Dupage Policy Journal

Dupage Policy Journal

Friday, February 21, 2020

Three senators ask FDA to probe several OxyELITE products

By Mark Reccek | Mar 18, 2015

U.S. Sen. Dick Durbin (D-IL) | Contributed photo

U.S. Sens. Dick Durbin (D-IL), Dianne Feinstein (D-CA) and Richard Blumenthal (D-CT) sent a letter on Tuesday to the Food and Drug Administration, asking that it conduct an extensive investigation into all OxyELITE Pro Super Thermogenic products on the market and, if necessary, ensure they are removed from the market.

“This is not the first time OxyELITE, or manufacturer USPlabs, has come under fire,” the senators said. “FDA should follow OxyELITE Pro Super Thermogenic’s Public Notification Health Fraud Alert by working with USPlabs to ensure the products currently on the market pose no risk to consumer health, and if necessary, remove these products from store shelves as soon as possible. Use the full extent of FDA’s authority today to prevent a repeat of the needless harm USPlabs' products caused in 2013.”

In February, the FDA confirmed that international shipments of OxyELITE Pro Super Thermogenic – manufactured by USPlabs – contained fluoxetine, a potentially harmful antidepressant linked to suicidal thinking, abnormal bleeding and seizures.

In October 2013, the FDA issued a health advisory, warning consumers to stop taking OxyELITE Pro while the agency investigated cases of acute hepatitis illness and liver injury associated with the supplement.

In August 2013, Durbin and Blumenthal introduced the Dietary Supplement Labeling Act, which grants more authority to the FDA to require manufacturers to register their products and ingredients, and to provide proof of any health-benefit claims.

The legislation would also require more information on product labels and decrease the prevalence of drinks and foods that appear as dietary supplements to avoid FDA scrutiny.

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U.S. Senator Richard Durbin