Tuesday, January 21, 2014

FDA Finalizes 2009 Draft Guidance on Distinguishing Liquid Dietary Supplements from Beverages - FDA Law Blog

FDA Law Blog: FDA Finalizes 2009 Draft Guidance on Distinguishing Liquid Dietary Supplements from Beverages:

"Compared to the 2009 draft guidance, the final guidance “Distinguishing Liquid Dietary Supplements from Beverages” provides considerably more information, including specific examples, on the factors FDA considers when determining whether the product is a conventional food or a dietary supplement.  As mentioned in the draft guidance, FDA considers labeling and advertising, product name, product packaging, serving size and recommended daily intake, directions for use, marketing practices and composition.  Where the draft guidance merely listed these factors, the final guidance discusses each factor and provides specific examples."

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The two new guidances:
Distinguishing Liquid Dietary Supplements from Beverages (PDF)
Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplement (PDF)

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Friday, January 17, 2014

Drinking diet soda just makes you eat more - TODAY.com

Drinking diet soda just makes you eat more - TODAY.com:

"Don't depend on diet soda to help you lose weight. A new study shows that overweight and obese people who drink diet beverages consume more calories from food than heavy people who consume sugary drinks, according to a new Johns Hopkins study."

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Tuesday, January 7, 2014

CDC: 25 states, including Va., reporting widespread flu | WTVR.com

English: Logo of the Centers for Disease Contr...
English: Logo of the Centers for Disease Control and Prevention, an agency within the United States Department of Health and Human Services. White on blue background with white rays but no white "burst". No detailed wording. (Photo credit: Wikipedia)
CDC: 25 states, including Va., reporting widespread flu | WTVR.com:

"The number of states reporting widespread seasonal flu activity jumped from 10 to 25 last week, the Centers for Disease Control and Prevention said Friday.

Widespread activity was reported in Alabama, Alaska, Arkansas, Colorado, Connecticut, Georgia, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Nebraska, Nevada, New York, North Carolina, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington state and Wyoming, according to the CDC’s weekly flu advisory report, covering the week ending December 28.

“Widespread” means that more than 50% of geographic regions in a state — counties, for example — are reporting flu activity. It addresses the spread of the flu, not its severity."

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Paleo diet ranks last on 'best diets' list - CNN.com

Paleo diet ranks last on 'best diets' list - CNN.com:

"For the fourth year in a row, the DASH Diet Eating Plan was named the best overall diet. DASH, or Dietary Approaches to Stop Hypertension, was developed by the National Institutes of Health for people with high blood pressure. But it is also effective in lowering cholesterol and reducing a person's risk for heart disease, stroke, kidney stones and diabetes, its website states."

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Monday, January 6, 2014

Americans Living Longer Than Ever: CDC – WebMD

Americans Living Longer Than Ever: CDC – WebMD:

"People born in 2009 can expect to live 78.5 years. That's an increase from just a year earlier -- when life expectancy at birth was 78.1 years. Since these latest statistics were collected, life expectancy has increased even more, according to the U.S. Centers for Disease Control and Prevention website, and now stands at 78.7 years.

Much of the continued increase in life expectancy owes to better treatment of cardiovascular disease, a CDC researcher said."

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Emergency Situations (Medical Devices) > FDA Offers Tips about Medical Devices

Emergency Situations (Medical Devices) > FDA Offers Tips about Medical Devices and Hurricane Disasters:

"Warning about Potential Carbon Monoxide Problems when Using Generators

Since many medical devices used in the home require a source of electrical power, generators are often used to supply electricity during a general power outage. The following points should be followed to prevent carbon monoxide poisoning." . . .

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Friday, January 3, 2014

Samsung gets FDA clearance for S Health app | mobihealthnews

Samsung gets FDA clearance for S Health app | mobihealthnews:

"For the first time, Samsung has received FDA 510(k) clearance for its S Health app. The categorization of the clearance as a cardiology signal transmitter suggests that the clearance will allow S Health to interface with additional connected medical devices in the United States."

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2013 warning letters: NDIs, beverage vs supplement, and brand holders' obligations among important themes

2013 warning letters: NDIs, beverage vs supplement, and brand holders' obligations among important themes:

"Some themes that can be gleaned from 2013’s warning letters are part of a constant drumbeat.  Firms are cited by FDA for basic GMP violations and for making non-compliant disease claims on their products.  But other themes, while perhaps not new per se, have acquired a renewed emphasis in the last year, Prochnow said, including the following:" . . .

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Why a Safety Device That Can Stop Overdoses by Kids Isn’t Widely Used - ProPublica

The Fix Isn’t In: Why a Safety Device That Can Stop Overdoses by Kids Isn’t Widely Used - ProPublica:

""If flow restrictors work, they should be placed on all liquid products," said Dr. G. Randall Bond, a pediatrician and poison expert who has consulted with drug makers. “We need a technological change to get us to the next level of safety.”"

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