The FDA has reported that Sunset Natural Products Inc. has been issued a consent
decree of permanent injunction by U.S. Magistrate Judge Edwin G. Torres of the
U.S. District Court for the Southern District of Florida on Monday, September
28th. The owners of the company, Teresa Martinez and Elsy Cruz, were
manufacturing and distributing adulterated dietary supplements in their Miami,
Florida facility.
The U.S. Department of Justice filed a complaint and sought
a permanent injunction against Sunset Natural Products because they were
manufacturing dietary supplements in conditions that did not meet the Food
& Drug Administration’s requirements for Good Manufacturing Practice
(cGMP).
The company is barred from manufacturing and selling dietary
supplements until they are in compliance with the FDA’s cGMP requirements and
also the Federal Food, Drug, and Cosmetic Act.
Sunset Products was issued a Warning Letter on behalf of the FDA in March 2013 for cGMP requirements violations,
as well as unapproved drug claims. In subsequent inspections, the company had
removed dubious product claims but were still not within cGMP.
Under the consent decree, the company is prohibited from
marketing their supplements and must recall existing distributed products, as
well as destroying their stock dating back since April 2014. A cGMP expert must
be hired to get them into compliance and they must receive written permission
from the FDA in order to resume manufacturing and distributing.
InstantGMP produces a cloud-based cGMP software solution for
companies that produce dietary supplements, medical devices, and e-liquids for
e-cigarettes that brings them into compliance and reinforces Good Manufacturing
Practices.