Silver Spring, MD—The Food and Drug Administration (FDA) issued a news release announcing that Judge Edward R. Korman, of the U.S. District Court for the Eastern District of New York, entered an order of permanent injunction against Confidence USA Inc., of Long Island, New York, and two of its executives: Helen Chian, President, and Jim Chao, General Manager and Founder. Confidence USA Inc. has manufactured and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store, the FDA reported. The company manufactures and distributes these products through Amazon, Walmart, and its own online store.
The permanent injunction requires the defendants to cease manufacturing, holding, or distributing dietary supplements until they hire an independent expert to ensure that they are following the CGMP regulations, and, following an inspection, receive the FDA’s approval to resume operations. Among the violations outlined in the release:
- The defendants violated the FD&C Act because their products were prepared, packed, or held in violation of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements.
- Multiple FDA inspections showed that the defendants repeatedly failed to verify the identity of each dietary ingredient used in the manufacture of their supplements.
- The defendants failed to verify that their products met specifications for purity, strength, composition, and contamination limits.
“Consumers deserve access to dietary supplements that are manufactured to assure their quality,” said Judy McMeekin, Pharm.D., Associate Commissioner for Regulatory Affairs at the FDA. “If a dietary supplement company repeatedly fails to comply with good manufacturing practice requirements, the public cannot trust that their products are what they say they are. The FDA will continue to protect American consumers by taking appropriate actions necessary when companies violate the law.”