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Authorities putting more pressure on supplement manufacturers.
VivaCeuticals, Inc., a California dietary supplement manufacturer, recently closed its doors and recalled of all of its products, and several Colorado supplements makers were ordered to close until they comply with federal regulations.
VivaCeuticals, Inc., doing business as Regeneca Worldwide, is conducting a nationwide recall of its entire line of herbal and dietary supplement products, after signing a consent decree with the U.S. Department of Justice.
In January, the DOJ filed a proposed consent decree of permanent injunction in the U.S. District Court for the Central District of California against VivaCeuticals Inc. and its CEO, Matthew A. Nicosia, to prevent violations of the Federal Food, Drug, and Cosmetic Act (FDCA). In early March, the company said in a statement that it was ceasing operations and recalling its products.
Vivaceutical’s recall applies to all of the company’s products manufactured and sold between June 1, 2011 and February 8, 2017. All lot numbers of RegeneSlim, RegenErect, RegeneArouse, RegeneBlend, RegeneBoost, RegeneBlast, and RegeneFit are included.
Vivaceuticals violated the FDCA by failing to manufacture dietary supplements in accordance with the FDA’s current good manufacturing practice (CGMP) regulations, according to a DOJ statement. The company also distributed RegeneSlim Appetite Control, which contained the unsafe food additive 1, 3 dimethylamylamine (DMAA), and did not disclose the presence of DMAA in RegeneSlim labeling.
The action stems from a 2015 complaint alleging that the defendants violated the FDCA by marketing RegeneSlim to be used in the cure, mitigation, treatment, or prevention of disease, “thereby causing RegeneSlim to be an unapproved new drug and a misbranded drug,” according to the DOJ statement.
“When dietary supplement manufacturers place unsafe and undisclosed ingredients in their products and disregard CGMP regulations, they put the public health 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 closely with the FDA to prevent dietary supplement manufacturers from jeopardizing public health.”
The government’s enforcement action resulted after a series of FDA inspections found recurring FDCA violations in the defendants’ manufacturing facility “which the defendants failed to correct despite FDA warnings,” the DOJ statement said.
Consumers who have purchased Regeneca products are advised to immediately stop using them and return them to the place of purchase for a possible exchange. Consumers with questions can contact the company via email at: firstname.lastname@example.org.
In addition, the U.S. District Court for Colorado entered a consent decree of permanent injunction against EonNutra LLC, CDSM LLC and HABW LLC, manufacturers and distributors of unapproved drugs and dietary supplements, and their owner, Michael Floren. The businesses must immediately cease operations until they come into compliance with federal laws, according to a FDA statement.
During four inspections beginning in 2012, the FDA determined that Floren’s dietary supplement products were misbranded and unapproved new drugs because they were being marketed with drug claims despite not being approved for any use. “Some of the claims Floren’s dietary supplement products were marketed with included the treatment of high cholesterol, hypertension, diabetes, depression, and muscle pain,” FDA said.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of the products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. They can complete and submit the report online here. They can also download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.