Tag Archives: FDA

FDA looking at serving size

New York Times reporter William Neuman in the article “FDA weighs update to standard serving sizes” writes that the FDA wants to encourage manufacturers to post vital nutritional information, including calorie counts, on the front of food packages.

FDA Seeks to Transform Food Safety System, Invest in Medical Product Safety, Regulatory Science

The U.S. Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President’s fiscal year 2011 budget – a 23 percent increase over the agency’s current $3.28 billion budget.

The FY 2011 request includes increases of $146 million in budget authority and $601 million in industry user fees.

“The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day,” said FDA Commissioner Margaret Hamburg. “This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences.”

The budget request reflects the FDA’s resolve to transform food safety practices, improve medical product safety, protect patients and modernize FDA regulatory science to advance public health. Funding in the FY 2011 request also supports new regulatory authority to regulate cigarettes and other tobacco products received in June 2009. The proposed budget includes support for the FDA’s investment in addressing the challenges of the 21st century. The FDA envisions a transformed U.S. food safety system that focuses on prevention, increased efforts to address medical product safety challenges and a focus on modernizing regulatory science at the FDA.

One of the four initiatives highlighted in the FY2011 budget increase is a $318 million request for Transforming Food Safety. This initiative reflects President Obama’s vision of a new food safety system to protect the American public. The FDA will set standards for safety, expand laboratory capacity, pilot track and trace technology, strengthen its import safety program, improve data collection and risk analysis and begin to establish an integrated national food safety system with strengthened inspection and response capacity.

You can read more about the proposal here.

Obama 2011 budget request: Food and Drug Administration – Washington Post

FDA Unveils First Phase of Transparency Initiative

The U.S. Food and Drug Administration has unveiled the first phase of its Transparency Initiative which is designed to explain agency operations, how it makes decisions, and the drug approval process.

During an online presentation, the chair of the FDA’s Transparency Task Force, Principal Deputy FDA Commissioner Joshua Sharfstein, described a Web-based curriculum called “FDA Basics,” aimed at helping the public better understand what the agency does. The curriculum is accessible via a link on the FDA Web site.

The curriculum includes:

  • Questions and answers about the agency and the products it regulates
  • Short videos that explain various agency activities
  • Conversations with agency personnel about the work of their office

In addition, senior officials from FDA product centers and offices will answer questions on various topics during future online sessions. Each of these sessions will be announced on the FDA Web site.

In one of her first acts after assuming the office last spring, FDA Commissioner Margaret A. Hamburg, M.D. announced the formation of an internal task force to develop recommendations for enhancing the transparency of the FDA’s operations and decision-making processes.

“The launch of FDA Basicsis our first step towards making FDA a more transparent agency,” said Dr. Sharfstein.

In recent months, the Task Force solicited public input on improving agency transparency through a public docket, an online blog, and two public meetings. The Transparency Task Force received hundreds of comments from various stakeholders, including regulated industry, consumers, patients, health care providers, and others. As a result of comments from the public, the Task Force decided to develop its recommendations in three phases. FDA Basics represents the result of the initial phase, to be followed by two additional phases.

In phase two of the initiative, the Task Force intends to make recommendations to the Commissioner regarding how to make information about agency activities more transparent, useful, and understandable to the public, in a manner compatible with the agency’s goal of protecting confidential information, as appropriate.

In the final phase of the initiative, the Task Force intends to make recommendations to the Commissioner regarding FDA’s transparency to regulated industries.

FDA Issues 2009 FDA Food Code

The Food and Drug Administration has published the new FDA Food Code, a model code and reference document that provides a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry. The 2009 FDA Food Code is a key component of the President’s overall public-health-focused food safety framework for maintaining a safe food supply.

State, city, county, tribal, and territorial agencies regulate more than 1 million restaurants, retail food stores, and vending and food service operations in institutions such as schools, hospitals, nursing homes, and child care centers. The model FDA Food Code provides the basis for most of those agencies’ licensing, inspection, and enforcement activities, as well as serves as a model for their food statutes, regulations, and ordinances.

Release of the FDA Food Code provides all levels of government with practical, science-based guidance and manageable, enforceable provisions for mitigating known risks of foodborne illness. The FDA Food Code also serves as a reference document for the retail food industry.

“The FDA is spearheading an important initiative to improve the nation’s food safety system by establishing a fully integrated national system with federal, state, local, tribal, and territorial regulatory agencies,” said Dr. Stephen Sundlof, director of FDA’s Center for Food Safety and Applied Nutrition. “Food Code adoption and implementation in all jurisdictions are important for achieving uniform national food safety standards and for enhancing the efficiency and effectiveness of our nation’s food safety system.”

The 2009 edition of the Food Code is the seventh full edition published by the FDA. The previous full edition was released in 2005 with a supplement published in 2007.

 

FDA To Look Into Safety of Caffeinated Alcoholic Beverages

The Food and Drug Administration today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.

Of the combined use of caffeine and alcohol among U.S. college students in the few studies on this topic, the prevalence was as high as 26 percent.

Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS).    FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS.  For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.

The FDA alerted manufacturers to the fact that the agency is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned.  To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million.  It has not approved caffeine for use at any level in alcoholic beverages.

Senate food safety bill discussed

Agweek reporter Jerry Hagstrom in the article “Senate moves food safety bill forward” writes that the U.S. Food and Drug Administration food safety bill sponsored by Senate Majority Whip Dick Durbin, D-Ill., finally moved forward Oct. 22 with a hearing in the Senate, while a key food lobbyist predicted President Obama would sign a food safety bill in early 2010.

Commissioner Hamburg talks food safety with Senate committee

Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. spoke before the U.S. Senate Committee on Health, Education, Labor, and Pensions about food safety today.

Here is her testimony.