FDA reconsiders safety of OSP use for bowel cleansing as an OTC indication
SILVER SPRING, Md. — The Food and Drug Administration will propose an amendment to the over-the-counter laxative monograph that sodium phosphate salts are not generally recognized as safe for bowel cleansing.
A request for public comments will be published in Friday’s Federal Register.
“[The] FDA is issuing this proposed rule after a careful review of new data and information on the serious side effects that have been associated with the customary dose of OTC sodium phosphates solution … for bowel cleansing prior to colonoscopy,” the agency stated.
The FDA initially raised safety concerns in 2008, after which Fleet Labs, which fielded an OTC product containing a sodium phosphate solution, voluntarily recalled that product (Fleet Phospho-soda).
Oral sodium phosphate products often are recommended by physicians for bowel cleansing prior to a colonoscopy or other medical procedure.
The safety issues raised by the prescription and professional use of OSP for bowel cleansing has led the FDA to reconsider the appropriateness of bowel cleansing as an OTC indication. However, the agency planned to address the status of bowel cleansing as an OTC indication in a future Federal Register publication.
CRN hearts Vitamin Angels with $10,000 and counting
WASHINGTON — The Council for Responsible Nutrition on Wednesday announced a charity drive “tweet-a-thon” to be hosted at its Life…supplemented Twitter site, @wannabwell. The program’s “Spread the Love Tweet-a-thon” will take place Feb. 14 through 18 to raise money for Vitamin Angels, an organization dedicated to reducing child mortality worldwide by connecting infants and children younger than 5 years old with essential micronutrients.
Participants in the tweet-a-thon can ensure a donation in a number of ways, including:
By entering the “Life…supplemented” Wellness Challenge Sweepstakes by completing a My Wellness Scorecard and tweeting their personalized music video that follows participants’ scorecard results; and
By using the #3pillars hashtag on their tweets.
For every personalized music video posted to Twitter or tweet using the #3pillars hashtag, “Life…supplemented” will donate $5 to Vitamin Angels, up to a total of $5,000. Additionally, consumers will have the opportunity to double their donations by engaging in the tweet-a-thon during “Love Fest” hours — every day between noon and 2 p.m. — for $10 per tweet (following the same criteria listed above).
This is the second 2011 initiative that “Life…supplemented” has dedicated to raising money and awareness for Vitamin Angels. In early January, the campaign hosted a 60-minute live video stream with host Hungry Girl Lisa Lillien and wellness experts, registered dietitian Dave Grotto, licensed naturopathic doctor Duffy MacKay and certified personal trainer Andrea Metcalf. That event garnered more than 900 participants and raised $10,000 for the Vitamin Angels organization.
A month-long Facebook initiative also is being planned for March to raise additional funds for Vitamin Angels.
Metamucil unveils presentation on ways to lower cholesterol
CINCINNATI — Procter & Gamble on Tuesday unveiled its Metamucil presentation, "The Five Things Every American Needs to do to Lower Their Cholesterol."
The presentation is made by Michael Roizen, chairman of the Wellness Institute at Cleveland Clinic and host of an upcoming PBS series, "Younger You."
“I often see that people are not getting enough fiber in their daily diets. Most Americans only get 10 g to 15 g of fiber per day, versus the recommended 20 g to 35 g,” Roizen said. “That’s why one of my five tips is to supplement your diet with psyllium fiber, which is proven to help lower cholesterol.”
The five tips are: Take psyllium; wear a pedometer and increase daily activity; get an exercise buddy; beware of hidden fats and sugars in the diet; and supplement the diet with DHA, an omega-3 fatty acid found in fish oil supplements.
On Feb. 7, "The Dr. Oz Show" coupled "The Five Things” presentation with the announcement that consumers have an opportunity to win a “Heart-to-Heart” with Dr. Oz, courtesy of Metamucil, after registering at WinAHeartToHeart.com. The heart-to-heart is a lunch in New York with Dr. Oz. The winner also receives a three-day/two-night trip for two to New York, including round-trip airfare, hotel, airport transfers, meals, daily spending money and two tickets to "The Dr. Oz Show."