch, with the assistance from Senior Counsel Michele Svonkin of the Department of Health and Human Services’ Office of General Counsel – Food and Drug Division.