GNC
settles dietary supplements case with U.S. government
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[December 08, 2016]
By Sarah N. Lynch
WASHINGTON (Reuters) - GNC Holdings Inc,
the largest global dietary supplement retailer, has agreed to pay $2.25
million to avoid federal prosecution over its alleged sale of illegal
dietary supplements, the U.S. Department of Justice said on Wednesday.
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GNC admitted no wrongdoing as part of the agreement. But a senior
Justice Department official hailed it as "a significant step forward
in reforming an industry rife with alarming practices."
“Unlawful dietary supplements are an important enforcement
priority,” Benjamin C. Mizer, the department's principal deputy
assistant attorney general, said in a statement.
The non-prosecution agreement, under which GNC will reform some
practices, stems from allegations that it sold a misbranded
supplement in 2013 called OxyElite Pro Advanced Formula, made by
Dallas-based USP Labs.
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USP Labs was indicted in November 2015 in a federal court in Dallas
on charges that it engaged in a conspiracy to import ingredients
from China using false certificates of analysis and false labeling,
according to the Justice Department.
The case against the company has not yet gone to trial. But it was
accused of falsely claiming its dietary supplements contained
natural plant extracts when they actually contained synthetic
stimulants made in China, the department said.
In a statement, GNC said it was pleased to have resolved the
misbranded supplements matter with the government and had removed
certain USP Labs products from the shelves of its stores "years
ago."
The agreement with the government affirmed that GNC was in "full
compliance" with the Federal Food, Drug and Cosmetic Act, the
company said, adding that USP had provided "false assurances" about
its products.
As part of the non-prosecution agreement, GNC vowed to suspend the
sale of any products the Food and Drug Administration (FDA) has
issued a public warning about. It also agreed to create lists of
acceptable and unacceptable ingredients for use in supplements,
conduct more due diligence on its vendors, and help establish an
industry-wide quality seal program.
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Wednesday's case was investigated by a number of federal offices,
including the FDA's Office of Criminal Investigations (OCI).
Although the government identified problems with supplements sold by
GNC, a separate probe conducted last year by the OCI into
supplements sold at major retailers uncovered no evidence of
wrongdoing.
In that probe, agents conducted undercover purchases of supplements
at GNC, the Vitamin Shoppe and Vitamin World.
All of the supplements, including some made by USP Labs, came back
with a clean bill of health from the FDA's labs, according to
records reviewed by Reuters.
(Reporting by Sarah N. Lynch Editing by W Simon and Tom Brown)
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