FDA Warning: Potentially Hazardous Dietary Supplements;Total Product Recall, says Jeni’s Ice Creams

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The Food and Drug Administration sent warning letters to the makers of eight dietary supplements that their products contain BMPEA, a synthetic stimulant that medical experts say is potentially dangerous.

The supplements are marketed to help consumers lose weight, improve athletic performance and enhance cognitive function. But researchers have found that these supplements contain an amphetamine-like substance known as BMPEA.

In December, the Canadian government, which called BMPEA “a serious health risk,” pulled supplements that contain it from store shelves.

BMPEA does not meet the legal definition of a dietary ingredient, the FDA states. Some of the supplement makers identify the source of this stimulant as the plant “Acacia rigidula.” The FDA informed the supplement makers that BMPEA was neither an appropriate dietary ingredient nor an extract of acacia rigidula.

The FDA’s warning letters Thursday came after pressure from some lawmakers and researchers led by an expert at Harvard Medical School.

The FDA first tested 21 workout and weight loss supplements in 2013 that listed the obscure plant called acacia rigidula. The agency found that nine of these products contained BMPEA, but it did not release the names of the supplements or warn consumers about the risk at the time.

Two weeks ago, researchers led by Pieter Cohen, an assistant professor at Harvard Medical School, published a study identifying BMPEA in 11 of 21 supplements that mentioned acacia rigidula as one of their ingredients.

Medical experts say that BMPEA could affect blood pressure and other risk factors for heart disease and stroke.

The FDA to the supplement makers: “We request that you advise us in writing, within 15 days of receipt of this letter, as to the specific steps that have been or will be taken to correct these violations, including any steps taken with respect to product currently in the marketplace.”

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    — John Fernandez

     

    Contamination Fears Spark the Recall of Jeni’s Splendid Ice Creams

    Another ice cream company — Jeni’s Splendid Ice Creams — has recalled its entire product line because of fears that its  ice cream treats may be tainted with Listeria monocytogenes, a bacteria linked to potential health risks.

    “Jeni’s Splendid Ice Creams has initiated a voluntary recall of all ice creams, frozen yogurts, sorbets, and ice cream sandwiches for all flavors and containers because of the possible presence of Listeria monocytogenes. The company is ceasing all sales and closing all scoop shops until all products are ensured to be 100 percent safe,” according to a prepared statement from the company.

    The presence of Listeria in the Jeni’s product line was detected when the Nebraska Department of Agriculture collected a random sample of ice cream from the company.

    “Listeriosis is a life-threatening infection caused by eating food contaminated with the bacterium (germ) Listeria monocytogenes,” according to the U.S. Centers for Disease Control and Prevention (CDC).

    People with greatest risk of contracting listeriosis include:

  • Pregnant women.
  •  Newborns.
  • Adults 65 and older.
  •  People with weakened immune systems.
  • “Jeni’s Splendid Ice Creams is not aware of any illness reports to date related to the recalled products,” the company said. “Customers who have purchased any of the products are urged to dispose of them or return them to the store where they were purchased for an exchange or full refund, and consult with their physician regarding any medical questions.”

    The nationwide recall is the second wide-scale recall of ice cream products this week. On April 20, All Blue Bell brand products were recalled due to fears that the items have been contaminated with listeria, according to the . The recalled product list includes all Blue Bell ice cream, frozen yogurt, sherbet and frozen snacks.

    For the recall linked to the Blue Bell products, 10 people have come down with listeriosis as of April 21, 2015, with cases in Arizona Kansas, Oklahoma and Texas. There have been three fatal cases in Kansas, linked to the Blue Bell outbreak, according to the CDC.

    Related story:

  • CDC: All Blue Bell Products Recalled After Contamination Fears

     

    –Sharon Harvey Rosenberg

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