3 LI Companies Ordered To Stop Distributing Unapproved Drugs

LONG ISLAND, NY - Three Long Island-based corporations and their owner were ordered to stop distributing misbranded dietary supplements and unapproved drugs, the U.S. attorney announced on Thursday.

The decree, approved by United States District Judge LaShann DeArcy Hall, requires ABH Nature’sProducts, Inc., ABH Pharma, Inc., and StockNutra.com, Inc. all based in Edgewood, as well as their owner, Mohammed Islam, to destroy all dietary supplements and drugs in their possession within 15 days, according to the U.S. attorney.

The injunction also requires the company and Islam to implement consumer safety measures before manufacturing or distributing the dietary supplements, the U.S. attorney said. This includes hiring an independent expert to inspect the facility and make sure they are complying with current good manufacturing practices, the U.S. attorney said.

The decision was made following a lawsuit filed on Nov. 21 at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, ABH and Islam manufactured, prepared, labeled, packed, held and/or distributed dietary supplements under conditions that failed to comply with current good manufacturing practice regulations, the U.S. attorney said.

The FDA documented several violations of the current good manufacturing practice regulations during at least six inspections of ABH’s facilities conducted over the past several years, including failures to conduct at least one appropriate test to verify the identity of a dietary ingredient; verify that finished batches of dietary supplements meet product specifications for identity, purity, strength and composition; include required information in batch production records; and properly review and investigate a consumer complaint, the U.S. attorney said.

In addition, the lawsuit claimed that ABH and Islam also violated the federal Food, Drug, and Cosmetic Act by distributing unapproved and misbranded "new drugs" into interstate commerce, the U.S. attorney said.

For example, the company made claims that certain products could be used to treat such medical conditions as cancer, heart disease, HIV and AIDS, even though the FDA had not approved those products for those uses, according to the U.S. attorney. There were also no published adequate and well-controlled investigations showing that such products are generally recognized as safe and effective for any use, the U.S. attorney said.

"Manufacturers of products labeled as dietary supplements have an obligation to evaluate the safety and labeling to ensure their products are manufactured correctly to meet all federal requirements and are not misleading to consumers," Melinda K. Plaisier, FDA associate commissioner for regulatory affairs, said. "Americans expect and deserve products that meet appropriate standards, and the FDA remains committed to taking action against companies and owners who place the health of American consumers at risk."