FDA new Recommendation on added Fluoride in Bottled Water.

bottled water glassThe FDA has Issued a Letter for Manufacturers with new Recommendations on the appropriate levels of Fluoride added to Bottled Water

In concert with a new U.S. Public Health Service (PHS) recommendation for fluoride levels in community water systems, the U.S. Food and Drug Administration (FDA) has issued a letter to industry recommending that bottled water manufacturers, distributors and importers limit the amount of fluoride they add to bottled water so that it contains no more than 0.7 milligrams per liter (mg/L). The new PHS recommendation was developed by a panel of scientists from several federal agencies, who undertook an extensive review of the scientific literature on the relationship between fluoride intake and oral health.

Fluoride prevents tooth decay (dental caries) in children and adults. But children exposed to excessive amounts of fluoride have an increased risk of developing discoloration of their tooth enamel (dental fluorosis).

The PHS recommendation replaces a previous recommendation for fluoride concentrations that ranged from 0.7-1.2 mg/L, and is designed to achieve an optimal fluoride level that provides the best balance of protection from dental caries while limiting the risk of dental fluorosis. More information on the PHS recommendations can be found on the Public Health Reports website.

FDA’s recommendation is specific to fluoride that is added to bottled water and does not affect the levels of fluoride permitted under FDA’s bottled water regulations.

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Mucinex Fast-MAX Products: Recall – Incorrect Labeling

Mucinex Fast-MAX Products: Recall – Incorrect Labeling

Including certain lots of Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe Congestion & Cough and Mucinex Fast-MAX Cold, Flu & Sore Throat

RB (formerly Reckitt Benckiser) has recalled certain lots of liquid bottles of Mucinex Fast-MAX Nighmt Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe Congestion & Cough and Mucinex Fast-MAX Cold, Flu & Sore Throat because the over-the-counter medications, which correctly label the product on the front of the bottle and lists all active ingredients, may not have the correct corresponding drug facts label on the back. This mislabeling could cause the consumer to be unaware of side effects and/or risks associated with the ingestion of certain product ingredients which include acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.

Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine. Consumers would not be adequately warned of side effects which could potentially lead to health complications requiring urgent medical intervention, particularly in the case of acetaminophen use in people with liver impairment.

RB is notifying its distributors and customers by direct correspondence. See the press release for a listing of affected product lot numbers.

RB is asking consumers to responsibly dispose of any unused product in accordance with the following recommended guidance for drug disposal in your household trash:

Mix liquid medicines with an unpalatable substance such as kitty litter or used coffee grounds;
Place the mixture in a container such as a sealed plastic bag; and
Throw the container in your household trash.

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Caramel Apple Recall Warning

The FDA has announced that it is conducting an ongoing investigation of an outbreak of Listeriosis believed to be caused by prepackaged caramel apples.

The CDC reports that 29 people in 10 states have been reported to have been infected with the bacteria strain Listeria monocytogenes. All 29 people have been hospitalized and five deaths have been reported. It has also been reported that 9 of the cases were pregnancy related.

Listeriosis can be fatal, especially in certain high-risk groups. These groups include the elderly, and people with weakened immune systems and certain chronic medical conditions such as cancer.

BACKGROUND: Happy Apple Company of Washington, Missouri, issued a recall of Happy Apple Brand caramel apples with a best use by date between August 25th and November 23rd 2014, because they have the potential to be contaminated with Listeria monocytogenes. Happy Apple caramel apples are sold in single pack, three packs, four packs and eight packs and each package will have a best use by date on the front of the label. They were available for retail sale through grocery, discount and club stores, generally in the produce section and were distributed to retailers in the following states: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Louisiana, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Mexico, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, Wisconsin.

RECOMMENDATIONS: Health professionals should inform patients to not eat commercially-produced, prepackaged whole caramel apples, including those containing nuts, sprinkles, chocolate, or other toppings, until more specific guidance can be provided. Consumers should throw away any commercially produced, prepackaged caramel apples that they may have in their homes until more specific guidance can be provided.

Anyone who experiences fever and muscle aches, sometimes preceded by diarrhea or other gastrointestinal symptoms, or develops fever and chills after eating commercially-produced, prepackaged caramel apples should seek medical care and tell the health care provider about any history of eating those caramel apples.

The FDA is working to identify the source of contamination and to determine what products may be contaminated. New information will be provided as it becomes available.

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