Posts Tagged ‘FDA’

Arsenic-based Animal Drugs and Poultry

Tuesday, June 9th, 2015

U.S. Food and Drug Administration — Arsenic is in the environment as a naturally occurring substance or as a contaminant and is found in water, air, soil, and food. Published scientific reports have indicated that organic arsenic, a less toxic form of arsenic and the form present in 3-Nitro® (roxarsone), an approved animal drug, could transform into inorganic arsenic. In response, scientists from the FDA’s Center for Veterinary Medicine and the Center for Food Safety and Applied Nutrition developed an analytical method capable of detecting very low levels of inorganic arsenic in edible tissue.

Using the new method, FDA scientists found that the levels of inorganic arsenic in the livers of chickens treated with 3-Nitro® were increased relative to levels in the livers of the untreated control chickens.

Alpharma, a subsidiary of Pfizer, Inc., decided to voluntarily suspend sale of 3-Nitro® and to facilitate an orderly process for suspending use of the product in the United States. Ownership of the veterinary drug subsequently changed to Zoetis, Inc., who continued the suspension from sale of 3- Nitro®. On February 27, 2014, Zoetis, Inc. voluntarily withdrew the new animal drug application for 3- Nitro®. On the same day, Zoetis, Inc. and Huvepharma AD voluntarily withdrew all new animal drug approvals and supplements for 3- Nitro®, as well as arsanilic acid and carbarsone (two other arsenical new animal drugs) for use in animal feed (including all combinations with other approved new animal drugs).

On April 1, 2015, Zoetis announced that it would discontinue marketing Histostat (nitarsone), the only remaining arsenic-based animal drug on the market, by Fall 2015, and would request withdrawal of the approval for the drug by the end of 2015. Histostat (nitarsone) is approved for the prevention of histomoniasis (blackhead disease) in turkeys and chickens, and is the only approved animal drug for this indication. Histomoniasis is a disease that occurs regionally and seasonally in turkeys, and causes significant mortality. Histostat (nitarsone) will cease to be available in the 2016 growing season.

Nutrition Facts Label

Monday, March 10th, 2014

A lot has changed in the American diet since the Nutrition Facts label was introduced in 1993 to provide important nutritional information on food packages.

People are eating larger serving sizes. Rates of obesity, heart disease and stroke remain high. More is known about the relationship between nutrients and the risk of chronic diseases.

So the Food and Drug Administration (FDA) proposes bringing this familiar rectangular box—which has become one of the most recognized graphics in the world—up to date with changes to its design and content.

“Obesity, heart disease and other chronic diseases are leading public health problems,” says Michael Landa, director of FDA’s Center for Food Safety and Applied Nutrition. “The proposed new label is intended to bring attention to calories and serving sizes, which are important in addressing these problems. Further, we are now proposing to require the listing of added sugars. The 2010 Dietary Guidelines for Americans recommends reducing calories from added sugars and solid fats.”

Jessica Leighton, Ph.D., senior nutrition science and policy advisor in FDA’s Office of Foods and Veterinary Medicine, and Claudine Kavanaugh, Ph.D., M.P.H., R.D., a health scientist at FDA, explain what you can expect to see if the proposed changes are enacted.

“The goal is to make people aware of what they are eating and give them the tools to make healthy dietary choices throughout the day,” says Leighton.

What’s Different? And Why?

  • The first thing consumers would notice is a greater emphasis—with larger and bolder type—on calories. “The number of calories is especially important to maintaining a healthy weight,” says Leighton.
  • For the first time, “Added Sugars” would be included on the label. On average, Americans eat 16 percent of their daily calories from sugars added during food production.
  • And the calories from fat would no longer be listed. “We know that the type of fat is more important than the total amount of fat,” says Kavanaugh. Total, saturated and trans fat will still be required.
  • The number of servings per package would also be more prominent. And “Amount Per Serving,” would now have the actual serving size listed, such as “Amount per cup.”
  • FDA proposes updating serving size requirements. These updates would reflect the reality of what people actually eat, according to recent food consumption data. By law, serving sizes must be based on what people actually eat, not on what they “should” be eating.
  • FDA would update Daily Values for various nutrients. Daily Values are used to calculate the Percent Daily Value (%DV) on the label, which helps consumers understand the nutrition information in the context of a total diet. In addition, the %DV would be shifted to the left of the label. FDA wants to help consumers visually and quickly put nutrient information in context.
  • The amounts of potassium and Vitamin D would be required on the label. Vitamin D is important for healthy bones, especially among women and the elderly. And potassium helps to lower blood pressure and prevent hypertension. “We have evidence that people are not consuming enough of these nutrients to protect against chronic diseases,” says Leighton.

 

What’s the Goal?

Both Leighton and Kavanaugh stress that the primary goal of the proposed changes to the Nutrition Facts label is not to tell people what they should be eating, but to expand and highlight the information they most need when making food choices. “It’s all about providing information that people can use to make their own choices.” Kavanaugh says.

For people with certain health issues, the information can be particularly valuable. “Although the label is made for the general population, many of us are at risk for cardiovascular disease, high blood pressure and stroke or simply want to eat fewer calories,” Kavanaugh says.

  • If you are concerned about high blood pressure and strokes, you may want to pay attention to sodium and potassium amounts on food labels.
  • For cardiovascular health, seek foods lower in saturated fats, cholesterol, trans fats and sodium.

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Thursday, February 11th, 2010

FDA NEWS RELEASE

For Immediate Release: Feb. 9, 2010
Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
Initiative to focus on 3 types of procedures with high radiation doses

The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S. population and use much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.

CT, nuclear medicine, and fluoroscopic imaging have led to early diagnosis of disease, improved treatment planning, and image-guided therapies that help save lives every day. The FDA continues to support a strong dialogue between patients and physicians over the medical necessity and risk associated with these types of imaging studies.

However, like all medical procedures, CT, nuclear medicine, and fluoroscopy pose risks. These types of imaging exams expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries, such as skin burns, hair loss and cataracts. Health care decisions made by patients and their physicians should include discussions of the medical need and associated risks for each procedure.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

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