Remove Artificial Trans-Fat from Processed Foods

Based on a thorough review of the scientific evidence, the U.S. Food and Drug Administration today finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products.

“The FDA’s action on this major source of artificial trans fat demonstrates the agency’s commitment to the heart health of all Americans,” said FDA’s Acting Commissioner Stephen Ostroff, M.D. “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.”

This determination will significantly reduce the use of PHOs, the major source of artificial trans fats, in the food supply. In 2013, the FDA made a tentative determination that PHOs could no longer be considered GRAS and is finalizing that determination after considering public comments.

Since 2006, manufacturers have been required to include trans fat content information on the Nutrition Facts label of foods. Between 2003 and 2012, the FDA estimates that consumer trans fat consumption decreased about 78 percent and that the labeling rule and industry reformulation of foods were key factors in informing healthier consumer choices and reducing trans fat in foods. While transfat intake has significantly decreased, the current intake remains a public health concern. The Institute of Medicine recommends that consumption of trans fat be as low as possible while consuming a nutritionally-adequate diet.

“Studies show that diet and nutrition play a key role in preventing chronic health problems, such as cardiovascular disease and today’s action goes hand in hand with other FDA initiatives to improve the health of Americans, including updating the nutrition facts label,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition. “This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period.”

The FDA has set a compliance period of three years. This will allow companies to either reformulate products without PHOs and/or petition the FDA to permit specific uses of PHOs. Following the compliance period, no PHOs can be added to human food unless they are otherwise approved by the FDA.

The FDA encourages consumers seeking to reduce trans fat intake to check a food’s ingredient list for partially hydrogenated oils to determine whether or not a product contains PHOs. Currently, foods are allowed to be labeled as having “0” grams trans fat if they contain less than 0.5 grams of trans fat per serving, including PHOs, the primary dietary source of artificial trans fat in processed foods.

Many companies have already been working to remove PHOs from processed foods and the FDA anticipates that many may eliminate them ahead of the three-year compliance date.

 

Modernizing the Food Safety System.

The U.S. Food and Drug Administration (FDA) today took one of the most significant steps in decades to prevent foodborne illness by finalizing the first two of seven major rules under the bipartisan FDA Food Safety Modernization Act (FSMA).

Today’s action is the first step in putting greater emphasis on the prevention of foodborne illness, holding imported food to the same food safety standard as domestically produced food, and developing a nationally integrated food safety system in partnership with state and local authorities.

An estimated 48 million people (1 in 6 Americans) get sick each year from foodborne diseases, according to recent data from the U.S. Centers for Disease Control and Prevention. Approximately 128,000 are hospitalized, and 3,000 die each year. Over the past few years, high-profile outbreaks related to various foods, from spinach to peanut products, have underscored the need to make continuous improvements in food safety.

“Today’s announcement sets us on the path to a modern food safety system that will prevent illnesses and continue to build confidence in the safety of the food served to our families every day,” said Dr. Stephen Ostroff, acting FDA commissioner.

The two rules finalized today, the preventive controls rules, focus on implementing modern food manufacturing processes for both human and animal foods.  Today’s announcement will ensure that food companies are taking action and working with the FDA to prevent hazards to customers on the front end, rather than waiting to act until an outbreak has occurred.

The preventive controls rules require human and animal food facilities to develop and implement written food safety plans that indicate the possible problems that could affect the safety of their products and outline steps the facility would take to prevent or significantly minimize the likelihood of those problems occurring. This means that food companies will be accountable for monitoring their facilities and identifying any potential hazards in their products and prevent those hazards.  Under these rules, the FDA will be able to assess these systems and their outcomes to prevent problems, will better be able to respond when food safety problems occur, and better protect the safety of manufactured food.

The preventive controls final rules announced today are the result of an extensive outreach effort, and incorporate thousands of public comments, including valuable input from farmers, consumers, the food industry and academic experts, to create a flexible and targeted approach to ensuring food safety.

“We’ve been working with states, food companies, farmers and consumers to create smart, practical and meaningful rules,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine, FDA. “And we have made a firm commitment to provide guidance, technical assistance and training to advance a food safety culture that puts prevention first.”

Once the seven FSMA rules are finalized in 2016, they will work together to systematically strengthen the food safety system and better protect public health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety and effectiveness of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.

New grants to boost the development of products for patients with rare diseases

The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical sites domestically and internationally.

» Read more

Federal judge enters permanent injunction against Wisconsin dietary supplement manufacturers

Three dietary supplement companies, under the same ownership and located in Wautoma, Wisconsin, will not be allowed to manufacture or sell dietary supplement products until FDA has determined that the businesses are in compliance with federal manufacturing regulations and other requirements, according to a federal court order signed Aug. 4, 2015.

» Read more

FDA Grants Breakthrough Therapy Designation to Bristol-Myers Squibb’s HIV Candidate

Bristol-Myers Company today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients.

» Read more

Pfizer’s Rapamune Receives FDA Approval for Treatment of Rare Lung Disease

Pfizer_Logo.svg

Today, Pfizer Inc. announced that US health regulators approved the first drug to treat a rare, progressive lung disease.

The company said that the US Food and Drug Administration (FDA) approved its Rapamune (sirolimus) for the treatment of lymphangioleiomyomatosis (LAM), a rare, progressive disease that affects the lungs, kidneys and the lymphatic system.

» Read more

FDA approves targeted therapy for first-line treatment of patients with a type of metastatic lung cancer

800px-FDA-Logo

The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.

» Read more

Breakthrough : New drug to tackle Heart Failure

Heart failure is a common condition affecting around 5.1 million people in the United States. It is a condition in which the heart can’t pump enough blood to meet the body’s needs. Heart failure generally worsens over time as the heart’s pumping action grows weaker. The leading causes of heart failure are diseases that damage the heart, such as heart attacks and high blood pressure.

» Read more